Informed consent in neurosurgery--translating ethical theory into action.

Science.gov (United States)

Schmitz, Dagmar; Reinacher, Peter C

2006-09-01

Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

Informed consent in neurosurgery—translating ethical theory into action

Science.gov (United States)

Schmitz, Dagmar; Reinacher, Peter C

2006-01-01

Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Science.gov (United States)

2010-06-30

... FEDERAL TRADE COMMISSION [File No. 092 3093] Twitter, Inc.; Analysis of Proposed Consent Order to... in paper form. Comments should refer to``Twitter, Inc., File No. 092 3093'' to facilitate the... weblink: ( http://public.commentworks.com/ftc/twitter ) and following the instructions on the web-based...

Should informed consent be based on rational beliefs?

Science.gov (United States)

Savulescu, J; Momeyer, R W

1997-10-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement and Testing Consent Order

Science.gov (United States)

EPA has issued an enforceable consent agreement (ECA) with The Dow Chemical Company; Vulcan Materials Company; Occidental Chemical Corp; Oxy Vinyls, LP; Georgia Gulf Corp; Westlake Chemical Corp; PPG, Borden Chemicals & Plastics, and Formosa Plastics.

77 FR 52322 - McClellan Air Force Base Superfund Site Proposed Notice of Administrative Order on Consent

Science.gov (United States)

2012-08-29

... limited liability company. The proposed administrative order on consent concerns cleanup of portions of...; request for public comment. SUMMARY: Notice is hereby given that a proposed administrative order on... of Suitability for Early Transfer (``FOSET''), which has been subject to a public comment period. The...

76 FR 70722 - Healthcare Technology Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Orders To...

Science.gov (United States)

2011-11-15

... FEDERAL TRADE COMMISSION [File No. 111 0097] Healthcare Technology Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid Public Comment Correction In notice document 2011-28497 appearing on pages 68189-68191 in the issue of Thursday, November 3, 2011, make the following corrections: 1...

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Science.gov (United States)

2010-07-01

... section sets forth a list of substances and mixtures which are the subject of testing consent orders... the substances and mixtures which are the subject of these orders and the Federal Register citations... Crotonaldehyde Environmental effects November 9, 1989. Chemical fate November 9, 1989. 4675-54-3 Bisphenol A...

76 FR 62066 - Phusion Projects, LLC, et al.; Analysis of Proposed Consent Order To Aid Public Comment

Science.gov (United States)

2011-10-06

..., including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm . Analysis of Agreement Containing Consent Order To Aid Public Comment The Federal... servings of alcohol in the container. Part II of the proposed order further prohibits, commencing six (6...

First order actions for gravitational systems, strings and membranes

International Nuclear Information System (INIS)

Lindstrom, U.

1988-01-01

The authors discuss first order actions in general and the construction of first order actions by eliminating Lagrange multipliers in particular. A number of first order actions for gravitational theories are presented. Part of the article reviews first order actions, some of them well-known and some lesser known. New examples of first order actions include Weyl-invariant actions for membranes, with and without rigidity terms, as well as for Abelian and non-Abelian Born-Infeld actions in two dimensions

19 CFR 210.75 - Proceedings to enforce exclusion orders, cease and desist orders, consent orders, and other...

Science.gov (United States)

2010-04-01

... STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND... the unfair practices that were originally the basis for issuing such order; (ii) Bring civil actions...

77 FR 52021 - Proposed CERCLA Administrative Settlement Agreement and Order on Consent for the Mercury Refining...

Science.gov (United States)

2012-08-28

... and Order on Consent for the Mercury Refining Superfund Site, Towns of Guilderland and Colonie, Albany... Solutions Services, Inc., Scientific Ecology Group, Inc., Genesys Regional Medical Center, Ingot Metal... Management of Michigan, Inc. (hereafter ``Settling Parties'') pertaining to the Mercury Refining Superfund...

77 FR 14523 - Western Digital Corporation; Analysis of Agreement Containing Consent Order to Aid Public Comment

Science.gov (United States)

2012-03-12

... purchases from several suppliers simultaneously in order to obtain competitive pricing and adequate supply... to coordinate on pricing or output. In addition, HDD customers generally wish to have at least three... Consent Agreement resolves the competitive concerns raised by Western Digital's proposed acquisition of...

78 FR 40140 - Proposed CERCLA Administrative Settlement Agreement and Order on Consent for the Mercury Refining...

Science.gov (United States)

2013-07-03

... and Order on Consent for the Mercury Refining Superfund Site, Towns of Guilderland and Colonie, Albany...'') pertaining to the Mercury Refining Superfund Site (``Site'') located in the Towns of Guilderland and Colonie...-1866. Comments should be sent to the individual identified below and should reference the Mercury...

Corrective Action Plan for Corrective Action Unit 151: Septic Systems and Discharge Area, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

NSTec Environmental Restoration

2007-01-01

Corrective Action Unit (CAU) 151, Septic Systems and Discharge Area, is listed in the Federal Facility Agreement and Consent Order (FFACO) of 1996 (FFACO, 1996). CAU 151 consists of eight Corrective Action Sites (CASs) located in Areas 2, 12, and 18 of the Nevada Test Site (NTS), which is located approximately 65 miles northwest of Las Vegas, Nevada

What is presumed when we presume consent?

Directory of Open Access Journals (Sweden)

Pierscionek Barbara K

2008-04-01

Full Text Available Abstract Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable

Law & Order, CSI, and NCIS: The Association Between Exposure to Crime Drama Franchises, Rape Myth Acceptance, and Sexual Consent Negotiation Among College Students.

Science.gov (United States)

Hust, Stacey J T; Marett, Emily Garrigues; Lei, Ming; Ren, Chunbo; Ran, Weina

2015-01-01

Previous research has identified that exposure to the crime drama genre lowers rape myth acceptance and increases sexual assault prevention behaviors such as bystander intervention. However, recent content analyses have revealed marked differences in the portrayal of sexual violence within the top three crime drama franchises. Using a survey of 313 college freshmen, this study explores the influence of exposure to the three most popular crime drama franchises: Law & Order, CSI, and NCIS. Findings indicate that exposure to the Law & Order franchise is associated with decreased rape myth acceptance and increased intentions to adhere to expressions of sexual consent and refuse unwanted sexual activity; whereas exposure to the CSI franchise is associated with decreased intentions to seek consent and decreased intentions to adhere to expressions of sexual consent. Exposure to the NCIS franchise was associated with decreased intentions to refuse unwanted sexual activity. These results indicate that exposure to the specific content of each crime drama franchise may have differential results on sexual consent negotiation behaviors.

76 FR 2908 - Nonprofit Management LLC and Jeremy Ryan Claeys; Analysis of Proposed Consent Order To Aid Public...

Science.gov (United States)

2011-01-18

... furnishing businesses with the certification and the tools to advertise it, respondents provided such... doing business as Tested Green (``respondents''). The proposed consent order has been placed on the... involves the advertising, marketing, and sale of environmental certifications. From approximately February...

Royal Wine Corporation d/b/a/ Royal Kedem (Herzog Wine Cellars), Oxnard, CA; Consent Agreement and Final Order

Science.gov (United States)

Consent Agreement and Final Order (Proposed CA/FO), between the U.S. Environmental Protection Agency, Region 9 (EPA or Complainant), and Royal Wine Corporation, d/b/a Royal Kedem (Herzog Wine Cellars or Respondent). Docket Number CWA-09-2018-0004.

78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

Science.gov (United States)

2013-12-20

... Consent Order also requires firewalls to prevent information from a space vehicle provider being shared by ULA with its Boeing or LMC parent company. Similarly, Boeing and LMC must have firewalls to ensure...

16 CFR 1605.13 - Procedures for Consent Order Agreements.

Science.gov (United States)

2010-01-01

... executed by a person, sole proprietorship, partnership, or corporation (Consenting Party) and a Commission... staff, with the approval of the Commission may propose to the person, sole proprietorship, partnership..., sole proprietorship, partnership, or corporation. (c) Upon receiving an executed agreement, the...

78 FR 46949 - Essentia Natural Memory Foam Company, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Science.gov (United States)

2013-08-02

... representations that a memory foam mattress lacks the common smell associated with memory foam to mean that the... FEDERAL TRADE COMMISSION [File No. 122 3130] Essentia Natural Memory Foam Company, Inc.; Analysis... containing a consent order from Essentia Natural Memory Foam Company, Inc., a corporation (``respondent...

41 CFR 60-30.13 - Consent findings and order.

Science.gov (United States)

2010-07-01

... Administrative Law Judge after consideration of the nature of the proceeding, the requirments of the public... to the Administrative Law Judge for his consideration; (2) Inform the Administrative Law Judge that... 41 Public Contracts and Property Management 1 2010-07-01 2010-07-01 true Consent findings and...

Corrective Action Investigation Plan for Corrective Action Unit 545: Dumps, Waste Disposal Sites, and Buried Radioactive Materials Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Alfred Wickline

2007-01-01

Corrective Action Unit 545, Dumps, Waste Disposal Sites, and Buried Radioactive Materials, consists of seven inactive sites located in the Yucca Flat area and one inactive site in the Pahute Mesa area. The eight CAU 545 sites consist of craters used for mud disposal, surface or buried waste disposed within craters or potential crater areas, and sites where surface or buried waste was disposed. The CAU 545 sites were used to support nuclear testing conducted in the Yucca Flat area during the 1950s through the early 1990s, and in Area 20 in the mid-1970s. This Corrective Action Investigation Plan has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Under the Federal Facility Agreement and Consent Order, this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Fieldwork will be conducted following approval

Corrective Action Investigation Plan for Corrective Action Unit 232: Area 25 Sewage Lagoons, Nevada Test Site, Nevada, Revision 0

International Nuclear Information System (INIS)

1999-01-01

The Corrective Action Investigation Plan for Corrective Action Unit 232, Area 25 Sewage Lagoons, has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the U.S. Department of Energy, Nevada Operations Office; the State of Nevada Division of Environmental Protection; and the U. S. Department of Defense. Corrective Action Unit 232 consists of Corrective Action Site 25-03-01, Sewage Lagoon. Corrective Action Unit 232, Area 25 Sewage Lagoons, received sanitary effluent from four buildings within the Test Cell ''C'' Facility from the mid-1960s through approximately 1996. The Test Cell ''C'' Facility was used to develop nuclear propulsion technology by conducting nuclear test reactor studies. Based on the site history collected to support the Data Quality Objectives process, contaminants of potential concern include volatile organic compounds, semivolatile organic compounds, Resource Conservation and Recovery Act metals, petroleum hydrocarbons, polychlorinated biphenyls, pesticides, herbicides, gamma emitting radionuclides, isotopic plutonium, isotopic uranium, and strontium-90. A detailed conceptual site model is presented in Section 3.0 and Appendix A of this Corrective Action Investigation Plan. The conceptual model serves as the basis for the sampling strategy. Under the Federal Facility Agreement and Consent Order, the Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Field work will be conducted following approval of the plan. The results of the field investigation will support a defensible evaluation of corrective action alternatives in the Corrective Action Decision Document

Corrective Action Investigation Plan for Corrective Action Unit 232: Area 25 Sewage Lagoons, Nevada Test Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

USDOE/NV

1999-05-01

The Corrective Action Investigation Plan for Corrective Action Unit 232, Area 25 Sewage Lagoons, has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the U.S. Department of Energy, Nevada Operations Office; the State of Nevada Division of Environmental Protection; and the U. S. Department of Defense. Corrective Action Unit 232 consists of Corrective Action Site 25-03-01, Sewage Lagoon. Corrective Action Unit 232, Area 25 Sewage Lagoons, received sanitary effluent from four buildings within the Test Cell ''C'' Facility from the mid-1960s through approximately 1996. The Test Cell ''C'' Facility was used to develop nuclear propulsion technology by conducting nuclear test reactor studies. Based on the site history collected to support the Data Quality Objectives process, contaminants of potential concern include volatile organic compounds, semivolatile organic compounds, Resource Conservation and Recovery Act metals, petroleum hydrocarbons, polychlorinated biphenyls, pesticides, herbicides, gamma emitting radionuclides, isotopic plutonium, isotopic uranium, and strontium-90. A detailed conceptual site model is presented in Section 3.0 and Appendix A of this Corrective Action Investigation Plan. The conceptual model serves as the basis for the sampling strategy. Under the Federal Facility Agreement and Consent Order, the Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Field work will be conducted following approval of the plan. The results of the field investigation will support a defensible evaluation of corrective action alternatives in the Corrective Action Decision Document.

Hanford Federal Facility Agreement and Consent Order, quarterly progress report, March 31, 1992

International Nuclear Information System (INIS)

1992-05-01

This is the twelfth quarterly report as required by the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) (Ecology et al. 1990), established between the US Department of Energy (DOE), the US Environmental Protection Agency (EPA), and the Washington State Department of Ecology (Ecology). The Tri-Party Agreement sets the plan and schedule for achieving regulatory compliance and cleanup of waste sites at the Hanford Site. This report covers progress for the quarter that ended March 31, 1992. Topics covered under technical status include: disposal of tank wastes; cleanup of past-practice units; permitting and closure of treatment, storage, and disposal units; and other tri-party agreement activities and issues

Corrective Action Plan for Corrective Action Unit 490: Station 44 Burn Area, Tonopah Test Range, Nevada

Energy Technology Data Exchange (ETDEWEB)

K. B. Campbell

2002-04-01

Corrective Action Unit (CAU) 490, Station 44 Burn Area is located on the Tonopah Test Range (TTR). CAU 490 is listed in the Federal Facility Agreement and Consent Order (FFACO, 1996) and includes for Corrective Action Sites (CASs): (1) Fire Training Area (CAS 03-56-001-03BA); (2) Station 44 Burn Area (CAS RG-56-001-RGBA); (3) Sandia Service Yard (CAS 03-58-001-03FN); and (4) Gun Propellant Burn Area (CAS 09-54-001-09L2).

76 FR 81929 - San Fernando Valley Area 2; Notice of Proposed Administrative Order on Consent Re: 4057 and 4059...

Science.gov (United States)

2011-12-29

... the Trust on ability to pay grounds. Under the Agreement, the Trust will pay $1500 (one thousand five... notice of a proposed administrative order on consent (Agreement)with the Spirito Family Trust and Alice C...: EPA will receive written comments relating to the settlement until January 30, 2012. EPA will consider...

Corrective Action Decision Document/Closure Report for Corrective Action Unit 477: Area 12 N-Tunnel Muckpile, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 477, N-Tunnel Muckpile. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 477 is comprised of one Corrective Action Site (CAS): • 12-06-03, Muckpile The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure with no further action, by placing use restrictions on CAU 477.

Environmental restoration remedial action quality assurance requirements document

International Nuclear Information System (INIS)

Cote, R.F.

1991-01-01

The environmental Restoration Remedial Action Quality Assurance Requirements Document (DOE/RL 90-28) defines the quality assurance program requirements for the US Department of Energy-Richland Field Office Environmental Restoration Remedial Action Program at the Hanford Site, Richland, Washington. This paper describes the objectives outlined in DOE/RL 90-28. The Environmental Restoration Remedial Action Program implements significant commitments made by the US Department of Energy in the Hanford Federal Facility Agreement and Consent Order entered into with the Washington State Department of Ecology and the US Environmental Protection Agency

No Understanding, No Consent: The Case Against Alternative Medicine.

Science.gov (United States)

Shahvisi, Arianne

2016-02-01

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 476: Area 12 T-Tunnel Muckpile, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 476, Area 12 T-Tunnel Muckpile. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 476 is comprised of one Corrective Action Site (CAS): • 12-06-02, Muckpile The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with use restrictions for CAU 476.

77 FR 64519 - Magnesium Elektron; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Science.gov (United States)

2012-10-22

... (``Consent Agreement'') from Magnesium Elektron North America, Inc. (``MEL'') to remedy the anticompetitive effects stemming from MEL's acquisition of Revere Graphics Worldwide, Inc. (``Revere''). Under the terms of the proposed Consent Agreement, MEL is required to sell assets used in the development...

Click here to consent forever: Expiry dates for informed consent

Directory of Open Access Journals (Sweden)

Bart Custers

2016-01-01

Full Text Available The legal basis for processing personal data and some other types of Big Data is often the informed consent of the data subject involved. Many data controllers, such as social network sites, offer terms and conditions, privacy policies or similar documents to which a user can consent when registering as a user. There are many issues with such informed consent: people get too many consent requests to read everything, policy documents are often very long and difficult to understand and users feel they do not have a real choice anyway. Furthermore, in the context of Big Data refusing consent may not prevent predicting missing data. Finally, consent is usually asked for when registering, but rarely is consent renewed. As a result, consenting once often implies consent forever. At the same time, given the rapid changes in Big Data and data analysis, consent may easily get outdated (when earlier consent no longer reflects a user’s preferences. This paper suggests expiry dates for consent, not to settle questions, but to put them on the table as a start for further discussion on this topic. Although such expiry dates may not solve all the issues of informed consent, they may be a useful tool in some situations.

IMPLEMENTASI PERSETUJUAN TINDAKAN KEDOKTERAN (INFORMED CONSENT DALAM PERJANJIAN TERAPEUTIK OLEH TENAGA KESEHATAN TERHADAP PASIEN RUMAH SAKIT DI PROVINSI BALI

Directory of Open Access Journals (Sweden)

Ida Ayu Sri Kusuma Wardhani

2014-03-01

Full Text Available Health is the most important part of human life that can affect productivity and optimal human activity. When a person's health is compromised, then that person will seek treatment in health care facilities in the hospital one of them in order to get action. Measures of medicine containing the high risk should get written consent from patient/family called Informed Consent. The legal relationship between health professionals with patients occurs because of the agreement that causes the therapeutic relationship inspaningverbintenis law (treaty effort. Similarly in the Bali Provincial Hospital in any medical act especially those containing a high risk, which is done by some health professionals are also using the Informed Consent. But if there is negligence actions that cause harm, who will be responsible for the risks in the suffering patient / family? and how the efforts of patient / family to resolve medical disputes against the risk of Informed Consent? The method used in this research is an empirical law derived from primary data and secondary data. The nature of the study is descriptive, with qualitative data analysis. Overall the results of these analyzes are presented in the description which describes the complete problem under study, along with a critical discussion. Based on the Theory of Legal System of L. M. Friedman, legal systems theory described by Soerjono Soekanto be legal efficacy theory, the theory of Hans Kelsen responsibility, and legislation as well as the results of research in the field, it is known that the liability of health professionals based on Informed Consent Agreement Therapeutic Hospital in Bali province is on the doctor who signed the operator of the informed consent form. However, if the patient / family prosecute acts of negligence committed by health professionals, the hospital will be responsible jointly and severally against such negligence. From the result of  research in the hospital in the province of

Corrective Action Decision Document/Closure Report for Corrective Action Unit 478: Area 12 T-Tunnel Ponds, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 478, Area 12 T-Tunnel Ponds. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 478 is comprised of one corrective action site (CAS): • 12-23-01, Ponds (5) RAD Area The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with use restrictions for CAU 478.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 559: T Tunnel Compressor/Blower Pad, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 559, T-Tunnel Compressor/Blower Pad. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 559 is comprised of one Corrective Action Site (CAS): • 12-25-13, Oil Stained Soil and Concrete The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with use restrictions for CAU 559.

Preferential semantics for action specification in first-order modal action logic

NARCIS (Netherlands)

Broersen, Jan; Wieringa, Roelf J.

In this paper we investigate preferential semantics for declarative specifications in a First Order Modal Action Logic. We address some well known problems: the frame problem, the qualification problem and the ramification problem. We incorporate the assumptions that are inherent to both the frame

Access to special care dentistry, part 3. Consent and capacity.

Science.gov (United States)

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

Covariant effective action for loop quantum cosmology from order reduction

International Nuclear Information System (INIS)

Sotiriou, Thomas P.

2009-01-01

Loop quantum cosmology (LQC) seems to be predicting modified effective Friedmann equations without extra degrees of freedom. A puzzle arises if one decides to seek for a covariant effective action which would lead to the given Friedmann equation: The Einstein-Hilbert action is the only action that leads to second order field equations and, hence, there exists no covariant action which, under metric variation, leads to a modified Friedmann equation without extra degrees of freedom. It is shown that, at least for isotropic models in LQC, this issue is naturally resolved and a covariant effective action can be found if one considers higher order theories of gravity but faithfully follows effective field theory techniques. However, our analysis also raises doubts on whether a covariant description without background structures can be found for anisotropic models.

"Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

Science.gov (United States)

Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

2016-01-01

This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

From Informed Consent to Negotiated Consent.

Science.gov (United States)

Moody, Harry R.

1988-01-01

Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from…

Corrective Action Decision Document/Closure Report for Corrective Action Unit 570: Area 9 Yucca Flat Atmospheric Test Sites, Nevada National Security Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Matthews, Patrick [Navarro-Intera, LLC (N-I), Las Vegas, NV (United States)

2013-11-01

This Corrective Action Decision Document/Closure Report presents information supporting the closure of Corrective Action Unit (CAU) 570: Area 9 Yucca Flat Atmospheric Test Sites, Nevada National Security Site, Nevada. This complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. The purpose of the CADD/CR is to provide justification and documentation supporting the recommendation that no further corrective action is needed.

Housekeeping category corrective action unit work plan

International Nuclear Information System (INIS)

1996-08-01

The purpose of this Corrective Action Unit (CAU) Work Plan is to provide a strategy to be used by the US Department of Energy Nevada Operations Office (DOE/NV), the US Department of Defense (DoD) Defense Special Weapons Agency (DSWA) (formerly the Defense Nuclear Agency), and contractor personnel for conducting corrective actions at the Nevada Test Site (NTS) and Nevada off-site locations including the Tonopah Test Range (TTR), the Project Shoal Area, and the Central Nevada Test Area. This Work Plan applies to housekeeping category CAUs already listed in the Federal Facility Agreement and Consent Order (FFACO) Appendices (FFACO, 1996) as well as newly identified Corrective Action Sites (CASs) that will follow the housekeeping process

HWMA/RCRA Closure Plan for the Fluorinel Dissolution Process Makeup and Cooling and Heating Systems Voluntary Consent Order SITE-TANK-005 Action Plan Tank Systems INTEC-066, INTEC-067, INTEC-068, and INTEC-072

International Nuclear Information System (INIS)

M.E. Davis

2007-01-01

This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the fluorinel dissolution process makeup and cooling and heating systems located in the Fluorinel Dissolution Process and Fuel Storage Facility (CPP-666), Idaho Nuclear Technology and Engineering Center, Idaho National Laboratory Site, was developed to meet milestones established under the Voluntary Consent Order. The systems to be closed include waste piping associated with the fluorinel dissolution process makeup systems. This closure plan presents the closure performance standards and methods of achieving those standards

HWMA/RCRA Closure Plan for the Fluorinel Dissolution Process Makeup and Cooling and Heating Systems Voluntary Consent Order SITE-TANK-005 Action Plan Tank Systems INTEC-066, INTEC-067, INTEC-068, and INTEC-072

Energy Technology Data Exchange (ETDEWEB)

M.E. Davis

2007-05-01

This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the fluorinel dissolution process makeup and cooling and heating systems located in the Fluorinel Dissolution Process and Fuel Storage Facility (CPP-666), Idaho Nuclear Technology and Engineering Center, Idaho National Laboratory Site, was developed to meet milestones established under the Voluntary Consent Order. The systems to be closed include waste piping associated with the fluorinel dissolution process makeup systems. This closure plan presents the closure performance standards and methods of achieving those standards.

Interactive informed consent: randomized comparison with paper consents.

Directory of Open Access Journals (Sweden)

Michael C Rowbotham

Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

Informed consent and the readability of the written consent form.

Science.gov (United States)

Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

2017-11-01

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 370: T-4 Atmospheric Test Site, Nevada Test Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Patrick Matthews

2009-05-01

This Corrective Action Decision Document/Closure Report has been prepared for Corrective Action Unit (CAU) 370, T-4 Atmospheric Test Site, located in Area 4 at the Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order (FFACO). Corrective Action Unit 370 is comprised of Corrective Action Site (CAS) 04-23-01, Atmospheric Test Site T-4. The purpose of this Corrective Action Decision Document/Closure Report is to provide justification and documentation supporting the recommendation that no further corrective action is needed for CAU 370 due to the implementation of the corrective action of closure in place with administrative controls. To achieve this, corrective action investigation (CAI) activities were performed from June 25, 2008, through April 2, 2009, as set forth in the Corrective Action Investigation Plan for Corrective Action Unit 370: T-4 Atmospheric Test Site and Record of Technical Change No. 1.

Consolidated Quarterly Report: Number of potential release sites subject to corrective action

Energy Technology Data Exchange (ETDEWEB)

Cochran, John R.; Cochran, John R.

2017-04-01

This Sandia National Laboratories, New Mexico Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) fulfills all quarterly reporting requirements set forth in the Resource Conservation and Recovery Act Facility Operating Permit and the Compliance Order on Consent. The 12 sites in the corrective action process are listed in Table I-1.

Informed Consent and Capacity to Give Consent in Mental Disorders

Directory of Open Access Journals (Sweden)

Zeynep Mackali

2014-09-01

Full Text Available Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2014; 6(3.000: 227-242

Closure Report for Corrective Action Unit 134: Aboveground Storage Tanks, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2009-01-01

Corrective Action Unit (CAU) 134 is identified in the Federal Facility Agreement and Consent Order (FFACO) as 'Aboveground Storage Tanks' and consists of the following four Corrective Action Sites (CASs), located in Areas 3, 15, and 29 of the Nevada Test Site: (1) CAS 03-01-03, Aboveground Storage Tank; (2) CAS 03-01-04, Tank; (3) CAS 15-01-05, Aboveground Storage Tank; and (4) CAS 29-01-01, Hydrocarbon Stain

Anonymity and informed consent in artificial procreation: a report from Denmark

DEFF Research Database (Denmark)

Lebech, Anne Mette

1997-01-01

a problem concerning its application when dealing with people having a serious mental, social or even physical disability. Within the field of artificial procreation there are even more problems. Informed written consent is often demanded from anonymous donors of gametes in order to ensure their consent...

Should informed consent be based on rational beliefs?

OpenAIRE

Savulescu, J; Momeyer, R W

1997-01-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide ...

Informed consent in paediatric critical care research--a South African perspective.

Science.gov (United States)

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

Informed consent: using a structured interview changes patients' attitudes towards informed consent.

Science.gov (United States)

Dawes, P J; O'Keefe, L; Adcock, S

1993-09-01

Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

Closure Report for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2010-01-01

Corrective Action Unit (CAU) 563 is identified in the Federal Facility Agreement and Consent Order (FFACO) as 'Septic Systems' and consists of the following four Corrective Action Sites (CASs), located in Areas 3 and 12 of the Nevada Test Site: (1) CAS 03-04-02, Area 3 Subdock Septic Tank; (2) CAS 03-59-05, Area 3 Subdock Cesspool; (3) CAS 12-59-01, Drilling/Welding Shop Septic Tanks; and (4) CAS 12-60-01, Drilling/Welding Shop Outfalls Closure activities were conducted from September to November 2009 in accordance with the FFACO (1996, as amended February 2008) and the Corrective Action Plan for CAU 563. The corrective action alternatives included No Further Action and Clean Closure.

Closure Report for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-02-28

Corrective Action Unit (CAU) 563 is identified in the Federal Facility Agreement and Consent Order (FFACO) as “Septic Systems” and consists of the following four Corrective Action Sites (CASs), located in Areas 3 and 12 of the Nevada Test Site: · CAS 03-04-02, Area 3 Subdock Septic Tank · CAS 03-59-05, Area 3 Subdock Cesspool · CAS 12-59-01, Drilling/Welding Shop Septic Tanks · CAS 12-60-01, Drilling/Welding Shop Outfalls Closure activities were conducted from September to November 2009 in accordance with the FFACO (1996, as amended February 2008) and the Corrective Action Plan for CAU 563. The corrective action alternatives included No Further Action and Clean Closure.

Informed Consent in Dentistry.

Science.gov (United States)

Reid, Kevin I

2017-03-01

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

Directory of Open Access Journals (Sweden)

Hammami Muhammad M

2012-11-01

Full Text Available Abstract Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD age was 32(9 year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002. Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p  Conclusions We conclude that: 1 most respondents were in favor of posthumous organ donation, 2 mandated choice system was the most preferred and presumed consent system was the least preferred, 3 there was no difference between preference and perception of norm in consenting systems ranking, and 4 financial (especially in females and medical (especially in males incentives reduced preference.

Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

Science.gov (United States)

De Vries, Raymond Gene; Tomlinson, Tom; Kim, Hyungjin Myra; Krenz, Chris; Haggerty, Diana; Ryan, Kerry A; Kim, Scott Y H

2016-01-01

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

Informed consent to medical treatment--the Israeli experience.

Science.gov (United States)

Weil, Z

1998-01-01

The ideological foundation of the doctrine of "informed consent" is rooted in the concept of personal freedom and freedom of choice. The concept of individual autonomy is represented by the "reasonable patient" standard which requires the disclosure of all information which a reasonable person in the position of the patient would need in order to make a rational decision regarding a proposed medical treatment. This attitude, however, conflicts with the traditional paternalism which is reflected in the "reasonable physician" standard, that is that a doctor must disclose that medical information which a rational doctor would relate to a patient in order to receive his consent. The enactment of the Patients' Rights Law in Israel in 1996 was an essential turning point in Israeli medical law. Section 13 of the new law explicitly establishes the requirement of informed consent and the details which a doctor must relate to a patient in order to reach the said agreement. Nevertheless, the law does not state the standard according to which it should be assessed whether the disclosure was proper. In a recent decision (C.A. 434/94 Shai Berman et al. v. Mor--the Institute for Medical Information, Ltd.) the Israeli Supreme Court took a step forward and determined that the duty to inform a patient will be judged by recognised criteria of negligence as they apply to the merits of each case.

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

Science.gov (United States)

2012-01-01

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

Securing recruitment and obtaining informed consent in minority ethnic groups in the UK

Directory of Open Access Journals (Sweden)

Roy Tapash

2008-03-01

Full Text Available Abstract Background Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1 our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2 the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Methods Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Results Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Conclusion Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

Corrective Action Decision Document for Corrective Action Unit 224: Decon Pad and Septic Systems Nevada Test Site, Nevada, Rev. No.: 0

Energy Technology Data Exchange (ETDEWEB)

David A. Strand

2005-05-01

This Corrective Action Decision Document has been prepared for Corrective Action Unit (CAU) 224, Decon Pad and Septic Systems, in Areas 2, 3, 5, 6, 11, and 23 of the Nevada Test Site, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (1996). Corrective Action Unit 224 is comprised of the following corrective action sites (CASs): (1) 02-04-01, Septic Tank (Buried); (2) 03-05-01, Leachfield; (3) 05-04-01, Septic Tanks (4)/Discharge Area; (4) 06-03-01, Sewage Lagoons (3); (5) 06-05-01, Leachfield; (6) 06-17-04, Decon Pad and Wastewater Catch; (7) 06-23-01, Decon Pad Discharge Piping; (8) 11-04-01, Sewage Lagoon; and (9) 23-05-02, Leachfield. The purpose of this Corrective Action Decision Document is to identify and provide the rationale for the recommendation of a corrective action alternative for the nine CASs within CAU 224. Corrective action investigation activities were performed from August 10, 2004, through January 18, 2005, as set forth in the CAU 224 Corrective Action Investigation Plan.

Negligence in securing informed consent and medical malpractice.

Science.gov (United States)

Perry, C

1988-01-01

The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

Informed Consent and Routinisation

DEFF Research Database (Denmark)

Ploug, Thomas; Holm, Søren

2013-01-01

provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent...

Corrective Action Decision Document for Corrective Action Unit 516: Septic Systems and Discharge Points, Nevada Test Site, Nevada, Rev. No.: 1 with ROTC 1

Energy Technology Data Exchange (ETDEWEB)

Alfred N. Wickline

2004-04-01

This Corrective Action Decision Document (CADD) has been prepared for Corrective Action Unit (CAU) 516, Septic Systems and Discharge Points, Nevada Test Site, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (1996). Corrective Action Unit 516 is comprised of the following Corrective Action Sites (CASs): (1) 03-59-01 - Bldg 3C-36 Septic System; (2) 03-59-02 - Bldg 3C-45 Septic System; (3) 06-51-01 - Sump and Piping; (4) 06-51-02 - Clay Pipe and Debris; (5) 06-51-03 - Clean Out Box and Piping; and (7) 22-19-04 - Vehicle Decontamination Area. The purpose of this CADD is to identify and provide the rationale for the recommendation of an acceptable corrective action alternative for each CAS within CAU 516. Corrective action investigation activities were performed between July 22 and August 14, 2003, as set forth in the Corrective Action Investigation Plan. Supplemental sampling was conducted in late 2003 and early 2004.

Corrective Action Investigation Plan for Corrective Action Unit 166: Storage Yards and Contaminated Materials, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

David Strand

2006-01-01

contaminants of concern are present. (5) If contaminants of concern are present, collect additional step-out samples to define the extent of the contamination. (6) Collect samples of investigation-derived waste, as needed, for waste management and minimization purposes. This Corrective Action Investigation Plan has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Under the ''Federal Facility Agreement and Consent Order'', this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection, and field work will commence following approval

Corrective Action Investigation Plan for Corrective Action Unit 554: Area 23 Release Site, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Boehlecke, Robert F.

2004-01-01

for CAU 554 includes the following activities: (1) Move surface debris and/or materials, as needed, to facilitate sampling. (2) Perform field screening. (3) Collect and submit environmental samples for laboratory analysis to determine if contaminants of concern are present. (4) If contaminants of concern are present, collect additional step-out samples to define the extent of the contamination. (5) Collect samples of investigation-derived waste, as needed, for waste management and minimization purposes. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Under the ''Federal Facility Agreement and Consent Order'', this CAIP will be submitted to the Nevada Division of Environmental Protection for approval. Field work will be conducted following approval of the plan

Corrective Action Plan for Corrective Action Unit 168: Area 25 and 26 Contaminated Materials and Waste Dumps, Nevada Test Site, Nevada, REV 1

International Nuclear Information System (INIS)

NSTec Environmental Restoration

2007-01-01

Corrective Action Unit (CAU) 168 is identified in the Federal Facility Agreement and Consent Order of 1996 as Area 25 and 26 Contaminated Materials and Waste Dumps. CAU 168 consists of twelve Corrective Action Sites (CASs) in Areas 25 and 26 of the Nevada Test Site, which is approximately 105 kilometers (65 miles) northwest of Las Vegas, Nevada. The CASs contain surface and subsurface debris, impacted soil, and contaminated materials. Site characterization activities were conducted in 2002, and the results are presented in the Corrective Action Decision Document (CADD) for CAU 168 (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2006). Site characterization results indicated that soil at several sites exceeded the clean-up criteria for total petroleum hydrocarbons (TPH), polychlorinated biphenyls (PCBs), and radionuclides. The Nevada Division of Environmental Protection approved the proposed corrective actions specified in the CADD (NNSA/NSO, 2006). The approved corrective actions include no further action, clean closure, and closure in place with administrative controls

77 FR 50508 - Brain-Pad, Inc; Analysis of Proposed Consent Order To Aid Public Comment

Science.gov (United States)

2012-08-21

... appropriate action or make final the agreement's proposed order. This matter involves respondents' advertising... basis to represent in advertising and on packaging for their mouthguards that they reduced the risk of concussions. The FTC further alleges that the respondents made the false and misleading claim that they...

Weakly Isolated horizons: first order actions and gauge symmetries

Science.gov (United States)

Corichi, Alejandro; Reyes, Juan D.; Vukašinac, Tatjana

2017-04-01

The notion of Isolated Horizons has played an important role in gravitational physics, being useful from the characterization of the endpoint of black hole mergers to (quantum) black hole entropy. With an eye towards a canonical formulation we consider general relativity in terms of connection and vierbein variables and their corresponding first order actions. We focus on two main issues: (i) The role of the internal gauge freedom that exists, in the consistent formulations of the action principle, and (ii) the role that a 3  +  1 canonical decomposition has in the allowed internal gauge freedom. More concretely, we clarify in detail how the requirement of having well posed variational principles compatible with general weakly isolated horizons (WIHs) as internal boundaries does lead to a partial gauge fixing in the first order descriptions used previously in the literature. We consider the standard Hilbert-Palatini action together with the Holst extension (needed for a consistent 3  +  1 decomposition), with and without boundary terms at the horizon. We show in detail that, for the complete configuration space—with no gauge fixing—, while the Palatini action is differentiable without additional surface terms at the inner WIH boundary, the more general Holst action is not. The introduction of a surface term at the horizon—that renders the action for asymptotically flat configurations differentiable—does make the Holst action differentiable, but only if one restricts the configuration space and partially reduces the internal Lorentz gauge. For the second issue at hand, we show that upon performing a 3  +  1 decomposition and imposing the time gauge, there is a further gauge reduction of the Hamiltonian theory in terms of Ashtekar-Barbero variables to a U(1)-gauge theory on the horizon. We also extend our analysis to the more restricted boundary conditions of (strongly) isolated horizons as inner boundary. We show that even when the

Weakly Isolated horizons: first order actions and gauge symmetries

International Nuclear Information System (INIS)

Corichi, Alejandro; Reyes, Juan D; Vukašinac, Tatjana

2017-01-01

The notion of Isolated Horizons has played an important role in gravitational physics, being useful from the characterization of the endpoint of black hole mergers to (quantum) black hole entropy. With an eye towards a canonical formulation we consider general relativity in terms of connection and vierbein variables and their corresponding first order actions. We focus on two main issues: (i) The role of the internal gauge freedom that exists, in the consistent formulations of the action principle, and (ii) the role that a 3  +  1 canonical decomposition has in the allowed internal gauge freedom. More concretely, we clarify in detail how the requirement of having well posed variational principles compatible with general weakly isolated horizons (WIHs) as internal boundaries does lead to a partial gauge fixing in the first order descriptions used previously in the literature. We consider the standard Hilbert–Palatini action together with the Holst extension (needed for a consistent 3  +  1 decomposition), with and without boundary terms at the horizon. We show in detail that, for the complete configuration space—with no gauge fixing—, while the Palatini action is differentiable without additional surface terms at the inner WIH boundary, the more general Holst action is not. The introduction of a surface term at the horizon—that renders the action for asymptotically flat configurations differentiable—does make the Holst action differentiable, but only if one restricts the configuration space and partially reduces the internal Lorentz gauge. For the second issue at hand, we show that upon performing a 3  +  1 decomposition and imposing the time gauge, there is a further gauge reduction of the Hamiltonian theory in terms of Ashtekar–Barbero variables to a U (1)-gauge theory on the horizon. We also extend our analysis to the more restricted boundary conditions of (strongly) isolated horizons as inner boundary. We show that even when

CLOSURE REPORT FOR CORRECTIVE ACTION UNIT 204: STORAGE BUNKERS, NEVADA TEST SITE, NEVADA

International Nuclear Information System (INIS)

2006-01-01

Corrective Action Unit (CAU) 330 consists of four Corrective Action Sites (CASs) located in Areas 6, 22, and 23 of the Nevada Test Site (NTS). The unit is listed in the Federal Facility Agreement and Consent Order (FFACO, 1996) as CAU 330: Areas 6, 22, and 23 Tanks and Spill Sites. CAU 330 consists of the following CASs: CAS 06-02-04, Underground Storage Tank (UST) and Piping CAS 22-99-06, Fuel Spill CAS 23-01-02, Large Aboveground Storage Tank (AST) Farm CAS 23-25-05, Asphalt Oil Spill/Tar Release

Corrective Action Decision Document/Closure Report for Corrective Action Unit 383: Area E-Tunnel Sites, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document/Closure Report (CADD/CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 383, Area 12 E-Tunnel Sites, which is the joint responsibility of DTRA and the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO). This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the DOE, and the U.S. Department of Defense. Corrective Action Unit 383 is comprised of three Corrective Action Sites (CASs) and two adjacent areas: • CAS 12-06-06, Muckpile • CAS 12-25-02, Oil Spill • CAS 12-28-02, Radioactive Material • Drainage below the Muckpile • Ponds 1, 2, and 3 The purpose of this CADD/CR is to provide justification and documentation to support the recommendation for closure with no further corrective action, by placing use restrictions at the three CASs and two adjacent areas of CAU 383.

Blockchain protocols in clinical trials: Transparency and traceability of consent

Science.gov (United States)

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2018-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

Blockchain protocols in clinical trials: Transparency and traceability of consent.

Science.gov (United States)

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

Corrective Action Decision Document for Corrective Action Unit 166: Storage Yards and Contaminated Materials, Nevada Test Site, Nevada with Errata Sheet

Energy Technology Data Exchange (ETDEWEB)

Grant Evenson

2007-03-01

This Corrective Action Decision Document (CADD) has been prepared for Corrective Action Unit (CAU) 166, Storage Yards and Contaminated Materials, in accordance with the Federal Facility Agreement and Consent Order (1996). The corrective action sites (CASs) are located in Areas 2, 3, 5, and 18 of the Nevada Test Site, Nevada. Corrective Action Unit 166 is comprised of the following CASs: • 02-42-01, Cond. Release Storage Yd - North • 02-42-02, Cond. Release Storage Yd - South • 02-99-10, D-38 Storage Area • 03-42-01, Conditional Release Storage Yard • 05-19-02, Contaminated Soil and Drum • 18-01-01, Aboveground Storage Tank • 18-99-03, Wax Piles/Oil Stain The purpose of this CADD is to identify and provide the rationale for the recommendation of a corrective action alternative (CAA) for the seven CASs within CAU 166. Corrective action investigation (CAI) activities were performed from July 31, 2006, through February 28, 2007, as set forth in the CAU 166 Corrective Action Investigation Plan (NNSA/NSO, 2006).

Corrective Action Investigation Plan for Corrective Action Unit 552: Area 12 Muckpile and Ponds, Nevada Test Site, Nevada: Revision 0

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2004-04-06

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach for collecting the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 552: Area 12 Muckpile and Ponds, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. Located in Area 12 on the NTS, CAU 552 consists of two Corrective Action Sites (CASs): 12-06-04, Muckpile; 12-23-05, Ponds. Corrective Action Site 12-06-04 in Area 12 consists of the G-Tunnel muckpile, which is the result of tunneling activities. Corrective Action Site 12-23-05 consists of three dry ponds adjacent to the muckpile. The toe of the muckpile extends into one of the ponds creating an overlap of two CASs. The purpose of the investigation is to ensure that adequate data are collected to provide sufficient and reliable information to identify, evaluate, and select technic ally viable corrective actions. The results of the field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.

76 FR 34983 - Proposed Consent Decree, Clean Air Act Citizen Suit

Science.gov (United States)

2011-06-15

... startup, shutdown, malfunction and maintenance; failed to act on a Wyoming SIP submission addressing... Plaintiffs for EPA's alleged failure to take timely action under CAA sections 110(k)(2) and 110(c) on SIPs... addition, the proposed consent decree requires that no later than 10 business days following signature of...

Impact of verbal explanation and modified consent materials on orthodontic informed consent.

Science.gov (United States)

Carr, Kelly M; Fields, Henry W; Beck, F Michael; Kang, Edith Y; Kiyak, H Asuman; Pawlak, Caroline E; Firestone, Allen R

2012-02-01

Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any

UMTRA consent form acquisition: a survey of nonrespondents

International Nuclear Information System (INIS)

Gonsalves, L.L.; Carpenter, D.; Borak, T.B.; Kearney, P.

1986-01-01

The Radiological Survey Activities group of the Health and Safety Research Division at Oak Ridge National Laboratory is the Inclusion Survey Contractor (ISC) for the Uranium Mill Tailings Remedial Action (UMTRA) project in Grand Junction, Colorado. The ISC is responsible for performing any required radiological surveys and data analyses for the recommendation of inclusion or exclusion of designated properties in the UMTRA project. One of the responsibilities of the ISC is to obtain consent from the property owners to conduct radiological surveys. In Grand Junction, Colorado 30-40% of the owners of designated properties have not responded to the consent-for-access requests sent by certified mail. A questionnaire was designed to identify and study this nonresponse through personal interviews with 100 randomly selected nonrespondents. A profile of the population of nonrespondents, reasons for nonresponse, as well as suggestions to encourage response were identified and analyzed

UMTRA consent form acquisition: a survey of nonrespondents

International Nuclear Information System (INIS)

Gonsalves, L.L.; Borak, T.B.; Kearney, P.; Carpenter, D.

1986-01-01

The Radiological Survey Activities group of the Health and Safety Research Division at Oak Ridge National Laboratory is the Inclusion Survey Contractor (ISC) for the Uranium Mill Tailings Remedial Action (UMTRA) project in Grand Junction, Colorado. The ISC is responsible for performing any required radiological surveys and data analyses for the recommendation of inclusion or exclusion of designated properties in the UMTRA project. One of the responsibilities of the ISC is to obtain consent from the property owners to conduct radiological surveys. In Grand Junction, Colorado 30 to 40% of the owners of designated properties have not responded to the consent-for-access requests sent by certified mail. A questionnaire was designed to identify and study this nonresponse through personal interviews with 100 randomly selected nonrespondents. A profile of the population of nonrespondents, reasons for nonresponse, as well as suggestions to encourage response were identified and analyzed

76 FR 18762 - Google, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Science.gov (United States)

2011-04-05

... protections; and Evaluate and adjust its privacy program in light of the results of the testing and monitoring... other competitors as much or more than the terms will hurt that party. That may occur, for example, when a consent agreement is used as ``leverage in dealing with the practices of other competitors.'' Part...

Adolescents and consent to treatment.

Science.gov (United States)

Dickens, B M; Cook, R J

2005-05-01

Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

Science.gov (United States)

Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

2016-01-01

Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Informed consent to healthcare interventions in people with learning disabilities--an integrative review.

Science.gov (United States)

Goldsmith, Lesley; Skirton, Heather; Webb, Christine

2008-12-01

This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions--or be assessed as incompetent to give consent. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. An integrative review was conducted and the data analysed thematically. Twenty-two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.

77 FR 73655 - Epic Marketplace, Inc., and Epic Media Group, LLC; Analysis of Proposed Consent Order To Aid...

Science.gov (United States)

2012-12-11

... action or make final the agreement's proposed order. Epic Marketplace, Inc. (``Epic'') is an advertising company that engages in online behavioral advertising, which is the practice of tracking a consumer's online activities in order to deliver advertising targeted to the consumer's interests. Epic is a wholly...

Use of altered informed consent in pragmatic clinical research.

Science.gov (United States)

McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

2015-10-01

There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

Applying a sociolinguistic model to the analysis of informed consent documents.

Science.gov (United States)

Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

2009-11-01

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

75 FR 40855 - Notice of Action Subject to Intergovernmental Review Under Executive Order 12372

Science.gov (United States)

2010-07-14

... management, marketing, finance, operations, planning, taxes, and any other general or technical area of... SMALL BUSINESS ADMINISTRATION Notice of Action Subject to Intergovernmental Review Under Executive Order 12372 AGENCY: U.S. Small Business Administration. ACTION: Notice of Action Subject to...

76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

Science.gov (United States)

2011-10-19

... FEDERAL TRADE COMMISSION [File No. 111 0166] Teva Pharmaceutical Industries Ltd. and Cephalon, Inc... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl...

iConsent an Electronic Consent Platform with the MS Register

Directory of Open Access Journals (Sweden)

Rod Middleton

2017-04-01

Patients who have been e-consented have expressed satisfaction in the ease of use and security of the software. Patients being unable to rest their hands on the screen is being examined. Newer tablets can ignore inputs other than the stylus. The MS Register intends to use the software in additional centres to capture patient consent.

Corrective Action Investigation Plan for Corrective Action Unit 166: Storage Yards and Contaminated Materials, Nevada Test Site, Nevada, Rev. No.: 0

Energy Technology Data Exchange (ETDEWEB)

David Strand

2006-06-01

contaminants of concern are present. (5) If contaminants of concern are present, collect additional step-out samples to define the extent of the contamination. (6) Collect samples of investigation-derived waste, as needed, for waste management and minimization purposes. This Corrective Action Investigation Plan has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Under the ''Federal Facility Agreement and Consent Order'', this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection, and field work will commence following approval.

Corrective Action Plan for Corrective Action Unit 543: Liquid Disposal Units, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

NSTec Environmental Restoration

2006-01-01

Corrective Action Unit (CAU) 543, Liquid Disposal Units, is listed in Appendix III of the Federal Facility Agreement and Consent Order of 1996. CAU 543 consists of seven Corrective Action Sites (CASs) located in Areas 6 and 15 of the Nevada Test Site, which is approximately 65 miles northwest of Las Vegas, Nevada. CAU 543 consists of the following seven CASs: (sm b ullet) CAS 06-07-01, Decon Pad (sm b ullet) CAS 15-01-03, Aboveground Storage Tank (sm b ullet) CAS 15-04-01, Septic Tank (sm b ullet) CAS 15-05-01, Leachfield (sm b ullet) CAS 15-08-01, Liquid Manure Tank (sm b ullet) CAS 15-23-01, Underground Radioactive Material Area (sm b ullet) CAS 15-23-03, Contaminated Sump, Piping From January 24, 2005 through April 14, 2005, CAU 543 site characterization activities were conducted, and are reported in Appendix A of the CAU 543 Corrective Action Decision Document (CADD) (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2005). The recommended corrective action as stated in the approved CADD is No Further Action for five of the CAU 543 CASs, and Closure In Place for the remaining two CASs

Trends and Determinants of Familial Consent for Corneal Donation in Chinese.

Science.gov (United States)

Lee, Allie; Ni, Michael Y; Luk, Amanda C K; Lau, Jessie K P; Lam, Karen S Y; Li, Tom K; Wong, Catherine S M; Wong, Victoria W Y

2017-03-01

Corneal transplantation is the treatment of choice for many corneal diseases. At present, there is a global shortage of corneal transplant tissues, and failure to obtain consent from families of potential donors is a major limiting factor in tissue procurement. All family members of potential donors after cardiac death approached by the local eye bank staff members from January 2008 to December 2014 in Hong Kong were included. Reasons for consent or refusal and sociodemographic details of the deceased and the family members approached were reviewed. Trends in consent rates from 2008 to 2014 were examined. Multivariable logistic regression was performed to examine determinants of donation among cases from 2013 to 2014. A total of 1740 cases were identified. The overall consent rate was 36.8%, and the consent rate did not change significantly over the 7-year study period (P = 0.24). The most common reason for consent by family members was "the wish to help others" (86.0%), and the most common reason for refusal was "traditional Chinese culture to keep the body intact after death" (42.7%). From the multivariable analysis in the subset of cases from 2013 to 2014 (n = 628), family members were more likely to consent when the deceased was female (adjusted odds ratio 1.45, P = 0.03), with a do-not-resuscitate order (adjusted odds ratio 2.27, P < 0.001). The consent rate for eye donation did not change significantly from 2008 to 2014. Our findings suggest that health education and promotion campaigns need to address cultural barriers to organ donation.

Corrective Action Decision Document for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada: Revision 0, Including Errata Sheet

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2004-04-01

This Corrective Action Decision Document identifies the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's corrective action alternative recommendation for each of the corrective action sites (CASs) within Corrective Action Unit (CAU) 204: Storage Bunkers, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. An evaluation of analytical data from the corrective action investigation, review of current and future operations at each CAS, and a detailed comparative analysis of potential corrective action alternatives were used to determine the appropriate corrective action for each CAS. There are six CASs in CAU 204, which are all located between Areas 1, 2, 3, and 5 on the NTS. The No Further Action alternative was recommended for CASs 01-34-01, 02-34-01, 03-34-01, and 05-99-02; and a Closure in Place with Administrative Controls recommendation was the preferred corrective action for CASs 05-18-02 and 05-33-01. These alternatives were judged to meet all requirements for the technical components evaluated as well as applicable state and federal regulations for closure of the sites and will eliminate potential future exposure pathways to the contaminated media at CAU 204.

Analisis Penerapan Informed Consent Di Bagian SMF Bedah dan SMF Kandungan RSUD Deli Serdang Lubuk Pakam

OpenAIRE

Siahaan, Hetty Erawaty

2015-01-01

An Informed consent is individual agreement given by a patient or closed family following get detail information about a medical action or in dental with any option shall be taken upon the patient. The explanation with information given to patient at least including medical diagnosis and the administration, the purpose of action, alternative action and its risks, the other risks and complication may emerge, and prognosis upon the action shall be taken as well as estimation of cost. The inform...

Architecture of a consent management suite and integration into IHE-based Regional Health Information Networks.

Science.gov (United States)

Heinze, Oliver; Birkle, Markus; Köster, Lennart; Bergh, Björn

2011-10-04

The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are

Corrective Action Investigation Plan for Corrective Action Unit 536: Area 3 Release Site, Nevada Test Site, Nevada (Rev. 0 / June 2003), Including Record of Technical Change No. 1

Energy Technology Data Exchange (ETDEWEB)

None

2003-06-27

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 536: Area 3 Release Site, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 536 consists of a single Corrective Action Site (CAS): 03-44-02, Steam Jenny Discharge. The CAU 536 site is being investigated because existing information on the nature and extent of possible contamination is insufficient to evaluate and recommend corrective action alternatives for CAS 03-44-02. The additional information will be obtained by conducting a corrective action investigation (CAI) prior to evaluating CAAs and selecting the appropriate corrective action for this CAS. The results of this field investigation are to be used to support a defensible evaluation of corrective action alternatives in the corrective action decision document. Record of Technical Change No. 1 is dated 3-2004.

Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

Science.gov (United States)

D'Cruz, L

2010-07-24

Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

Capacity to consent to research among patients with bipolar disorder.

Science.gov (United States)

Misra, Sahana; Ganzini, Linda

2004-06-01

Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of 'choice', 'understanding', 'appreciation' and 'rational reasoning', as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences 'understanding' and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient's understanding of the research protocol, but also alter the patient's views, values and level of insight, thus impairing decision-making abilities at the 'appreciation' standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

OpenAIRE

Borello Alessandro; Ferrarese Alessia; Passera Roberto; Surace Alessandra; Marola Silvia; Buccelli Claudio; Niola Massimo; Di Lorenzo Pierpaolo; Amato Maurizio; Di Domenico Lorenza; Solej Mario; Martino Valter

2016-01-01

Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a grap...

Corrective Action Plan for Corrective Action Unit 261: Area 25 Test Cell A Leachfield System, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

T. M. Fitzmaurice

2000-08-01

This Corrective Action Plan (CAP) has been prepared for the Corrective Action Unit (CAU)261 Area 25 Test Cell A Leachfield System in accordance with the Federal Facility and Consent Order (Nevada Division of Environmental Protection [NDEP] et al., 1996). This CAP provides the methodology for implementing the approved corrective action alternative as listed in the Corrective Action Decision Document (U.S. Department of Energy, Nevada Operations Office, 1999). Investigation of CAU 261 was conducted from February through May of 1999. There were no Constituents of Concern (COCs) identified at Corrective Action Site (CAS) 25-05-07 Acid Waste Leach Pit (AWLP). COCs identified at CAS 25-05-01 included diesel-range organics and radionuclides. The following closure actions will be implemented under this plan: Because COCs were not found at CAS 25-05-07 AWLP, no action is required; Removal of septage from the septic tank (CAS 25-05-01), the distribution box and the septic tank will be filled with grout; Removal of impacted soils identified near the initial outfall area; and Upon completion of this closure activity and approval of the Closure Report by NDEP, administrative controls, use restrictions, and site postings will be used to prevent intrusive activities at the site.

Consented Autopsy and the Middle-East.

Science.gov (United States)

Kharoshah, Magdy A; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

2017-02-01

Consented autopsy is almost non-existent in the Middle-East where established social and cultural beliefs regarding the procedure might discourage family members from requesting a consented autopsy. Evidence suggests that new information is obtained from consented autopsies. It would not be in the best interest of medicine if social and cultural misconceptions succeed in erasing the existence of consented autopsies entirely.

Closure Report for Corrective Action Unit 366: Area 11 Plutonium Valley Dispersion Sites, Nevada National Security Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

None, None

2013-12-31

This Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 366, Area 11 Plutonium Valley Dispersion Sites, and provides documentation supporting the completed corrective actions and confirmation that closure objectives for CAU 366 were met. This CR complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; the U.S. Department of Energy (DOE), Environmental Management; the U.S. Department of Defense; and DOE, Legacy Management (FFACO, 1996 as amended).

Corrective Action Plan for Corrective Action Unit 143: Area 25 Contaminated Waste Dumps, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Gustafason, D.L.

2001-01-01

This Corrective Action Plan (CAP) has been prepared for Corrective Action Unit (CAU) 143: Area 25 Contaminated Waste Dumps, Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order of 1996. This CAP provides the methodology for implementing the approved corrective action alternative as listed in the Corrective Action Decision Document (U.S. Department of Energy, Nevada Operations Office, 2000). The CAU includes two Corrective Action Sites (CASs): 25-23-09, Contaminated Waste Dump Number 1; and 25-23-03, Contaminated Waste Dump Number 2. Investigation of CAU 143 was conducted in 1999. Analytes detected during the corrective action investigation were evaluated against preliminary action levels to determine constituents of concern for CAU 143. Radionuclide concentrations in disposal pit soil samples associated with the Reactor Maintenance, Assembly, and Disassembly Facility West Trenches, the Reactor Maintenance, Assembly, and Disassembly Facility East Trestle Pit, and the Engine Maintenance, Assembly, and Disassembly Facility Trench are greater than normal background concentrations. These constituents are identified as constituents of concern for their respective CASs. Closure-in-place with administrative controls involves use restrictions to minimize access and prevent unauthorized intrusive activities, earthwork to fill depressions to original grade, placing additional clean cover material over the previously filled portion of some of the trenches, and placing secondary or diversion berm around pertinent areas to divert storm water run-on potential

Informed Consent and Capacity to Give Consent in Mental Disorders

OpenAIRE

Zeynep Mackali

2014-01-01

Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interacti...

Nudging, informed consent and bullshit.

Science.gov (United States)

Simkulet, William

2017-11-18

Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Corrective Action Plan for Corrective Action Unit 261: Area 25 Test Cell A Leachfield System, Nevada Test Site, Nevada; TOPICAL

International Nuclear Information System (INIS)

T. M. Fitzmaurice

2000-01-01

This Corrective Action Plan (CAP) has been prepared for the Corrective Action Unit (CAU)261 Area 25 Test Cell A Leachfield System in accordance with the Federal Facility and Consent Order (Nevada Division of Environmental Protection[NDEP] et al., 1996). This CAP provides the methodology for implementing the approved corrective action alternative as listed in the Corrective Action Decision Document (U.S. Department of Energy, Nevada Operations Office, 1999). Investigation of CAU 261 was conducted from February through May of 1999. There were no Constituents of Concern (COCs) identified at Corrective Action Site (CAS) 25-05-07 Acid Waste Leach Pit (AWLP). COCs identified at CAS 25-05-01 included diesel-range organics and radionuclides. The following closure actions will be implemented under this plan: Because COCs were not found at CAS 25-05-07 AWLP, no action is required; Removal of septage from the septic tank (CAS 25-05-01), the distribution box and the septic tank will be filled with grout; Removal of impacted soils identified near the initial outfall area; and Upon completion of this closure activity and approval of the Closure Report by NDEP, administrative controls, use restrictions, and site postings will be used to prevent intrusive activities at the site

Informed consent in surgical trials.

Science.gov (United States)

Etchells, E

1999-12-01

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

Directory of Open Access Journals (Sweden)

Borello Alessandro

2016-01-01

Full Text Available Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study

NARCIS (Netherlands)

Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Christiaans, Imke; Grisso, Thomas; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

2015-01-01

Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to

Disclosing details about the medical treatment of a deceased public figure in a book: Who should have consented to the disclosures in Mandela's Last Days?

Science.gov (United States)

McQuoid-Mason, D J

2017-11-27

A recently published book by the head of Nelson Mandela's medical team made personal disclosures about his treatment of the late president in his final years up until his death. The author claimed that he had written the book at the request of family members. This was contested by some family members and the executors of Mandela's estate, and the book was subsequently withdrawn by the publishers. The Mandela book case raises ethical and legal questions about who should consent to publication of medical information about public figures after their death. The ethical rules of conduct of the Health Professions Council of South Africa (HPCSA) state that confidential information about a deceased person should only be divulged 'with the written consent of his or her next of kin or the executor of his or her estate'. 'Next of kin' is not defined, however, and problems arise when family members and the executors are divided about giving such written consent. It is recommended that in such cases the specific order of priority for consent by relatives in the National Health Act be followed. However, conduct that is unethical under the rules of the HPCSA may not necessarily be actionable under the law. For instance, the law does not protect the confidentiality of deceased persons, and generally when people die their constitutional and common-law personality rights - including their right to privacy and confidentiality - die with them. This means that the next of kin or executors of the estates of deceased persons may not bring actions for damages on behalf of such persons for breaches of confidentiality arising after their deaths. The next of kin may, however, sue in their personal capacity if they can show that the disclosures were an unlawful invasion of their own privacy. Conversely, if the privacy of interests of the next of kin are not harmed where there has been publication without their consent, they will not be able to sue for damages.

77 FR 17479 - Star Pipe Products, Ltd.; Analysis of Proposed Consent Order To Aid Public Comment

Science.gov (United States)

2012-03-26

... FEDERAL TRADE COMMISSION [Docket No. 9351] Star Pipe Products, Ltd.; Analysis of Proposed Consent... ``Star Pipe, Docket No. 9351'' on your comment, and file your comment online at https://ftcpublic..., 2012. Write ``Star Pipe, Docket No. 9351'' on your comment. Your comment-- including your name and your...

Implementing the legal criteria for meaningful consent in the concept of mobile advertising

DEFF Research Database (Denmark)

Cleff, Evelyne Beatrix

2007-01-01

Advancements of the wired Internet and mobile telecommunication networks offer companies new advertising opportunities but this development creates a need to consider acceptance and usability issues in order to ensure permission-based advertising. According to the law of the European Union (EU......), only permission-based mobile advertising is allowed. In order to obtain consent from the mobile user, the advertiser is obliged to make an effective disclosure. However, these rules are not specific to this new context. It will be a great challenge for advertisers to translate the requirements...... into actual business practices in order to obtain meaningful consent from the mobile user. This article focuses on the evaluation of legal problems related to these issues in order to find adequate technical solutions concerning m-advertising. It is assumed that a technological design, which is in line...

17 CFR 240.15b1-5 - Consent to service of process to be furnished by nonresident brokers or dealers and by...

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Consent to service of process... § 240.15b1-5 Consent to service of process to be furnished by nonresident brokers or dealers and by...) stipulates and agrees that any such civil suit or action may be commended by the service of process upon the...

Informed Consent in Adult Psychiatry

Directory of Open Access Journals (Sweden)

Ahmed Bait Amer

2013-07-01

Full Text Available This article addresses some of the groundwork of informed consent in people with mental illness whose decision-making capacity has obviously been compromised. This article examines four crucial aspects in particular, namely: i the main elements of informed consent; ii difficulties pertaining to psychiatric illnesses; iii the effect of psychiatric disorders on the patient’s capability; iv how to assess situations in which consents may not be required.

Informed consent for radiotherapy: Our responsibility

International Nuclear Information System (INIS)

Colyer, Hazel

2007-01-01

This article describes and contextualises the findings from an email survey of cancer centres in the United Kingdom (UK) conducted early in 2005. It sought to discover how widely the model consent policy and process, published in 2001 [Department of Health. Good practice in consent. Achieving the NHS Plan commitment to patient-centred consent practice. HSC 2001/023. NHS Executive; November 2001], had been implemented and, more controversially, which professional groups gained the consent of patients to radiotherapy. The survey was sent on the author's behalf by the Society and College of Radiographers (SCoR) to all cancer centres in the UK, including five private sector facilities (n = 63). Forty-eight responses were received (76%). A majority of cancer centres have implemented the new procedures and these are undertaken most commonly by consultant oncologists and trained specialist registrars. In 10 centres, therapeutic radiographers (radiographers) are among the team gaining consent to radiotherapy and other centres have radiographers in training. There is widespread adherence to government guidance for obtaining consent and a growing number of centres are implementing radiographer-led consent. However, this is controversial from both medical and radiographic professional perspectives despite guidance indicating that the person who is actually treating the patients should seek their consent [Department of Health. 12 Key points on consent: the law in England. March 2001]. In the context of creating person-centred services, the significance for the development of the profession of therapeutic radiography is evaluated. In particular, the implications of radiographers both capitalising on and failing to assume this professional responsibility were explored

[Schizophrenia and informed consent to research].

Science.gov (United States)

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

Science.gov (United States)

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

2016-06-01

The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

75 FR 51460 - Novartis AG; Analysis of Proposed Agreement Containing Consent Orders to Aid Public Comment

Science.gov (United States)

2010-08-20

... of a controlling interest in Alcon, Inc. (``Alcon'') from Nestle, S.A. The proposed Consent Agreement..., Novartis proposes to acquire all of the outstanding shares of Alcon held by Nestle in a transaction valued... pharmaceuticals headquartered in Basel, Switzerland. Nestle is the world's largest food company, and is...

78 FR 55076 - Ganley Ford West, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Science.gov (United States)

2013-09-09

... FEDERAL TRADE COMMISSION [File No. 122 3269] Ganley Ford West, Inc.; Analysis of Proposed Consent... for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Ganley Ford, File No. 122... receive it on or before October 3, 2013. Write ``Ganley Ford, File No. 122 3269'' on your comment. Your...

Corrective Action Investigation Plan for Corrective Action Unit 322: Areas 1 and 3 Release Sites and Injection Wells, Nevada Test Site, Nevada: Revision 0, Including Record of Technical Change No. 1

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2003-07-16

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 322, Areas 1 and 3 Release Sites and Injection Wells, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 322 consists of three Corrective Action Sites (CASs): 01-25-01, AST Release (Area 1); 03-25-03, Mud Plant AST Diesel Release (Area 3); 03-20-05, Injection Wells (Area 3). Corrective Action Unit 322 is being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. The investigation of three CASs in CAU 322 will determine if hazardous and/or radioactive constituents are present at concentrations and locations that could potentially pose a threat to human health and the environment. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.

Informed consent in psychotherapy.

Science.gov (United States)

Beahrs, J O; Gutheil, T G

2001-01-01

The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

Science.gov (United States)

Williams, Barbara F; French, John K; White, Harvey D

2003-03-15

Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Use of informed consent with therapeutic paradox.

Science.gov (United States)

Farkas, M M

1992-01-01

Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

Informed consent in physiotherapy practice: it is not what is said but how it is said.

Science.gov (United States)

Copnell, G

2018-03-01

This paper discusses the concept of informed consent in the context of contemporary biomedical ethics. A change in UK law regarding what information should be provided to patients has brought to the fore the role of physiotherapists in the process of gaining informed consent. It is important that physiotherapists are aware of how this change in the law will affect their practice. For an individual to consent, they need to have both the capacity and freedom to exercise rational thought. These concepts are challenged in contemporary biomedical ethics. An individual's ability to make rational decisions has been increasingly questioned by empirical evidence from behavioural psychology. In addition, the concept of freedom in contemporary neoliberal societies has also been critically examined. Liberal paternalism has been advocated by some as a means of helping patients to make better decisions about their care. Actualised as a 'nudge', liberal paternalism has been influential in a number of health policies, and has recently been discussed as a means of gaining consent from patients for assessments and treatments. Physiotherapists engage directly with patients and, through this engagement, construct a therapeutic environment that aims to build mutual trust. This paper questions the legitimacy of informed consent, and presents the argument that, through communicative actions, physiotherapists nudge patients into consenting to assessments and treatments. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 266: Area 25 Building 3124 Leachfield, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

NNSA/NV

2000-02-17

This Corrective Action Decision Document/Closure Report (CADD/CR) was prepared for Corrective Action Unit (CAU) 266, Area 25 Building 3124 Leachfield, in accordance with the Federal Facility Agreement and Consent Order. Located in Area 25 at the Nevada Test Site in Nevada, CAU 266 includes Corrective Action Site (CAS) 25-05-09. The Corrective Action Decision Document and Closure Report were combined into one report because sample data collected during the corrective action investigation (CAI) indicated that contaminants of concern (COCs) were either not present in the soil, or present at concentrations not requiring corrective action. This CADD/CR identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's recommendation that no corrective action was necessary for CAU 266. From February through May 1999, CAI activities were performed as set forth in the related Corrective Action Investigation Plan. Analytes detected during the three-stage CAI of CAU 266 were evaluated against preliminary action levels (PALs) to determine COCs, and the analysis of the data generated from soil collection activities indicated the PALs were not exceeded for total volatile/semivolatile organic compounds, total petroleum hydrocarbons, polychlorinated biphenyls, total Resource Conservation and Recovery Act metals, gamma-emitting radionuclides, isotopic uranium/plutonium, and strontium-90 for any of the samples. However, COCs were identified in samples from within the septic tank and distribution box; and the isotopic americium concentrations in the two soil samples did exceed PALs. Closure activities were performed at the site to address the COCs identified in the septic tank and distribution box. Further, no use restrictions were required to be placed on CAU 266 because the CAI revealed soil contamination to be less than the 100 millirems per year limit established by DOE Order 5400.5.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 266: Area 25 Building 3124 Leachfield, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2000-01-01

This Corrective Action Decision Document/Closure Report (CADD/CR) was prepared for Corrective Action Unit (CAU) 266, Area 25 Building 3124 Leachfield, in accordance with the Federal Facility Agreement and Consent Order. Located in Area 25 at the Nevada Test Site in Nevada, CAU 266 includes Corrective Action Site (CAS) 25-05-09. The Corrective Action Decision Document and Closure Report were combined into one report because sample data collected during the corrective action investigation (CAI) indicated that contaminants of concern (COCs) were either not present in the soil, or present at concentrations not requiring corrective action. This CADD/CR identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's recommendation that no corrective action was necessary for CAU 266. From February through May 1999, CAI activities were performed as set forth in the related Corrective Action Investigation Plan. Analytes detected during the three-stage CAI of CAU 266 were evaluated against preliminary action levels (PALs) to determine COCs, and the analysis of the data generated from soil collection activities indicated the PALs were not exceeded for total volatile/semivolatile organic compounds, total petroleum hydrocarbons, polychlorinated biphenyls, total Resource Conservation and Recovery Act metals, gamma-emitting radionuclides, isotopic uranium/plutonium, and strontium-90 for any of the samples. However, COCs were identified in samples from within the septic tank and distribution box; and the isotopic americium concentrations in the two soil samples did exceed PALs. Closure activities were performed at the site to address the COCs identified in the septic tank and distribution box. Further, no use restrictions were required to be placed on CAU 266 because the CAI revealed soil contamination to be less than the 100 millirems per year limit established by DOE Order 5400.5

Corrective Action Investigation Plan for Corrective Action Unit 214: Bunkers and Storage Areas Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2003-01-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 214 under the Federal Facility Agreement and Consent Order. Located in Areas 5, 11, and 25 of the Nevada Test Site, CAU 214 consists of nine Corrective Action Sites (CASs): 05-99-01, Fallout Shelters; 11-22-03, Drum; 25-99-12, Fly Ash Storage; 25-23-01, Contaminated Materials; 25-23-19, Radioactive Material Storage; 25-99-18, Storage Area; 25-34-03, Motor Dr/Gr Assembly (Bunker); 25-34-04, Motor Dr/Gr Assembly (Bunker); and 25-34-05, Motor Dr/Gr Assembly (Bunker). These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives (CAAs). The suspected contaminants and critical analyte s for CAU 214 include oil (total petroleum hydrocarbons-diesel-range organics [TPH-DRO], polychlorinated biphenyls [PCBs]), pesticides (chlordane, heptachlor, 4,4-DDT), barium, cadmium, chronium, lubricants (TPH-DRO, TPH-gasoline-range organics [GRO]), and fly ash (arsenic). The land-use zones where CAU 214 CASs are located dictate that future land uses will be limited to nonresidential (i.e., industrial) activities. The results of this field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the corrective action decision document

Reason, Consent and Contract The Difficult Least Common Denominator of Contractualist Theories

Directory of Open Access Journals (Sweden)

Felipe Schwember Augier Felipe Schwember Augier

2014-12-01

Full Text Available “Contractualism” refers to the diverse theories that maintain that the obligatory nature of norms rests on the consent of those bound by them. However, this general characterization overlooks crucial differences among the different contractualist theories. The article analyzes diverse typologies in order to highlight these differences and reach a more precise characterization of contractualism. It concludes that the distinction between hypothetical and ideal consent made by some of these versions makes it impossible to formulate a univocal definition of contractualism.

Corrective Action Investigation Plan for Corrective Action Unit 542: Disposal Holes, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Laura Pastor

2006-01-01

locate previously unidentified features at CASs 03-20-07, 03-20-09, 03-20-10, 03-20-11, and 06-20-03. (4) Perform field screening. (5) Collect and submit environmental samples for laboratory analysis to determine whether contaminants of concern (COCs) are present. (6) Collect quality control samples for laboratory analyses to evaluate the performance of measurement systems and controls based on the requirements of the data quality indicators. (7) If COCs are present at the surface/near surface (< 15 feet below ground surface), collect additional step-out samples to define the extent of the contamination. (8) If COCs are present in the subsurface (i.e., base of disposal hole), collect additional samples to define the vertical extent of contamination. A conservative use restriction will be used to encompass the lateral extent of subsurface contamination. (9) Stake or flag sample locations in the field, and record coordinates through global positioning systems surveying. (10) Collect samples of investigation-derived waste, as needed, for waste management and minimization purposes. This Corrective Action Investigation Plan has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Under the ''Federal Facility Agreement and Consent Order'', this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Field work will be conducted following approval of the plan

32 CFR 634.8 - Implied consent.

Science.gov (United States)

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Implied consent. 634.8 Section 634.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent to blood, breath, or urine tests....

Semantic Representation of Mutual-Consent Divorce

Directory of Open Access Journals (Sweden)

مهری سادات موسوی

2016-09-01

Full Text Available This article discussed mutual-consent divorce in the context of thoughts and attitude of female applicants of this type of divorce with an inductive qualitative and ethnographic method. Based on the qualitative purposive sampling, 30 women of those who had referred for divorce to family court of Karaj, were selected and deeply interviewed. The results obtained in six major categories as follows: Rethinking the role of men as families’ breadwinners, inappropriate sexual relationships, emotional conflicts, cultural- social dissensions, normative pressures of family and relatives, and personality and behavioral disorders. The core-oriented category of this study is "Women's attitude towards mutual-consent divorce" that includes other major categories and can semantically alter and redirect women’s opinion about mutual-consent divorce. According to the results, the term of mutual-consent is thought-provoking in this type of divorce; because considering the situations which were leaded to mutual-consent divorce and quantifying them revealed that nearly 32% of mutual-consent divorces were not mutual in fact; since, these women accepted divorce with desperation, coercion and threat.

A descriptive study of consent documentation.

LENUS (Irish Health Repository)

Murphy, K

2011-09-01

The aim of this study was to observe the error rate in the consent process of a university hospital and to illicit the opinions of the consenting doctors on the process. A prospective observational review of theatre consent forms was performed along with an anonymous survey of non-consultant hospital doctors (NCHD\\'s). No potential risks were documented in 95.3% of the 64 scrutinized consents and late alterations were required in 9%. Respondents to the NCHD survey estimated that they were unsure of the procedure or risks involved in an average of 29% of occasions. Interns admitted to being unsure of the details of the procedure in almost a third (32%) of cases, making them less well informed than their senior colleagues (p=0.024). This study highlights the difficulties encountered by consenting doctors, an issue which may lead to patient dissatisfaction, threaten the efficient running of a surgical unit and potentially expose its staff to avoidable litigation. It also recommends the use of multimedia adjuncts to facilitate both patient and doctor education in the consent process.

Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

Science.gov (United States)

Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

2017-08-25

Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

The Court versus Consent Decrees? Schools, "Horne v. Flores" and Judicial Strategies of Institutional Reform Litigation

Science.gov (United States)

Chilton, Bradley; Chwialkowski, Paul

2014-01-01

Is the U.S. Supreme Court inviting litigants to take aim at unraveling injunctions in institutional reform litigation--especially consent decrees in the schools? In "Horne v. Flores" (2009), the court remanded a 17-year-old school reform case to a federal judge with orders to look beyond consent decrees on financing, reducing class…

USign--a security enhanced electronic consent model.

Science.gov (United States)

Li, Yanyan; Xie, Mengjun; Bian, Jiang

2014-01-01

Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

Enhancing informed consent for research and treatment.

Science.gov (United States)

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

Science.gov (United States)

Sugarman, J; McCrory, D C; Hubal, R C

1998-04-01

To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve

Implementing the legal criteria of meaningful consent in the concept of mobile advertising

DEFF Research Database (Denmark)

Cleff, Evelyne Beatrix

2006-01-01

Advancements of the wired Internet and mobile telecommunication networks offer companies new advertising opportunities but this development also creates a need to consider acceptance and usability issues in order to ensure permission-based advertising. According to the law of the European Union (EU......), only permission-based mobile advertising is allowed. In order to obtain consent from the mobile user, the advertiser is obliged to make an effective disclosure. However, these rules are not specific to this new context. It will be a great challenge for advertisers to translate the requirements...... into actual business practices in order to obtain meaningful consent from the mobile user. This article focuses on the evaluation of legal problems related to these issues in order to find adequate technical solutions concerning m-advertising. It is assumed that a technological design, which is in line...

National Comparative Audit of Blood Transfusion: report on the 2014 audit of patient information and consent.

Science.gov (United States)

Booth, C; Grant-Casey, J; Lowe, D; Court, E L; Allard, S

2017-11-28

The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened. © 2017 British Blood Transfusion Society.

Assault in medical law: revisiting the boundaries of informed consent to medical treatment in South Africa.

Science.gov (United States)

Wilson, Maria C I

2009-05-01

This article focuses on assault as a cause of action in medical law, with particular emphasis on the requirements for informed consent, both under common law and under the National Health Act 2003 (Sth Africa). In particular, the test for consent, adopted in Castell v De Greef 1994 (4) SA 408 (C), is analysed in detail. It is noted that the wording of this test for informed consent mirrors the wording of the test for negligence laid down in the Australian case of Rogers v Whitaker (1992) 175 CLR 479. Further, the relationship between the delictual elements of wrongfulness and fault in assault is discussed. It is argued that in South African law a valid consent to medical treatment requires knowledge not only of the general nature of medical treatment but also of the consequences of the treatment and, in determining which consequences should be disclosed to a patient, the constitutional rights to equality and self-determination support the application of a subjective patient-centred test for informed consent. However, it is also proposed that the broad right of a patient to information is reined in at the fault element of assault, so that a limited requirement of consciousness of wrongfulness on the part of the defendant negates liability for delictual assault.

17 CFR 260.10a-4 - Consent of trustee to service of process.

Science.gov (United States)

2010-04-01

... § 260.10a-4 Consent of trustee to service of process. At the time of filing an application pursuant to... such suit, action or proceeding may be commenced by the service of process upon said agent for service of process, and that such service shall be taken and held in all courts to be as valid and binding as...

Well Completion Report for Corrective Action Unit 447, Project Shoal Area, Churchill County, Nevada

International Nuclear Information System (INIS)

Rick Findlay

2006-01-01

This Well Completion Report is being provided as part of the implementation of the Corrective Action Decision Document (CADD)/Corrective Action Plan (CAP) for Corrective Action Unit (CAU) 447 (NNSA/NSO, 2006a). The CADD/CAP is part of an ongoing U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO) funded project for the investigation of CAU 447 at the Project Shoal Area (PSA). All work performed on this project was conducted in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996), and all applicable Nevada Division of Environmental Protection (NDEP) policies and regulations. Investigation activities included the drilling, construction, and development of three monitoring/validation (MV) wells at the PSA. This report summarizes the field activities and data collected during the investigation

Environmental Restoration Remedial Action quality assurance requirements document

International Nuclear Information System (INIS)

1991-01-01

This document defines the quality assurance requirements for the US Department of Energy-Richland Operations Office Environmental Restoration Remedial Action program at the Hanford Site. The Environmental Restoration Remedial Action program implements significant commitments made by the US Department of Energy in the Hanford Federal Facility Agreement and Consent Order entered into with the Washington State Department of Ecology and the US Environmental Protection Agency. This document combines quality assurance requirements from various source documents into one set of requirements for use by the US Department of Energy-Richland Operations Office and other Environmental Restoration Remedial Action program participants. This document will serve as the basis for developing Quality Assurance Program Plans and implementing procedures by the participants. The requirements of this document will be applied to activities affecting quality, using a graded approach based on the importance of the item, service, or activity to the program objectives. The Quality Assurance Program that will be established using this document as the basis, together with other program and technical documents, form an integrated management control system for conducting the Environmental Restoration Remedial Action program activities in a manner that provides safety and protects the environment and public health

A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

Science.gov (United States)

Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

2015-01-01

In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

[Evaluation and improvement of the management of informed consent in the emergency department].

Science.gov (United States)

del Pozo, P; García, J A; Escribano, M; Soria, V; Campillo-Soto, A; Aguayo-Albasini, J L

2009-01-01

To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.

The informed consent process in randomised controlled trials: a nurse-led process.

Science.gov (United States)

Cresswell, Pip; Gilmour, Jean

2014-03-01

Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

Informed consent

International Nuclear Information System (INIS)

Bundy, A.L.

1988-01-01

Numerous articles on informed consent have appeared in medical and legal journals over the past few years. Many of these have been in the radiological literature. This chapter presents an overview of the legal principles behind this controversial topic. Recent articles are reviewed and specific suggestions are made where applicable. The doctrine of informed consent is both a product of and the basis for the physician-patient relationship. Their communications to each other establish the relationship, but once established, heightened degrees of expectations on the patient's part have dictated the need for a more sophisticated level of communication. Since patients and physicians often expect different things of each other, it is imperative that the relationship leads to effective and respectful conversation

75 FR 42785 - Notice of Lodging of Consent Decree Under the Clean Air Act

Science.gov (United States)

2010-07-22

... given that on July 7, 2010, a proposed Consent Decree in United States of America, et al. v. Wise Alloys..., Alabama which contains two affected sources, the Alabama Reclamation Operations and the Alloys Cast House... should refer to United States of America, et al. v. Wise Alloys, LLC, Civil Action No. CV-10-TMP-1811-NW...

Challenges associated with informed consent in low- and low-middle-income countries

Directory of Open Access Journals (Sweden)

Melissa Upjohn

2016-10-01

Full Text Available Frontiers in Veterinary Medicine endorse the Helsinki declaration and guidelines of the International Committee of Medical and Journal Editors, including the requirement to obtain informed consent from all research participants. Whilst the concept of informed consent is well understood in western research environments, its components require further consideration when reviewing studies involving humans and owned animals in low- and middle-income countries (LMICs in order to take account of different social, educational and research norms. This piece identifies some of the challenges that need to be considered and how they might affect the process of obtaining informed consent. It explains the approach taken by an animal welfare non-governmental organization working in LMICs to addressing these challenges. It also identifies questions that reviewers might consider when asked to comment on work originating in this context.

The effect of multimedia interventions on the informed consent process for cataract surgery in rural South India

Directory of Open Access Journals (Sweden)

Abraar Karan

2014-01-01

Full Text Available Context: The provision of ocular surgical interventions for poorer, less educated populations is increasing as a result of increased globalization and outreach. However, these populations still have trouble understanding surgical concepts and are not always fully informed decision makers. Aims: We aimed to test the effect that a multimedia addition to a traditional verbal informed consent would have on patient comprehension of relatively difficult cataract surgical concepts. Settings and Design: We conducted a randomized controlled trial with relatively uneducated patients reporting to a private surgical hospital in Chennai, India. 47 patients were placed into the intervention group and 50 patients were placed into the control group. Materials and Methods: The intervention group was presented with a scripted verbal informed consent as well as a 3-fold pamphlet and a presentation with a 3-dimensional model of the eye. The control group was only presented with a scripted verbal informed consent. The two groups were tested using an 11 item "True/False/I don′t know" quiz directly before the informed consent, directly after the informed consent, and one-day postoperatively. Statistical Analysis Used: Scores on the quiz were compared across groups and time-points using paired t-tests. Results: Patients in the both groups showed a significant improvement in scores between pre- and post-informed consent quizzes (P value on the order of 10 -6 and the improvement in scores was significantly greater in the intervention group than the control group (P value on the order of 10 -16 . There was no significant difference observed in either group with regards to the change in scores between post-informed consent and post-operative quizzes. Conclusion: Multimedia aids in addition to a standard informed consent process are effective in improving patient comprehension even for patients with low literacy and limited knowledge of surgical interventions.

Informed consent comprehension in African research settings.

Science.gov (United States)

Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

2014-06-01

Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

Consent in escrow.

Science.gov (United States)

Van der Loos, Kiah I; Longstaff, Holly; Virani, Alice; Illes, Judy

2015-02-01

Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.

75 FR 17770 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

Science.gov (United States)

2010-04-07

...., Civil Action No. 3:10-cv-00222-RET-CN, was lodged with the United States District Court for the Middle... or e-mailing a request to Tonia Fleetwood ( [email protected] ), fax number (202) 514-0097, phone confirmation number (202) 514-1547. In requesting a copy from the Consent Decree Library, please...

Dynamic axes of informed consent in Japan.

Science.gov (United States)

Specker Sullivan, Laura

2017-02-01

Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

Gravitational effective action at second order in curvature and gravitational waves

International Nuclear Information System (INIS)

Calmet, Xavier; Pryer, Daniel; Capozziello, Salvatore

2017-01-01

We consider the full effective theory for quantum gravity at second order in curvature including non-local terms. We show that the theory contains two new degrees of freedom beyond the massless graviton: namely a massive spin-2 ghost and a massive scalar field. Furthermore, we show that it is impossible to fine-tune the parameters of the effective action to eliminate completely the classical spin-2 ghost because of the non-local terms in the effective action. Being a classical field, it is not clear anyway that this ghost is problematic. It simply implies a repulsive contribution to Newton's potential. We then consider how to extract the parameters of the effective action and show that it is possible to measure, at least in principle, the parameters of the local terms independently of each other using a combination of observations of gravitational waves and measurements performed by pendulum type experiments searching for deviations of Newton's potential. (orig.)

Gravitational effective action at second order in curvature and gravitational waves

Energy Technology Data Exchange (ETDEWEB)

Calmet, Xavier; Pryer, Daniel [University of Sussex, Department of Physics and Astronomy, Brighton (United Kingdom); Capozziello, Salvatore [Universita di Napoli ' ' Federico II' ' , Dipartimento di Fisica ' ' E. Pancini' ' , Naples (Italy); Istituto Nazionale di Fisica Nucleare (INFN), Naples (Italy); Gran Sasso Science Institute, L' Aquila (Italy)

2017-09-15

We consider the full effective theory for quantum gravity at second order in curvature including non-local terms. We show that the theory contains two new degrees of freedom beyond the massless graviton: namely a massive spin-2 ghost and a massive scalar field. Furthermore, we show that it is impossible to fine-tune the parameters of the effective action to eliminate completely the classical spin-2 ghost because of the non-local terms in the effective action. Being a classical field, it is not clear anyway that this ghost is problematic. It simply implies a repulsive contribution to Newton's potential. We then consider how to extract the parameters of the effective action and show that it is possible to measure, at least in principle, the parameters of the local terms independently of each other using a combination of observations of gravitational waves and measurements performed by pendulum type experiments searching for deviations of Newton's potential. (orig.)

Gravitational effective action at second order in curvature and gravitational waves

Science.gov (United States)

Calmet, Xavier; Capozziello, Salvatore; Pryer, Daniel

2017-09-01

We consider the full effective theory for quantum gravity at second order in curvature including non-local terms. We show that the theory contains two new degrees of freedom beyond the massless graviton: namely a massive spin-2 ghost and a massive scalar field. Furthermore, we show that it is impossible to fine-tune the parameters of the effective action to eliminate completely the classical spin-2 ghost because of the non-local terms in the effective action. Being a classical field, it is not clear anyway that this ghost is problematic. It simply implies a repulsive contribution to Newton's potential. We then consider how to extract the parameters of the effective action and show that it is possible to measure, at least in principle, the parameters of the local terms independently of each other using a combination of observations of gravitational waves and measurements performed by pendulum type experiments searching for deviations of Newton's potential.

Gravitational effective action at second order in curvature and gravitational waves.

Science.gov (United States)

Calmet, Xavier; Capozziello, Salvatore; Pryer, Daniel

2017-01-01

We consider the full effective theory for quantum gravity at second order in curvature including non-local terms. We show that the theory contains two new degrees of freedom beyond the massless graviton: namely a massive spin-2 ghost and a massive scalar field. Furthermore, we show that it is impossible to fine-tune the parameters of the effective action to eliminate completely the classical spin-2 ghost because of the non-local terms in the effective action. Being a classical field, it is not clear anyway that this ghost is problematic. It simply implies a repulsive contribution to Newton's potential. We then consider how to extract the parameters of the effective action and show that it is possible to measure, at least in principle, the parameters of the local terms independently of each other using a combination of observations of gravitational waves and measurements performed by pendulum type experiments searching for deviations of Newton's potential.

Doctors’ perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study

OpenAIRE

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul Richard

2016-01-01

Background\\ud The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment.\\ud \\ud Objectives\\ud To explore doctors’ perspectives of gaining informed consent for routine surgical procedures.\\ud \\ud Design\\u...

19 CFR 210.34 - Protective orders; reporting requirement; sanctions and other actions.

Science.gov (United States)

2010-04-01

...; sanctions and other actions. 210.34 Section 210.34 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND ENFORCEMENT Discovery and... order of the Commission or the administrative law judge; (7) That a trade secret or other confidential...

Corrective Action Investigation Plan for Corrective Action Unit 232: Area 25 Sewage Lagoons Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

DOE/NV Operations Office

1999-05-01

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) (1996) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense. The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUs) or Corrective Action Sites (CASs). According to the FFACO, CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites. A CAU consists of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and criteria for conducting site investigation activities at CAU 232, Area 25 Sewage Lagoons. Corrective Action Unit 232 consists of CAS 25-03-01, Sewage Lagoon, located in Area 25 of the Nevada Test Site (NTS). The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1) (DOE/NV, 1996a). The Area 25 Sewage Lagoons (Figure 1-2) (IT, 1999b) are located approximately 0.3 mi south of the Test Cell 'C' (TCC) Facility and were used for the discharge of sanitary effluent from the TCC facility. For purposes of this discussion, this site will be referred to as either CAU 232 or the sewage lagoons.

Corrective Action Plan for Corrective Action Unit 139: Waste Disposal Sites, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2007-07-01

Corrective Action Unit (CAU) 139, Waste Disposal Sites, is listed in the Federal Facility Agreement and Consent Order (FFACO) of 1996 (FFACO, 1996). CAU 139 consists of seven Corrective Action Sites (CASs) located in Areas 3, 4, 6, and 9 of the Nevada Test Site (NTS), which is located approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1). CAU 139 consists of the following CASs: CAS 03-35-01, Burn Pit; CAS 04-08-02, Waste Disposal Site; CAS 04-99-01, Contaminated Surface Debris; CAS 06-19-02, Waste Disposal Site/Burn Pit; CAS 06-19-03, Waste Disposal Trenches; CAS 09-23-01, Area 9 Gravel Gertie; and CAS 09-34-01, Underground Detection Station. Details of the site history and site characterization results for CAU 139 are provided in the approved Corrective Action Investigation Plan (CAIP) (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2006) and in the approved Corrective Action Decision Document (CADD) (NNSA/NSO, 2007). The purpose of this Corrective Action Plan (CAP) is to present the detailed scope of work required to implement the recommended corrective actions as specified in Section 4.0 of the approved CADD (NNSA/NSO, 2007). The approved closure activities for CAU 139 include removal of soil and debris contaminated with plutonium (Pu)-239, excavation of geophysical anomalies, removal of surface debris, construction of an engineered soil cover, and implementation of use restrictions (URs). Table 1 presents a summary of CAS-specific closure activities and contaminants of concern (COCs). Specific details of the corrective actions to be performed at each CAS are presented in Section 2.0 of this report.

Corrective Action Plan for Corrective Action Unit 139: Waste Disposal Sites, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

NSTec Environmental Restoration

2007-01-01

Corrective Action Unit (CAU) 139, Waste Disposal Sites, is listed in the Federal Facility Agreement and Consent Order (FFACO) of 1996 (FFACO, 1996). CAU 139 consists of seven Corrective Action Sites (CASs) located in Areas 3, 4, 6, and 9 of the Nevada Test Site (NTS), which is located approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1). CAU 139 consists of the following CASs: CAS 03-35-01, Burn Pit; CAS 04-08-02, Waste Disposal Site; CAS 04-99-01, Contaminated Surface Debris; CAS 06-19-02, Waste Disposal Site/Burn Pit; CAS 06-19-03, Waste Disposal Trenches; CAS 09-23-01, Area 9 Gravel Gertie; and CAS 09-34-01, Underground Detection Station. Details of the site history and site characterization results for CAU 139 are provided in the approved Corrective Action Investigation Plan (CAIP) (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2006) and in the approved Corrective Action Decision Document (CADD) (NNSA/NSO, 2007). The purpose of this Corrective Action Plan (CAP) is to present the detailed scope of work required to implement the recommended corrective actions as specified in Section 4.0 of the approved CADD (NNSA/NSO, 2007). The approved closure activities for CAU 139 include removal of soil and debris contaminated with plutonium (Pu)-239, excavation of geophysical anomalies, removal of surface debris, construction of an engineered soil cover, and implementation of use restrictions (URs). Table 1 presents a summary of CAS-specific closure activities and contaminants of concern (COCs). Specific details of the corrective actions to be performed at each CAS are presented in Section 2.0 of this report

Corrective Action Investigation Plan for Corrective Action Unit 528: Polychlorinated Biphenyls Contamination, Nevada Test Site, Nevada, Rev. 0

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2003-05-08

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 528, Polychlorinated Biphenyls Contamination (PCBs), Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. Located in the southwestern portion of Area 25 on the NTS in Jackass Flats (adjacent to Test Cell C [TCC]), CAU 528 consists of Corrective Action Site 25-27-03, Polychlorinated Biphenyls Surface Contamination. Test Cell C was built to support the Nuclear Rocket Development Station (operational between 1959 and 1973) activities including conducting ground tests and static firings of nuclear engine reactors. Although CAU 528 was not considered as a direct potential source of PCBs and petroleum contamination, two potential sources of contamination have nevertheless been identified from an unknown source in concentrations that could potentially pose an unacceptable risk to human health and/or the environment. This CAU's close proximity to TCC prompted Shaw to collect surface soil samples, which have indicated the presence of PCBs extending throughout the area to the north, east, south, and even to the edge of the western boundary. Based on this information, more extensive field investigation activities are being planned, the results of which are to be used to support a defensible evaluation of corrective action alternatives in the corrective action decision document.

Corrective Action Investigation Plan for Corrective Action Unit 551: Area 12 Muckpiles, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Boehlecke, Robert F.

2004-01-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 551, Area 12 muckpiles, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the 'Federal Facility Agreement and Consent Order' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 551 is located in Area 12 of the NTS, which is approximately 110 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Area 12 is approximately 40 miles beyond the main gate to the NTS. Corrective Action Unit 551 is comprised of the four Corrective Action Sites (CASs) shown on Figure 1-1 and listed below: (1) 12-01-09, Aboveground Storage Tank and Stain; (2) 12-06-05, Muckpile; (3) 12-06-07, Muckpile; and (4) 12-06-08, Muckpile. Corrective Action Site 12-01-09 is located in Area 12 and consists of an above ground storage tank (AST) and associated stain. Corrective Action Site 12-06-05 is located in Area 12 and consists of a muckpile associated with the U12 B-Tunnel. Corrective Action Site 12-06-07 is located in Area 12 and consists of a muckpile associated with the U12 C-, D-, and F-Tunnels. Corrective Action Site 12-06-08 is located in Area 12 and consists of a muckpile associated with the U12 B-Tunnel. In keeping with common convention, the U12B-, C-, D-, and F-Tunnels will be referred to as the B-, C-, D-, and F-Tunnels. The corrective action investigation (CAI) will include field inspections, radiological surveys, and sampling of media, where appropriate. Data will also be obtained to support waste management decisions

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness.

Science.gov (United States)

Braude, Hillel; Kimmelman, Jonathan

2012-03-01

Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. © 2010 Blackwell Publishing Ltd.

Transitional paternalism: how shared normative powers give rise to the asymmetry of adolescent consent and refusal.

Science.gov (United States)

Manson, Neil C

2015-02-01

In many jurisdictions, adolescents acquire the right to consent to treatment; but in some cases their refusals - e.g. of life-saving treatment - may not be respected. This asymmetry of adolescent consent and refusal seems puzzling, even incoherent. The aim here is to offer an original explanation, and a justification, of this asymmetry. Rather than trying to explain the asymmetry in terms of a variable standard of competence - where the adolescent is competent to consent to, but not refuse, certain interventions - the account offered here focuses more closely on the normative power to render actions permissible. Where normative powers are shared they can readily give rise to an asymmetry between consent and refusal. We then turn to why it is justifiable that normative powers be shared in adolescence. Transitional paternalism holds that the acquisition of normative powers by competent adolescents should not be an instant one, achieved in a single step, but that there should be a transitional period where paternalistic protection is rolled back, but not entirely withdrawn until a later date. Transitional paternalism could be implemented without generating the asymmetry between consent and refusal but, it is argued, the asymmetric version of transitional paternalism is to be preferred insofar as it offers a greater respect for the adolescent's decisions than the symmetrical alternative. © 2014 John Wiley & Sons Ltd.

Towards next-to-leading order transport coefficients from the four-particle irreducible effective action

International Nuclear Information System (INIS)

Carrington, M. E.; Kovalchuk, E.

2010-01-01

Transport coefficients can be obtained from two-point correlators using the Kubo formulas. It has been shown that the full leading order result for electrical conductivity and (QCD) shear viscosity is contained in the resummed two-point function that is obtained from the three-loop three-particle irreducible resummed effective action. The theory produces all leading order contributions without the necessity for power counting, and in this sense it provides a natural framework for the calculation. In this article we study the four-loop four-particle irreducible effective action for a scalar theory with cubic and quartic interactions, with a nonvanishing field expectation value. We obtain a set of integral equations that determine the resummed two-point vertex function. A next-to-leading order contribution to the viscosity could be obtained from this set of coupled equations.

[The meaning of autonomy in Chinese culture: obtaining informed consent for operation].

Science.gov (United States)

Lin, Mei-Ling; Wu, Jo Yung-Wei; Huang, Mei-Chih

2008-10-01

The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.

Area 2 Photo Skid Wastewater Pit corrective action decision document Corrective Action Unit Number 332: Part 1, and Closure report: Part 2

International Nuclear Information System (INIS)

1997-01-01

The Area 2 Photo Skid Wastewater Pit, Corrective Action Site (CAS) Number 02-42-03, the only CAS in Corrective Action Unit (CAU) Number 332, has been identified as a source of unquantified, uncontrolled, and unpermitted wastewater discharge. The Photo Skid was used for photographic processing of film for projects related to weapons testing, using Kodak RA4 and GPX film processing facilities for black and white and color photographs. The CAU is located in Area 2 of the Nevada Test Site, Nye County, Nevada. The CAS consists of one unlined pit which received discharged photographic process wastewater from 1984 to 1991. The Corrective Action Decision Document (CADD) and the Closure Report (CR) have been developed to meet the requirements of the Federal Facility Agreement and Consent Order (FFACO, 1996). The CADD and the CR for this CAS have been combined because sample data collected during the site investigation do not exceed regulatory limits established during the Data Quality Objectives (DQO) process. The purpose of the CADD and the CR is to justify why no corrective action is necessary at the CAU based on process knowledge and the results of the corrective action investigation and to request closure of the CAU. This document contains Part 1 of the CADD and Part 2 of the CR

Ophthalmologists' awareness of informed consent and their compliance to its requirements.

Science.gov (United States)

Ehteshami, Asghar; Isfahani, Sakineh Saghaeiannejad; Saeedbakhsh, Saeed; Isfahani, Mahtab Kasaei

2013-01-01

Healthcare providers' awareness of laws governing medical documents and patients' health-related information is essential in securing the patients' rights. Given the existing legal problems in documentation of medical record of Consent and Acquittal, we decided to perform an investigation examining the levels of ophthalmologists' awareness of legal requirements for medical record of consent and acquittal and how they complied with such requirements at Feiz Teaching Hospital, Isfahan in the year 2011. This research is an applied, descriptive-analytic one. The research population for awareness measurement includes attending ophthalmologists at Feiz Hospital. Filled-in consent record forms recorded in medical document were used to examine the levels of compliance with legal requirements governing medical record of consent and acquittal. Sampling among the attending ophthalmologists was performed using consensus which included 14 ophthalmologists. The files were samples using the statistical formula, resulting in a sample of 303 files. Data collection tools included a questionnaire and a check list. The questionnaire's reliability was estimated through Cronbach's alpha calculation (0.8); and the check list was completed through a survey among professors of Health Information Technology Management department. In a first step, investigators handed a questionnaire containing 12 items to the ophthalmologists in order to assess their levels of awareness from legal Aspects of medical Informed consent and acquittal, and received the completed questionnaire after answering their possible queries on the issue. In the next step the researchers went to the hospital and evaluated the levels of compliance with legal aspects of medical informed consent and acquittal within the files using a check list and by direct observation. Analytic statistics and SPSS software were used to analyze the data; and Pearson test was applied to evaluate the assumed relationship. The findings were

Mercy killing without consent. Historical comments on a controversial issue.

Science.gov (United States)

Lauter, H; Meyer, J E

1982-02-01

In recent discussions on euthanasia the question about mercy killing without consent of mentally ill persons has turned up, particularly in cases of hopeless suffering among senile or chronically insane patients. Possible analogies to the actions under the German Nazi-regimen and relations to the concept of Social Darwinism with suggestions about active eugenic control as propagated in the early part of this century are outlined in a historical review. The implications and obvious dangers of misuse of any such kind of active euthanasia in psychiatry are discussed on this background.

Role of informed consent for intravascular contrast media

International Nuclear Information System (INIS)

Hopper, K.D.; Tyler, H.N. Jr.

1988-01-01

To evaluate the usefulness of different degrees of informed consent for intravascular contrast media, the authors divided 100 patients into four groups: (1) informed consent with no information on intravascular contrast media, (2) simple written informed consent that detailed common risks, (3) detailed written informed consent that detailed all known risks, and (4) MD informed consent, during which a radiologist discussed all known risks of intravascular contrast media. Physician counseling time for group 4 averaged 11.4 minutes. On a postprocedure test about the common complications and risk factors of intravascular contrast media, the average scores were: group 1, 38.4%; group 2, 68.2%; group 3, 63.2%; and group 4, 69.8%. There was no statistical difference between groups 2-4 on the postprocedure test. If informed consent is to be used prior to intravascular contrast media administration, a simple written consent detailing the common risks and risk factors appears to be the best method

The limits of informed consent.

Science.gov (United States)

1975-09-01

The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

Corrective Action Investigation Plan for Corrective Action Unit 137: Waste Disposal Sites, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Wickline, Alfred

2005-01-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 137: Waste Disposal Sites. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 137 contains sites that are located in Areas 1, 3, 7, 9, and 12 of the Nevada Test Site (NTS), which is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 137 is comprised of the eight corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-08-01, Waste Disposal Site; (2) CAS 03-23-01, Waste Disposal Site; (3) CAS 03-23-07, Radioactive Waste Disposal Site; (4) CAS 03-99-15, Waste Disposal Site; (5) CAS 07-23-02, Radioactive Waste Disposal Site; (6) CAS 09-23-07, Radioactive Waste Disposal Site; (7) CAS 12-08-01, Waste Disposal Site; and (8) CAS 12-23-07, Waste Disposal Site. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 137 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by conducting a CAI before evaluating and selecting corrective action

Patient autonomy and informed consent in critically lll

Directory of Open Access Journals (Sweden)

Todorović Zoran M.

2017-01-01

Full Text Available Patient autonomy has been a cornerstone of contemporary clinical ethics since the Nuremberg trial, especially in American school of bioethics. Topic: Patient autonomy has been defined in the Nuremberg Code, and re-defined in the Declaration of Helsinki, Belmont Report and Barcelona Declaration. Founders and followers of the rights-oriented bioethics (for example, Hellegers, Beauchamp and Childers have established and promoted the patient autonomy as the main principle of bio(medical ethics since 1970s. However, there is a lot of controversy surrounding such a principle, especially in vulnerable patients. We aimed at evaluating the real meaning and value of patient autonomy in critical care settings regarding the communication between health workers and their patients and families. Conclusion: Protection of patients autonomy in critically ill is a complex issue. Careful benefit-risk assessment is needed in order to find the most appropriate way of obtaining the informed consent, proxy consent or to omit or delay it.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 232: Area 25 Sewage Lagoons, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

US Department of Energy Nevada Operations Office

1999-01-01

This Corrective Action Decision Document/Closure Report (CADD/CR) has been prepared for Corrective Action Unit (CAU) 232, Area 25 Sewage Lagoons, in accordance with the Federal Facility Agreement and Consent Order. Located at the Nevada Test Site in Nevada, approximately 65 miles northwest of Las Vegas, CAU 232 is comprised of Corrective Action Site 25-03-01, Sewage Lagoon. This CADD/CR identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) recommendation that no corrective action is deemed necessary for CAU 232. The Corrective Action Decision Document and Closure Report have been combined into one report because sample data collected during the July 1999 corrective action investigation (CAI) activities disclosed no evidence of contamination at the site. Contaminants of potential concern (COPCs) addressed during the CAI included total volatile organic compounds, total semivolatile organic compounds, total Resource Conservation and Recovery Act metals, total pesticides, total herbicides, total petroleum hydrocarbons (gasoline and diesel/oil range), polychlorinated biphenyls, isotopic uranium, isotopic plutonium, strontium-90, and gamma-emitting radionuclides. The data confirmed that none of the COPCs identified exceeded preliminary action levels outlined in the CAIP; therefore, no corrective actions were necessary for CAU 232. After the CAI, best management practice activities were completed and included installation of a fence and signs to limit access to the lagoons, cementing Manhole No. 2 and the diverter box, and closing off influent and effluent ends of the sewage lagoon piping. As a result of the CAI, the DOE/NV recommended that: (1) no further actions were required; (2) no Corrective Action Plan would be required; and (3) no use restrictions were required to be placed on the CAU

Corrective Action Decision Document/Closure Report for Corrective Action Unit 511: Waste Dumps (Piles and Debris) Nevada Test Site, Nevada, Rev. No.: 0

Energy Technology Data Exchange (ETDEWEB)

Pastor, Laura

2005-12-01

This Corrective Action Decision Document/Closure Report has been prepared for Corrective Action Unit (CAU) 511, Waste Dumps (Piles & Debris). The CAU is comprised of nine corrective action sites (CASs) located in Areas 3, 4, 6, 7, 18, and 19 of the Nevada Test Site, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (1996). Corrective Action Unit 511 is comprised of nine CASs: (1) 03-08-02, Waste Dump (Piles & Debris); (2) 03-99-11, Waste Dump (Piles); (3) 03-99-12, Waste Dump (Piles & Debris); (4) 04-99-04, Contaminated Trench/Berm; (5) 06-16-01, Waste Dump (Piles & Debris); (6) 06-17-02, Scattered Ordnance/Automatic Weapons Range; (7) 07-08-01, Contaminated Mound; (8) 18-99-10, Ammunition Dump; and (9) 19-19-03, Waste Dump (Piles & Debris). The purpose of this Corrective Action Decision Document/Closure Report is to provide justification and documentation supporting the recommendation for closure of CAU 511 with no further corrective action. To achieve this, corrective action investigation (CAI) and closure activities were performed from January 2005 through August 2005, as set forth in the ''Corrective Action Investigation Plan for Corrective Action Unit 511: Waste Dumps (Piles & Debris)'' (NNSA/NSO, 2004) and Record of Technical Change No. 1. The purpose of the CAI was to fulfill the following data needs as defined during the data quality objective process: (1) Determine whether contaminants of concern (COCs) are present. (2) If COCs are present, determine their nature and extent. (3) Provide sufficient information and data to complete appropriate corrective actions. The CAU 511 dataset from the investigation results was evaluated based on the data quality indicator parameters. This evaluation demonstrated the quality and acceptability of the dataset for use in fulfilling the data quality objective data needs. Analytes detected during the CAI were evaluated against appropriate preliminary

Improving the Proficiency of Research Consent Administrators

Science.gov (United States)

Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

2015-01-01

Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061

12 CFR 980.6 - Finance Board consent.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

Interactive multimedia consent for biobanking: a randomized trial.

Science.gov (United States)

Simon, Christian M; Klein, David W; Schartz, Helen A

2016-01-01

The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

Readability of Invasive Procedure Consent Forms.

Science.gov (United States)

Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

2015-12-01

Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p readability guidelines for patient materials of 6th grade (p readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. © 2015 Wiley Periodicals, Inc.

2008 Groundwater Monitoring Report Central Nevada Test Area, Corrective Action Unit 443

Energy Technology Data Exchange (ETDEWEB)

None

2009-03-01

This report presents the 2008 groundwater monitoring results collected by the U.S. Department of Energy (DOE) Office of Legacy Management (LM) for the Central Nevada Test Area (CNTA) Subsurface Corrective Action Unit (CAU) 443. Responsibility for the environmental site restoration of the CNTA was transferred from the DOE Office of Environmental Management (DOE-EM) to DOE-LM on October 1, 2006. The environmental restoration process and corrective action strategy for CAU 443 are conducted in accordance with the Federal Facility Agreement and Consent Order (FFACO 2005) entered into by DOE, the U.S. Department of Defense, and the State of Nevada. The corrective action strategy for the site includes proof-of-concept monitoring in support of site closure. This report summarizes investigation activities associated with CAU 443 that were conducted at the site during fiscal year 2008. This is the second groundwater monitoring report prepared by DOE-LM for the CNTA.

2008 Groundwater Monitoring Report Central Nevada Test Area, Corrective Action Unit 443

International Nuclear Information System (INIS)

2009-01-01

This report presents the 2008 groundwater monitoring results collected by the U.S. Department of Energy (DOE) Office of Legacy Management (LM) for the Central Nevada Test Area (CNTA) Subsurface Corrective Action Unit (CAU) 443. Responsibility for the environmental site restoration of the CNTA was transferred from the DOE Office of Environmental Management (DOE-EM) to DOE-LM on October 1, 2006. The environmental restoration process and corrective action strategy for CAU 443 are conducted in accordance with the Federal Facility Agreement and Consent Order (FFACO 2005) entered into by DOE, the U.S. Department of Defense, and the State of Nevada. The corrective action strategy for the site includes proof-of-concept monitoring in support of site closure. This report summarizes investigation activities associated with CAU 443 that were conducted at the site during fiscal year 2008. This is the second groundwater monitoring report prepared by DOE-LM for the CNTA

Corrective Action Investigation Plan for Corrective Action Unit No. 423: Building 03-60 Underground Discharge Point, Tonopah Test Range, Nevada

Energy Technology Data Exchange (ETDEWEB)

DOE/NV

1997-10-01

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV), the State of Nevada Division of Environmental Protection (NDEP), and the US Department of Defense. The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUS) or Corrective Action Sites (CASs) (FFACO, 1996). As per the FFACO (1996), CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites. Corrective Action Units consist of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and the criteria for conducting site investigation activities at CAU No. 423, the Building 03-60 Underground Discharge Point (UDP), which is located in Area 3 at the Tonopah Test Range (TTR). The TTR, part of the Nellis Air Force Range, is approximately 225 kilometers (km) (140 miles [mi]) northwest of Las Vegas, Nevada (Figures 1-1 and 1-2). Corrective Action Unit No. 423 is comprised of only one CAS (No. 03-02-002-0308), which includes the Building 03-60 UDP and an associated discharge line extending from Building 03-60 to a point approximately 73 meters (m) (240 feet [ft]) northwest as shown on Figure 1-3.

Corrective Action Plan for Corrective Action Unit 254: Area 25 R-MAD Decontamination Facility Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Obi, C.M.

2000-01-01

The Area 25 Reactor Maintenance, Assembly, and Disassembly Decontamination Facility is identified in the Federal Facility Agreement and Consent Order (FFACO) as Corrective Action Unit (CAU) 254. CAU 254 is located in Area 25 of the Nevada Test Site and consists of a single Corrective Action Site CAS 25-23-06. CAU 254 will be closed, in accordance with the FFACO of 1996. CAU 254 was used primarily to perform radiological decontamination and consists of Building 3126, two outdoor decontamination pads, and surrounding soil within an existing perimeter fence. The site was used to decontaminate nuclear rocket test-car hardware and tooling from the early 1960s through the early 1970s, and to decontaminate a military tank in the early 1980s. The site characterization results indicate that, in places, the surficial soil and building materials exceed clean-up criteria for organic compounds, metals, and radionuclides. Closure activities are expected to generate waste streams consisting of nonhazardous construction waste. petroleum hydrocarbon waste, hazardous waste, low-level radioactive waste, and mixed waste. Some of the wastes exceed land disposal restriction limits and will require off-site treatment before disposal. The recommended corrective action was revised to Alternative 3- ''Unrestricted Release Decontamination, Verification Survey, and Dismantle Building 3126,'' in an addendum to the Correction Action Decision Document

Obtaining consent to oral and maxillofacial surgery.

Science.gov (United States)

Poswillo, D

1989-09-01

The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

Corrective Action Investigation Plan for Corrective Action Unit 406: Area 3 Building 03-74 and Building 03-58 Under ground Discharge Points and Corrective Action Unit 429: Area 3 Building 03-55 and Area 9 Building 09-52 Underground Discharge Points, Tonopah Test Range, Nevada

Energy Technology Data Exchange (ETDEWEB)

DOE/NV

1999-05-20

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense (FFACO, 1996). The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUs) or Corrective Action Sites (CASs). According to the FFACO (1996), CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites. Corrective Action Units consist of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and the criteria for conducting site investigation activities at the Underground Discharge Points (UDPs) included in both CAU 406 and CAU 429. The CAUs are located in Area 3 and Area 9 of the Tonopah Test Range (TTR). The TTR, included in the Nellis Air Force Range, is approximately 255 kilometers (km) (140 miles [mi]) northwest of Las Vegas, Nevada.

76 FR 17071 - Amendment of the Commission's Rules Related to Retransmission Consent

Science.gov (United States)

2011-03-28

... compensation for carriage in retransmission consent negotiations. The legislative history of section 325... Order). Given the dearth of guidance in section 325 and its legislative history, the Commission drew... consumers, noting that ``[c]ompanies shouldn't force cable-watching football fans to scramble for other...

Corrective Action Decision Document for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Grant Evenson

2008-02-01

This Corrective Action Decision Document has been prepared for Corrective Action Unit (CAU) 563, Septic Systems, in accordance with the Federal Facility Agreement and Consent Order (FFACO, 1996; as amended January 2007). The corrective action sites (CASs) for CAU 563 are located in Areas 3 and 12 of the Nevada Test Site, Nevada, and are comprised of the following four sites: •03-04-02, Area 3 Subdock Septic Tank •03-59-05, Area 3 Subdock Cesspool •12-59-01, Drilling/Welding Shop Septic Tanks •12-60-01, Drilling/Welding Shop Outfalls The purpose of this Corrective Action Decision Document is to identify and provide the rationale for the recommendation of a corrective action alternative (CAA) for the four CASs within CAU 563. Corrective action investigation (CAI) activities were performed from July 17 through November 19, 2007, as set forth in the CAU 563 Corrective Action Investigation Plan (NNSA/NSO, 2007). Analytes detected during the CAI were evaluated against appropriate final action levels (FALs) to identify the contaminants of concern (COCs) for each CAS. The results of the CAI identified COCs at one of the four CASs in CAU 563 and required the evaluation of CAAs. Assessment of the data generated from investigation activities conducted at CAU 563 revealed the following: •CASs 03-04-02, 03-59-05, and 12-60-01 do not contain contamination at concentrations exceeding the FALs. •CAS 12-59-01 contains arsenic and chromium contamination above FALs in surface and near-surface soils surrounding a stained location within the site. Based on the evaluation of analytical data from the CAI, review of future and current operations at CAS 12-59-01, and the detailed and comparative analysis of the potential CAAs, the following corrective actions are recommended for CAU 563.

Well Completion Report for Corrective Action Unit 447, Project Shoal Area, Churchill County, Nevada, Rev. No.: 0

Energy Technology Data Exchange (ETDEWEB)

Rick Findlay

2006-09-01

This Well Completion Report is being provided as part of the implementation of the Corrective Action Decision Document (CADD)/Corrective Action Plan (CAP) for Corrective Action Unit (CAU) 447 (NNSA/NSO, 2006a). The CADD/CAP is part of an ongoing U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO) funded project for the investigation of CAU 447 at the Project Shoal Area (PSA). All work performed on this project was conducted in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996), and all applicable Nevada Division of Environmental Protection (NDEP) policies and regulations. Investigation activities included the drilling, construction, and development of three monitoring/validation (MV) wells at the PSA. This report summarizes the field activities and data collected during the investigation.

The acceptability of conducting data linkage research without obtaining consent: lay people's views and justifications.

Science.gov (United States)

Xafis, Vicki

2015-11-17

processes sufficiently in order to consider ethical issues associated with consent preferences. Shifts in views reveal the complexity of such decisions. While privacy protection remained an important consideration for most participants, adequate protection measures adopted in best practice data linkage were viewed by most as protection enough for data linkage to proceed without specific individual consent.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 190: Contaminated Waste Sites, Nevada Test Site, Nevada, Revision 0

International Nuclear Information System (INIS)

Alfred Wickline

2008-01-01

This Corrective Action Decision Document/Closure Report has been prepared for Corrective Action Unit (CAU) 190, Contaminated Waste Sites, Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; U.S. Department of Energy, Environmental Management; U.S. Department of Defense; and DOE, Legacy Management (1996, as amended January 2007). Corrective Action Unit 190 is comprised of the following four corrective action sites (CASs): (1) 11-02-01, Underground Centrifuge; (2) 11-02-02, Drain Lines and Outfall; (3) 11-59-01, Tweezer Facility Septic System; (4) 14-23-01, LTU-6 Test Area The purpose of this Corrective Action Decision Document/Closure Report is to provide justification and documentation supporting the recommendation for closure of CAU 190 with no further corrective action. To achieve this, corrective action investigation (CAI) activities were performed from March 21 through June 26, 2007. All CAI activities were conducted as set forth in the Corrective Action Investigation Plan for Corrective Action Unit 190: Contaminated Waste Sites, Nevada Test Site, Nevada (NNSA/NSO, 2006). The purpose of the CAI was to fulfill the following data needs as defined during the data quality objective process: (1) Determine whether contaminants of concern (COCs) are present. (2) If COCs are present, determine their nature and extent. (3) Provide sufficient information and data to complete appropriate corrective actions. The CAU 190 dataset from the investigation results was evaluated based on the data quality indicator parameters. This evaluation demonstrated the quality and acceptability of the dataset for use in fulfilling the data quality objective data needs

[The origin of informed consent].

Science.gov (United States)

Mallardi, V

2005-10-01

historical viewpoint to be considered as conceptual elements and doctrinal and socio-cultural products, even if at that time, of little practical importance, which belong to the European culture and, in particular, and almost paradoxically, in the light of what happened, to the German culture. The United States of America is held to be the country of origin of informed consent, the initial aim of which was make sure that the correct dignity of the patient's independence be reserved at the time of decision making and choice of medical options. Reports on this topic, in fact, first appeared in the USA, at the beginning of the 18th Century, with problems focusing on and limited to only the simple rights of the patient in giving his/her approval of the health intervention later to be conceptually developed, along the lines of an itinerary with, at intervals, famous legal actions, until in the 20th Century, informed consent was reached, a criterion that, as is well known, foresees and includes not only the important and fundamental autonomy of the patient to decide, which stems ones personal rights, but also the essential objective element, which is, information. The expression informed consent has simply been transposed in Italian and roughly translated in an ambiguous fashion into "consenso informato" when, on the contrary, it should be referred to as "informazione per il consenso" "information for consensus" not only to respect the concept but, surely, for a more correct deciphering and a more precise interpretation related to the numerous concepts it presupposes and implies. Information and consent may be compared to the two sides of the same coin. These are the two important pillars that coincide and are joined giving weight to the medical responsibility, as far as concerns consent to the health intervention: on the one hand, having obtained consent,following correct and sincere information interpreted and deciphered as an important phase and an essential indicator of

Parental And Clinician Views Of Consent In Neonatal Research

LENUS (Irish Health Repository)

O’Shea, N

2018-03-01

Informed consent is an obligatory requirement for research participation1. The process of informed consent states that certain measures must be followed to ensure a research participant has made an informed decision about their participation in a research study2,3. Consent for research should be voluntary, informed, and understood by the consenting individual who must also be competent to do so. In the case of neonatal research informed consent is acquired from parent(s)\\/guardian(s) of a patient.

Corrective Action Investigation Plan for Corrective Action Unit 105: Area 2 Yucca Flat Atmospheric Test Sites Nevada National Security Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Patrick Matthews

2012-09-01

105 will be evaluated based on information collected from a field investigation. Radiological contamination will be evaluated based on a comparison of the total effective dose at sample locations to the dose-based final action level. The total effective dose will be calculated as the total of separate estimates of internal and external dose. Results from the analysis of soil samples will be used to calculate internal radiological dose. Thermoluminescent dosimeters placed at the center of each sample location will be used to measure external radiological dose. Appendix A provides a detailed discussion of the DQO methodology and the DQOs specific to each CAS. This Corrective Action Investigation Plan has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; DOE, Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. Under the Federal Facility Agreement and Consent Order, this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Fieldwork will be conducted after the plan is approved.

Unanimous Constitutional Consent and the Immigration Problem

OpenAIRE

Josten, Stefan D.; Zimmermann, Klaus W.

2004-01-01

This paper utilizes the cross-cutting cleavages approach to evaluate the probability of a unanimous constitutional consent and, based on these results, discusses the implications of immigration on an existing constitutional consent. It is shown that previous conclusions of beneficial effects stemming from a multitude of political dimensions for a unanimous constitutional consent crucially depend on the assumption of an extreme mode of intrapersonal compensation of constitutional majority and ...

Underground Test Area (UGTA) Closure Report for Corrective Action Unit 98: Frenchman Flat Nevada National Security Site, Nevada, Revision 1 ROTC-1

International Nuclear Information System (INIS)

Farnham, Irene

2016-01-01

This Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 98, Frenchman Flat, Nevada National Security Site (NNSS), Nevada. The Frenchman Flat CAU was the site of 10 underground nuclear tests, some of which have impacted groundwater near the tests. This work was performed as part of the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) Underground Test Area (UGTA) Activity in accordance with the Federal Facility Agreement and Consent Order (FFACO). This CR describes the selected corrective action to be implemented during closure to protect human health and the environment from the impacted groundwater

Underground Test Area (UGTA) Closure Report for Corrective Action Unit 98: Frenchman Flat Nevada National Security Site, Nevada, Revision 1 ROTC-1

Energy Technology Data Exchange (ETDEWEB)

Farnham, Irene [Navarro-Intera, LLC (N-I), Las Vegas, NV (United States)

2016-08-01

This Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 98, Frenchman Flat, Nevada National Security Site (NNSS), Nevada. The Frenchman Flat CAU was the site of 10 underground nuclear tests, some of which have impacted groundwater near the tests. This work was performed as part of the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) Underground Test Area (UGTA) Activity in accordance with the Federal Facility Agreement and Consent Order (FFACO). This CR describes the selected corrective action to be implemented during closure to protect human health and the environment from the impacted groundwater

76 FR 11756 - Action Affecting Export Privileges; Ali Amirnazmi; Order Denying Export Privileges

Science.gov (United States)

2011-03-03

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Action Affecting Export Privileges; Ali Amirnazmi; Order Denying Export Privileges In the Matter of: Ali Amirnazmi, Register 63302-066, FCI... release and forfeit $81,277.37. Section 766.25 of the Export Administration Regulations (``EAR'' or...

Description of a Mobile-based Electronic Informed Consent System Development.

Science.gov (United States)

Hwang, Min-A; Kwak, In Ja

2015-01-01

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

Voluntary Informed Consent in Paediatric Oncology Research.

Science.gov (United States)

Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

2016-07-01

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

Corrective action investigation plan for Corrective Action Unit 342: Area 23 Mercury Fire Training Pit, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-03-01

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense (FFACO, 1996). The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUs) or Corrective Action Sites (CASs). According to the FFACO, CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites (FFACO, 1996). Corrective Action Units consist of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and the criteria for conducting site investigation activities at CAU 342, the Area 23 Mercury Fire Training Pit (FTP), which is located in Area 23 at the Nevada Test Site (NTS). The NTS is approximately 88 km (55 mi) northwest of Las Vegas, Nevada. Corrective Action Unit 342 is comprised of CAS 23-56-01. The FTP is an area approximately 100 m by 140 m (350 ft by 450 ft) located west of the town of Mercury, Nevada, which was used between approximately 1965 and 1990 to train fire-fighting personnel (REECo, 1991; Jacobson, 1991). The surface and subsurface soils in the FTP have likely been impacted by hydrocarbons and other contaminants of potential concern (COPC) associated with burn activities and training exercises in the area.

Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

Science.gov (United States)

Mellado, J M

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Closure Report for Corrective Action Unit 330: Areas 6, 22, and 23 Tanks and Spill Sites, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

A. T. Urbon

2003-07-01

This Closure Report (CR) documents the activities performed to close Corrective Action Unit (CAU) 330: Areas 6, 22, and 23 Tanks and Spill Sites, in accordance with the Federal Facility Agreement and Consent Order (FFACO of 1996), and the Nevada Division of Environmental Protection (NDEP)-approved Streamlined Approach for Environmental Restoration (SAFER) Plan for CAU 330: Areas 6, 22, and 23 Tanks and Spill Sites, Nevada Test Site (NTS), Nevada (U.S. Department of Energy, National Nuclear Security Administration Nevada Operation Office [NNSA/NV], 2001). CAU 330 consists of the following four Corrective Action Sites (CASs): 06-02-04, 22-99-06, 23-01-02, and 23-25-05 (Figure 1).

Free will and psychiatric assessments of criminal responsibility: a parallel with informed consent.

Science.gov (United States)

Meynen, Gerben

2010-11-01

In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice.

Informed consent: Enforcing pharmaceutical companies' obligations abroad.

Science.gov (United States)

Lee, Stacey B

2010-06-15

The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258

Directory of Open Access Journals (Sweden)

Weeks Andrew

2006-05-01

Full Text Available Abstract Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled.

Time to address the problem of post-mortem procurement of organs for transplantation occurring without proper pre-mortem consent.

Science.gov (United States)

Garwood-Gowers, Austen

2013-09-01

Current cadaveric organ transplant systems allow individuals to be classified as donors after death where they registered wishes in favour of this prior to death. However, systems for registering wishes pertaining to donation fall woefully short of securing proper consent. Furthermore, even jurisdictions which technically require consent to be obtained in order to treat an individual as a donor, allow that consent to be given by next of kin after death in circumstances where there is no evidence of the individual having refused prior to death. This article explores these and related issues with current systems from the perspectives of health law norms, ethics and human rights. It concludes that proper pre-mortem consent ought to be a pre-requisite for post-mortem organ transplantation.

Disclosing details about the medical treatment of a deceased public figure in a book: Who should have consented to the disclosures in Mandela’s Last Days

Directory of Open Access Journals (Sweden)

D McQuoid-Mason

2017-11-01

Full Text Available A recently published book by the head of Nelson Mandela’s medical team made personal disclosures about his treatment of the late president in his final years up until his death. The author claimed that he had written the book at the request of family members. This was contested by some family members and the executors of Mandela’s estate, and the book was subsequently withdrawn by the publishers. The Mandela book case raises ethical and legal questions about who should consent to publication of medical information about public figures after their death. The ethical rules of conduct of the Health Professions Council of South Africa (HPCSA state that confidential information about a deceased person should only be divulged ‘with the written consent of his or her next of kin or the executor of his or her estate’. ‘Next of kin’ is not defined, however, and problems arise when family members and the executors are divided about giving such written consent. It is recommended that in such cases the specific order of priority for consent by relatives in the National Health Act be followed. However, conduct that is unethical under the rules of the HPCSA may not necessarily be actionable under the law. For instance, the law does not protect the confidentiality of deceased persons, and generally when people die their constitutional and common-law personality rights – including their right to privacy and confidentiality – die with them. This means that the next of kin or executors of the estates of deceased persons may not bring actions for damages on behalf of such persons for breaches of confidentiality arising after their deaths. The next of kin may, however, sue in their personal capacity if they can show that the disclosures were an unlawful invasion of their own privacy. Conversely, if the privacy of interests of the next of kin are not harmed where there has been publication without their consent

Competence for Contract and Competence to Consent to Treatment

OpenAIRE

前田, 泰

2008-01-01

This paper analyzes assessing competence to consent to treatment. It focuses on problems of competence for contract and competence to consent to treatment. Finally, it discusses the degree of assessing competence to consent to treatment.

Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales.

Science.gov (United States)

Wood, Fiona; Prout, Hayley; Bayer, Antony; Duncan, Donna; Nuttall, Jacqueline; Hood, Kerenza; Butler, Christopher C

2013-08-09

Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies. Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes. Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study. Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a

Closure Report for Corrective Action Unit 230: Area 22 Sewage Lagoons and Corrective Action Unit 320: Area 22 Desert Rock Airport Strainer Box Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

D. S. Tobiason

2001-07-01

This Closure Report (CR) describes the remediation activities performed and the results of verification sampling conducted at Corrective Action Unit (CAU) 230, Area 22 Sewage Lagoons and CAU 320, Area 22 Desert Rock Airport Strainer Box. The CAU is currently listed in Appendix III of the Federal Facility Agreement and Consent Order (FFACO, 1996). The CAU is located in Area 22 of the Nevada Test Site (NTS) (Figure 1) and consists of the following Corrective Action Sites (CASs): 22-03-01- Sewage Lagoon (CAU 230); and 22-99-01- Strainer Box (CAU 320). Included with CAS 22-99-01 is a buried Imhoff tank and a sludge bed. These CAUs will be collectively referred to in this plan as the Area 22 Sewage Lagoons site. Site characterization activities were done during September 1999. Characterization of the manholes associated with the septic system leading to the Imhoff tank was done during March 2000. The results of the characterization presented in the Corrective Action Decision Document (CADD) indicated that only the sludge bed (CAS 22-99-01) contained constituents of concern (COC) above action levels and required remediation (U.S. Department of Energy, Nevada Operations Office [DOE/NV], 2000a).

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

Science.gov (United States)

Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

2015-01-01

Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication

Draft Hanford Remedial Action Environmental Impact Statement and Comprehensive Land Use Plan: Volume 2 of 4

International Nuclear Information System (INIS)

1996-08-01

This appendix discusses the scope of actions addressed in the Draft Hanford Remedial Action Environmental Impact Statement and Comprehensive Land Use Plan. To address the purpose and need for agency action identified in Chapter 2.0 of the HRA-EIS, the scope includes an evaluation of the potential environmental impacts associated with the remedial actions to be conducted by the US Department of Energy (DOE) under the provisions of the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) (Ecology et al. 1989). These remedial actions would bring the Hanford Site into compliance with the applicable requirements of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) and the Resource Conservation and Recovery Act of 1976 (RCRA). The DOE program responsible for conducting remedial actions at the Hanford Site is referred to as the Richland Environmental Restoration (ER) Project. The Richland ER Project encompasses the following projects: radiation area remedial actions and underground storage tanks (UST); RCRA closures; single-shell tank (SST) closures; past-practice waste site operable unit (source and groundwater) remedial actions; surplus facility decommissioning; and waste storage and disposal facilities

Applicable or relevant and appropriate requirements (ARARs) for remedial actions at the Portsmouth Gaseous Diffusion Plant: A compendium of environmental laws and guidance

International Nuclear Information System (INIS)

Houlberg, L.M.; Eaton, L.A.; Martin, J.A.; McDonald, E.P.; Etnier, E.L.

1992-02-01

Section 121 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1990 (CERCLA) specifies that remedial actions for cleanup of hazardous substances must comply with applicable or relevant and appropriate requirements (ARARs) or standards under federal and state environmental laws. Although the US Department of Energy (DOE) Portsmouth Gaseous Diffusion Plant (PORTS) has not at this time been proposed for inclusion on the US Environmental Protection Agency National Priorities List, under Sect. I of an administrative consent order signed by DOE and the US Environmental Protection Agency on September 29, 1989, effective October 4, 1989, any necessary response actions at PORTS stipulated in the administrative consent order must be performed in a manner consistent with the Resource Conservation and Recovery Act of 1976 and CERCLA. Section 121 of CERCLA calls for the preparation of a draft listing of all ARARs. This report supplies a preliminary list of available federal and state ARARs that might be considered for remedial response at PORTS. A description of the terms ''applicable'' and ''relevant and appropriate'' is provided, as well as definitions of chemical-, location-, and action-specific ARARs. ARARs promulgated by the federal government and by the state of Ohio are listed in tables. In addition, the major provisions of the Resource Conservation and Recovery Act, Safe Drinking Water Act, Clean Water Act, and other acts, as they apply to hazardous waste cleanup, are discussed

Corrective action investigation plan for the Roller Coaster RADSAFE Area, Corrective Action Unit 407, Tonopah Test Range, Nevada

International Nuclear Information System (INIS)

1998-04-01

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense (FFACO, 1996). The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUs) or Corrective Action Sites (CASs). According to the FFACO (1996), CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites. CAUs consist of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and the criteria for conducting site investigation activities at CAU No. 407, the Roller Coaster RADSAFE Area (RCRSA) which is located on the Tonopah Test Range (TTR). The TTR, included in the Nellis Air Force Range Complex, is approximately 255 km (140 mi) northwest of Las Vegas, Nevada. CAU No. 407 is comprised of only one CAS (TA-23-001-TARC). The RCRSA was used during May and June 1963 to decontaminate vehicles, equipment, and personnel from the Clean Slate tests. The surface and subsurface soils are likely to have been impacted by plutonium and other contaminants of potential concern (COPCs) associated with decontamination activities at this site. The purpose of the corrective action investigation described in this CAIP is to: identify the presence and nature of COPCs; determine the vertical and lateral extent of COPCs; and provide sufficient information and data to develop and evaluate appropriate corrective actions for the CAS

Testing an alternate informed consent process.

Science.gov (United States)

Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

2009-01-01

One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

Corrective Action Decision Document for Corrective Action Unit 516: Septic Systems and Discharge Points, Nevada Test Site, Nevada: Revision 1

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2004-04-28

This Corrective Action Decision Document (CADD) identifies and rationalizes the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's selection of a recommended corrective action alternative appropriate to facilitate the closure of Corrective Action Unit (CAU) 516: Septic Systems and Discharge Points, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. Located in Areas 3, 6, and 22 on the NTS, CAU 516 includes six Corrective Action Sites (CASs) consisting of two septic systems, a sump and piping, a clean-out box and piping, dry wells, and a vehicle decontamination area. Corrective action investigation activities were performed from July 22 through August 14, 2003, with supplemental sampling conducted in late 2003 and early 2004. The potential exposure pathways for any contaminants of concern (COCs) identified during the development of the DQOs at CAU 516 gave rise to the following objectives: (1) prevent or mitigate exposure to media containing COCs at concentrations exceeding PALs as defined in the corrective action investigation plan; and (2) prevent the spread of COCs beyond each CAS. The following alternatives have been developed for consideration at CAU 516: Alternative 1 - No Further Action; Alternative 2 - Clean Closure; and Alternative 3 - Closure in Place with Administrative Controls. Alternative 1, No Further Action, is the preferred corrective action for two CASs (06-51-02 and 22-19-04). Alternative 2, Clean Closure, is the preferred corrective action for four CASs (03-59-01, 03-59-02, 06-51-01, and 06-51-03). The selected alternatives were judged to meet all requirements for the technical components evaluated, as well as meeting all applicable state and federal regulations for closure of the site and will further eliminate the contaminated media at CAU 516.

Closure Report for Corrective Action Unit 415: Project 57 No. 1 Plutonium Dispersion (NTTR) Nevada Test and Training Range, Nevada, Revision 0 with ROTC-1

Energy Technology Data Exchange (ETDEWEB)

Sloop, Christina

2017-12-01

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 415: Project 57 No. 1 Plutonium Dispersion, which is located on Range 4808A of the Nevada Test and Training Range (NTTR). This CR complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. CAU 415 comprises one corrective action site (CAS): NAFR-23-02, Pu Contaminated Soil. The purpose of this CR is to provide justification and documentation supporting the recommendation that no further corrective action is needed for CAU 415 based on the implementation of the corrective action of Closure in Place.

Informed Consent in the Field of Language and Sexuality

DEFF Research Database (Denmark)

Mortensen, Kristine Køhler

2015-01-01

In order to understand how sexual and romantic relations are established and negotiated in discourse, the field of language and sexuality is dependent upon empirical data from naturally occurring spontaneous interaction. However, detailed discussions of research methods are lacking in the field...... argue that institutionalized informed consent procedures may undercut participant agency and expose symbolic violence towards their carefully built interactional framework. The analysis demonstrates participants’ ability to negotiate ethical issues and to turn such issues into a contribution...

Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

Science.gov (United States)

Osuji, Peter I

2018-03-01

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

[Dentistry and healthcare legislation 3: informed consent].

Science.gov (United States)

Brands, W G; van der Ven, J M; Eijkman, M A J

2013-06-01

The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

Legal protection of informed consent of minors.

Science.gov (United States)

Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

Closure Report for Corrective Action Unit 230: Area 22 Sewage Lagoons and Corrective Action Unit 320: Area 22 Desert Rock Airport Strainer Box Nevada Test Site, Nevada; TOPICAL

International Nuclear Information System (INIS)

D. S. Tobiason

2001-01-01

This Closure Report (CR) describes the remediation activities performed and the results of verification sampling conducted at Corrective Action Unit (CAU) 230, Area 22 Sewage Lagoons and CAU 320, Area 22 Desert Rock Airport Strainer Box. The CAU is currently listed in Appendix III of the Federal Facility Agreement and Consent Order (FFACO, 1996). The CAU is located in Area 22 of the Nevada Test Site (NTS) (Figure 1) and consists of the following Corrective Action Sites (CASs): 22-03-01- Sewage Lagoon (CAU 230); and 22-99-01- Strainer Box (CAU 320). Included with CAS 22-99-01 is a buried Imhoff tank and a sludge bed. These CAUs will be collectively referred to in this plan as the Area 22 Sewage Lagoons site. Site characterization activities were done during September 1999. Characterization of the manholes associated with the septic system leading to the Imhoff tank was done during March 2000. The results of the characterization presented in the Corrective Action Decision Document (CADD) indicated that only the sludge bed (CAS 22-99-01) contained constituents of concern (COC) above action levels and required remediation (U.S. Department of Energy, Nevada Operations Office[DOE/NV], 2000a)

Informed consent for braces.

Science.gov (United States)

Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

2014-05-01

The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

HIV testing and informed consent - ethical considerations

African Journals Online (AJOL)

donation; and the protection of third parties, including the health care worker. .... closest available relative or, in the case of a minor, the consent of the medical ... case informed consent to the taking of blood is obviously mandatory. . Blood ...

Consent to tissue banking for research: qualitative study and recommendations.

Science.gov (United States)

Soto, Carmen; Tarrant, Carolyn; Pritchard-Jones, Kathy; Dixon-Woods, Mary

2012-07-01

To explore how families of children with cancer experience giving consent for tissue banking and to produce recommendations on good practice. 79 participants from 42 families (41 mothers, 18 fathers, 20 children and young people with cancer) took part in semistructured interviews to explore their experiences of being approached for consent to tissue banking. Tertiary care facilities for childhood cancer. Families are generally supportive of tissue banking, although they report that it may be difficult for them to consider all the implications when asked for consent. They typically do not want detailed information when consent is sought close to diagnosis, preferring to see tissue banking as part of routine practice. Families often recognise that their consent may not be fully informed, but are content to give consent based on their understanding at the time. Some may want a chance to go over the information and revisit their decision when things have settled. Families' views can inform practical recommendations for optimising the experience of consent for tissue banking. Current guidelines for obtaining consent should be revisited to take account of families' preferences.

Corrective Action Decision Document for Corrective Action Unit 240: Area 25 Vehicle Washdown, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

US Department of Energy Nevada Operations Office

1999-01-01

This Corrective Action Decision Document identifies and rationalizes the U.S. Department of Energy, Nevada Operations Offices's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 240: Area 25 Vehicle Washdown, Nevada Test Site, Nevada. This corrective action investigation was conducted in accordance with the Corrective Action Investigation Plan for CAU 240 as developed under the Federal Facility Agreement and Consent Order. Located in Area 25 at the Nevada Test Site in Nevada, CAU 240 is comprised of three Corrective Action Sites (CASs): 25-07-01, Vehicle Washdown Area (Propellant Pad); 25-07-02, Vehicle Washdown Area (F and J Roads Pad); and 25-07-03, Vehicle Washdown Station (RADSAFE Pad). In March 1999, the corrective action investigation was performed to detect and evaluate analyte concentrations against preliminary action levels (PALs) to determine contaminants of concern (COCs). There were no COCs identified at CAS 25-07-01 or CAS 25-07-03; therefore, there was no need for corrective action at these two CASs. At CAS 25-07-02, diesel-range organics and radionuclide concentrations in soil samples from F and J Roads Pad exceeded PALs. Based on this result, potential CAAs were identified and evaluated to ensure worker, public, and environmental protection against potential exposure to COCs in accordance with Nevada Administrative Code 445A. Following a review of potential exposure pathways, existing data, and future and current operations in Area 25, two CAAs were identified for CAU 240 (CAS 25-07-02): Alternative 1 - No Further Action and Alternative 2 - Clean Closure by Excavation and Disposal. Alternative 2 was identified as the preferred alternative. This alternative was judged to meet all requirements for the technical components evaluated, compliance with all applicable state and federal regulations for closure of the site, as well as minimizing potential future exposure

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

Science.gov (United States)

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

A survey of doctors at a UK teaching hospital to assess understanding of recent changes to consent law.

Science.gov (United States)

O'Brien, J W; Natarajan, M; Shaikh, I

2017-06-01

The UK Supreme Court recently ruled that when consenting patients for treatments or procedures, clinicians must also discuss any associated material risks. We surveyed medical staff at a large UK teaching hospital in order to ascertain knowledge of consent law and current understanding of this change. Email survey sent to medical staff in all specialities at Norfolk and Norwich University Hospital in February 2016. 245 responses (141 Consultants and 104 junior doctors, response rate 32%). 82% consent patients for procedures at least monthly and 23% daily. 31% were not familiar with the concept of material risk. 35% were familiar with the recent change in consent law, 41% were not. 18% were "very uncertain" and 64% "a little uncertain" that their consenting process meets current legal requirements. >92% think that landmark cases and changes in law should be discussed through professional bodies and circulated better locally. The majority were not familiar with the concept of material risk and recent legal changes. A majority were not confident that their practice meets current requirements, suggesting that recent changes in consent law may not be widely understood at this hospital. We suggest more guidance and education may be necessary than is currently available. Increased understanding of recent changes to consent law will reduce the risk taken by NHS trusts and offer patients a service compliant with Supreme Court guidance.

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.

Science.gov (United States)

Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

2015-09-18

Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Mixed method survey, interview and focus group study. 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). 12 UK children's hospitals. Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-07-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

Corrective Action Investigation Plan for Corrective Action Unit 230: Area 22 Sewage Lagoons and Corrective Action Unit 320: Area 22 Desert Rock Airport Strainer Box, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

1999-01-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operation Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 230/320 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 230 consists of Corrective Action Site (CAS) 22-03-01, Sewage Lagoon; while CAU 320 consists of CAS 22-99-01, Strainer Box. These CAUs are referred to as CAU 230/320 or the Sewage Lagoons Site. The Sewage Lagoons Site also includes an Imhoff tank, sludge bed, and associated buried sewer piping. Located in Area 22, the site was used between 1951 to 1958 for disposal of sanitary sewage effluent from the historic Camp Desert Rock Facility at the Nevada Test Site in Nevada. Based on site history, the contaminants of potential concern include volatile organic compounds (VOCs), semivolatile organic compounds, total petroleum hydrocarbons (TPH), and radionuclides. Vertical migration is estimated to be less than 12 feet below ground surface, and lateral migration is limited to the soil immediately adjacent to or within areas of concern. The proposed investigation will involve a combination of field screening for VOCs and TPH using the direct-push method and excavation using a backhoe to gather soil samples for analysis. Gamma spectroscopy will also be conducted for waste management purposes. Sampling locations will be biased to suspected worst-case areas including the nearby sludge bed, sewage lagoon inlet(s) and outlet(s), disturbed soil surrounding the lagoons, surface drainage channel south of the lagoons, and the area near the Imhoff tank. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document

Non-completion and informed consent.

Science.gov (United States)

Wertheimer, Alan

2014-02-01

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

The changing face of informed surgical consent.

LENUS (Irish Health Repository)

Oosthuizen, J C

2012-03-01

To determine whether procedure-specific brochures improve patients\\' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed \\'Request for Treatment\\' consenting process is viable on a large scale.

Consenting to Heteronormativity: Assumptions in Biomedical Research

NARCIS (Netherlands)

Cottingham, M.D.; Fisher, J.A.

2015-01-01

The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of

Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

Directory of Open Access Journals (Sweden)

Verheijde Joseph L

2006-12-01

Full Text Available Abstract Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47, 79% (57–86, and 75% (50–100, respectively. The informed consent score was 0% (0–33. The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

Changing trends in informed consent

OpenAIRE

Victor Lim

2014-01-01

Abstract: Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decisi...

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics.

NARCIS (Netherlands)

Brons, S.; Becking, A.G.; Tuinzing, D.B.

2009-01-01

PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

Value of informed consent in surgical orthodontics

NARCIS (Netherlands)

Brons, Sander; Becking, Alfred G.; Tuinzing, D. Bram

2009-01-01

Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was

Consent and assessment of capacity to decide or refuse treatment.

Science.gov (United States)

Simpson, Owena

Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.

Optimizing Opt-Out Consent for Record Linkage

Directory of Open Access Journals (Sweden)

Das Marcel

2014-09-01

Full Text Available This article reports on a study testing the effects of different ways of administering an opt-out consent for record linkage in a probability-based Internet panel. First, we conducted cognitive interviews to explore reactions to a draft version of the opt-out consent text. Second, we conducted a two-factor experiment to test the effects of content manipulations and mode. The results indicate that the way in which respondents were informed did not have much effect on opting out. Results from a follow-up survey on attitudes regarding privacy, confidentiality, and trust, along with knowledge questions about the process of linking, showed no evidence that presenting the opt-out consent statement makes respondents more concerned about privacy. Knowledge about the aspects of record linkage is generally not high. When looking at long-term effects of sending an opt-out consent statement, we found no evidence that this leads to higher attrition or lower participation rates.

Actions, topological terms and boundaries in first-order gravity: A review

Science.gov (United States)

Corichi, Alejandro; Rubalcava-García, Irais; Vukašinac, Tatjana

2016-03-01

In this review, we consider first-order gravity in four dimensions. In particular, we focus our attention in formulations where the fundamental variables are a tetrad eaI and a SO(3, 1) connection ωaIJ. We study the most general action principle compatible with diffeomorphism invariance. This implies, in particular, considering besides the standard Einstein-Hilbert-Palatini term, other terms that either do not change the equations of motion, or are topological in nature. Having a well defined action principle sometimes involves the need for additional boundary terms, whose detailed form may depend on the particular boundary conditions at hand. In this work, we consider spacetimes that include a boundary at infinity, satisfying asymptotically flat boundary conditions and/or an internal boundary satisfying isolated horizons boundary conditions. We focus on the covariant Hamiltonian formalism where the phase space Γ is given by solutions to the equations of motion. For each of the possible terms contributing to the action, we consider the well-posedness of the action, its finiteness, the contribution to the symplectic structure, and the Hamiltonian and Noether charges. For the chosen boundary conditions, standard boundary terms warrant a well posed theory. Furthermore, the boundary and topological terms do not contribute to the symplectic structure, nor the Hamiltonian conserved charges. The Noether conserved charges, on the other hand, do depend on such additional terms. The aim of this manuscript is to present a comprehensive and self-contained treatment of the subject, so the style is somewhat pedagogical. Furthermore, along the way, we point out and clarify some issues that have not been clearly understood in the literature.

Corrective Action Decision Document for Corrective Action Unit 428: Area 3 Septic Waste Systems 1 and 5, Tonopah Test Range, Nevada

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, Nevada Operations Office

2000-02-08

This Corrective Action Decision Document identifies and rationalizes the US Department of Energy, Nevada Operations Office's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 428, Septic Waste Systems 1 and 5, under the Federal Facility Agreement and Consent Order. Located in Area 3 at the Tonopah Test Range (TTR) in Nevada, CAU 428 is comprised of two Corrective Action Sites (CASs): (1) CAS 03-05-002-SW01, Septic Waste System 1 and (2) CAS 03-05-002- SW05, Septic Waste System 5. A corrective action investigation performed in 1999 detected analyte concentrations that exceeded preliminary action levels; specifically, contaminants of concern (COCs) included benzo(a) pyrene in a septic tank integrity sample associated with Septic Tank 33-1A of Septic Waste System 1, and arsenic in a soil sample associated with Septic Waste System 5. During this investigation, three Corrective Action Objectives (CAOs) were identified to prevent or mitigate exposure to contents of the septic tanks and distribution box, to subsurface soil containing COCs, and the spread of COCs beyond the CAU. Based on these CAOs, a review of existing data, future use, and current operations in Area 3 of the TTR, three CAAs were developed for consideration: Alternative 1 - No Further Action; Alternative 2 - Closure in Place with Administrative Controls; and Alternative 3 - Clean Closure by Excavation and Disposal. These alternatives were evaluated based on four general corrective action standards and five remedy selection decision factors. Based on the results of the evaluation, the preferred CAA was Alternative 3. This alternative meets all applicable state and federal regulations for closure of the site and will eliminate potential future exposure pathways to the contaminated soils at the Area 3 Septic Waste Systems 1 and 5.

Remedial design and remedial action guidance for the Idaho National Engineering Laboratory

International Nuclear Information System (INIS)

1993-10-01

The US Department of Energy, Idaho Operations Office (DOE-ID), the US Environmental Protection Agency, Region X (EPA), and the Idaho Department of Health and Welfare (IDHW) have developed this guidance on the remedial design and remedial action (RD/RA) process. This guidance is applicable to activities conducted under the Idaho National Engineering Laboratory (INEL) Federal Facility Agreement and Consent Order (FFA/CO) and Action Plan. The INEL FFA/CO and Action Plan provides the framework for performing environmental restoration according to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The guidance is intended for use by the DOE-ID, the EPA, and the IDHW Waste Area Group (WAG) managers and others involved in the planning and implementation of CERCLA environmental restoration activities. The scope of the guidance includes the RD/RA strategy for INEL environmental restoration projects and the approach to development and review of RD/RA documentation. Chapter 2 discusses the general process, roles and responsibilities, and other elements that define the RD/RA strategy. Chapters 3 through 7 describe the RD/RA documents identified in the FFA/CO and Action Plan. Chapter 8 provides examples of how this guidance can be applied to restoration projects. Appendices are included that provide excerpts from the FFA/CO pertinent to RD/RA (Appendix A), a applicable US Department of Energy (DOE) orders (Appendix B), and an EPA Engineering ''Data Gaps in Remedial Design'' (Appendix C)

Informed Consent: An Ethical Obligation or Legal Compulsion?

OpenAIRE

Satyanarayana Rao, K H

2008-01-01

Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.

42 CFR 50.205 - Consent form requirements.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Consent form requirements. 50.205 Section 50.205 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form...

Informed consent - a survey of doctors' practices in South Africa ...

African Journals Online (AJOL)

Informed consent - a survey of doctors' practices in South Africa. ... whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent ...

75 FR 25202 - Action Affecting Export Privileges; Orion Air, S.L. and Syrian Pearl Airlines; Order Renewing...

Science.gov (United States)

2010-05-07

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Action Affecting Export Privileges; Orion Air, S.L. and Syrian Pearl Airlines; Order Renewing Order Temporarily Denying Export Privileges Orion... Denying the Export Privileges of Respondents Orion Air, S.L. (``Orion Air'') and Syrian Pearl Airlines...

An Alternative Consent Process for Minimal Risk Research in the ICU.

Science.gov (United States)

Terry, Melissa A; Freedberg, Daniel E; Morris, Marilyn C

2017-09-01

Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Prospective cohort study. Five ICUs within a tertiary care hospital. Newly admitted ICU patients 18 years old or older. We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

Hamilton-Jacobi approach for first order actions and theories with higher derivatives

International Nuclear Information System (INIS)

Bertin, M.C.; Pimentel, B.M.; Pompeia, P.J.

2008-01-01

In this work, we analyze systems described by Lagrangians with higher order derivatives in the context of the Hamilton-Jacobi formalism for first order actions. Two different approaches are studied here: the first one is analogous to the description of theories with higher derivatives in the hamiltonian formalism according to [D.M. Gitman, S.L. Lyakhovich, I.V. Tyutin, Soviet Phys. J. 26 (1983) 730; D.M. Gitman, I.V. Tyutin, Quantization of Fields with Constraints, Springer-Verlag, New York, Berlin, 1990] the second treats the case where degenerate coordinate are present, in an analogy to reference [D.M. Gitman, I.V. Tyutin, Nucl. Phys. B 630 (2002) 509]. Several examples are analyzed where a comparison between both approaches is made

Research participation by people with intellectual disability and mental health issues: an examination of the processes of consent.

Science.gov (United States)

Taua, Chris; Neville, Christine; Hepworth, Julie

2014-12-01

Balancing the demands of research and ethics is always challenging, and even more so when recruiting vulnerable groups. Within the context of current legislation and international human rights declarations, it is strongly advocated that research can and must be undertaken with all recipients of health-care services. Research in the field of intellectual disability presents particular challenges in regards to consenting processes. This paper is a reflective overview and analysis of the complex processes undertaken, and events that occurred in gaining informed consent from people with intellectual disability to participate in a study exploring their experiences of being an inpatient in mental health hospitals within Aotearoa/New Zealand. A framework based on capacity, information, and voluntariness is presented, with excerpts from the field provided to explore consenting processes. The practical implications of the processes utilized are then discussed in order to stimulate debate regarding clearer and enhanced methods of gaining informed consent from people with intellectual disability. © 2014 Australian College of Mental Health Nurses Inc.

Consent, ethics and genetic biobanks: the case of the Athlome project.

Science.gov (United States)

Thompson, Rachel; McNamee, Michael J

2017-11-14

This article provides a critical overview of the ethics and governance of genetic biobank research, using the Athlome Consortium as a large scale instance of collaborative sports genetic biobanking. We present a traditional model of written informed consent for the acquisition, storage, sharing and analysis of genetic data and articulate the challenges to it from new research practices such as genetic biobanking. We then articulate six possible alternative consent models: verbal consent, blanket consent, broad consent, meta consent, dynamic consent and waived consent. We argue that these models or conceptions of consent must be articulated in the context of the complexities of international legislation and non legislative national and international biobank governance frameworks and policies, those which govern research in the field of sports genetics. We discuss the tensions between individual rights and public benefits of genomic research as a critical ethical issue, particularly where benefits are less obvious, as in sports genomics. The inherent complexities of international regulation and biobanking governance are challenging in a relatively young field. We argue that there is much nuanced ethical work still to be done with regard to governance of sports genetic biobanking and the issues contained therein.

Corrective Action Decision Document for Corrective Action Unit 140: Waste Dumps, Burn Pits, and Storage Area, Nevada Test Site, Nevada: Revision No. 0

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2003-10-17

This Corrective Action Decision Document identifies and rationalizes the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's selection of a recommended corrective action alternative appropriate to facilitate the closure of Corrective Action Unit (CAU) 140: Waste Dumps, Burn Pits, and Storage Area, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. Located in Areas 5, 22, and 23 of the NTS, CAU 140 consists of nine corrective action sites (CASs). Investigation activities were performed from November 13 through December 11, 2002, with additional sampling to delineate the extent of contaminants of concern (COCs) conducted on February 4 and March 18 and 19, 2003. Results obtained from the investigation activities and sampling indicated that only 3 of the 9 CASs at CAU 140 had COCs identified. Following a review of existing data, future land use, and current operations at the NTS, the following preferred alternatives were developed for consideration: (1) No Further Action - six CASs (05-08-02, 05-17-01, 05-19-01, 05-35-01, 05-99-04, and 22-99-04); (2) Clean Closure - one CAS (05-08-01), and (3) Closure-in-Place - two CASs (05-23-01 and 23-17-01). These alternatives were judged to meet all requirements for the technical components evaluated. Additionally, the alternatives meet all applicable state and federal regulations for closure of the site and will eliminate potential future exposure pathways to the contaminated media at CAU 140.

Value of informed consent in surgical orthodontics.

Science.gov (United States)

Brons, Sander; Becking, Alfred G; Tuinzing, D Bram

2009-05-01

Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was given to all aspects of the treatment. However, because of "insurance-related factors," the need for treatment because of functional reasons was stressed over esthetics. The recall of information given during an informed consent interview before orthognathic surgery was measured using a questionnaire. Patients with a mandibular deficiency with a low mandibular plane angle were questioned after an informed consent interview regarding surgical orthodontic treatment. Esthetics were more frequently and functional problems were less frequently recalled as the reason for operation than was expected. The risk of a change in the sensation of the lower lip by surgery was frequently recalled as a reason to refrain from the operation. The overall recall rate of the possible risks and complications of orthodontic surgery was 40%. No reports were found of comparable research on the preoperative recall after consultation before surgical orthodontic surgery. The aspects of communication that can improve recall must be clarified. A recall rate of 100% seems a utopia, although an arbitrary line is needed to determine the quality of an informed consent interview.

Autonomy and informed consent: a mistaken association?

Science.gov (United States)

Kristinsson, Sigurdur

2007-09-01

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

Closure Report Central Nevada Test Area Subsurface Corrective Action Unit 443 January 2016

Energy Technology Data Exchange (ETDEWEB)

Findlay, Rick [US Department of Energy, Washington, DC (United States). Office of Legacy Management

2015-11-01

The U.S. Department of Energy (DOE) Office of Legacy Management (LM) prepared this Closure Report for the subsurface Corrective Action Unit (CAU) 443 at the Central Nevada Test Area (CNTA), Nevada, Site. CNTA was the site of a 0.2- to 1-megaton underground nuclear test in 1968. Responsibility for the site’s environmental restoration was transferred from the DOE, National Nuclear Security Administration, Nevada Field Office to LM on October 1, 2006. The environmental restoration process and corrective action strategy for CAU 443 are conducted in accordance with the Federal Facility Agreement and Consent Order (FFACO 1996, as amended 2011) and all applicable Nevada Division of Environmental Protection (NDEP) policies and regulations. This Closure Report provides justification for closure of CAU 443 and provides a summary of completed closure activities; describes the selected corrective action alternative; provides an implementation plan for long-term monitoring with well network maintenance and approaches/policies for institutional controls (ICs); and presents the contaminant, compliance, and use-restriction boundaries for the site.

Informed consent in Malaysia: an overview.

Science.gov (United States)

Che Ngah, Anisah

2005-01-01

The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

Corrective Action Investigation Plan for Corrective Action Unit 321: Area 22 Weather Station Fuel Storage, Nevada Test Site, Nevada; TOPICAL

International Nuclear Information System (INIS)

1999-01-01

This Corrective Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense (FFACO, 1996). The CAIP is a document that provides or references all of the specific information for investigation activities associated with Corrective Action Units (CAUs) or Corrective Action Sites (CASs). According to the FFACO (1996), CASs are sites potentially requiring corrective action(s) and may include solid waste management units or individual disposal or release sites. A CAU consists of one or more CASs grouped together based on geography, technical similarity, or agency responsibility for the purpose of determining corrective actions. This CAIP contains the environmental sample collection objectives and the criteria for conducting site investigation activities at the CAU 321 Area 22 Weather Station Fuel Storage, CAS 22-99-05 Fuel Storage Area. For purposes of this discussion, this site will be referred to as either CAU 321 or the Fuel Storage Area. The Fuel Storage Area is located in Area 22 of the Nevada Test Site (NTS). The NTS is approximately 105 kilometers (km) (65 miles[mi]) northwest of Las Vegas, Nevada (Figure 1-1) (DOE/NV, 1996a). The Fuel Storage Area (Figure 1-2) was used to store fuel and other petroleum products necessary for motorized operations at the historic Camp Desert Rock facility which was operational from 1951 to 1958 at the Nevada Test Site, Nevada. The site was dismantled after 1958 (DOE/NV, 1996a)

Corrective Action Plan for Corrective Action Unit 407: Roller Coaster RADSAFE Area, Tonopah Test Range, Nevada

Energy Technology Data Exchange (ETDEWEB)

T. M. Fitzmaurice

2000-05-01

This Corrective Action Plan (CAP) has been prepared for the Roller Coaster RADSAFE Area Corrective Action Unit 407 in accordance with the Federal Facility and Consent Order (Nevada Division of Environmental Protection [NDEP] et al., 1996). This CAP provides the methodology for implementing the approved Corrective Action Alternative as listed in the Corrective Action Decision Document (U.S. Department of Energy, Nevada Operations Office, 1999). The RCRSA was used during May and June of 1963 to decontaminate vehicles, equipment, and personnel from the Clean Slate tests. The Constituents of Concern (COCs) identified during the site characterization include plutonium, uranium, and americium. No other COCS were identified. The following closure actions will be implemented under this plan: (1) Remove and dispose of surface soils which are over three times background for the area. Soils identified for removal will be disposed of at an approved disposal facility. Excavated areas will be backfilled with clean borrow soil fi-om a nearby location. (2) An engineered cover will be constructed over the waste disposal pit area where subsurface COCS will remain. (3) Upon completion of the closure and approval of the Closure Report by NDEP, administrative controls, use restrictions, and site postings will be used to prevent intrusive activities at the site. Barbed wire fencing will be installed along the perimeter of this unit. Post closure monitoring will consist of site inspections to determine the condition of the engineered cover. Any identified maintenance and repair requirements will be remedied within 90 working days of discovery and documented in writing at the time of repair. Results of all inspections/repairs for a given year will be addressed in a single report submitted annually to the NDEP.

N Springs expedited response action proposal

Energy Technology Data Exchange (ETDEWEB)

1994-01-01

Since signing the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) in 1989, the parties to the agreement have recognized the need to modify the approach to conducting investigations, studies, and cleanup actions at Hanford. To implement this approach, the parties have jointly developed the Hanford Past-Practice Strategy. The strategy defines a non-time-critical expedited response action (ERA) as a response action ``needed to abate a threat to human health or welfare or the environment where sufficient time exists for formal planning prior to initiation of response. In accordance with the past-practice strategy, DOE proposes to conduct an ERA at the N Springs, located in the Hanford 100 N Area, to substantially reduce the strontium-90 transport into the river through the groundwater pathway. The purpose of this ERA proposal is to provide sufficient information to select a preferred alternative at N Springs. The nature of an ERA requires that alternatives developed for the ERA be field ready; therefore, all the technologies proposed for the ERA should be capable of addressing the circumstances at N Springs. A comparison of these alternatives is made based on protectiveness, cost, technical feasibility, and institutional considerations to arrive at a preferred alternative. Following the selection of an alternative, a design phase will be conducted; the design phase will include a detailed look at design parameters, performance specifications, and costs of the selected alternative. Testing will be conducted as required to generate design data.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 504: 16a-Tunnel Muckpile, Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

NSTec Environmental Restoration

2010-03-15

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 504, 16a-Tunnel Muckpile. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. Corrective Action Unit 504 is comprised of four Corrective Action Sites (CASs): • 16-06-01, Muckpile • 16-23-01, Contaminated Burial Pit • 16-23-02, Contaminated Area • 16-99-01, Concrete Construction Waste Corrective Action Site 16-23-01 is not a burial pit; it is part of CAS 16-06-01. Therefore, there is not a separate data analysis and assessment for CAS 16-23-01; it is included as part of the assessment for CAS 16-06-01. In addition to these CASs, the channel between CAS 16-23-02 (Contaminated Area) and Mid Valley Road was investigated with walk-over radiological surveys and soil sampling using hand tools. The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with use restrictions for CAU 504. A CADD was originally submitted for CAU 504 and approved by the Nevada Division of Environmental Protection (NDEP). However, following an agreement between NDEP, DTRA, and the DOE, National Nuclear Security Administration Nevada Site Office to change to a risk-based approach for assessing the corrective action investigation (CAI) data, NDEP agreed that the CAU could be re-evaluated using the risk-based approach and a CADD/CR prepared to close the site.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 500: Test Cell A Septic System, Nevada Test Site, Nevada, Rev. 0

International Nuclear Information System (INIS)

2000-01-01

This Corrective Action Decision Document/Closure Report (CADD/CR) has been prepared for Corrective Action Unit (CAU) 500: Test Cell A Septic System, in accordance with the Federal Facility Agreement and Consent Order. Located in Area 25 at the Nevada Test Site in Nevada, CAU 500 is comprised of one Corrective Action Site, CAS 25-04-05. This CADD/CR identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) recommendation that no corrective action is deemed necessary for CAU 500. The Corrective Action Decision Document and Closure Report have been combined into one report based on sample data collected during the field investigation performed between February and May 1999, which showed no evidence of soil contamination at this site. The clean closure justification for CAU 500 is based on these results. Analytes detected were evaluated against preliminary action levels (PALs) to determine contaminants of concern (COCs) for CAU 500, and it was determined that the PALs were not exceeded for total volatile organic compounds, total semivolatile organic compounds, total petroleum hydrocarbons, polychlorinated biphenyls, total Resource Conservation and Recovery Act metals, gamma-emitting radionuclides, isotopic uranium, and strontium-90 for any of the soil samples collected. COCs were identified only within the septic tank and distribution box at the CAU. No COCs were identified outside these two areas; therefore, no corrective action was necessary for the soil. Closure activities were performed to address the COCs identified within the septic tank and distribution box. The DOE/NV recommended that neither corrective action nor a corrective action plan was required at CAU 500. Further, no use restrictions were required to be placed on CAU 500, and the septic tank and distribution box have been closed in accordance with all applicable state and federal regulations for closure of the site

76 FR 60765 - Mail or Telephone Order Merchandise Rule

Science.gov (United States)

2011-09-30

..., gift card, or other universally accepted method of payment.'' Nwokeji at 3-4. For these exceptions, he.... The MTOR covers post-purchase events, such as actions that a seller must take when it learns it cannot... pre-purchase practices, such as disclosures made before a customer consents to pay. The MTOR covers...

Corrective Action Decision Document/Closure Report for Corrective Action Unit 551: Area 12 Muckpiles, Nevada Test Site, Nevada, Rev. No.: 1

Energy Technology Data Exchange (ETDEWEB)

Wickline, Alfred

2006-11-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 551, Area 12 Muckpiles, Nevada Test Site (NTS), Nevada. The corrective actions proposed in this document are in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada, U.S. Department of Energy (DOE), and the U.S. Department of Defense (FFACO, 1996). The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 551 is comprised of the four Corrective Action Sites (CASs) that are shown on Figure 1-2 and listed below: CAS 12-01-09, Aboveground Storage Tank and Stain; CAS 12-06-05, U-12b Muckpile; CAS 12-06-07, Muckpile; and CAS 12-06-08, Muckpile. A detailed discussion of the history of this CAU is presented in the ''Corrective Action Investigation Plan (CAIP) for Corrective Action Unit 551: Area 12 Muckpiles'' (NNSA/NSO, 2004). This CADD/CR provides justification for the closure of CAU 551 in place with administrative controls. This justification is based upon process knowledge and the results of the investigative activities conducted in accordance with the CAIP (NNSA/NSO, 2004). The CAIP provides information relating to the history, planning, and scope of the investigation; therefore, this information will not be repeated in the CADD/CR. Corrective Action Unit 551, Area 12 Muckpiles, consists of four inactive sites located in the southwestern portion of Area 12. The four CAU 551 sites consist of three muckpiles, and an aboveground storage tank (AST) and stain. The CAU 551 sites were all used during underground nuclear testing at the B-, C-, D- and F-Tunnels in the late 1950s and early 1960s and have mostly remained inactive since that period.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 551: Area 12 Muckpiles, Nevada Test Site, Nevada, Rev. No.: 1

International Nuclear Information System (INIS)

Wickline, Alfred

2006-01-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 551, Area 12 Muckpiles, Nevada Test Site (NTS), Nevada. The corrective actions proposed in this document are in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada, U.S. Department of Energy (DOE), and the U.S. Department of Defense (FFACO, 1996). The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 551 is comprised of the four Corrective Action Sites (CASs) that are shown on Figure 1-2 and listed below: CAS 12-01-09, Aboveground Storage Tank and Stain; CAS 12-06-05, U-12b Muckpile; CAS 12-06-07, Muckpile; and CAS 12-06-08, Muckpile. A detailed discussion of the history of this CAU is presented in the ''Corrective Action Investigation Plan (CAIP) for Corrective Action Unit 551: Area 12 Muckpiles'' (NNSA/NSO, 2004). This CADD/CR provides justification for the closure of CAU 551 in place with administrative controls. This justification is based upon process knowledge and the results of the investigative activities conducted in accordance with the CAIP (NNSA/NSO, 2004). The CAIP provides information relating to the history, planning, and scope of the investigation; therefore, this information will not be repeated in the CADD/CR. Corrective Action Unit 551, Area 12 Muckpiles, consists of four inactive sites located in the southwestern portion of Area 12. The four CAU 551 sites consist of three muckpiles, and an aboveground storage tank (AST) and stain. The CAU 551 sites were all used during underground nuclear testing at the B-, C-, D- and F-Tunnels in the late 1950s and early 1960s and have mostly remained inactive since that period

The accompanying adult: authority to give consent in the UK.

Science.gov (United States)

Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

2007-05-01

Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study

NARCIS (Netherlands)

Wood, F.; Martin, S.M.; Carson-Stevens, A.; Elwyn, G.; Precious, E.; Kinnersley, P.

2016-01-01

BACKGROUND: The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need

Informed consent in Sri Lanka: a survey among ethics committee members.

Science.gov (United States)

Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-05-20

Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

Improving consent in patients undergoing surgery for fractured neck of femur.

Science.gov (United States)

Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

2018-05-02

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of

Is The Consent Process Appropriate - The Interns’ Perspective?

LENUS (Irish Health Repository)

Rohan, P

2018-04-01

Consent is an integral component to any medical procedure involving a competent patient, a communicating doctor, and transfer of information about the procedure. The aim of this study was to assess interns’ experience of the consent process.

A randomized controlled trial of an electronic informed consent process.

Science.gov (United States)

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan

Directory of Open Access Journals (Sweden)

M Kusunose

2015-09-01

Full Text Available Informed consent (IC is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency. 

Scientists' perspectives on consent in the context of biobanking research.

Science.gov (United States)

Master, Zubin; Campo-Engelstein, Lisa; Caulfield, Timothy

2015-05-01

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

Science.gov (United States)

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

Science.gov (United States)

Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

2017-05-24

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for

Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting.

Directory of Open Access Journals (Sweden)

Fasil Tekola

2009-07-01

Full Text Available Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis in southern Ethiopia.We adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent.Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis.

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

Science.gov (United States)

Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-07-20

Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the

Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

Science.gov (United States)

Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

2012-01-01

Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

Simplifying informed consent for biorepositories: stakeholder perspectives.

Science.gov (United States)

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-09-01

Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

[Informed consent].

Science.gov (United States)

López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

2003-11-01

Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

Action Research: Order Out of Chaos.

Science.gov (United States)

Geffen, Mitzi

2002-01-01

Describes on Israeli English-as-a-Foreign-Language teacher's action research project that focused on how to teach reading comprehension in English to a class of ninth grade boys. Outlines the teacher's goals, implementation of the project, and thoughts on the outcomes. (Author/VWL)

Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

Science.gov (United States)

Mellado, J M

2016-01-01

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Corrective Action Investigation Plan for Corrective Action Unit 137: Waste Disposal Sites, Nevada Test Site, Nevada, Rev. No.:0

Energy Technology Data Exchange (ETDEWEB)

Wickline, Alfred

2005-12-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 137: Waste Disposal Sites. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 137 contains sites that are located in Areas 1, 3, 7, 9, and 12 of the Nevada Test Site (NTS), which is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 137 is comprised of the eight corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-08-01, Waste Disposal Site; (2) CAS 03-23-01, Waste Disposal Site; (3) CAS 03-23-07, Radioactive Waste Disposal Site; (4) CAS 03-99-15, Waste Disposal Site; (5) CAS 07-23-02, Radioactive Waste Disposal Site; (6) CAS 09-23-07, Radioactive Waste Disposal Site; (7) CAS 12-08-01, Waste Disposal Site; and (8) CAS 12-23-07, Waste Disposal Site. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 137 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by conducting a CAI before evaluating and selecting

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

Science.gov (United States)

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

El consentimiento informado; una acción imprescindible en la investigación médic The informed consent is a compulsory action in medical research

Directory of Open Access Journals (Sweden)

Miguel L. Castellanos Arcís

2009-03-01

Full Text Available Se hace una revisión de los conceptos éticos y bioéticos para adentrarnos en el consentimiento informado. El conocimiento científico ha conducido a notables avances que han sido de gran beneficio para la humanidad. El desarrollo de estas ramas científicas trae consigo serios problemas éticos, por los cuales deben velar los hombres de ciencia y además todos los miembros de la sociedad. La Medicina hoy día, posee una fuerte carga experimental y surgen extrapolaciones desde el laboratorio de investigaciones, al hombre. Las investigaciones que se realizan, cada vez con mayor frecuencia, hacen partícipes a las personas, y un procedimiento imprescindible en las investigaciones con seres humanos, lo constituye el otorgamiento por los sujetos del consentimiento informado para su inclusión en el estudio. Este aspecto no constituye una acción aislada destinada a lograr que el paciente firme un documento autorizando al equipo de salud, a realizar un tratamiento o investigación, sino un proceso donde deben ser explicadas todas las acciones para la salud, en cualquiera de los 3 niveles de atención. En esta revisión se detallan los aspectos fundamentales que deben discutirse con el paciente sobre los principios y elementos que deben estar contenidos en la conversación y planilla para el otorgamiento del consentimiento.We made a review of ethical and bioethical features to enter the heart of informed consent. Scientific knowledge has allows significant advances very beneficial for mankind. Development of these scientific branches give raise many serious ethical problems, by which the scientists and also all the society members must to look after. Present Medicine, has a strong experimental charge and from research laboratories give raise extrapolations for men. Researches performed, each time with a great frequency, allow the involvement of persons, and a compulsory procedure in researches with human beings, is the informed consent for their

Informed consent and collaborative research: perspectives from the developing world.

Science.gov (United States)

Hyder, Adnan A; Wali, Salman A

2006-03-01

Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

Corrective Action Investigation Plan for Corrective Action Unit 214: Bunkers and Storage Areas Nevada Test Site, Nevada: Revision 0, Including Record of Technical Change No. 1 and No. 2

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2003-05-16

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 214 under the Federal Facility Agreement and Consent Order. Located in Areas 5, 11, and 25 of the Nevada Test Site, CAU 214 consists of nine Corrective Action Sites (CASs): 05-99-01, Fallout Shelters; 11-22-03, Drum; 25-99-12, Fly Ash Storage; 25-23-01, Contaminated Materials; 25-23-19, Radioactive Material Storage; 25-99-18, Storage Area; 25-34-03, Motor Dr/Gr Assembly (Bunker); 25-34-04, Motor Dr/Gr Assembly (Bunker); and 25-34-05, Motor Dr/Gr Assembly (Bunker). These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives (CAAs). The suspected contaminants and critical analyte s for CAU 214 include oil (total petroleum hydrocarbons-diesel-range organics [TPH-DRO], polychlorinated biphenyls [PCBs]), pesticides (chlordane, heptachlor, 4,4-DDT), barium, cadmium, chronium, lubricants (TPH-DRO, TPH-gasoline-range organics [GRO]), and fly ash (arsenic). The land-use zones where CAU 214 CASs are located dictate that future land uses will be limited to nonresidential (i.e., industrial) activities. The results of this field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the corrective action decision document.

Corrective Action Plan for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2009-01-01

This Corrective Action Plan (CAP) has been prepared for Corrective Action Unit (CAU) 563, Septic Systems, in accordance with the Federal Facility Agreement and Consent Order. CAU 563 consists of four Corrective Action Sites (CASs) located in Areas 3 and 12 of the Nevada Test Site. CAU 563 consists of the following CASs: CAS 03-04-02, Area 3 Subdock Septic Tank CAS 03-59-05, Area 3 Subdock Cesspool CAS 12-59-01, Drilling/Welding Shop Septic Tanks CAS 12-60-01, Drilling/Welding Shop Outfalls Site characterization activities were performed in 2007, and the results are presented in Appendix A of the CAU 563 Corrective Action Decision Document. The scope of work required to implement the recommended closure alternatives is summarized below. CAS 03-04-02, Area 3 Subdock Septic Tank, contains no contaminants of concern (COCs) above action levels. No further action is required for this site; however, as a best management practice (BMP), all aboveground features (e.g., riser pipes and bumper posts) will be removed, the septic tank will be removed, and all open pipe ends will be sealed with grout. CAS 03-59-05, Area 3 Subdock Cesspool, contains no COCs above action levels. No further action is required for this site; however, as a BMP, all aboveground features (e.g., riser pipes and bumper posts) will be removed, the cesspool will be abandoned by filling it with sand or native soil, and all open pipe ends will be sealed with grout. CAS 12-59-01, Drilling/Welding Shop Septic Tanks, will be clean closed by excavating approximately 4 cubic yards (yd3) of arsenic- and chromium-impacted soil. In addition, as a BMP, the liquid in the South Tank will be removed, the North Tank will be removed or filled with grout and left in place, the South Tank will be filled with grout and left in place, all open pipe ends will be sealed with grout or similar material, approximately 10 yd3 of chlordane-impacted soil will be excavated, and debris within the CAS boundary will be removed. CAS 12

Improving participant comprehension in the informed consent process.

Science.gov (United States)

Cohn, Elizabeth; Larson, Elaine

2007-01-01

To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

Informed consent in Sri Lanka: A survey among ethics committee members

Directory of Open Access Journals (Sweden)

Siriwardhana Chesmal

2008-05-01

Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

Consent on cadaveric organ donation in Serbian law

Directory of Open Access Journals (Sweden)

Baturan Luka

2013-01-01

Full Text Available Organ transplantation often presents the only way for efficient treatment of various diseases. According to current legal regulations, in order to use an organ of a deceased person for transplantation, it is necessary that the decedent gave written consent ("opting out model" before death. Under certain circumstances, that consent could be given by close relatives of the decedent, in case that the decedent had not previously explicitly declared that he was against it. These legal regulations do not ensure efficient allocation of scarce goods but they create great social costs. If a legislator accepted "opting in model", the basic assumption for efficient allocation and increase of social welfare would be provided. The first part of the paper presents the legal framework for organ donation in the Republic of Serbia. The problem of insufficient supply of organs is elaborated in the second part. The third part of the paper contains attempts to increase the level of supply of organs through the promotion of transplantation. In the fourth part of the paper, the effects of different legal solutions are compared, and those are opt-in and opt-out models. The fifth section offers an analysis of criminal-law protection in the area of organ transplantation and its effects on potential organ donors.

The unbearable lightness of user consent

Directory of Open Access Journals (Sweden)

Rikke Frank Joergensen

2014-10-01

Full Text Available The article discusses challenges to privacy protection in social media platforms, focusing in particular on the principle of user consent. Based on a Danish study, the article argues that in relation to Facebook, user consent de facto served as the price for participating and for gaining access to a social infrastructure. The article opens with a brief introduction to privacy as a human right, followed by a discussion of some of the critique that has been raised towards social media platforms vis-à-vis the right to privacy. Second, it presents the findings from a study conducted amongst 68 Danish high school students in October 2013 concerning their privacy perceptions and practices when using social media platforms. Thirdly, it discusses the implications of these findings in relation to the principle of user consent as a means of providing individuals with control over their personal information in the context of social media platforms.

Can children withhold consent to treatment?

Science.gov (United States)

Devereux, J A; Jones, D P; Dickenson, D L

1993-05-29

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.

Informed consent for medical photography in Nigerian surgical ...

African Journals Online (AJOL)

Background: The aim of this study is to assess the current practice of informed consent for medical photography in the Nigerian surgical practice and how it compares to international best practices. Methods: Self-administered questionnaires were distributed to consenting surgeons attending two major surgical conferences.

Practice variation across consent templates for biobank research. A survey of German biobanks

Directory of Open Access Journals (Sweden)

Irene eHirschberg

2013-11-01

Full Text Available Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondi-tion for biobank research. Valid consent protects donors’ rights and helps maintain public trust in biobank research. Harmonisation of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks in-cluding data and sample sharing. So far, no study has assessed and compared the content of current consent forms for biobank research. The objective of this study was to perform a con-tent analysis of consent forms in German biobanks. Methods: Based on 10 guidelines for biomedical research, we developed an assessment ma-trix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012. Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items Right to withdraw consent (without disadvantage, Policy for genetic infor-mation / consent to genetic analyses and International cooperation / transborder use were addressed in 97%, 40% and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22% to 88% out of 41 items.Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent is-sues that must be addressed in biobank research. The findings show that the majority of con-sent forms for German biobanks, if not all, should be improved and harmonised to better sup-port an informed and balanced choice of potential donors and to facilitate networking of bi-obanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.

Can a subject consent to a 'Ulysses contract'?

Science.gov (United States)

1982-08-01

A case study is presented in which a schizophrenic consents to experimental drug treatment while competent and then refuses the treatment when in a psychotic state. Three commentaries consider the ethical and legal issues involved in permitting informed consent by the mentally ill by means of a "Ulysses contract," i.e., by agreeing at the time of consent that later refusal of treatment is to be ignored if the patient is no longer competent. The commentators see value in such agreements, provided that safeguards are included to ensure that the patient's legitimate wishes and interests are not ignored.

Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

LENUS (Irish Health Repository)

2012-02-29

Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

Evaluating nurse understanding and participation in the informed consent process.

Science.gov (United States)

Axson, Sydney A; Giordano, Nicholas A; Hermann, Robin M; Ulrich, Connie M

2017-01-01

Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. This study examines hospital-based nurses' experiences and understandings of the informed consent process. This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of

Improving readability of informed consents for research at an academic medical institution.

Science.gov (United States)

Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

2017-12-01

The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Making a difference: incorporating theories of autonomy into models of informed consent.

Science.gov (United States)

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 529: Area 25 Contaminated Materials, Nevada Test Site, Nevada, Rev. No.: 1

Energy Technology Data Exchange (ETDEWEB)

Robert F. Boehlecke

2004-11-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 529, Area 25 Contaminated Materials, Nevada Test Site (NTS), Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) that was agreed to by the State of Nevada, U.S. Department of Energy (DOE), and the U.S. Department of Defense (FFACO, 1996). The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Site (CAS) 25-23-17, Contaminated Wash, is the only CAS in CAU 529 and is located in Area 25 of the NTS, in Nye County, Nevada (Figure 1-2). Corrective Action Site 25-23-17, Contaminated Wash, was divided into nine parcels because of the large area impacted by past operations and the complexity of the source areas. The CAS was subdivided into separate parcels based on separate and distinct releases as determined and approved in the Data Quality Objectives (DQO) process and Corrective Action Investigation Plan (CAIP). Table 1-1 summarizes the suspected sources for the nine parcels. Corrective Action Site 25-23-17 is comprised of the following nine parcels: (1) Parcel A, Kiwi Transient Nuclear Test (TNT) 16,000-foot (ft) Arc Area (Kiwi TNT); (2) Parcel B, Phoebus 1A Test 8,000-ft Arc Area (Phoebus); (3) Parcel C, Topopah Wash at Test Cell C (TCC); (4) Parcel D, Buried Contaminated Soil Area (BCSA) l; (5) Parcel E, BCSA 2; (6) Parcel F, Borrow Pit Burial Site (BPBS); (7) Parcel G, Drain/Outfall Discharges; (8) Parcel H, Contaminated Soil Storage Area (CSSA); and (9) Parcel J, Main Stream/Drainage Channels.

Can children withhold consent to treatment?

OpenAIRE

Devereux, J A; Jones, D P; Dickenson, D L

1993-01-01

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose c...

42 CFR 35.15 - Consent to operative procedures.

Science.gov (United States)

2010-10-01

... emergencies when the patient is physically or mentally incapable of consenting and the delay required to... operative procedure shall be undertaken unless the patient or, in the case of a minor or incompetent, his... or refusal of consent shall be made a part of the clinical record. ...

40 CFR 26.1117 - Documentation of informed consent.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

Science.gov (United States)

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2014-09-01

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

Closure Report for Corrective Action Unit 124, Storage Tanks, Nevada Test Site, Nevada with Errata Sheet, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Alfred Wickline

2008-01-01

This Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 124, Storage Tanks, Nevada Test Site (NTS), Nevada. This report complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management (FFACO, 1996; as amended January 2007). This CR provides documentation and justification for the closure of CAU 124 without further corrective action. This justification is based on process knowledge and the results of the investigative activities conducted in accordance with the Streamlined Approach for Environmental Restoration (SAFER) Plan for Corrective Action Unit 124: Storage Tanks, Nevada Test Site, Nevada (NNSA/NSO, 2007). The SAFER Plan provides information relating to site history as well as the scope and planning of the investigation. Therefore, this information will not be repeated in this CR.

Closure Report for Corrective Action Unit 481: Area 12 T-Tunnel Conditional Release Storage Yard, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2008-01-01

Corrective Action Unit (CAU) 481 is identified in the Federal Facility Agreement and Consent Order (FFACO) as Area 12 T-Tunnel Conditional Release Storage Yard. CAU 481 is located in Area 12 of the Nevada Test Site, which is approximately 65 miles northwest of Las Vegas, Nevada. This CAU consists of one Corrective Action Site (CAS), CAS 12-42-05, Housekeeping Waste. CAU 481 closure activities were conducted by the Defense Threat Reduction Agency from August 2007 through July 2008 according to the FFACO and Revision 3 of the Sectored Clean-up Work Plan for Housekeeping Category Waste Sites. Closure activities included removal and disposal of construction debris and low-level waste. Drained fluids, steel, and lead was recycled as appropriate. Waste generated during closure activities was appropriately managed and disposed.

Corrective Action Plan for Corrective Action Unit 562: Waste Systems, Nevada National Security Site, Nevada

International Nuclear Information System (INIS)

2011-01-01

This Corrective Action Plan has been prepared for Corrective Action Unit (CAU) 562, Waste Systems, in accordance with the Federal Facility Agreement and Consent Order (1996; as amended March 2010). CAU 562 consists of 13 Corrective Action Sites (CASs) located in Areas 2, 23, and 25 of the Nevada National Security Site. Site characterization activities were performed in 2009 and 2010, and the results are presented in Appendix A of the Corrective Action Decision Document for CAU 562. The scope of work required to implement the recommended closure alternatives is summarized. (1) CAS 02-26-11, Lead Shot, will be clean closed by removing shot. (2) CAS 02-44-02, Paint Spills and French Drain, will be clean closed by removing paint and contaminated soil. As a best management practice (BMP), asbestos tile will be removed. (3) CAS 02-59-01, Septic System, will be clean closed by removing septic tank contents. As a BMP, the septic tank will be removed. (4) CAS 02-60-01, Concrete Drain, contains no contaminants of concern (COCs) above action levels. No further action is required; however, as a BMP, the concrete drain will be removed. (5) CAS 02-60-02, French Drain, was clean closed. Corrective actions were completed during corrective action investigation activities. As a BMP, the drain grates and drain pipe will be removed. (6) CAS 02-60-03, Steam Cleaning Drain, will be clean closed by removing contaminated soil. As a BMP, the steam cleaning sump grate and outfall pipe will be removed. (7) CAS 02-60-04, French Drain, was clean closed. Corrective actions were completed during corrective action investigation activities. (8) CAS 02-60-05, French Drain, will be clean closed by removing contaminated soil. (9) CAS 02-60-06, French Drain, contains no COCs above action levels. No further action is required. (10) CAS 02-60-07, French Drain, requires no further action. The french drain identified in historical documentation was not located during corrective action investigation

Corrective Action Decision Document/Closure Report for Corrective Action Unit 545: Dumps, Waste Disposal Sites, and Buried Radioactive Materials Nevada Test Site, Nevada, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Alfred Wickline

2008-04-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 545, Dumps, Waste Disposal Sites, and Buried Radioactive Materials, in Areas 2, 3, 9, and 20 of the Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management (1996, as amended February 2008). Corrective Action Unit 545 is comprised of the following eight Corrective Action Sites (CASs): • 02-09-01, Mud Disposal Area • 03-08-03, Mud Disposal Site • 03-17-01, Waste Consolidation Site 3B • 03-23-02, Waste Disposal Site • 03-23-05, Europium Disposal Site • 03-99-14, Radioactive Material Disposal Area • 09-23-02, U-9y Drilling Mud Disposal Crater • 20-19-01, Waste Disposal Site While all eight CASs are addressed in this CADD/CR, sufficient information was available for the following three CASs; therefore, a field investigation was not conducted at these sites: • For CAS 03-08-03, though the potential for subsidence of the craters was judged to be extremely unlikely, the data quality objective (DQO) meeting participants agreed that sufficient information existed about disposal and releases at the site and that a corrective action of close in place with a use restriction is recommended. Sampling in the craters was not considered necessary. • For CAS 03-23-02, there were no potential releases of hazardous or radioactive contaminants identified. Therefore, the Corrective Action Investigation Plan for CAU 545 concluded that: “Sufficient information exists to conclude that this CAS does not exist as originally identified. Therefore, there is no environmental concern associated with CAS 03-23-02.” This CAS is closed with no further action. • For CAS 03-23-05, existing information about the two buried sources and lead pig was considered to be

21 CFR 50.25 - Elements of informed consent.

Science.gov (United States)

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

Alcohol and Sexual Consent Scale: Development and Validation

Science.gov (United States)

Ward, Rose Marie; Matthews, Molly R.; Weiner, Judith; Hogan, Kathryn M.; Popson, Halle C.

2012-01-01

Objective: To establish a short measure of attitudes toward sexual consent in the context of alcohol consumption. Methods: Using a multistage and systematic measurement development process, the investigators developed the Alcohol and Sexual Consent Scale using a sample of college students. Results: The resulting 12-item scale, the Alcohol and…

[Informed consent right of the appraised individuals in forensic clinical examination].

Science.gov (United States)

Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

2015-02-01

Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

Customising informed consent procedures for people with schizophrenia in India.

Science.gov (United States)

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

Housekeeping Closure Report for Corrective Action Unit 119: Storage Tanks, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2000-01-01

The Federal Facility Agreement and Consent Order was entered into by the State of Nevada, US Department of Energy, and US Department of Defense to identify sites of potential historical contamination and implement corrective actions based on public health and environmental considerations. The facilities subject to this agreement include the Nevada Test Site (NTS), parts of the Tonopah Test Range, parts to the Nellis Air Force Range, the Central Nevada Test Area, and the Project Shoal Area. Corrective Action Sites (CASs) are areas potentially requiring corrective actions and may include solid waste management units, individual disposal, or release sites. Based on geography, technical similarity, agency responsibility, or other appropriate reasons, CASs are grouped together into Corrective Action Units (CAUs) for the purpose of determining appropriate corrective actions. This report contains the Closure Verification Forms for cleanup activities that were performed at 19 CASs with in CAU 119 on the NTS. The form for each CAS provides the location, directions to the site, general description, and photographs of the site before and after cleanup activities. Activities included verification of the prior removal of both aboveground and underground gas/oil storage tanks, gas sampling tanks, pressure fuel tanks, tank stands, trailers, debris, and other material. Based on these former activities, no further action is required at these CASs

Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

Science.gov (United States)

Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

2013-11-25

In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study

Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

Science.gov (United States)

2013-01-01

Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need

[Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

Science.gov (United States)

Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

2013-01-01

The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

I had no other option: Women, electroconvulsive therapy, and informed consent.

Science.gov (United States)

Clarke, Karen-Ann; Barnes, Margaret; Ross, Dyann

2018-06-01

Electroconvulsive therapy (ECT) is a controversial procedure used in the management of depression. Whilst it may be administered under mental health legislation, it is usually given to people who voluntarily consent. At the practice level, the consent process for ECT requires a detailed explanation of the procedure. The person consenting must have capacity to make this decision, and consent must be given freely and without coercion. Research using a feminist narrative approach unexpectedly highlighted the issue of potential coercion in the context of explaining the procedure. In-depth interviews were used to understand seven women's accounts of deciding to receive ECT. A thematic analysis of their narratives uncovered a shared concern with how they consented to the treatment. Four subthemes were identified that related to the way in which they provided their consent: (i) 'Not enough information'; (ii) 'I had no other choice'; (iii) 'Just go along with it'; and (iv) 'Lacking capacity'. A consent process that includes elements of passive coercion and a lack of timely and appropriate information influences the way some women make decisions. These factors can disempower women at the point of decision-making. A practice shift is needed where women are enabled to have control over decisions. Further, there is a need to adhere more rigorously to noncoercive practice when obtaining consent. © 2017 Australian College of Mental Health Nurses Inc.

Ethical Issues Regarding Informed Consent for Minors for Space Tourism

Science.gov (United States)

Marsh, Melvin S.

2010-01-01

This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

Corrective action decision document, Second Gas Station, Tonopah test range, Nevada (Corrective Action Unit No. 403)

International Nuclear Information System (INIS)

1997-11-01

This Corrective Action Decision Document (CADD) for Second Gas Station (Corrective Action Unit [CAU] No. 403) has been developed for the U.S. Department of Energy's (DOE) Nevada Environmental Restoration Project to meet the requirements of the Federal Facility Agreement and Consent Order (FFACO) of 1996 as stated in Appendix VI, open-quotes Corrective Action Strategyclose quotes (FFACO, 1996). The Second Gas Station Corrective Action Site (CAS) No. 03-02-004-0360 is the only CAS in CAU No. 403. The Second Gas Station CAS is located within Area 3 of the Tonopah Test Range (TTR), west of the Main Road at the location of former Underground Storage Tanks (USTs) and their associated fuel dispensary stations. The TTR is approximately 225 kilometers (km) (140 miles [mi]) northwest of Las Vegas, Nevada, by air and approximately 56 km (35 mi) southeast of Tonopah, Nevada, by road. The TTR is bordered on the south, east, and west by the Nellis Air Force Range and on the north by sparsely populated public land administered by the Bureau of Land Management and the U.S. Forest Service. The Second Gas Station CAS was formerly known as the Underground Diesel Tank Site, Sandia Environmental Restoration Site Number 118. The gas station was in use from approximately 1965 to 1980. The USTs were originally thought to be located 11 meters (m) (36 feet [ft]) east of the Old Light Duty Shop, Building 0360, and consisted of one gasoline UST (southern tank) and one diesel UST (northern tank) (DOE/NV, 1996a). The two associated fuel dispensary stations were located northeast (diesel) and southeast (gasoline) of Building 0360 (CAU 423). Presently the site is used as a parking lot, Building 0360 is used for mechanical repairs of vehicles

Language, cultural brokerage and informed consent – will ...

African Journals Online (AJOL)

2014-05-14

May 14, 2014 ... focus of recent debate around ethical issues relating to the standard of care and ... Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a .... patients did not understand the meaning of the word 'consent' and .... [24] Lindegger and Richter[25] looked at.

Corrective Action Decision Document for Corrective Action Unit 417: Central Nevada Test Area Surface, Nevada

International Nuclear Information System (INIS)

1999-01-01

This Corrective Action Decision Document (CADD) identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 417: Central Nevada Test Area Surface, Nevada, under the Federal Facility Agreement and Consent Order. Located in Hot Creek Valley in Nye County, Nevada, and consisting of three separate land withdrawal areas (UC-1, UC-3, and UC-4), CAU 417 is comprised of 34 corrective action sites (CASs) including 2 underground storage tanks, 5 septic systems, 8 shaker pad/cuttings disposal areas, 1 decontamination facility pit, 1 burn area, 1 scrap/trash dump, 1 outlier area, 8 housekeeping sites, and 16 mud pits. Four field events were conducted between September 1996 and June 1998 to complete a corrective action investigation indicating that the only contaminant of concern was total petroleum hydrocarbon (TPH) which was found in 18 of the CASs. A total of 1,028 samples were analyzed. During this investigation, a statistical approach was used to determine which depth intervals or layers inside individual mud pits and shaker pad areas were above the State action levels for the TPH. Other related field sampling activities (i.e., expedited site characterization methods, surface geophysical surveys, direct-push geophysical surveys, direct-push soil sampling, and rotosonic drilling located septic leachfields) were conducted in this four-phase investigation; however, no further contaminants of concern (COCs) were identified. During and after the investigation activities, several of the sites which had surface debris but no COCs were cleaned up as housekeeping sites, two septic tanks were closed in place, and two underground storage tanks were removed. The focus of this CADD was to identify CAAs which would promote the prevention or mitigation of human exposure to surface and subsurface soils with contaminant

Implications of the UK NHS consent policy for nuclear medicine practice.

Science.gov (United States)

Greaves, Claire D; Tindale, Wendy B

2005-02-01

To comply with government policy on consent, the Sheffield Teaching Hospitals (STH) National Health Service (NHS) Trust introduced a new consent policy in February 2002. Verbal or written consent (depending on the level of risk) must be obtained prior to each study. The patient must be fully informed and given time to reach a decision. Consideration needs to be given to the following: to whom, when and how to provide such information and obtain consent. Each study type and patient circumstance needs to be classified according to risk. Consideration of the risks resulted in a local policy in which written consent is required for the following: therapeutic procedures, studies on pregnant women, studies in which pregnancy needs to be avoided, research procedures, cardiac stress for myocardial perfusion scintigraphy and intrathecal administration. Patient information leaflets have been updated with new information about the study and any risks. Information is now available for both patients and hospital staff. Compliance with the consent policy in a service department provides logistic challenges, but it is possible to fully inform patients in advance about their treatment, allowing them to give informed consent.

Informed consent: not just for procedures anymore.

Science.gov (United States)

Feld, Andrew D

2004-06-01

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 484: Surface Debris, Waste Sites, and Burn Area, Tonopah Test Range, Nevada

International Nuclear Information System (INIS)

Bechel Nevada

2004-01-01

This Streamlined Approach for Environmental Restoration plan details the activities necessary to close Corrective Action Unit (CAU) 484: Surface Debris, Waste Sites, and Burn Area (Tonopah Test Range). CAU 484 consists of sites located at the Tonopah Test Range, Nevada, and is currently listed in Appendix III of the Federal Facility Agreement and Consent Order. CAU 484 consists of the following six Corrective Action Sites: (1) CAS RG-52-007-TAML, Davis Gun Penetrator Test; (2) CAS TA-52-001-TANL, NEDS Detonation Area; (3) CAS TA-52-004-TAAL, Metal Particle Dispersion Test; (4) CAS TA-52-005-TAAL, Joint Test Assembly DU Sites; (5) CAS TA-52-006-TAPL, Depleted Uranium Site; and (6) CAS TA-54-001-TANL, Containment Tank and Steel Structure

How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

Directory of Open Access Journals (Sweden)

Kavit Natujwa

2010-06-01

Full Text Available Abstract Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions

Presuming consent in the ethics of posthumous sperm procurement and conception.

Science.gov (United States)

Kroon, Frederick

2015-12-01

This paper compares standard conceptions of consent with the conception of consent defended by Kelton Tremellen and Julian Savulescu in their attempt to re-orient the ethical debate around posthumous sperm procurement and conception, as published in Reproductive BioMedicine Online in 2015. According to their radical proposal, the surviving partner's wishes are, in effect, the only condition that needs to be considered for there to be a legitimate moral case for these procedures: the default should be presumed consent to the procedures, whether or not the agent did consent or would have consented. The present paper argues that Tremellen and Savulescu's case for this position is flawed, but offers a reconstruction that articulates what may well be a hidden, and perhaps reasonable, assumption behind the argument. But while the new argument appears more promising, the reconstruction also suggests that the position of presumed consent is currently unlikely to be acceptable as policy.

Presuming consent in the ethics of posthumous sperm procurement and conception

Directory of Open Access Journals (Sweden)

Frederick Kroon

2015-12-01

Full Text Available This paper compares standard conceptions of consent with the conception of consent defended by Kelton Tremellen and Julian Savulescu in their attempt to re-orient the ethical debate around posthumous sperm procurement and conception, as published in Reproductive BioMedicine Online in 2015. According to their radical proposal, the surviving partner’s wishes are, in effect, the only condition that needs to be considered for there to be a legitimate moral case for these procedures: the default should be presumed consent to the procedures, whether or not the agent did consent or would have consented. The present paper argues that Tremellen and Savulescu’s case for this position is flawed, but offers a reconstruction that articulates what may well be a hidden, and perhaps reasonable, assumption behind the argument. But while the new argument appears more promising, the reconstruction also suggests that the position of presumed consent is currently unlikely to be acceptable as policy.

Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

Science.gov (United States)

Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

2017-11-01

The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

Science.gov (United States)

Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

Informed Consent in Research on Second Language Acquisition

Science.gov (United States)

Thomas, Margaret; Pettitt, Nicole

2017-01-01

The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

Corrective Action Investigation Plan for Corrective Action Unit 555: Septic Systems Nevada Test Site, Nevada, Rev. No.: 0 with Errata

International Nuclear Information System (INIS)

Pastor, Laura

2005-01-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 555: Septic Systems, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 555 is located in Areas 1, 3 and 6 of the NTS, which is approximately 65 miles (mi) northwest of Las Vegas, Nevada, and is comprised of the five corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-59-01, Area 1 Camp Septic System; (2) CAS 03-59-03, Core Handling Building Septic System; (3) CAS 06-20-05, Birdwell Dry Well; (4) CAS 06-59-01, Birdwell Septic System; and (5) CAS 06-59-02, National Cementers Septic System. An FFACO modification was approved on December 14, 2005, to include CAS 06-20-05, Birdwell Dry Well, as part of the scope of CAU 555. The work scope was expanded in this document to include the investigation of CAS 06-20-05. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 555 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by conducting a CAI

Corrective Action Investigation Plan for Corrective Action Unit 555: Septic Systems Nevada Test Site, Nevada, Rev. No.: 0 with Errata

Energy Technology Data Exchange (ETDEWEB)

Pastor, Laura

2005-12-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 555: Septic Systems, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 555 is located in Areas 1, 3 and 6 of the NTS, which is approximately 65 miles (mi) northwest of Las Vegas, Nevada, and is comprised of the five corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-59-01, Area 1 Camp Septic System; (2) CAS 03-59-03, Core Handling Building Septic System; (3) CAS 06-20-05, Birdwell Dry Well; (4) CAS 06-59-01, Birdwell Septic System; and (5) CAS 06-59-02, National Cementers Septic System. An FFACO modification was approved on December 14, 2005, to include CAS 06-20-05, Birdwell Dry Well, as part of the scope of CAU 555. The work scope was expanded in this document to include the investigation of CAS 06-20-05. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 555 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by

Streamlined approach for environmental restoration plan for corrective action unit 430, buried depleted uranium artillery round No. 1, Tonopah test range

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-09-01

This plan addresses actions necessary for the restoration and closure of Corrective Action Unit (CAU) No. 430, Buried Depleted Uranium (DU) Artillery Round No. 1 (Corrective Action Site No. TA-55-003-0960), a buried and unexploded W-79 Joint Test Assembly (JTA) artillery test projectile with high explosives (HE), at the U.S. Department of Energy, Nevada Operations Office (DOE/NV) Tonopah Test Range (TTR) in south-central Nevada. It describes activities that will occur at the site as well as the steps that will be taken to gather adequate data to obtain a notice of completion from Nevada Division of Environmental Protection (NDEP). This plan was prepared under the Streamlined Approach for Environmental Restoration (SAFER) concept, and it will be implemented in accordance with the Federal Facility Agreement and Consent Order (FFACO) and the Resource Conservation and Recovery Act (RCRA) Industrial Sites Quality Assurance Project Plan.

Streamlined approach for environmental restoration plan for corrective action unit 430, buried depleted uranium artillery round No. 1, Tonopah test range

International Nuclear Information System (INIS)

1996-09-01

This plan addresses actions necessary for the restoration and closure of Corrective Action Unit (CAU) No. 430, Buried Depleted Uranium (DU) Artillery Round No. 1 (Corrective Action Site No. TA-55-003-0960), a buried and unexploded W-79 Joint Test Assembly (JTA) artillery test projectile with high explosives (HE), at the U.S. Department of Energy, Nevada Operations Office (DOE/NV) Tonopah Test Range (TTR) in south-central Nevada. It describes activities that will occur at the site as well as the steps that will be taken to gather adequate data to obtain a notice of completion from Nevada Division of Environmental Protection (NDEP). This plan was prepared under the Streamlined Approach for Environmental Restoration (SAFER) concept, and it will be implemented in accordance with the Federal Facility Agreement and Consent Order (FFACO) and the Resource Conservation and Recovery Act (RCRA) Industrial Sites Quality Assurance Project Plan

Non-Informed Consent Cultures: Privacy policies and app contracts on Facebook

DEFF Research Database (Denmark)

Bechmann, Anja

2014-01-01

of consent practices on Facebook, the article argues that with the growing importance and use of these services the consent culture of the internet has turned into a blind non-informed consent culture, heavily relying on social incentives and group dynamics in decision-making that are not adequately...

Closure Report for Corrective Action Unit 262: Area 25 Septic Systems and Underground Discharge Point, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Tobiason, D. S.

2003-01-01

This Closure Report (CR) documents the activities undertaken to close Corrective Action Unit (CAU) 262: Area 25 Septic Systems and Underground Discharge Point, in accordance with the Federal Facility Agreement and Consent Order (FFACO) of 1996. Site closure was performed in accordance with the Nevada Division of Environmental Protection (NDEP)-approved Corrective Action Plan (CAP) for CAU 262 (U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office [NNSA/NV, 2002a]). CAU 262 is located at the Nevada Test Site (NTS) approximately 105 kilometers (65 miles) northwest of Las Vegas, Nevada. CAU 262 consists of the following nine Corrective Action Sites (CASs) located in Area 25 of the NTS: CAS 25-02-06, Underground Storage tank CAS 25-04-06, Septic Systems A and B CAS 25-04-07, Septic System CAS 25-05-03, Leachfield CAS 25-05-05, Leachfield CAS 25-05-06, Leachfield CAS 25-05-08, Radioactive Leachfield CAS 25-05-12, Leachfield CAS 25-51-01, Dry Well

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

Science.gov (United States)

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

From actors to authors: a first account about the involvement of patients in the informed consent governance of a major Italian translational research hospital.

Science.gov (United States)

Casati, Sara; Monti, Paolo; Bonino, Ferruccio

2010-01-01

From 2007 to 2009 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, one of the major public research hospitals in Italy, has invested on a participatory action to promote a good practice of informed consent. The project focused on the improvement and innovation of informed consent considered as a participated act through the involvement of all the actors at stake. The main purpose was to improve the informative practices through the participatory innovation of institutional and organizational elements as conditions of possibility. Therefore the project has pursued the involvement of managers, healthcare professionals, patients and their associations in the institutional governance of informed consent. The involvement of citizens and patients within the whole process meant to put them in charge not just as actors or final evaluators of a good practice, but as co-authors in defining standards, tools and conditions for a good practice. Several actions were taken, including a phase of analysis which involved 20 patients from 8 Associations, a phase of innovation and education where 113 patients and citizens worked together with clinicians from 53 Units in deliberative laboratories, the institution of a multidisciplinary committee inclusive of representatives from 6 associations of patients.The project has produced different outcomes: new institutional guidelines adopted by the hospital; the renewal of consent forms and procedures as part of an explicit shared informative process; an increased implementation of institutional standards of good informative practice; the measure and communication of the outcomes of care and their bench-marking; bottom-up building of paths of validation; the creation of participatory electronic tools; an innovative education on the field for patients and clinicians.

Assessing the Magnitude of Non-Consent Biases in Linked Survey and Administrative Data

Directory of Open Access Journals (Sweden)

Joseph W. Sakshaug

2012-07-01

Full Text Available Administrative records are increasingly being linked to survey records to highten the utility of the survey data. Respondent consent is usually needed to perform exact record linkage; however, not all respondents agree to this request and several studies have found significant differences between consenting and non-consenting respondents on the survey variables. To the extent that these survey variables are related to variables in the administrative data, the resulting administrative estimates can be biased due to non-consent. Estimating non-consent biases for linked administrative estimates is complicated by the fact that administrative records are typically not available for the non-consenting respondents. The present study can overcome this limitation by utilizing a unique data source, the German Panel Study "Labour Market and Social Security" (PASS, and linking the consent indicator to the administrative records (available for the entire sample. This situation permits the estimation of non-consent biases for administrative variables and avoids the need to link the survey responses. The impact of non-consent bias can be assessed relative to other sources of bias (nonresponse, measurement for several administrative estimates. The results show that non-consent biases are present for few estimates, but are generally small relative to other sources of bias.

Corrective Action Investigation Plan for Corrective Action Unit 409: Other Waste Sites, Tonopah Test Range, Nevada (Rev. 0)

International Nuclear Information System (INIS)

2000-01-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 409 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 409 consists of three Corrective Action Sites (CASs): TA-53-001-TAB2, Septic Sludge Disposal Pit No.1; TA-53-002-TAB2, Septic Sludge Disposal Pit No.2; and RG-24-001-RGCR, Battery Dump Site. The Septic Sludge Disposal Pits are located near Bunker Two, close to Area 3, on the Tonopah Test Range. The Battery Dump Site is located at the abandoned Cactus Repeater Station on Cactus Peak. The Cactus Repeater Station was a remote, battery-powered, signal repeater station. The two Septic Sludge Disposal Pits were suspected to be used through the late 1980s as disposal sites for sludge from septic tanks located in Area 3. Based on site history collected to support the Data Quality Objectives process, contaminants of potential concern are the same for the disposal pits and include: volatile organic compounds (VOCs), semivolatile organic compounds, total petroleum hydrocarbons (TPHs) as gasoline- and diesel-range organics, polychlorinated biphenyls, Resource Conservation and Recovery Act metals, and radionuclides (including plutonium and depleted uranium). The Battery Dump Site consists of discarded lead-acid batteries and associated construction debris, placing the site in a Housekeeping Category and, consequently, no contaminants are expected to be encountered during the cleanup process. The corrective action the at this CAU will include collection of discarded batteries and construction debris at the Battery Dump Site for proper disposal and recycling, along with photographic documentation as the process progresses. The corrective action for the remaining CASs involves the collection of background radiological data through borings drilled at

Nudging and informed consent.

Science.gov (United States)

Cohen, Shlomo

2013-01-01

Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

Closure Report for Corrective Action Unit 143: Area 25 Contaminated Waste Dumps, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Tobiason, D. S.

2002-01-01

This Closure Report (CR) has been prepared for the Area 25 Contaminated Waste Dumps (CWD), Corrective Action Unit (CAU) 143 in accordance with the Federal Facility Agreement and Consent Order [FFACO] (FFACO, 1996) and the Nevada Division of Environmental Protection (NDEP)-approved Corrective Action Plan (CAP) for CAU 143: Area 25, Contaminated Waste Dumps, Nevada Test Site, Nevada. CAU 143 consists of two Corrective Action Sites (CASs): 25-23-09 CWD No.1, and 25-23-03 CWD No.2. The Area 25 CWDs are historic disposal units within the Area 25 Reactor Maintenance, Assembly, and Disassembly (R-MAD), and Engine Maintenance, Assembly, and Disassembly (E-MAD) compounds located on the Nevada Test Site (NTS). The R-MAD and E-MAD facilities originally supported a portion of the Nuclear Rocket Development Station in Area 25 of the NTS. CWD No.1 CAS 25-23-09 received solid radioactive waste from the R-MAD Compound (East Trestle and West Trench Berms) and 25-23-03 CWD No.2 received solid radioactive waste from the E-MAD Compound (E-MAD Trench)

Corrective Action Decision Document for Corrective Action Unit 254: Area 25 R-MAD Decontamination Facility, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

2000-01-01

This Corrective Action Decision Document identifies and rationalizes the US Department of Energy, Nevada Operations Office's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 254, R-MAD Decontamination Facility, under the Federal Facility Agreement and Consent Order. Located in Area 25 at the Nevada Test Site in Nevada, CAU 254 is comprised of Corrective Action Site (CAS) 25-23-06, Decontamination Facility. A corrective action investigation for this CAS as conducted in January 2000 as set forth in the related Corrective Action Investigation Plan. Samples were collected from various media throughout the CAS and sent to an off-site laboratory for analysis. The laboratory results indicated the following: radiation dose rates inside the Decontamination Facility, Building 3126, and in the storage yard exceeded the average general dose rate; scanning and static total surface contamination surveys indicated that portions of the locker and shower room floor, decontamination bay floor, loft floor, east and west decon pads, north and south decontamination bay interior walls, exterior west and south walls, and loft walls were above preliminary action levels (PALs). The investigation-derived contaminants of concern (COCs) included: polychlorinated biphenyls, radionuclides (strontium-90, niobium-94, cesium-137, uranium-234 and -235), total volatile and semivolatile organic compounds, total petroleum hydrocarbons, and total Resource Conservation and Recovery Act (Metals). During the investigation, two corrective action objectives (CAOs) were identified to prevent or mitigate human exposure to COCs. Based on these CAOs, a review of existing data, future use, and current operations at the Nevada Test Site, three CAAs were developed for consideration: Alternative 1 - No Further Action; Alternative 2 - Unrestricted Release Decontamination and Verification Survey; and Alternative 3 - Unrestricted

Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.

Science.gov (United States)

Owen, Deborah; Aresti, Nick; Mulligan, Alex; Kosuge, Dennis

2018-02-02

This article presents an audit cycle supported quality improvement project addressing best practice in the consent process for lower limb arthroplasty which takes into account the new standard in surgical consent and the importance of material risks. 50 consecutive total hip and total knee replacement consent forms over a 3-month period were reviewed for legibility and completeness. Following the introduction of a new, pre-printed but customizable consent form the review process was repeated. The introduction of a customizable, pre-printed consent form that can be adjusted to reflect the individualized material risks of each patient increased legibility, reduced inappropriate human error variation and abolished the use of abbreviations and medical jargon. When used as part of an extended consent process, the authors feel that the use of pre-printed but customizable consent forms improves legibility, completeness and consistency and also provides the ability to highlight those complications that are of particular importance for that patient to satisfy the new accepted standard in surgical consent.

Selections from Unequal Partners: Teaching about Power, Consent, and Healthy Relationships

Science.gov (United States)

deFur, Kirsten

2016-01-01

The Center for Sex Education recently published the fourth edition of "Unequal Partners: Teaching about Power, Consent, and Healthy Relationships, Volumes 1 and 2." Included here are two lesson plans about sexual consent selected from each volume. "What does it take … to give sexual consent?" [Sue Montfort and Peggy Brick] is…

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2018-02-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

Directory of Open Access Journals (Sweden)

Mehdi Benchoufi

2017-12-01

Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

Futility, autonomy, and informed consent.

Science.gov (United States)

Trau, J M

1994-03-01

If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

Consent in dentistry: ethical and deontological issues.

Science.gov (United States)

Conti, Adelaide; Delbon, Paola; Laffranchi, Laura; Paganelli, Corrado

2013-01-01

In Italy, consent for health treatment, aside from being an ethical and deontological obligation, constitutes an essential requirement for any medical treatment according to articles 13 and 32 of the National Constitution and also in accordance with the Council of Europe's 'Convention on Human Rights and Biomedicine'. An essential requirement for the validity of consent is that clear, exhaustive and adequate information be provided to the patient himself: the practice of informed consent is a communicative relationship in which the patient can express doubts, perplexities and clarification requests to the dentist. Furthermore, dental treatment has specific peculiarities: the relationship between dentistry and aesthetics, the concomitant presence of pathologies requiring different treatments, the elongated care process and the establishment of a trustworthy relationship and familiarity with the patient represent important aspects in the configuration of the dentist-patient relationship and in the process of acquiring informed consent. The dentist must offer correct information on diagnosis, prognosis, the therapeutic perspective and the likely consequences of therapy, alternative therapy and refusal of therapy, as well as eventual commitments for the period after treatment. Particular consideration must be given to minors and patients of unsound mind: the dentist's approach to these patients needs to be clear and appropriate to the person's age and understanding ability, even if the decisional power for sanitary treatment may be in the hands of a third person.

29 CFR 70.42 - Consent to Pay Fees.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent to Pay Fees. 70.42 Section 70.42 Labor Office of the....42 Consent to Pay Fees. (a) The filing of a request under this subpart will be deemed to constitute an agreement by the requester to pay all applicable fees charged under this part up to and including...

Informed consent: Do not be afraid

Directory of Open Access Journals (Sweden)

Dominique Sprumont

2017-04-01

Full Text Available Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

75 FR 68620 - Notice of Lodging Proposed Consent Decree

Science.gov (United States)

2010-11-08

... Florida on November 1, 2010. The proposed Consent Decree concerns a First Amended Complaint filed by the...; Century Partners Group, Ltd.; Century Homebuilders of South Florida, LLC; and Cesar E. Llano to obtain...). The proposed Consent Decree resolves these allegations by requiring the defendants to enhance wetlands...

Corrective Action Decision Document for Corrective Action Unit 417: Central Nevada Test Area Surface, Nevada Appendix D - Corrective Action Investigation Report, Central Nevada Test Area, CAU 417

International Nuclear Information System (INIS)

1999-01-01

This Corrective Action Decision Document (CADD) identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 417: Central Nevada Test Area Surface, Nevada, under the Federal Facility Agreement and Consent Order. Located in Hot Creek Valley in Nye County, Nevada, and consisting of three separate land withdrawal areas (UC-1, UC-3, and UC-4), CAU 417 is comprised of 34 corrective action sites (CASs) including 2 underground storage tanks, 5 septic systems, 8 shaker pad/cuttings disposal areas, 1 decontamination facility pit, 1 burn area, 1 scrap/trash dump, 1 outlier area, 8 housekeeping sites, and 16 mud pits. Four field events were conducted between September 1996 and June 1998 to complete a corrective action investigation indicating that the only contaminant of concern was total petroleum hydrocarbon (TPH) which was found in 18 of the CASs. A total of 1,028 samples were analyzed. During this investigation, a statistical approach was used to determine which depth intervals or layers inside individual mud pits and shaker pad areas were above the State action levels for the TPH. Other related field sampling activities (i.e., expedited site characterization methods, surface geophysical surveys, direct-push geophysical surveys, direct-push soil sampling, and rotosonic drilling located septic leachfields) were conducted in this four-phase investigation; however, no further contaminants of concern (COCs) were identified. During and after the investigation activities, several of the sites which had surface debris but no COCs were cleaned up as housekeeping sites, two septic tanks were closed in place, and two underground storage tanks were removed. The focus of this CADD was to identify CAAs which would promote the prevention or mitigation of human exposure to surface and subsurface soils with contaminant

An approach to radiotherapy under informed consent

International Nuclear Information System (INIS)

Okazaki, Atsushi; Maehara, Tadayuki; Baba, Sadaaki; Nakamura, Yuji; Kamitani, Hiroshi

1996-01-01

Over the past two years, we have attempted to practice radiotherapy in accordance with the principle of informed consent. The procedure used in our radiotherapy, which consists of informing the patient of the seriousness of his or her disease (malignant and benign) and receiving signed consent forms, is a new system in Japan. This is a report of our experience with this system and its advantages and disadvantages. We are satisfied with the clinical results of the attempt. Radiotherapy in accordance with informed consent has now become routine at our hospital. We feel that this practice will produce the mutual enhancement of our responsibility to patients and their trust in us, and improve cure rates. In promoting mutual understanding between our patients and ourselves, we must keep in mind that we, radiation oncologists, are not only radiotherapists but also health-care providers in our capacity as medical and surgical doctors. It is also necessary to achieve the best radiotherapeutic system in Japan. (author)

Informed consent and the law--an English legal perspective.

Science.gov (United States)

Hassan, Majid

2008-01-01

'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

Corrective Action Investigation Plan for Corrective Action Unit 487: Thunderwell Site, Tonopah Test Range, Nevada (Rev. No.: 0, January 2001)

Energy Technology Data Exchange (ETDEWEB)

DOE/NV

2001-01-02

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 487, Thunderwell Site, Tonopah Test Range (TTR), Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 487 consists of a single Corrective Action Site (CAS), RG 26-001-RGRV, Thunderwell Site. The site is located in the northwest portion of the TTR, Nevada, approximately five miles northwest of the Area 3 Control Point and closest to the Cactus Flats broad basin. Historically, Sandia National Laboratories in New Mexico used CAU 487 in the early to mid-1960s for a series of high explosive tests detonated at the bottom of large cylindrical steel tubes. Historical photographs indicate that debris from these tests and subsequent operations may have been scattered and buried throughout the site. A March 2000 walk-over survey and a July 2000 geophysical survey indicated evidence of buried and surface debris in dirt mounds and areas throughout the site; however, a radiological drive-over survey also performed in July 2000 indicated that no radiological hazards were identified at this site. Based on site history, the scope of this plan is to resolve the problem statement identified during the Data Quality Objectives process that detonation activities at this CAU site may have resulted in the release of contaminants of concern into the surface/subsurface soil including total volatile and total semivolatile organic compounds, total Resource Conservation and Recovery Act metals, radionuclides, total petroleum hydrocarbons, and high explosives. Therefore, the scope of corrective action field investigation will involve excavation, drilling, and extensive soil sampling and analysis activities to determine the extent (if any) of both the lateral and vertical contamination

Corrective Action Investigation Plan for Corrective Action Unit 552: Area 12 Muckpile and Ponds, Nevada Test Site, Nevada, Rev. No.: 1 with ROTC 1 and 2

Energy Technology Data Exchange (ETDEWEB)

David A. Strand

2005-01-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 552: Area 12 Muckpile and Ponds, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 552 is comprised of the one Corrective Action Site which is 12-23-05, Ponds. One additional CAS, 12-06-04, Muckpile (G-Tunnel Muckpile), was removed from this CAU when it was determined that the muckpile is an active site. A modification to the FFACO to remove CAS 12-06-04 was approved by the Nevada Division of Environmental Protection (NDEP) on December 16, 2004. The G-Tunnel ponds were first identified in the 1991 Reynolds Electrical & Engineering Co., Inc. document entitled, ''Nevada Test Site Inventory of Inactive and Abandoned Facilities and Waste Sites'' (REECo, 1991). Corrective Action Unit 552 is being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. Therefore, additional information will be obtained by conducting a corrective action investigation (CAI) prior to evaluating and selecting the corrective action alternatives for the site. The CAI will include field inspections, radiological surveys, and sampling of appropriate media. Data will also be obtained to support investigation-derived waste (IDW) disposal and potential future waste management decisions.

Studying antioxidant, radioprotective and antibacterial actions of iron complexes

International Nuclear Information System (INIS)

Shamilov, E.N.

2006-01-01

Full Text: It was investigated regulation of the malone dialdehyde consent ration in the action of the chemical agents and radiation on the white rats liver tissue at participation of dittsiklopenthadienil-Fe and Fe-ru tinate, and it was also investigated the biological activity of some complexes of iron on some Gram positive bacteria strains of the genius of Basillus

Styling antioxidant, radioprotective and antibacterial actions of iron complexes

International Nuclear Information System (INIS)

Shamilov, E.N.

2006-01-01

Full Text: It was investigated regulation of the malone dialdehyde consent ration in the action of the chemical agents and radiation on the white rats liver tissue at participation of dittsiklopenthadienil-Fe and Fe-ru tinate, and it was also investigated the biological activity of some complexes of iron on some Gram positive bacteria strains of the genius of Basillus

Corrective action investigation plan for Corrective Action Unit 143: Area 25 contaminated waste dumps, Nevada Test Site, Nevada, Revision 1 (with Record of Technical Change No. 1 and 2)

Energy Technology Data Exchange (ETDEWEB)

USDOE Nevada Operations Office (DOE/NV)

1999-06-28

This plan contains the US Department of Energy, Nevada Operations Office's approach to collect the data necessary to evaluate correction action alternatives appropriate for the closure of Corrective Action Unit (CAU) 143 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 143 consists of two waste dumps used for the disposal of solid radioactive wastes. Contaminated Waste Dump No.1 (CAS 25-23-09) was used for wastes generated at the Reactor Maintenance Assembly and Disassembly (R-MAD) Facility and Contaminated Waste Dump No.2 (CAS 25-23-03) was used for wastes generated at the Engine Maintenance Assembly and Disassembly (E-MAD) Facility. Both the R-MAD and E-MAD facilities are located in Area 25 of the Nevada Test Site. Based on site history, radionuclides are the primary constituent of concern and are located in these disposal areas; vertical and lateral migration of the radionuclides is unlikely; and if migration has occurred it will be limited to the soil beneath the Contaminated Waste Disposal Dumps. The proposed investigation will involve a combination of Cone Penetrometer Testing within and near the solid waste disposal dumps, field analysis for radionuclides and volatile organic compounds, as well as sample collection from the waste dumps and surrounding areas for off-site chemical, radiological, and geotechnical analyses. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

Science.gov (United States)

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

2017-01-01

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study.

Science.gov (United States)

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Christiaans, Imke; Grisso, Thomas; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-12-01

Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to examine just age limits for alleged competence to consent in children, we evaluated feasibility of a standardized assessment tool, and investigated cutoff ages for children's competence to consent to PGT. We performed a pilot study, including 17 pediatric outpatients between 6 and 18 years at risk for an autosomal dominantly inherited cardiac disease, eligible for predictive genetic testing. The reference standard for competence was established by experts trained in the relevant criteria for competent decision-making. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) served as index test. Data analysis included raw agreement between competence classifications, difference in mean ages between children judged competent and judged incompetent, and estimation of cutoff ages for judgments of competence. Twelve (71 %) children were considered competent by the reference standard, and 16 (94 %) by the MacCAT-T, with an overall agreement of 76 %. The expert judgments disagreed in most cases, while the MacCAT-T judgments agreed in 65 %. Mean age of children judged incompetent was 9.3 years and of children judged competent 12.1 years (p = .035). With 90 % sensitivity, children younger than 10.0 years were judged incompetent, with 90 % specificity children older than 11.8 years were judged competent. Feasibility of the MacCAT-T in children is confirmed. Initial findings on age cutoffs are indicative for children between the age of 12 and 18 to be judged competent for involvement in the informed consent process. Future research on appropriate age-limits for children's alleged competence to consent is needed.

Closure plan for Corrective Action Unit 94: Building 650 Leachfield, Nevada Test Site, Nevada

International Nuclear Information System (INIS)

1998-03-01

The Building 650 Leachfield, Corrective Action Unit (CAU) 94, will be clean closed by removal in accordance with the Resource Conservation and Recover Act (RCRA) operational permit and the Federal Facility Agreement and Consent Order. Historically, laboratory effluent was discharged through pipelines leading from the Radiochemistry Laboratory in Building 650 to a distribution box and a series of pipes dispersed across the leachfield. Effluent from the laboratory contained both hazardous and radioactive constituents. Discharge of hazardous and radioactive waste began in 1965. Discharge of radioactive waste ended in 1979 and hazardous waste discharge ended in 1987. From 1987 to 1993 the leachfield was used for the disposal of non-hazardous waste water. The piping leading to the leachfield was sealed in 1993

Assessing Consent through External Signs. Three Cases of Madness, Repulsion and Love before the Tribunal of the Roman Rota (1579-1619

Directory of Open Access Journals (Sweden)

Isabelle Poutrin

2017-11-01

Full Text Available How can it be assumed that an individual is incapable of giving consent or does not give it freely? This article analyses three cases handled by the Tribunal of the Roman Rota between 1579 and 1619: the case of a nun from the monastery of Odivelas (Portugal suffering from mental disorders, and two demands for nullification of marriage based on the grounds of duress exerted by immediate family; the case of Doña Antonia Portocarrero y Cárdenas, of the diocese of Seville, married to Don Felipe de Guzman y Aragón; and the case of Manuel de Meneses and Branca de Baredo of the diocese of Coimbra. The testimonies on file relate the words and actions of the main parties involved, revealing affects and intentions. Auditors embarked on a complex operation to translate this information into the language of the law, in the light of legal experts’ theories on individual responsibility and the nature of violence or constraints that may alter freedom of consent. Yet this also encompassed social practices and representations in which individual behaviours exist. This study illustrates the contrast between judges’ know-how in assessing the absence of consent regarding marriage or religious profession and the fact that these notions were not taken into account regarding consent to baptism.

Sexual Consent as a Scientific Subject: A Literature Review

Science.gov (United States)

Fenner, Lydia

2017-01-01

Despite the presumed centrality of sexual consent to definitions of sexual violence, it remains an ambiguous and often unexamined concept both in lay and professional/scientific discourses. The following literature review of peer-reviewed research studying sexual consent as a scientific object will thematically present major findings from said…

Readability of Informed Consent Documents at University Counseling Centers

Science.gov (United States)

Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

2017-01-01

The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

Children's competency to consent: an ethical dilemma.

Science.gov (United States)

Spencer, G E

2000-01-01

The application of the best interests principle in current legislation creates an ethical dilemma in relation to children's consent to treatment. The guiding principle of the UN Convention on the Rights of the Child (1989) symbolises a formal expression of children's participation rights. Children's rights to consent to treatment are granted on socially determined ideals of competency. Children's participation in health care is increasingly advocated in legislation but many barriers remain. Nurses can facilitate children's participation through communicating information and creating partnerships with children.

Corrrective action decision document for the Cactus Spring Waste Trenches (Corrective Action Unit No. 426). Revision No. 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-06-01

The Corrective Action Decision Document (CADD) for the Cactus Spring Waste Trenches (Corrective Action Unit [CAU] No. 426) has been prepared for the US Department of Energy`s (DOE) Nevada Environmental Restoration Project. This CADD has been developed to meet the requirements of the Federal Facility Agreement and Consent Order (FFACO) of 1996, stated in Appendix VI, {open_quotes}Corrective Action Strategy{close_quotes} (FFACO, 1996). The Cactus Spring Waste Trenches Corrective Action Site (CAS) No. RG-08-001-RG-CS is included in CAU No. 426 (also referred to as the {open_quotes}trenches{close_quotes}); it has been identified as one of three potential locations for buried, radioactively contaminated materials from the Double Tracks Test. The trenches are located on the east flank of the Cactus Range in the eastern portion of the Cactus Spring Ranch at the Tonopah Test Range (TTR) in Nye County, Nevada, on the northern portion of Nellis Air Force Range. The TTR is approximately 225 kilometers (km) (140 miles [mi]) northwest of Las Vegas, Nevada, by air and approximately 56 km (35 mi) southeast of Tonopah, Nevada, by road. The trenches were dug for the purpose of receiving waste generated during Operation Roller Coaster, primarily the Double Tracks Test. This test, conducted in 1963, involved the use of live animals to assess the biological hazards associated with non-nuclear detonation of plutonium-bearing devices (i.e., inhalation uptake of plutonium aerosol). The CAS consists of four trenches that received solid waste and had an overall impacted area of approximately 36 meters (m) (120 feet [ft]) long x 24 m (80 ft) wide x 3 to 4.5 m (10 to 15 ft) deep. The average depressions at the trenches are approximately 0.3 m (1 ft) below land surface.

Corrective Action Decision Document/ Closure Report for Corrective Action Unit 556: Dry Wells and Surface Release Points, Nevada Test Site, Nevada with Errata Sheet, Revision 0

Energy Technology Data Exchange (ETDEWEB)

Grant Evenson

2008-09-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) has been prepared for Corrective Action Unit 556, Dry Wells and Surface Release Points, located at the Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order (FFACO, 1996; as amended February 2008). Corrective Action Unit (CAU) 556 is comprised of four corrective action sites (CASs): • 06-20-04, National Cementers Dry Well • 06-99-09, Birdwell Test Hole • 25-60-03, E-MAD Stormwater Discharge and Piping • 25-64-01, Vehicle Washdown and Drainage Pit The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure of CAU 556 with no further corrective action. To achieve this, corrective action investigation (CAI) activities began on February 7 and were completed on June 19, 2008, as set forth in the Corrective Action Investigation Plan for Corrective Action Unit 556: Dry Wells and Surface Release Points, Nevada Test Site, Nevada (NNSA/NSO, 2007). The purpose of the CAI was to fulfill the following data needs as defined during the data quality objective (DQO) process: • Determine whether contaminants of concern (COCs) are present. • If COCs are present, determine their nature and extent. • Provide sufficient information and data to complete appropriate corrective actions. The CAU 556 data were evaluated based on the data quality assessment process, which demonstrated the quality and acceptability of the data for use in fulfilling the DQO data needs. Analytes detected during the CAI were evaluated against appropriate final action levels (FALs) to identify the COCs for each CAS. The results of the CAI identified COCs at one of the four CASs in CAU 556 that required the completion of a corrective action. Assessment of the data generated from investigation activities conducted at CAU 556 revealed the following: • Corrective Action Sites 06-20-04, 06-99-09, and 25-64-01 do not contain contamination at

Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 113: Reactor Maintenance, Assembly, and Disassembly Building Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

J. L. Smith

2001-01-01

This Streamlined Approach for Environmental Restoration (SAFER) Plan addresses the action necessary for the closure in place of Corrective Action Unit (CAU) 113 Area 25 Reactor Maintenance, Assembly, and Disassembly Facility (R-MAD). CAU 113 is currently listed in Appendix III of the Federal Facility Agreement and Consent Order (FFACO) (NDEP, 1996). The CAU is located in Area 25 of the Nevada Test Site (NTS) and consists of Corrective Action Site (CAS) 25-04-01, R-MAD Facility (Figures 1-2). This plan provides the methodology for closure in place of CAU 113. The site contains radiologically impacted and hazardous material. Based on preassessment field work, there is sufficient process knowledge to close in place CAU 113 using the SAFER process. At a future date when funding becomes available, the R-MAD Building (25-3110) will be demolished and inaccessible radiologic waste will be properly disposed in the Area 3 Radiological Waste Management Site (RWMS).

Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 113: Reactor Maintenance, Assembly, and Disassembly Building Nevada Test Site, Nevada

International Nuclear Information System (INIS)

Smith, J. L.

2001-01-01

This Streamlined Approach for Environmental Restoration (SAFER) Plan addresses the action necessary for the closure in place of Corrective Action Unit (CAU) 113 Area 25 Reactor Maintenance, Assembly, and Disassembly Facility (R-MAD). CAU 113 is currently listed in Appendix III of the Federal Facility Agreement and Consent Order (FFACO) (NDEP, 1996). The CAU is located in Area 25 of the Nevada Test Site (NTS) and consists of Corrective Action Site (CAS) 25-04-01, R-MAD Facility (Figures 1-2). This plan provides the methodology for closure in place of CAU 113. The site contains radiologically impacted and hazardous material. Based on preassessment field work, there is sufficient process knowledge to close in place CAU 113 using the SAFER process. At a future date when funding becomes available, the R-MAD Building (25-3110) will be demolished and inaccessible radiologic waste will be properly disposed in the Area 3 Radiological Waste Management Site (RWMS)

Sole risk and non-consent

International Nuclear Information System (INIS)

Winsor, Tom

1994-01-01

This article discusses the subjects of sole risk and non-consent in joint operation agreements as used by oil and gas joint ventures in the United Kingdom. The difference between these two concepts is examined in detail. (UK)

Closure Report for Corrective Action Unit 553: Areas 19, 20 Mud Pits and Cellars, Nevada Test Site, Nevada, Revision 0

International Nuclear Information System (INIS)

Al Wickline

2007-01-01

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 553: Areas 19, 20 Mud Pits and Cellars, Nevada Test Site, Nevada. This CR complies with the requirements of the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. The corrective action sites (CASs) within CAU 553 are located within Areas 19 and 20 of the Nevada Test Site. Corrective Action Unit 553 is comprised of the following CASs: 19-99-01, Mud Spill 19-99-11, Mud Spill 20-09-09, Mud Spill 20-99-03, Mud Spill. The purpose of this CR is to provide documentation supporting the completed corrective actions and provide data confirming that the closure objectives for CASs within CAU 553 were met. To achieve this, the following actions were or will be performed: Review the current site conditions including the concentration and extent of contamination. Implement any corrective actions necessary to protect human health and the environment. Properly dispose of corrective action and investigation wastes. Document the Notice of Completion and closure of CAU 553 to be issued by Nevada Division of Environmental Protection

Informed consent for and regulation of critical care research.

Science.gov (United States)

Lemaire, François

2008-12-01

Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

Remote preenrollment checking of consent forms to reduce nonconformity.

Science.gov (United States)

Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

2013-01-01

In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information

Undergraduate Consent Form Reading in Relation to Conscientiousness, Procrastination, and the Point-of-Time Effect.

Science.gov (United States)

Theiss, Justin D; Hobbs, William B; Giordano, Peter J; Brunson, Olivia M

2014-07-01

Informed consent is central to conducting ethical research with human participants. The present study investigated differences in consent form reading in relation to conscientiousness, procrastination, and the point-of-time (PT) effect among undergraduate participants at a U.S. university. As hypothesized, conscientious participants and those who signed up to participate in a research study more days in advance and for earlier sessions (PT effect) read the consent form more thoroughly. However, procrastination was not related to consent form reading. Most importantly, consent form reading in general was poor, with 80% of participants demonstrating that they had not read the consent form. Conscientious participants were more likely to self-report reading the consent form, irrespective of their measured consent form reading. The article closes with suggestions to improve the process of obtaining informed consent with undergraduate participants. © The Author(s) 2014.

Corrective Action Investigation Plan for Corrective Action Unit 252: Area 25 Engine Test Stand 1 Decontamination Pad, Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

U.S. Department of Energy, Nevada Operations Office

1999-08-20

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit 252 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 252 consists of Corrective Action Site (CAS) 25-07-02, Engine Test Stand-1 (ETS-1) Decontamination Pad. Located in Area 25 at the intersection of Road H and Road K at the Nevada Test Site, ETS-1 was designed for use as a mobile radiation checkpoint and for vehicle decontamination. The CAS consists of a concrete decontamination pad with a drain, a gravel-filled sump, two concrete trailer pads, and utility boxes. Constructed in 1966, the ETS-1 facility was part of the Nuclear Rocket Development Station (NRDS) complex and used to test nuclear rockets. The ETS-1 Decontamination Pad and mobile radiation check point was built in 1968. The NRDS complex ceased primary operations in 1973. Based on site history, the focus of the field investigation activities will be to determine if any primary contaminants of potential concern (COPCs) (including radionuclides, total volatile organic compounds, total semivolatile organic compounds, total petroleum hydrocarbons as diesel-range organics, Resource Conservation and Recovery Act metals, total pesticides, and polychlorinated biphenyls) are present at this site. Vertical extent of migration of suspected vehicle decontamination effluent COPCs is expected to be less than 12 feet below ground surface. Lateral extent of migration of COPCs is expected to be limited to the sump area or near the northeast corner of the decontamination pad. Using a biased sampling approach, near-surface and subsurface sampling will be conducted at the suspected worst-case areas including the sump and soil near the northeast corner of the decontamination pad. The results of this field investigation will support a defensible e

Corrective Action Investigation Plan for Corrective Action Unit 487: Thunderwell Site, Tonopah Test Range, Nevada (Rev. No.: 0, January 2001); TOPICAL

International Nuclear Information System (INIS)

2001-01-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 487, Thunderwell Site, Tonopah Test Range (TTR), Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 487 consists of a single Corrective Action Site (CAS), RG 26-001-RGRV, Thunderwell Site. The site is located in the northwest portion of the TTR, Nevada, approximately five miles northwest of the Area 3 Control Point and closest to the Cactus Flats broad basin. Historically, Sandia National Laboratories in New Mexico used CAU 487 in the early to mid-1960s for a series of high explosive tests detonated at the bottom of large cylindrical steel tubes. Historical photographs indicate that debris from these tests and subsequent operations may have been scattered and buried throughout the site. A March 2000 walk-over survey and a July 2000 geophysical survey indicated evidence of buried and surface debris in dirt mounds and areas throughout the site; however, a radiological drive-over survey also performed in July 2000 indicated that no radiological hazards were identified at this site. Based on site history, the scope of this plan is to resolve the problem statement identified during the Data Quality Objectives process that detonation activities at this CAU site may have resulted in the release of contaminants of concern into the surface/subsurface soil including total volatile and total semivolatile organic compounds, total Resource Conservation and Recovery Act metals, radionuclides, total petroleum hydrocarbons, and high explosives. Therefore, the scope of corrective action field investigation will involve excavation, drilling, and extensive soil sampling and analysis activities to determine the extent (if any) of both the lateral and vertical contamination and whether

Predicting Participant Consent in mHealth Trials – A Caregiver’s Perspective

Directory of Open Access Journals (Sweden)

Yvonne O'Connor

2017-11-01

Full Text Available Informed consent is sought prior to conducting a healthcare intervention on a person. When a healthcare intervention involves a young child, their caregiver is required to provide informed consent on their behalf. However, little is known on the behavioural intentions of participants to provide consent when a mobile health (mHealth intervention is involved in a clinical trial scenario. Understanding this phenomenon is important, without consent appropriate data may not be collected to empirically examine the implications of mHealth initiatives when delivering healthcare services to children in a ‘real world context’. The objective of this paper is to explore the behavioural intentions of caregivers to provide consent for children (under five years of age to participate in mHealth Randomised Control Trials (RCT in developing countries and subsequently develop a predictive model for consent giving. Data was captured vis-à-vis interviews with Malawian caregivers in Africa. The findings reveal that emotional response stimuli play a major role during the participant informed consent process resulting in the involvement (or not of a child within an RCT. The study contributes to, and opens up, avenues for critical research on the role of informed consent as part of RCT-related projects, especially concerning the involvement of children. This new knowledge may be leveraged to address participant uncertainties and subsequently improve the rate of paediatric recruitment in mHealth trial scenarios.

"Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

Science.gov (United States)

Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

2016-01-01

Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

Optimization of informed consent for umbilical cord blood banking.

Science.gov (United States)

Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

2002-12-01

The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

Community perspectives on research consent involving vulnerable children in Western Kenya.

Science.gov (United States)

Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

2012-10-01

Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

49 CFR 190.233 - Corrective action orders.

Science.gov (United States)

2010-10-01

... effective, the Associate Administrator, OPS may request the Attorney General to bring an action for appropriate relief in accordance with § 190.235. (i) Upon petition by the Attorney General, the District... must notify the Associate Administrator, OPS of that election in writing within 10 days of service of...

A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

Science.gov (United States)

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-07-21

In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given

Corrective Action Decision Document for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada, Revision 0 with ROTC 1, 2, and Errata

Energy Technology Data Exchange (ETDEWEB)

Wickline, Alfred

2004-04-01

This Corrective Action Decision Document (CADD) has been prepared for Corrective Action Unit (CAU) 204 Storage Bunkers, Nevada Test Site (NTS), Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE); and the U.S. Department of Defense (FFACO, 1996). The NTS is approximately 65 miles (mi) north of Las Vegas, Nevada (Figure 1-1). The Corrective Action Sites (CASs) within CAU 204 are located in Areas 1, 2, 3, and 5 of the NTS, in Nye County, Nevada (Figure 1-2). Corrective Action Unit 204 is comprised of the six CASs identified in Table 1-1. As shown in Table 1-1, the FFACO describes four of these CASs as bunkers one as chemical exchange storage and one as a blockhouse. Subsequent investigations have identified four of these structures as instrumentation bunkers (CASs 01-34-01, 02-34-01, 03-34-01, 05-33-01), one as an explosives storage bunker (CAS 05-99-02), and one as both (CAS 05-18-02). The six bunkers included in CAU 204 were primarily used to monitor atmospheric testing or store munitions. The ''Corrective Action Investigation Plan (CAIP) for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada'' (NNSA/NV, 2002a) provides information relating to the history, planning, and scope of the investigation; therefore, it will not be repeated in this CADD. This CADD identifies potential corrective action alternatives and provides a rationale for the selection of a recommended corrective action alternative for each CAS within CAU 204. The evaluation of corrective action alternatives is based on process knowledge and the results of investigative activities conducted in accordance with the CAIP (NNSA/NV, 2002a) that was approved prior to the start of the Corrective Action Investigation (CAI). Record of Technical Change (ROTC) No. 1 to the CAIP (approval pending) documents changes to the preliminary action levels

Do chiropractic college faculty understand informed consent: a pilot study

Directory of Open Access Journals (Sweden)

Hondras Maria A

2006-12-01

Full Text Available Abstract Background The purpose of this study was to survey full-time faculty at a single chiropractic college concerning their knowledge of Institutional Review Board (IRB policies in their institution as they pertain to educational research. Methods All full-time faculty were invited to participate in an anonymous survey. Four scenarios involving educational research were described and respondents were asked to select from three possible courses of action for each. In addition, respondents were queried about their knowledge of IRB policies, how they learned of these policies and about their years of service and departmental assignments. Results The response rate was 55%. In no scenario did the level of correct answers by all respondents score higher than 41% and in most, the scores were closer to just under 1 in 3. Sixty-five percent of respondents indicated they were unsure whether Palmer had any policies in place at all, while 4% felt that no such policies were in place. Just over one-quarter (27% were correct in noting that students can decline consent, while more than half (54% did not know whether there were any procedures governing student consent. Conclusion Palmer faculty have only modest understanding about institutional policies regarding the IRB and human subject research, especially pertaining to educational research. The institution needs to develop methods to provide knowledge and training to faculty. The results from this pilot study will be instrumental in developing better protocols for a study designed to survey the entire chiropractic academic community.

Corrective Action Investigation Plan for Corrective Action Unit 190: Contaminated Waste Sites Nevada Test Site, Nevada, Rev. No.: 0

International Nuclear Information System (INIS)

Wickline, Alfred

2006-01-01

, to determine the potential for a release; (7) Collect samples of investigation-derived waste, as needed, for waste management and minimization purposes; and (8) Collect quality control samples. This Corrective Action Investigation Document (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, U.S. Department of Energy, and U.S. Department of Defense. Under the FFACO, this CAIP will be submitted to the Nevada Division of Environmental Protection for approval. Field work will be conducted following approval

Corrective Action Plan for CAU No. 95: Area 15 EPA Farm Laboratory Building, Decontamination and Demolition Closure Activities - Nevada Test Site. Rev. 0

International Nuclear Information System (INIS)

Olson, A.L.; Nacht, S.J.

1997-11-01

This Corrective Action Plan (CAP) provides the selected corrective action alternative and proposes the closure implementation methodology for the Environmental Protection Agency (EPA) Farm Laboratory Building 15-06 located in Area 15 of the Nevada Test Site (NTS), Nye County, Nevada. The facility is part of the Environmental Restoration Project managed by the U.S. Department of Energy/Nevada Operations Office (DOE/NV) under the Decontamination and Decommissioning (D ampersand D) Subproject which serves to manage and dispose of surplus facilities at the NTS in a manner that will protect personnel, the public, and the environment. It is identified as Corrective Action Unit (CAU) 95 in Appendix III of the Federal Facilities Agreement and Consent Order (FFACO). In July 1997, the DOE/NV verbally requested approval from the Nevada Division of Environmental Protection (NDEP) for the closure schedule to be accelerated. Currently, field activities are anticipated to be completed by September 30, 1997. In order to meet this new schedule NDEP has agreed to review this document as expeditiously as possible. Comments will be addressed in the Closure Report after field activities have been completed, unless significant issues require resolution during closure activities

Corrective Action Plan for CAU No. 95: Area 15 EPA Farm Laboratory Building, Decontamination and Demolition Closure Activities - Nevada Test Site. Rev. 0

Energy Technology Data Exchange (ETDEWEB)

Olson, A.L.; Nacht, S.J.

1997-11-01

This Corrective Action Plan (CAP) provides the selected corrective action alternative and proposes the closure implementation methodology for the Environmental Protection Agency (EPA) Farm Laboratory Building 15-06 located in Area 15 of the Nevada Test Site (NTS), Nye County, Nevada. The facility is part of the Environmental Restoration Project managed by the U.S. Department of Energy/Nevada Operations Office (DOE/NV) under the Decontamination and Decommissioning (D&D) Subproject which serves to manage and dispose of surplus facilities at the NTS in a manner that will protect personnel, the public, and the environment. It is identified as Corrective Action Unit (CAU) 95 in Appendix III of the Federal Facilities Agreement and Consent Order (FFACO). In July 1997, the DOE/NV verbally requested approval from the Nevada Division of Environmental Protection (NDEP) for the closure schedule to be accelerated. Currently, field activities are anticipated to be completed by September 30, 1997. In order to meet this new schedule NDEP has agreed to review this document as expeditiously as possible. Comments will be addressed in the Closure Report after field activities have been completed, unless significant issues require resolution during closure activities.

Informed consent for caesarean section at a Nigerian university ...

African Journals Online (AJOL)

Results: The mean age of the respondents was 32±1.8 yearswith 118(79%) of the surgeries being emergency Cesarean sections. The consent for CS were mostly given by the patients (96, 64.0%) and husbands (43, 28.6%). Majority of the respondents 123(81.5%) had the consent obtained in the labour ward with profuse ...

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Science.gov (United States)

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

Science.gov (United States)

Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

2015-08-01

Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

Science.gov (United States)

Paudel, B; Shrestha, G K

Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

Corrective Action Investigation Plan for Corrective Action Unit 97: Yucca Flat/Climax Mine, Nevada National Security Site, Nevada with ROTCs 1, 2, and 3 (Revision 0, September 2000)

Energy Technology Data Exchange (ETDEWEB)

Andrews, Robert; Marutzky, Sam

2000-09-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) approach to collect the data necessary to evaluate Corrective Action Alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 97 under the Federal Facility Agreement and Consent Order (FFACO). Corrective Action Unit 97, collectively known as the Yucca Flat/Climax Mine CAU, consists of 720 Corrective Action Sites (CASs). The Yucca Flat/Climax Mine CAU extends over several areas of the NTS and constitutes one of several areas used for underground nuclear testing in the past. The nuclear tests resulted in groundwater contamination in the vicinity as well as downgradient of the underground test areas. Based on site history, the Yucca Flat underground nuclear tests were conducted in alluvial, volcanic, and carbonate rocks; whereas, the Climax Mine tests were conducted in an igneous intrusion located in northern Yucca Flat. Particle-tracking simulations performed during the regional evaluation indicate that the local Climax Mine groundwater flow system merges into the much larger Yucca Flat groundwater flow systems during the 1,000-year time period of interest. Addressing these two areas jointly and simultaneously investigating them as a combined CAU has been determined the best way to proceed with corrective action investigation (CAI) activities. The purpose and scope of the CAI includes characterization activities and model development conducted in five major sequential steps designed to be consistent with FFACO Underground Test Area Project's strategy to predict the location of the contaminant boundary, develop and implement a corrective action, and close each CAU. The results of this field investigation will support a defensible evaluation of CAAs in the subsequent corrective action decision document.

Streamlined Approach for Environmental Restoration (SAFER) Plan for Corrective Action Unit 575: Area 15 Miscellaneous Sites, Nevada National Security Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

Matthews, Patrick [Navarro-Intera, LLC (N-I), Las Vegas, NV (United States)

2014-12-01

This Streamlined Approach for Environmental Restoration (SAFER) Plan addresses the actions needed to achieve closure for Corrective Action Unit (CAU) 575, Area 15 Miscellaneous Sites, identified in the Federal Facility Agreement and Consent Order (FFACO). CAU 575 comprises the following four corrective action sites (CASs) located in Area 15 of the Nevada National Security Site: 15-19-02, Waste Burial Pit, 15-30-01, Surface Features at Borehole Sites, 15-64-01, Decontamination Area, 15-99-03, Aggregate Plant This plan provides the methodology for field activities needed to gather the necessary information for closing each CAS. There is sufficient information and process knowledge from historical documentation and investigations of similar sites regarding the expected nature and extent of potential contaminants to recommend closure of CAU 575 using the SAFER process. Additional information will be obtained by conducting a field investigation to document and verify the adequacy of existing information, to affirm the predicted corrective action decisions, and to provide sufficient data to implement the corrective actions. This will be presented in a closure report that will be prepared and submitted to the Nevada Division of Environmental Protection (NDEP) for review and approval.

Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

Science.gov (United States)

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

2013-02-01

Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience

2014 Well Completion Report for Corrective Action Unit 447 Project Shoal Area Churchill County, Nevada October 2015

Energy Technology Data Exchange (ETDEWEB)

Findlay, Rick [US Department of Energy, Washington, DC (United States).Office of Legacy Management

2015-11-01

This report summarizes the drilling program conducted by the U.S. Department of Energy (DOE) Office of Legacy Management at the Project Shoal Area (Shoal) Subsurface Corrective Action Unit 447 in Churchill County, Nevada. Shoal was the location of an underground nuclear test conducted on October 26, 1963, as part of the Vela Uniform program sponsored jointly by the U.S. Department of Defense and the U.S. Atomic Energy Commission (a predecessor to DOE). The test consisted of detonating a 12-kiloton nuclear device in granitic rock at a depth of approximately 1,211 feet (ft) below ground surface (bgs) (AEC 1964). The corrective action strategy for the site is focused on revising the site conceptual model and evaluating the adequacy of the monitoring well network at the site. Field activities associated with the project were conducted in accordance with the Federal Facility Agreement and Consent Order (FFACO 1996, as amended) and applicable Nevada Division of Environmental Protection (NDEP) policies and regulations.

Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

Science.gov (United States)

Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

2014-04-01

Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: pmotivational consent procedure for enhancing recall of study information and human research protections.

Key factors in children's competence to consent to clinical research

NARCIS (Netherlands)

Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

2015-01-01

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

Science.gov (United States)

Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

2013-06-01

A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND

Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

Science.gov (United States)

Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

The Consent Solution to Punishment and the Explicit Denial Objection

Directory of Open Access Journals (Sweden)

Miroslav Imbrisevic

2010-06-01

Full Text Available Recently, David Boonin has put forward several objections to Carlos S. Nino's 'Consensual Theory of Punishment'. In this paper I will defend Nino against the 'explicit denial objection'. I will discuss whether Boonin's interpretation of Nino as a tacit consent theorist is right. I will argue that the offender's consent is neither tacit nor express, but a special category of implicit consent. Further, for Nino the legal-normative consequences of an act (of crime are 'irrevocable', i.e. one cannot (expressly and successfully deny liability to them. I will suggest an explanation for Nino's irrevocability claim.

A qualitative study of participants' views on re-consent in a longitudinal biobank.

Science.gov (United States)

Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

2017-03-23

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two