Sample records for nrdc consent decree
-
75 FR 68620 - Notice of Lodging Proposed Consent Decree
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...
-
78 FR 57176 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act
2013-09-17
... model of the system to plan for future needs. The consent decree also provides for the payment of a....html . We will provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box...
-
77 FR 36003 - Notice of Lodging of Consent Decree Under the Clean Water Act
2012-06-15
... adequate secondary containment system, and failing to prepare and implement an adequate Spill Prevention... may be examined on the following Department of Justice Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . A copy of the proposed Decree may also be obtained by mail from the Consent Decree Library...
-
77 FR 31040 - Notice of Lodging of Consent Decree Under the Clean Air Act
2012-05-24
... expert to audit the refrigeration system and recommend any necessary changes; and implement any changes..., the Consent Decree may also be examined on the following Department of Justice Web site, http://www... Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing...
-
77 FR 1085 - Notice of Lodging of Consent Decree Under the Oil Pollution Act
2012-01-09
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Oil Pollution Act Notice is hereby given that on December 21, 2011, a proposed Consent Decree in United States v. Marathon Pipe Line... resource damages under the Oil Pollution Act, 33 U.S.C. 2710, et seq., which arose from an alleged August...
-
2011-12-29
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental.... Cal.), with respect to the Middlefield-Ellis-Whisman Superfund Site in Mountain View, California (the..., which is attached as Appendix F to the First Amended Consent Decree. The Department of Justice will...
-
2011-09-29
... resources. The Consent Decree also requires, among other things, that Defendants assign their interests in insurance policies to a trust, established for the benefit of EPA and the natural resource trustees, and pay... comment period, the Consent Decree may be examined on the following Department of Justice Web site: http...
-
2012-12-10
... Defendants International Paper Company and Georgia-Pacific Consumer Products, LP (collectively, ``IP/GP... may be submitted either by email or by mail: To submit comments: Send them to: By email pubcomment-ees... per page reproduction cost) for the IP/GP consent decree and/or $4.75 for the Rexam consent decree...
-
78 FR 1251 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act
2013-01-08
... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On December 21, 2012, the Department of Justice lodged a proposed consent decree with the United States... Oil Pollution Act, 33 U.S.C. 2702, 2706, and Section 128D of the Hawaii Environmental Response law...
-
2011-01-31
... ability to pay. The settlement requires, among other things, that Defendants assign their interest in insurance policies to a trust, established for the benefit of EPA and the natural resource trustees, and pay... Department of Justice Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . A copy of the Consent Decree...
-
78 FR 69875 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act
2013-11-21
... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On November 15, 2013, the Department of Justice lodged a proposed consent decree with the United States... against Suncor (U.S.A.) Inc. (``Suncor'') pursuant to the Oil Pollution Act, 33 U.S.C. 2701-2762. The...
-
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…
-
2010-02-22
.... (``Defendants'') under the pre-treatment requirements of the Federal Water Pollution Control Act (Clean Water... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Federal Water Pollution Control Act Notice is hereby given that on February 16, 2010, a proposed Consent Decree was filed...
-
78 FR 5837 - Notice of Lodging Proposed Consent Decree
2013-01-28
... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Porter... complaint filed by the United States against Wesley Porter, Wes Porter Development Company, LLC, Temple and... Division, P.O. Box 7611, Washington, DC 20044, and refer to United States v. Porter, DJ 90-5-1-1-18341. The...
-
75 FR 24946 - Proposed Consent Decree, Clean Air Act Citizen Suit
2010-05-06
..., South Carolina, Wisconsin, Indiana, Michigan, Ohio, Louisiana, Kansas, Nebraska, Missouri, Colorado..., Wisconsin, Indiana, Michigan, Ohio, Louisiana, Kansas, Nebraska, Missouri, Colorado, Montana, South Dakota... ENVIRONMENTAL PROTECTION AGENCY [FRL-9146-3] Proposed Consent Decree, Clean Air Act Citizen Suit...
-
2011-05-17
... Response, Compensation, and Liability Act Notice is hereby given that on May 11, 2011, a proposed Consent Decree (the ``Decree'') in United States v. Alsol Corporation, SB Building Associates, Limited Partnership, SB Building GP, L.L.C., United States Land Resources, L.P., United States Realty Resources, Inc...
-
2010-07-26
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Federal Water Pollution Control Act (``Clean Water Act'') Notice is hereby given that on July 21, 2010, a proposed Consent Decree... Sections 301 and 308 of the Clean Water Act, 33 U.S.C. 1311 and 1318, at thirteen of its facilities in...
-
75 FR 40827 - Proposed Consent Decree, Clean Air Act Citizen Suit
2010-07-14
... Cement manufacturing (40 CFR part 63, subpart LLL). The proposed Consent Decree establishes deadlines for..., subpart II); (8) Wood Furniture Manufacturing Operations (40 CFR part 63, subpart JJ); (9) Primary Lead... and Paper Production (40 CFR part 63, subpart S); (12) Aerospace Manufacturing and Rework Facilities...
-
2011-11-28
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act and Safe Drinking Water Act Notice is hereby given that on November 21, 2011, a proposed Consent Decree (``proposed... penalties under the Clean Water Act, 33 U.S.C. 1251-387; the Safe Drinking Water Act, 42 U.S.C. 300f-300j-26...
-
2010-05-24
... implementation of the provisions of the seven consent decrees signed by the United States and diesel engine..., or anticipates receiving, requests from the diesel engine manufacturers for termination of their respective decrees. This meeting notice is also available on EPA's Diesel Engine Settlement Web site at http...
-
76 FR 34983 - Proposed Consent Decree, Clean Air Act Citizen Suit
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...
-
75 FR 1770 - Proposed Consent Decree, Clean Air Act Citizen Suit
2010-01-13
... Division, to the Public Service of Colorado to operate the Hayden Station power plant near Hayden, Colorado... Environment, Air Pollution Division, to the Public Service of Colorado to operate the Hayden Station power plant near Hayden, Colorado. Under the terms of the proposed consent decree, EPA has agreed to respond...
-
76 FR 75544 - Proposed Consent Decree, Clean Air Act Citizen Suit
2011-12-02
... holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file, avoiding the use of... U.S. Virgin Islands had failed to submit CAA SIPs for improving visibility in mandatory Federal..., Vermont, U.S. Virgin Islands, Virginia, Washington, and Wisconsin. The proposed consent decree would also...
-
2010-10-15
...; and will spend an estimated $5.8 million on stream mitigation activities along 8.5 miles of Bee Fork..., and either e-mailed to [email protected] or mailed to P.O. Box 7611, U.S. Department of... Consent Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S...
-
76 FR 79710 - Notice of Lodging of Consent Decree Under the Clean Water Act
2011-12-22
... ten times the average dry weather flow for the average design year. The proposed Consent Decree... control floatables in such waterways; (3) post construction monitoring following completion of TARP; (4...
-
76 FR 9610 - Notice of Proposed Consent Decree Under the Clean Air Act
2011-02-18
... pollution control technology; undertake periodic equipment testing; and to submit required reports. The... resolves allegations by the Environmental Protection Agency and the San Joaquin Valley Unified Air Pollution Control District (``District''), asserted in a complaint filed together with the Consent Decree...
-
76 FR 68788 - Notice of Lodging of Consent Decree Under the Clean Water Act
2011-11-07
... Regulations Governing the Control of Water Pollution, 7 Del. Admin. Code Sec. 7201. The United States and... Web site, http://www.usdoj.gov/enrd/Consent_Decrees.html , maintained by the Department of Justice. A...
-
78 FR 23957 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act
2013-04-23
... sand, gravel, crushed stone mining, and redi-mix concrete operation at 18 Dorre Road, Kingston, New... Justice Department Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . We will provide a paper copy...
-
2013-11-15
... in Rootstown, Ohio, formerly operating under Delphi's Packard Electric/Electronic Architecture... payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box 7611, Washington, DC 20044-7611. Please...
-
77 FR 23278 - Notice of Lodging of Consent Decree Under the Clean Air Act
2012-04-18
... accept small appliances, motor vehicle air conditioners (``MVACs''), or MVAC- like appliances with cut... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby... Agency (``U.S. EPA''), sought penalties and injunctive relief under the Clean Air Act (``CAA'') against...
-
78 FR 44599 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act
2013-07-24
... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On... seeking permanent injunctive relief and civil penalties under the Clean Water Act (``CWA''), 33 U.S.C..., manganese, potassium, sodium, strontium, bromide, chloride, [[Page 44600
-
76 FR 76762 - Notice of Lodging of Consent Decree Under the Clean Air Act
2011-12-08
... recovery at no additional cost; (2) no longer accept small appliances, motor vehicle air conditioners... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby.... Environmental Protection Agency (``U.S. EPA''), sought penalties and injunctive relief under the Clean Air Act...
-
76 FR 57764 - Notice of Lodging of Consent Decree Under the Clean Air Act
2011-09-16
... recovery at no additional cost; (2) no longer accept small appliances, motor vehicle air conditioners... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby... Agency (``U.S. EPA''), sought penalties and injunctive relief under the Clean Air Act (``CAA'') against...
-
76 FR 15998 - Notice of Lodging of Consent Decree Under the Clean Water Act
2011-03-22
..., treatment plant, and landfill. To address two mines with discharges into the Ohio River Basin, Defendants... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is..., Defendants will perform injunctive relief with two components. To address four mines with discharges into the...
-
2012-03-22
... address. Robert Brook, Assistant Chief, Environmental Enforcement Section, Environment and Natural...' natural resource damage assessment costs of $18,964.34, and will pay future travel costs incurred by... Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural...
-
2011-07-18
... generation, transportation, treatment, storage, handling and disposal of hazardous wastes, Fla. Admin. Code... Consent Decree, may also be examined on the following Department of Justice Web site, http://www.usdoj.gov...
-
2010-03-24
... Response, Compensation, and Liability Act Notice is hereby given that on March 18, 2010, the United States... her capacity as personal representative of the Estate, under CERCLA Section 107(a), 42 U.S.C. 9607(a... Consent Decree resolves the claims in the Complaint against the Estate and Barbara C. Harker, in her...
-
75 FR 70947 - Notice of Lodging of Consent Decree Pursuant to Oil Pollution Act
2010-11-19
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant to Oil Pollution Act Notice is... claims of the United States (on behalf of the Department of Commerce/National Oceanic and Atmospheric..., and the State of Rhode Island for natural resource damages under the Oil Pollution Act, 33 U.S.C. 2701...
-
77 FR 11158 - Notice of Lodging of Consent Decree Under the Toxic Substances Control Act
2012-02-24
... Dover Chemical to pay a $1.4 million civil penalty. Dover Chemical has halted manufacture of short-chain chlorinated paraffins and committed to submit premanufacture notices (``PMNs'') for medium and long-chain chlorinated paraffins, pursuant to TSCA Section 5. The proposed Consent Decree prohibits Dover Chemical from...
-
77 FR 66081 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act
2012-11-01
... District Court for the Western District of Michigan in the lawsuit entitled United States v. Kellogg USA... Implementation Plan, for violations at Kellogg's cereal and snack food manufacturing plants located in Battle Creek, Michigan and Grand Rapids, Michigan. The proposed Consent Decree requires Kellogg to reduce its...
-
75 FR 68620 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act
2010-11-08
..., the consent decree requires the Township to perform a wide variety of short-, medium, and long-term..., Environment and Natural Resources Division, and either e-mailed to [email protected] or mailed to... the U.S. Treasury. Maureen Katz, Assistant Chief Environmental Enforcement Section, Environment and...
-
75 FR 51483 - Notice of Lodging of Consent Decree Under the Clean Air Act
2010-08-20
... given that on August 9, 2010, a proposed Consent Decree in United States v. Middlesex County Utilities... Air Pollution Control Act, N.J.S.A. 26:2C-1 et seq., at the Middlesex County landfill in East... to the United States and New Jersey, and shall upgrade the Middlesex County Landfill Gas Collection...
-
2011-04-15
..., on Behalf of the National Oceanic and Atmospheric Administration and the United States Department of... section 1002(b) of the Oil Pollution Act (OPA), 33 U.S.C. 2702(b), for damages for injury to, destruction... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental...
-
75 FR 42785 - Notice of Lodging of Consent Decree Under the Clean Air Act
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...
-
75 FR 16177 - Notice of Lodging of Material Modification to Consent Decree Under the Clean Water Act
2010-03-31
... things, the 2002 Consent Decree required Anderson to develop and implement a Long Term Control Plan to... electronically to [email protected] or in hard copy to P.O. Box 7611, U.S. Department of Justice...
-
78 FR 38074 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act
2013-06-25
... manufacturing plants operating in as many states. The states of Arkansas, Idaho, Kansas, Montana, Nebraska... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On June... Court for the District of Kansas in the lawsuit entitled United States et al. v. Ash Grove Cement...
-
2012-01-26
... Modification'') in United States and Louisiana v. City of Baton Rouge, Civil Action No. 3:01-cv-00978-FJP-CN...-0097, phone confirmation number (202) 514-5271. If requesting a copy from the Consent Decree Library by...
-
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...
-
2010-08-12
..., among other things, that the Defendant pay $150,000, provide $50,000 worth of construction materials to..., established for the benefit of EPA and the natural resource trustees. For thirty (30) days after the date of... the following Department of Justice Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . A copy...
-
2012-07-26
... companies to clean up the Site and pay EPA $900,000 towards past and future costs. The cleanup will cost $56...), are resolving their liability in the Consent Decree by paying cash to the group of 27 companies that... projects. (This amount also covers some assessment, planning, and oversight costs.) The trustees are the...
-
Reyes, Luis O.
2006-01-01
In this article, Luis O. Reyes provides a retrospective of the historic 1974 Aspira Consent Decree between the New York City Board of Education and Aspira of New York, which established bilingual instruction as a legally enforceable federal entitlement for New York City's non-English-speaking Puerto Rican and Latino students. Reyes analyzes the…
-
76 FR 75913 - Notice of Lodging of Modification of Consent Decree Under the Clean Water Act
2011-12-05
... Elimination System Permit PR0000591. The Department of Justice will receive, for a period of thirty (30) days... the public comment period, the Modification may be examined on the following Department of Justice Web... by mail from the Consent Decree Library, P.O. Box 7611, United States Department of Justice...
-
78 FR 28242 - Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act
2013-05-14
... Drinking Water Act (SDWA) and the Surface Water Treatment Rule, promulgated under the SDWA. Under the terms... public water system and to pay $8,000 into an escrow account to be used by the association for future... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water...
-
2013-03-11
... Corporation d/b/a The Doe Run Company, and The Buick Resource Recycling Facility, LLC, (collectively ``Doe Run... Missouri. The Consent Decree required Doe Run to perform injunctive relief and mitigation projects and to...
-
2010-08-06
..., DC 20044-7611, and should refer to United States v. Hoosier Energy Rural Electric Cooperative, Inc... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree With Hoosier Energy Rural Electric Cooperative, Inc. Under The Clean Air Act Pursuant to 28 CFR 50.7, notice is hereby given that on...
-
76 FR 4723 - Notice of Lodging of a Consent Decree Modification Pursuant to The Clean Water Act
2011-01-26
... anticipated. The City and WMU considered another stream restoration project as an alternate, but easements.... Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to United States v... from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611...
-
77 FR 55861 - Notice of Lodging of Consent Decree Under the Oil Pollution Act of 1990 (“OPA”)
2012-09-11
... International under Section 1002 of OPA and Section 48-1-90 of the South Carolina Pollution Control Act, S.C... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Oil Pollution Act of 1990... United States Fish and Wildlife Service, and the National Oceanic and Atmospheric Administration, against...
-
2010-02-02
... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under Sections 106, 107 and 113 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, 42 U.S.C. 9606, 9607 and 9613, as... hazardous substances at or from the Armour Road Superfund Site, located at and adjacent to 2251 Armour Road...
-
2013-04-10
.... Attachment A to the Decree is the St. Lawrence River Environment Natural Resource Damage Assessment: Restoration and Compensation Determination Plan and Environmental Assessment (``RCDP''). The RCDP describes... York. The Decree provides for the Defendants to pay assessment costs, pay for natural resource...
-
2010-08-04
... Decree (``proposed Decree'') in United States of America v. Ray Crosby, Civil Action No. 2:10-cv-00715... portion of EPA's past response costs at the Site. Mr. Crosby owned the Site at the time of the release or.... Department of Justice, Washington D.C. 20044-7611, and should refer to United States of America v. Ray Crosby...
-
THE ART OF COLLECTING EXPERIMENTAL DATA INTERNATIONALLY: EXFOR, CINDA AND THE NRDC NETWORK
International Nuclear Information System (INIS)
HENRIKSSON, H.; SCHWERER, O.; ROCHMAN, D.; MIKHAYLYUKOVA, M.V.; OTUKA, N.
2007-01-01
The world-wide network of nuclear reaction data centers (NRDC) has, for about 40 years, provided data services to the scientific community. This network covers all types of nuclear reaction data, including neutron-induced, charged-particle-induced, and photonuclear data, used in a wide range of applications, such as fission reactors, accelerator driven systems, fusion facilities, nuclear medicine, materials analysis, environmental monitoring, and basic research. The now 13 nuclear data centers included in the NRDC are dividing the efforts of compilation and distribution for particular types of reactions and/or geographic regions all over the world. A central activity of the network is the collection and compilation of experimental nuclear reaction data and the related bibliographic information in the EXFOR and CINDA databases. Many of the individual data centers also distribute other types of nuclear data information, including evaluated data libraries, nuclear structure and decay data, and nuclear data reports. The network today ensures the world-wide transfer of information and coordinated evolution of an important source of nuclear data for current and future nuclear applications
-
The art of collecting experimental data internationally: EXFOR, CINDA and the NRDC network
International Nuclear Information System (INIS)
Henriksson, H.; Schwerer, O.; Rochman, D.; Mikhaylyukova, M.V.; Otuka, N.
2008-01-01
The world-wide network of nuclear reaction data centres (NRDC) has, for about 40 years, provided data services to the scientific community. This network covers all types of nuclear reaction data, including neutron-induced, charged-particle-induced, and photonuclear data, used in a wide range of applications, such as fission reactors, accelerator driven systems, fusion facilities, nuclear medicine, materials analysis, environmental monitoring, and basic research. The now 13 nuclear data centres included in the NRDC are dividing the efforts of compilation and distribution for particular types of reactions and/or geographic regions all over the world. A central activity of the network is the collection and compilation of experimental nuclear reaction data and the related bibliographic information in the EXFOR and CINDA databases. Many of the individual data centres also distribute other types of nuclear data information, including evaluated data libraries, nuclear structure and decay data, and nuclear data reports. The network today ensures the world-wide transfer of information and coordinated evolution of an important source of nuclear data for current and future nuclear applications. (authors)
-
Mora, Erika; Franco, G
2010-01-01
The recently introduced Italian law on the protection of workers' health states that the occupational health physician (competent physician) is required to act according to the Code of Ethics of the International Commission on Occupational Health (ICOH). This paper aims at examining the articles of legislative decree 81/2008 dealing with informed consent and confidentiality compared with the corresponding points of the ICOH Ethics Code. Analysis of the relationship between articles 25 and 39 (informed consent) and 18, 20 and 39 (confidentiality) of the decree shows that there are some points of disagreement between the legal requirements and the Code of Ethics, in particular concerning prescribed health surveillance, consent based on appropriate information (points 8, 10 and 12 of the Code) and some aspects of confidentiality (points 10, 20, 21, 22 and 23 of the Code). Although the competent physician is required to act according to the law, the decisional process could lead to a violation of workers' autonomy.
-
2011-04-12
... decree, GM obtained a performance bond from Westchester Fire Insurance Company (``Westchester''). After... Dearborn St., Chicago, Illinois 60604, and at U.S. EPA Region 5, 77 W. Jackson Blvd., Chicago, IL 60604...
-
77 FR 43860 - Notice of Lodging of a Consent Decree Pursuant to the Clean Water Act
2012-07-26
..., Chattanooga has agreed to perform a stream restoration supplemental environmental project at a cost of [email protected] or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 and... Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, or by faxing or...
-
2012-05-04
... (MDE) pertaining to the GenOn Chalk Point Generating Station (Chalk Point). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM... www.regulations.gov or email. The www.regulations.gov Web site is an ``anonymous access'' system...
-
Scholten, N.P.M.
2000-01-01
On the 1 October 1992 a change in the Dutch building legislation took effect: the revised Housing Act, the Building Decree and the technical documents related to this legislation came into force. This publication contains an English translation of the Building Decree. In order to give an idea of the
-
76 FR 45564 - Proposed Consent Decree, Clean Air Act Citizen Suit
2011-07-29
... operating permit issued by the Wisconsin Department of Natural Resources to Carmeuse Lime & Stone, a lime... to Carmeuse Lime & Stone, a lime kiln facility in Manitowoc, Wisconsin. Under the proposed consent... note that EPA's policy is that public comments, whether submitted electronically or in paper, will be...
-
2012-05-04
... Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SO X ), and nitrogen oxides (NO X....regulations.gov or email. The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA...
-
78 FR 20947 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act (“CAA”)
2013-04-08
... pay the sum of $1.5 million dollars cash, including interest, to the United States as a civil penalty and $1.5 million dollars cash, including interest, to the Commonwealth as a civil penalty. The... Decree upon written request and payment of reproduction costs. Please mail your request and payment to...
-
76 FR 11280 - Notice of Lodging of an Amendment to Consent Decree Under the Clean Air Act
2011-03-01
... Kilns 22 and 23 at Lafarge's Alpena, Michigan cement production facility. The proposed Amendment to the... both Kilns 22 and 23 at its Alpena, Michigan cement production facility, rather than the two Wet FGDs... three months earlier than currently required in the decree for one of the Alpena cement kilns; (2...
-
International Nuclear Information System (INIS)
Anon.
1973-01-01
This Decree amends the Radioactive Materials (Nuclear Energy Act) Decree of 1969 in order to insert special regulations for the use of radioactive luminous paint in timepieces. The amendment, which consists of a new Part 4a and an Annex to the 1969 Decree incorporates in Netherlands legislation the Radiation Protection Standards for Radioluminous Timepieces recommended for adoption by the OECD Council on 19th July 1966 and by the IAEA Board of Governors on 19th September 1966. An Explanatory Memorandum is also attached to the Decree. The new provisions specify the permissible nuclides as well as their activity limits for the different categories of timepieces, the markings, the requirements for the cases. The Annex lays down the tests and inspections to be carried out during manufacture of the timepieces; finally, the Explanatory Memorandum states that these standards have been incorporated with national legislation, in view of the increasing use of such products and analyses the new provisions. (N.E.A.) [fr
-
1989-01-01
This Colombian Decree authorizes civil divorce to take place before a notary by means of public document when the spouses are in mutual agreement; the ground for the divorce is separation, either decreed by a court or formalized before a notary; and the separation has lasted more than 2 years. Such a divorce produces the same legal effects as a divorce decreed by a court. The document is to set forth the duties of both spouses with respect to the provisions of sentence 3 of Article 166 of the Civil Code. If there are minors, the document must receive the approval of the municipal or district representative. Decree No. 2275 of 7 October 1989 (Diario Oficial, 7 October 1989, pp. 75-76) amends this Decree to provide that the judgment of the municipal or district representative must be made within 10 days after the document is received. Sentence 3 of Article 166 of the Civil Code requires that spouses who are separating by mutual consent send to a judge their agreement with respect to the care and support of children, which the judge may reject if necessary in the interests of the children.
-
2010-11-15
... Deep Rock Tunnel Connector (DRTC), which allowed the City to avoid several environmental and right-of-way impediments to the project. The DRTC, as conceived, would have improved the overall level of... Decree may also be examined on the following Department of Justice Web site: http://www.usdoj.gov/enrd...
-
U.S. Environmental Protection Agency — EPAs Office of Enforcement and Compliance Assurance (OECA) cases and settlements webpage contains links to selected settlements resolving civil enforcement cases...
-
International Nuclear Information System (INIS)
1990-01-01
This Decree amends Decree No. 63-1228 of 11 December 1963 laying down a prior licensing procedure for large nuclear installations. The amendments aim to harmonize the 1963 Decree with the Act of 1987 on the prevention of major risks. Henceforth decommissioning is taken into account, both in the application and in the licence itself [fr
-
International Nuclear Information System (INIS)
1982-01-01
This Decree, issued by the Ministers of the Interior and of Industry, Commerce and Crafts, amends a Decree of 27th September 1965 listing the facilities and activities, also in the nuclear reactor, subject to fire prevention controls. The new Decree expands the list to include facilities for the storage of nuclear substances, radioactive products or waste, and facilities where nuclear fuels are held. In addition, facilities for the production, preparation and treatment of nuclear substances as well as for the separation of isotopes are now covered by the 1982 Decree. (NEA) [fr
-
77 FR 61641 - Notice Lodging of Proposed Consent Decree Under the Clean Air Act
2012-10-10
...'') that will significantly reduce the inventory of anhydrous ammonia at each facility, improve the monitoring and alarm system at the Aguadilla facility, and provide training and/or equipment to medical... be examined and downloaded at this Justice Department Web site: http://www.usdoj.gov/enrd/Consent...
-
International Nuclear Information System (INIS)
1987-01-01
The 1969 transport Decree governs all modes of transport of fissile and radioactive materials as well as ores in and to and from the Netherlands. The 1987 Decree amends it, in particular, for modernization purposes. (NEA) [fr
-
International Nuclear Information System (INIS)
1973-01-01
This Decree lays down special regulations concerning the use of radioactive luminous paints for timepieces and prescribes activity limits for each timepiece. The Decree furthermore prohibits the manufacture in the Netherlands of timepieces which do not comply with these regulations and provides that such articles manufactured abroad may not be distributed in the Netherlands unless the supplier provides a statement certifying that they comply with the OECD Radiation Protection Standards for Radioluminous Timepieces. (NEA) [fr
-
[Making up tuberculosis risk groups from decreed contingents].
Kucherov, A L; Il'icheva, E Iu
2001-01-01
The paper provides materials to make up risk groups from decreed contingents by using the database developed and introduced in the Novomoskovsk district, as well as a programme for rapid determination of the risk of tuberculosis. This procedure reduces a scope of fluorographic surveys among the decreed contingents, as well as their expenditures by 60%. Moreover, it may be useful for professional choice in the employment of the decreed persons, which may promote a decrease in the incidence of tuberculosis among them.
-
International Nuclear Information System (INIS)
1988-07-01
The 1985 Decree had amended a 1979 Decree on the organisation of activities in the nuclear fuel cycle by providing in particular that the National Uranium Undertaking (Empresa Nacional del Uranio - ENUSA) should progressively reduce its stockpile of nuclear fuels. This Decree amends the 1985 Decree providing inter alia, that after the first nuclear fuel loading, pressurized water and boiling water reactors (PWR and BWR) in nuclear power plants should have a stockpile of fuel elements available at all times. The number of elements will be fixed for each plant by the Ministry of Industry and Energy [fr
-
International Nuclear Information System (INIS)
1983-01-01
For the Netherlands, international carriage by air of radioactive materials is governed by the regulations of the internationl Air Transport Association (IATA) which are partly based on the IAEA's recommendations in this respect. These were revised in 1973, and the present Decree amends the Transport Decree of 1969 to align it with the 1973 revision followed by IATA. (NEA) [fr
-
Decree No. 200 Of infringements on environmental
International Nuclear Information System (INIS)
1999-01-01
The present Decree establishes violations applicable to the environment without prejudice to existing or which may be established with respect to certain sectors of environmental protection. The system of administrative measures regarding environmental protection that this Decree-Law provides, including natural and legal persons or foreign nationals who commit misdemeanors that are punishable by this standard.
-
International Nuclear Information System (INIS)
1988-01-01
This Decree modifies the 1982 Royal Decree on Radiation Protection as a result of Spain's entry into the European Community and its taking into account of EURATOM Radiation Protection Directives 80/836. The 1987 Decree amends relevant provisions of the 1982 Decree to reflect the basic safety standards of the EURATOM Directives concerning the types of activities which imply exposure, the justification and optimisation of exposure and the requirement that individual doses not exceed specified limits. The annual dose equivalent limits are set out in Annex II to the Decree while Annex III gives the annual limits of intake by inhalation and ingestion for workers and members of the public [fr
-
Decree-law no 348/89 on protection against ionizing radiation
International Nuclear Information System (INIS)
1989-10-01
This Decree-Law sets up a National Commission for Protection against Radiation (Comissao Nacional de Proteccao contra Radiacoes - CNPCR) within the General Directorate for Health in the Health Ministry. The Commission has advisory functions covering protection against ionizing radiation resulting from all nuclear activities. It will make recommendations on harmonizing national radiation protection regulations with those of other European Community Member States and in accordance with Community Directives in this field. The Decree-Law repeals Decree-Law No 44 060 of 25 November 1961 and Decree-Law No 45 132 of 13 June 1963 on radiation protection [fr
-
International Nuclear Information System (INIS)
1982-01-01
This Decree issued by the Ministry of Industry, Commerce and Crafts, amends a similar one of 27 July 1966 made in implementation of Presidential Decree No 185 of 1964 on radiation protection. This new Decree simplifies the notification procedures. (NEA) [fr
-
International Nuclear Information System (INIS)
1978-01-01
This Decree which came into force on 1 June 1978 was made in implementation of Decree-Law No. 548/77 of 31 December 1977 deciding the creation of new departments in the Ministry for Industry and Technology in Portugal and the abolition of others, including the Junta de Energia Nuclear. The Decree divides up the Junta's activities among several administrative departments pending its actual abolition to be fixed by a subsequent Decree. (NEA) [fr
-
Nuclear Energy Decree of February 12, 1988
International Nuclear Information System (INIS)
1988-01-01
This decree no. 161/1988 entered into force on 1 March 1988. It was made in accordance with Section 82 of the 1987 Nuclear Energy Act and aims to define the scope of application of the Act. The Decree deals with the licensing procedure for nuclear installations and competence in this field. It also establishes exemptions to the licencing of radioactive materials and covers radioactive waste management and its financing. (NEA) [fr
-
International Nuclear Information System (INIS)
1970-01-01
With this Decree, nuclear power plants are subject only to the licensing system established by the 1963 Decree on nuclear installations, as amended subsequently by the Decree of 1973 and regulations specific to nuclear installations. (NEA) [fr
-
Decree-Law No. 199/88, 31 May 1988.
1988-01-01
This Decree-Law establishes criteria for the determination of final compensation for expropriation or nationalization of land or agricultural capital. The lack of legal definition of criteria for the determination of such final compensation was a gap in recent Portuguese legislation on land reform. Although the holdings of many landlords and farmers had been nationalized or expropriated after 11 March 1975, the compensation obtained prior to the enactment of this Decree-Law was provisional and reflected outdated values. This Decree-Law closes this gap by establishing the criteria for the determination of final compensation with adjusted value. Under it, any farmer whose land or capital has been nationalized or expropriated since March 1975 may apply for final compensation, from which shall be deducted the value of any provisional compensation previously obtained and any property previously devolved as a "right of reserve" pursuant to pertinent legislation (see Law No. 109/88 of 26 September 1988 and Decree No. 44/88 of 14 December 1988). The final compensation shall be determined by administrative procedure in which the Ministry of Agriculture, Fisheries, and Food; the Ministry of Finance; and the applicant are represented. full text
-
22 CFR 19.6 - Court orders and divorce decrees.
2010-04-01
... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Court orders and divorce decrees. 19.6 Section 19.6 Foreign Relations DEPARTMENT OF STATE PERSONNEL BENEFITS FOR SPOUSES AND FORMER SPOUSES OF PARTICIPANTS IN THE FOREIGN SERVICE RETIREMENT AND DISABILITY SYSTEM § 19.6 Court orders and divorce decrees. ...
-
International Nuclear Information System (INIS)
1971-01-01
This Decree lays down that rules may be made to secure the secrecy of a number of nuclear matters. An obligation to observe secrecy may be imposed upon persons engaged in the nuclear activities listed in the Decree if the interest of the State so requires. The competent Minister for the activity concerned is empowered to impose this obligation. (NEA) [fr
-
International Nuclear Information System (INIS)
1984-01-01
Under the Decree of 1979 the ''Empresa Nacional del Uranio SA'' (National Uranium Enterprise - ENUSA) was responsible for spent management while the Junta de Energia Nuclear (JEN) was responsible for the final storage of radioactive waste. However, these provisions do not cover waste resulting from activities outside the fuel cycle or the dismantling of nuclear and radioactive installations, nor do they provide a global solution to the different problems involved in organising the overall management of radioactive waste. Therefore, this Decree authorises the National Enterprise for Radioactive Waste (ENRESA) to perform the tasks prescribed in this field by the 1964 Nuclear Energy Act and the 1979 Decree. (NEA) [fr
-
Decree 2177/1967 of 22 June approving the Regulations on cover for nuclear risks
International Nuclear Information System (INIS)
1967-01-01
This Decree was made in implementation of Section 45 of the 1964 Act on nuclear energy. It contains provisions on third party liability for nuclear damage, the type of security to cover such liability and State intervention in compensating nuclear damage. The Decree was amended by two Decrees of 28 March 1968 and 7 November 1968 respectively. In particular, the latter Decree implements the provisions of the Paris Convention, ratified by Spain and fixes cover for nuclear risks at 350 million pesetas. (NEA) [fr
-
Decree No. 83/7405 of 18 November 1983 on the licensing procedure for nuclear installations
International Nuclear Information System (INIS)
1983-01-01
This Decree (No. 83/7405) on the licensing procedure for nuclear installations came into force on 19 December 1983 and supersedes Decree No. 7/9141 of 5 December 1974 on the same subject. The general lines of the licensing procedure laid down by this new Decree are similar to that provided by the 1979 Decree; it is also carried out in three stages: site, construction and operating licences are delivered in succession. (NEA) [fr
-
2013-02-15
..., Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2013-03517 Filed 2-14-13... natural resource damages claims through restoration and reimbursement of assessment costs. The consent... and future assessment costs of the trustees and the Hillsborough County Environmental Protection...
-
International Nuclear Information System (INIS)
1995-01-01
Some provisions of the Decree of the Czech Labor Safety Office No. 76/1989 on ensuring safety of technical facilities in the nuclear power sector are amended, particularly in the field of construction activities, assembling, reconstruction and repair of nuclear power facilities. The Decree entered into force on 28 June 1991. (J.B.)
-
Aspects pertaining to the legal regime of Presidential decrees in Romania
Directory of Open Access Journals (Sweden)
Camelia Florentina STOICA
2014-12-01
Full Text Available The doctrinal debates on the legal regime of presidential decrees and the recent case-law of the Constitutional Court have determined the present approach for analysis of some aspects pertaining to the issues arising in relation to these acts, especially their legal features and nature and, from this perspective, the differentiations with regard to the challenging of presidential decrees – we refer, in this context, to the extension of the control carried out by courts. The conclusions of the study reveal the importance of addressing and establishing the relations between public authorities, inclusively with regard to the substantiation, issuance and implementation of presidential decrees, in relation to the principle of constitutional loyalty.
-
International Nuclear Information System (INIS)
1981-01-01
This Decree determines the field of competence of the CEA, and the scope of its work. It also provides for the setting up of a Committee responsible for its administration, under the chairmanship of an Administrator-general who is in charge of the general management of the CEA. He is advised on scientific and technical questions by a High-commissioner. This Decree contains all the amendments made to it in 1974, 1976, 1978, 1979 and 1981. (NEA) [fr
-
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.
-
International Nuclear Information System (INIS)
1990-03-01
This Decree completes the transfer into national legislation of Euratom Directive No. 80-836 on radiation protection. It inserts in the General Regulations on extractive industries laid down by a Decree No. 80-331 of 1980 a Part 2 relating to environmental protection. Its provisions determine the annual permissible exposure limits to ionizing radiation during management of radioactive products, the monitoring of releases and the environment and the controls set up by the authorities [fr
-
Royal Decree-Law 1302/1986 of 28 June 1986 on environmental impact studies
International Nuclear Information System (INIS)
1986-01-01
This Royal Decree-Law (No 1302/1986) of 28th June 1986 was published in the Official Gazette of 30th June 1986. The purpose of this Decree-Law is to provide for assessments of the environmental impact of certain projected installations and activities. The installations and activities requiring environmental impact studies are listed in the Annex to the Decree-Law and include nuclear power plants and other nuclear reactors (excluding those whose thermal power does not exceed 1 kW) as well as installations for the disposal and final storage of radioactive waste (NEA) [fr
-
Nardilysin controls intestinal tumorigenesis through HDAC1/p53-dependent transcriptional regulation.
Kanda, Keitaro; Sakamoto, Jiro; Matsumoto, Yoshihide; Ikuta, Kozo; Goto, Norihiro; Morita, Yusuke; Ohno, Mikiko; Nishi, Kiyoto; Eto, Koji; Kimura, Yuto; Nakanishi, Yuki; Ikegami, Kanako; Yoshikawa, Takaaki; Fukuda, Akihisa; Kawada, Kenji; Sakai, Yoshiharu; Ito, Akihiro; Yoshida, Minoru; Kimura, Takeshi; Chiba, Tsutomu; Nishi, Eiichiro; Seno, Hiroshi
2018-04-19
Colon cancer is a complex disease affected by a combination of genetic and epigenetic factors. Here we demonstrate that nardilysin (N-arginine dibasic convertase; NRDC), a metalloendopeptidase of the M16 family, regulates intestinal tumorigenesis via its nuclear functions. NRDC is highly expressed in human colorectal cancers. Deletion of the Nrdc gene in ApcMin mice crucially suppressed intestinal tumor development. In ApcMin mice, epithelial cell-specific deletion of Nrdc recapitulated the tumor suppression observed in Nrdc-null mice. Moreover, epithelial cell-specific overexpression of Nrdc significantly enhanced tumor formation in ApcMin mice. Notably, epithelial NRDC controlled cell apoptosis in a gene dosage-dependent manner. In human colon cancer cells, nuclear NRDC directly associated with HDAC1, and controlled both acetylation and stabilization of p53, with alterations of p53 target apoptotic factors. These findings demonstrate that NRDC is critically involved in intestinal tumorigenesis through its epigenetic regulatory function, and targeting NRDC may lead to a novel prevention or therapeutic strategy against colon cancer.
-
International Nuclear Information System (INIS)
1986-01-01
This Decree repeals and replaces the Decree of 15th March 1967 on protection of workers against the hazards of ionizing radiation. Like the 1967 Decree, this Decree does not apply to major nuclear installations, including those classified as secret. The purpose of the 1986 Decree is to implement in domestic legislation the Euratom Directive of 15th July 1980, amended by the Directive of 3rd September 1984, to take into account developments in labour laws - in particular as regards the role of committees responsible for health, safety and working conditions and technology. Finally, it covers all work involving ionizing radiation, including agricultural activities. (NEA) [fr
-
Decree-Law No. 426/88, 18 November 1988.
1988-01-01
A 1988 Decree-Law of Portugal facilitates preventative and remedial actions with respect to discrimination against women in the civil service. Under the Decree-Law, discriminatory admission and promotion practices are forbidden in all levels of the central administration, independent agencies, the social security administration, and regional administrations. Practices forbidden include those having an unintended discriminatory impact and all job-related differentiation based on sex, directly or indirectly, as in cases where reference is made to a woman's marital or family status. The Decree-Law guarantees equality of remuneration for male and female workers for equal work or work of equal value and prohibits restrictions based on sex in entrance examinations and job advertising. Practices not considered discriminatory include those designed to correct the imbalance between male and female employees and those undertaken to protect maternity. Moreover, work may be restricted that poses risks or the potential of risk to genetic functions and jobs may be conditioned on sex if sex is essential to the performance of the job. Major procedural provisions are as follows: 1) the burden of proving that a decision affecting the position of a female civil servant is justified and does not violate the law is placed on the public authority accused of practicing discrimination; 2) workers have the right to challenge any act of alleged discrimination and may be represented by the pertinent body of collective representation in any proceeding arising under the Decree-Law; 3) no worker may be punished or otherwise penalized for alleging discrimination; 4) directors or workers whose actions have been judged as discriminatory are subject to disciplinary proceedings; and 5) any administrative authority conducting an inquiry regarding alleged discrimination or adopting disciplinary measures in connection with unfounded allegations of the practice of discrimination must obtain from the
-
The “May” Decrees of the President: objective, indicators, implementation dynamics
Directory of Open Access Journals (Sweden)
Mariya Aleksandrovna Pechenskaya
2015-01-01
Full Text Available Two and a half years have passed since the RF President’s adoption of a number of decrees aimed at improving social welfare of the citizens. The objectives of the given legal documents concern the issues of education and science, health, demography and social policy, economy and foreign policy, military service and development of the Armed Forces of Russia, inter-ethnic harmony, governance and quality of housing and utility services. V.V. Putin has set targets to be achieved in Russia by 2020. However, the acute budget crisis of regional systems hinders the implementation of Presidential Decrees. This article provides the reader with the analysis of the achieved results and states the problems of “May” requirements funding. In addition, there are possible options for the implementation of the targets laid down in the presidential decrees in the prescribed period
-
International Nuclear Information System (INIS)
2012-01-01
This decree is about the UTE transmission line which integrate the Uruguayan National Electricity System. This regulation are able to allow an increasing energy demand as well as a better public service, a main purpose of UTE.
-
From Informed Consent to Negotiated Consent.
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…
-
Decree No. 83/7467 of 24 November 1983 on visits of foreign armed forces vessels in Turkish waters
International Nuclear Information System (INIS)
1983-01-01
This Decree (No. 83/7467) lays down the principles and procedures for the visits of foreign armed forces vessels in Turkish harbours and inland waterways and came into force on 15 December 1983. This new Decree supersedes a similar Decree of 27 December 1978. (NEA) [fr
-
International Nuclear Information System (INIS)
1981-01-01
This Decree issued by the Minister of Health approves an amended list of insanitary industries which are subject to certain obligations under Section 216 of the Health Code of 1934. The amendments concern certain nuclear plants and laboratories. The 1981 Decree modifies a previous Decree of 1976. (NEA) [fr
-
Radiation Protection Decree 27.9.1957/328
International Nuclear Information System (INIS)
1957-01-01
This Decree as amended was made under the Radiation Protection Act 1957 and deals with the protection of workers against ionizing radiation. It specifies the licensing procedure required for possession, use, trade in, export and import of radioactive materials and equipment. (NEA) [fr
-
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.
-
Health Ministry - Regulatory Decree No 9/90 of 19 April
International Nuclear Information System (INIS)
1990-01-01
This Decree was adopted in implementation of Community Directives Nos. 80/836, 84/467 and 84/466/Euratom on radiation protection. The Decree establishes the basic principles in the field of radiation protection applicable to occupationally exposed persons, to individuals and to the population as a whole. It specifies the duties of the authorities and of the persons responsible for installations or activities likely to involve exposure to ionizing radiation. It also deals with exposure to radiation for medical purposes and provides for the measures to be taken by the authorities regarding emergency plans in case of a nuclear accident. (NEA) [fr
-
Informed consent and the readability of the written consent form.
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.
-
Decree no. 81-730 of 30 July 1981 concerning the responsibilities of the Minister of Industry
International Nuclear Information System (INIS)
1981-01-01
This Decree, which determines the competence of the Minister of Industry, provides that he shall discharge the duties previously given to the Minister of Industry by Decree No. 78-593 of 16 May 1978, with the exception of the responsibilities transferred to the Minister for Research and Technology by Decree No. 81-723 of 28 July 1981. He determines, proposes and implements, in liaison with the Ministers concerned, the Government's policy in industrial development, energy and source materials. (NEA) [fr
-
European Gas Appliances Directive and the Dutch Decree on Gas Appliances. Special section
International Nuclear Information System (INIS)
De Bruin, B.; Venhorst, T.; Van Tricht, A.
1998-01-01
The Gas Appliances Decree is the Dutch translation of the European Gas Appliances Directive. The Decree and the EU Directive contain substantial information, provided they will be read carefully. The EU Directive lays down general safety requirements for gas appliances. They serve as a practical tool for manufacturers and service engineers. In two articles, the Directive is explained, addressing uncertainties and answering important questions. 5 ills
-
Intermarriage, conflict and social control in Ireland - the decree 'ne temere'
Lee, Raymond M.
1985-01-01
The decree `Ne temere? of 1908 by which the Roman Catholic Church has, until recently, governed the marriage of one of its members to someone who is not a Roman Catholic has had attributed to it a number of deleterious consequences. The origins of the decree, as it has applied to Ireland, are described, as are the events following its promulgation which came to be referred to as the `McCann case?. It is argued that the McCann case can be thought of as a `moral panic?.
-
Decree 3322/1971 of 23 December on the purposes of the National Uranium Enterprise
International Nuclear Information System (INIS)
1972-01-01
This Decree determines the purposes of the National Uranium Enterprise set up by a Decree of 22 February 1969. In collaboration with the Junta de Energia Nuclear, the Enterprise will in particular work uranium deposits, produce uranium concentrates, enrich uranium, manufacture fuel elements, process nuclear fuel and engage in the trade of the products obtained. (NEA) [fr
-
International Nuclear Information System (INIS)
Delduc, P.; Blanc, P.; Michel, L.
2015-01-01
These decrees concern various actors of the geothermal sector in the case of projects and works of minor importance. The first one defines general technical prescriptions applicable to a geothermal site of minor importance, the conditions related to the implantation of a geothermal installation of minor importance, measures to be implemented when performing geothermal works and when stopping its exploitation, control and maintenance modalities in order to prevent risks for the environment and to preserve water resource quality. The second decree defines measures to be implemented by drilling companies in the case of geothermal projects of minor importance. The third decree defines the map of geothermal areas of minor importance, specifies the map elaboration methodology and its reviewing modalities
-
Ministry of the Environment and Natural Resources - Regulatory Decree No 34/92 of 4 December
International Nuclear Information System (INIS)
1992-01-01
This Decree sets out the radiation protection standards to be applied to uranium mining and related activities. It replaces an earlier Decree (No 78/84) to take into account more recent standards jointly issued by WHO, ILO, IAEA, NEA/OECD and EURATOM, on the basis of ICRP recommendations. (NEA)
-
International Nuclear Information System (INIS)
Philippe, Edouard; Hulot, Nicolas; Le Drian, Jean-Yves
2017-01-01
This rather brief decree specifies some modifications brought to a previous decree, and more particularly addresses conditions of derogation of attributions of foreign recipients of wastes produced by a processing in France of waste fuels and radioactive wastes coming from abroad
-
Decree 2869/1972 of 21 July approving the Regulations on nuclear and radioactive installations
International Nuclear Information System (INIS)
1972-01-01
This Decree determines nuclear and radioactive installations and establishes their licensing system which is carried out in several stages and differs according to the category concerned. The procedures cover in particular prior authorization, construction licence and operating licence. Provision is also made for inspections. The Annex to the Decree classifies the radionuclides for determining the category of the installation. (NEA) [fr
-
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
-
National Atomic Energy Commission. Decree No. 1540, August 30 1994
International Nuclear Information System (INIS)
1994-01-01
One of the objectives of the reorganization process of Argentina's public sector was to transfer to the private sector some of the Nation's productive activities, including those concerning the nuclear field. As a consequence, by Decree No. 1540 of August 30, 1994, (B.O. 2-Dec-94), CNEA's functions were partially reorganized. According to Decree No. 1540, the National Atomic Energy Commission (CNEA) maintained the missions and functions established by Decree-Law No. 22.498/56, with the exception of the regulation and surveillance of nuclear activities and the nuclear power generation activities. For the fulfillment of these activities, both the National Board of Nuclear Regulation (Ente Nacional Regulador Nuclear - ENREN) and Nucleoelectrica Argentina S.A. (NASA), were created. The National Board of Nuclear Regulation (ENREN), as an autarchical entity reporting to the Presidency of the Nation, shall be administered by a Board of Directors and shall be responsible for surveying and controlling all nuclear activities, shall suggest regulations and standards to ensure radiological and nuclear safety, personal protection, a controlled use of nuclear materials, licensing and surveillance of nuclear installations, and compliance with international safeguards. Nucleoelectrica Argentina S.A. (NASA) shall be organised as a corporation, reporting to the Ministry of Economy and Public Works and Services (Ministerio de Economia y Obras y Servicios Publicos) who will approve its statures. NASA shall take care of nuclear power generation at the Atucha I and Embalse nuclear power plants, as well as the construction, start-up and operation of the Atucha II nuclear power plant. As far as royalties are concerned, the Decree obliges Nucleoelectrica Argentina S.A. to pay CNEA for the performance of research and development activities, and to the ENREN an yearly regulatory tax per megawatt of installed nuclear power generation capacity. Also, Nucleoelectrica Argentina S.A. is declared
-
International Nuclear Information System (INIS)
1973-01-01
This text, which incorporates the amendments made by the 1973 Decree, regulates large nuclear installations in France and defines them. It lays down in detail their licensing procedure and also designates the competent authorities in that respect. (NEA) [fr
-
Directory of Open Access Journals (Sweden)
Ali Reza Khwajegir
Full Text Available The Sadraee's transcendental philosophy in theology affected by the authentic Divinity texts and discussions and has inspired in resolving many of the theological and philosophical problems of this school. Therefore, this school can be considered as the most prominent school. Although, Molla sadra does not know enough the argument and arguing without conscience and purification of self, but, the most based on imported sources of revelation and interpretations of Imams (AS and believes that truths of faith are not possible except by purifying heart from the whims, thinking of the Divine verses, hadith of the Prophet (The Prophet's massage and his tribe, and following the way of the pious men. Proposing the problem of Divine Decrees of fate in transcendental philosophy and explaining its principles that brought up in both the philosophical texts and exegesis of the followers of transcendental philosophy are of the most important Instances that this school takes impression from religious texts. Decrees of fate has various levels, such as essential and actual, scientific and objective, divine creation and divine legislation, fixed and variable, that is every level take into consideration the discussion of Divine Decrees of fate from a particular direction. Divine Decrees of fate in one dimension is related to the degrees of Divine knowledge and the quality of Divine knowledge on what is apart from God, on the other dimension, is related to the question of the necessity of The existence system and the quality of causal connection between the elements of the universe and the origin of necessity of The existence system that has been expressed in these schools with a certain thoughtfulness in both theology and cosmology. Divine Decrees of fate in comparing with universal realms of existence is considered the same as degree of intellectual forms beyond the spiritual and natural forms that emanated from the god, suddenly and timelessly and called one of
-
Directory of Open Access Journals (Sweden)
Alireza Khajegir
2013-08-01
Full Text Available The Sadraee's transcendental philosophy in theology affected by the authentic Divinity texts and discussions and has inspired in resolving many of the theological and philosophical problems of this school. Therefore, this school can be considered as the most prominent school. Although, Molla sadra does not know enough the argument and arguing without conscience and purification of self, but, the most based on imported sources of revelation and interpretations of Imams (AS and believes that truths of faith are not possible except by purifying heart from the whims, thinking of the Divine verses, hadith of the Prophet (The Prophet's massage and his tribe, and following the way of the pious men. Proposing the problem of Divine Decrees of fate in transcendental philosophy and explaining its principles that brought up in both the philosophical texts and exegesis of the followers of transcendental philosophy are of the most important Instances that this school takes impression from religious texts. Decrees of fate has various levels, such as essential and actual, scientific and objective, divine creation and divine legislation, fixed and variable, that is every level take into consideration the discussion of Divine Decrees of fate from a particular direction. Divine Decrees of fate in one dimension is related to the degrees of Divine knowledge and the quality of Divine knowledge on what is apart from God, on the other dimension, is related to the question of the necessity of The existence system and the quality of causal connection between the elements of the universe and the origin of necessity of The existence system that has been expressed in these schools with a certain thoughtfulness in both theology and cosmology. Divine Decrees of fate in comparing with universal realms of existence is considered the same as degree of intellectual forms beyond the spiritual and natural forms that emanated from the god, suddenly and timelessly and called
-
DEFF Research Database (Denmark)
Di Nucci, Ezio
2016-01-01
I argue against various versions of the 'attitude' view of consent and of the 'action' view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic ...
-
International Nuclear Information System (INIS)
1992-01-01
The purpose of this new Regulation is to unite in a single instrument the existing rules on this subject contained in Decree 2519/1982 as amended by Decree 1753/1987, now repealed, as well as to introduce certain modifications which have proved desirable in the light of the practical application of those rules. The 1987 Decree reflected the basic safety standards of the Euratom Directives. Like that Decree, the new regulation lays down the measures for protection of the public and occupationally exposed persons against the dangers of ionizing radiation. The Regulation is supplemented by Appendices providing for definitions of radiological, biological and medical terms, annual dose limits for the public and for occupationally exposed persons, etc. (NEA)
-
Decree No. 80-204 of 11 March 1980 concerning mining rights
International Nuclear Information System (INIS)
1980-01-01
This Decree repeals a Decree of 29 October 1970 on the same subject. However, it does not amend the Mining Code presently in Force, which contains provisions of substance governing mining resarch and exploitation. In connection with substances of use for atomic energy, any projects for taking out, modifying or suppressing mining rights must, as in the past, be submitted to the Committee for Atomic Energy before the file is forwarded to the General Council for Mines. It is now laid down that the Committee for Atomic Energy must take its decision within one month. The previous text contained no provision concerning a time-limit in this respect. (NEA) [fr
-
2012-03-14
..., expense and inevitable risk of litigation.'' United States v. Armour and Co., 402 U.S. 673, 681 (1971... antitrust consent decrees negotiated pre-trial. \\22\\ Cf: Armour, 402 U.S. at 681 (interpreting consent...
-
Informed consent: using a structured interview changes patients' attitudes towards informed consent.
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.
-
Directory of Open Access Journals (Sweden)
Alireza Khajegir
2013-09-01
Full Text Available The Sadraee's transcendental philosophy in theology affected by the authentic Divinity texts and discussions and has inspired in resolving many of the theological and philosophical problems of this school. Therefore, this school can be considered as the most prominent school. Although, Molla sadra does not know enough the argument and arguing without conscience and purification of self, but, the most based on imported sources of revelation and interpretations of Imams (AS and believes that truths of faith are not possible except by purifying heart from the whims, thinking of the Divine verses, hadith of the Prophet (The Prophet's massage and his tribe, and following the way of the pious men. Proposing the problem of Divine Decrees of fate in transcendental philosophy and explaining its principles that brought up in both the philosophical texts and exegesis of the followers of transcendental philosophy are of the most important Instances that this school takes impression from religious texts. Decrees of fate has various levels, such as essential and actual, scientific and objective, divine creation and divine legislation, fixed and variable, that is every level take into consideration the discussion of Divine Decrees of fate from a particular direction. Divine Decrees of fate in one dimension is related to the degrees of Divine knowledge and the quality of Divine knowledge on what is apart from God, on the other dimension, is related to the question of the necessity of The existence system and the quality of causal connection between the elements of the universe and the origin of necessity of The existence system that has been expressed in these schools with a certain thoughtfulness in both theology and cosmology. Divine Decrees of fate in comparing with universal realms of existence is considered the same as degree of intellectual forms beyond the spiritual and natural forms that emanated from the god, suddenly and timelessly and called
-
Informed Consent in Dentistry.
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.
-
Decree Law No. 38/90 of 8 November 1990 providing for environmental impact assessments
International Nuclear Information System (INIS)
1990-01-01
This Decree, made in implementation of Decree-Law No. 186/90 on environmental protection, provides that prior to any licence being granted to any project, including nuclear installations, the licensing authority must be provided with an environmental impact study of the planned installation. This study must include a description of the project, its site, its operational characteristics, physical, geological, hydrological, ecological, demographic data, as well as information on the quality of the environment [fr
-
International Nuclear Information System (INIS)
1981-01-01
English. This Decree of the Minister of labour and Social Affairs of 1 August 1981 concerns the procedure for admission to examinations, for inclusion in the national list, of qualified experts and approved medical practitioners who are competent in radiation protection matters. the Decree replaces a former Decree of 24 June 1978 on the same subjec [fr
-
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.
-
International Nuclear Information System (INIS)
1981-01-01
This Decree determines the organisation and tasks of the Ministry of Research and Technology. The General Policy Directorate, within the Ministry, is assigned certain duties which concern the Atomic Energy Commission (CEA). These tasks include the allocation of R and D funds and verification of their use, as well as the joint supervision of the CEA. This Decree repeals Chapter III of Decree No. 75-1002 of 29 October 1975. As Chapter III only concerned the General Delegation for Scientific and Technical Research (DGRST) this body is therefore suppressed. (NEA) [fr
-
International Nuclear Information System (INIS)
Lormeteau, Blanche
2015-01-01
In order to favour the use of small-scale geothermal energy, this decree has simplified the regulatory framework by substituting an on-line work declaration to the previous authorization-based regime. This article analyses and discusses the content of this decree which makes the distinction between small-scale geothermal energy, low temperature geothermal energy, and high temperature geothermal energy. The decree modifies the mining title regime, simplifies procedures of exploitation of small scale geothermal sites. The author outlines that this new regime will be more precisely defined by other decrees which are to be published during the summer 2015, and will be completed by arrangements which are part of the bill on energy transition
-
Consenting options for posthumous organ donation: presumed consent and incentives are not favored
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
-
Decree No. 92-1391 of 30 December 1992 on the National Radioactive Waste Management Agency
International Nuclear Information System (INIS)
1992-01-01
This Decree concerns the arrangement of the National Radioactive Waste Management's (ANDRA) administrative organization. It provides for the resources, type of management and supervision of the new public establishment, as well as for the transfer of assets, rights and obligations which tally with the tasks assigned to ANDRA. The Decree also prescribes that ANDRA must, each year, submit to its Ministerial supervisory authorities a report reviewing its work. (NEA)
-
International Nuclear Information System (INIS)
1982-01-01
This Decree lays down a detailed procedure for notification of the possession and accounting of special fissile materials and source materials. The Decree was made in pursuance of Decree No. 185 of 13 February 1964 of the President of the Republic concerning radiation protection and licensing procedures. (NEA) [fr
-
Lodged Consent Decree US Steel #2733655
The United States of America, by the authority of the Attorney General of the United States and through its undersigned attorneys, acting at the request of the United States Environmental Protection Agency (“EPA”), file this Complaint.
-
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...
-
Hardacker, Erin P.
2013-01-01
The Educational Decree of 1863 was an effort by Spain to reform the Philippine colonial education system. The Decree established a complete system of education in the archipelago--it required two elementary schools in each municipality (one for girls and one for boys), standardized the curriculum, and established normal schools, thus making…
-
International Nuclear Information System (INIS)
1984-01-01
This Decree was issued in pursuance of Decree-Law No. 426/83 of 7 December 1983 which provides that safety and radiological protection regulations shall be made for activities involving the mining of uranium and related treatment of uranium. It lays down definitions of technical radiation protection terms and sets out the requirements for permissible concentrations and internal and sets out the requirements for permissible concentrations and internal and external dose-limits for workers and members of the public. The Decree also sets up a Radiological Protection Service responsible for ensuring that the provisions of the Decree are observed. (NEA) [fr
-
International Nuclear Information System (INIS)
1981-01-01
This Decree was made to enable COGEMA to diversify its activities in the mining sector. It was therefore necessary to amend both the Decree of 26 December 1975 authorizing the Atomic Energy Commission (CEA) to set up the COGEMA and the Decree of 29 September 1970 relating to the CEA, in view of the specific nature of the duties entrusted to this body by the latter Decree. (NEA) [fr
-
Soviet Cinema and State Control: Lenin's Nationalization Decree Reconsidered.
Kepley, Vance, Jr.
1990-01-01
Proposes a revisionist account of the immediate conditions and consequences of the 1919 Soviet cinema nationalization decree. Argues that nationalization was the least successful of a set of stop-gap measures; that it dispersed and diluted control; and that it actually retarded the growth of the film industry. (KEH)
-
Decree-Law N0 678 of 26 November 1981 concerning the creation of local health centres
International Nuclear Information System (INIS)
1981-01-01
This Decree-Law provides for direct employment of workers by the Regions in connection with the creation of adequate health centres and radioactive decontamination centres, following nuclear emergencies in areas where nuclear power plants are located. This Decree-Law was converted into Act N 0 12 of 26th January 1982 and published in the Official Gazette of 27th January 1982. (NEA) [fr
-
International Nuclear Information System (INIS)
Biharyová, Michaela
2018-01-01
Following up amendment to the Slovak Atomic Act, the Decree No. 55/2006 on details concerning emergency planning in case of nuclear incident or accident has also been amended now. Following a short introductory text by the author, the entire text of the ‘Decree of the Nuclear Regulatory Authority of the Slovak Republic No 9/2018 Coll. of 2 January 2018 amending Decree of the Nuclear Regulatory Authority of the Slovak Republic No 55/2006 Coll. on details in emergency planning in case of nuclear incident or accident as amended by Decree No. 35/2012 Coll.’ is reproduced. The Amendment entered into force 1 February 2018. (orig.)
-
Impact of verbal explanation and modified consent materials on orthodontic informed consent.
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
-
International Nuclear Information System (INIS)
1980-01-01
This Decree which further reorganizes the Commissions and Directorates within the Ministry of Industry and Energy provides, inter alia, that the Commissioner for Energy and Mineral Resources shall also be the Chairman of the Junta de Energia Nuclear. (NEA) [fr
-
International Nuclear Information System (INIS)
1969-01-01
This decree-Law lists the nuclear activities subject to licensing in Portugal. These include: research involving use of nuclear laboratories, pilot and industrial facilities; prospecting for and exploration of radioactive ore deposits, including the production of concentrates; import and export of radioactive materials and nuclear fuels, including fabrication of the latter; nuclear reactors and power plants; trade in irradiated fuels and recycling of recovered fuels. The Decree-Law lays down that the licensing procedure for such activities will be fixed by decree. (NEA) [fr
-
International Nuclear Information System (INIS)
1999-01-01
The Ministry of Economy of the Slovak Republic constitutes: The decree of the Ministry of Economy of the Slovak Republic No. 15/1998 Collection of Acts on conditions of granting official permission for import and export of commodity and services in the version of the decree of the Ministry of Economy of the Slovak Republic No. 193/1998 Collection of Acts, o the decree of the Ministry of Economy of the Slovak Republic No. 311/1998 Collection of Acts, of the decree of the Ministry of Economy of the Slovak Republic No. 406/1998 Collection of Acts, and of the decree of the Ministry of Economy of the Slovak Republic No. 163/1999 Collection of Acts changes in this manner: heretofore appendixes A, B, C, D substitutes with new appendixes A, B, C, D. The Appendix A: List of commodity responsible to licensing at import: The Appendix B: List of commodity responsible to licensing at export; The Appendix C: List of commodity responsible to licensing at export to certain states or to group states; The Appendix D, Part II (List of commodity responsible to licensing at import and export) contains radioactive elements and isotopes and compounds other than 284410, 284420 or 284430; alloys, dispersions (cements are included), ceramic ware and mixtures containing these elements, isotopes or compounds; radioactive debris. This decree shall into effect on 1 January 2000
-
Ministry of the Environment and Natural Resources - Decree-Law No 186/90 of 6 of June
International Nuclear Information System (INIS)
1990-01-01
This Decree-Law was made in implementation of Community Directive 85/337/CEE of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment. According to the Decree-Law, approval of nuclear power plant projects and other nuclear reactor projects, as well as radioactive waste repositories is subject to a prior assessment of their effect on the environment. (NEA) [fr
-
Adolescents and consent to treatment.
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.
-
International Nuclear Information System (INIS)
1967-01-01
This Decree amends the table of radionuclides in the 1966 Decree to adopt the modifications to the Euratom Directives on protection against ionizing radiation made by the Directive of 27 October 1966. (NEA) [fr
-
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.
-
International Nuclear Information System (INIS)
1969-01-01
Under this Decree, no licence is required concerning fissionable materials, ores and radioactive materials, as well as establishments or equipment for use by the Netherlands Armed Forces or the Armed Forces of an allied country. However, exemptions from licensing under the Decree are without prejudice to the general provisions of the Nuclear Energy (Radioactive Materials) Decree and in the Fissionable Materials, Ores and Radioactive Materials (Transport) Decree. (NEA) [fr
-
International Nuclear Information System (INIS)
1975-01-01
This Decree supplements French regulations on radiation protection established by the Decree of 20 June 1966 on general radiation protection principles and that of 15 March 1967 on protection of workers against ionizing radiation hazards in other types of nuclear installation. This Decree refers to the provisions of the above-mentioned Decrees concerning maximum permissible dose equivalents and maximum permissible concentrations of the different radionuclides to be complied with in workplaces. It also lays down the provisions the head of the establishment must implement at administrative, technical and medical levels to ensure radiation protection in such premises. (NEA) [fr
-
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.
-
Decree No 85/9727 of 24/7/1985 on radiation safety regulation
International Nuclear Information System (INIS)
1985-01-01
This Decree took effect on 7 September 1985 and revises Decree No. 7/9038 of 30 November 1974. It was prepared on the basis of recommendation No. 26 of the International Commission on Radiological Protection (ICRP). Its purpose is to provide protection for persons against ionizing radiations arising from the medical, industrial, research and other applications of nuclear energy. According to its provisions, all persons and establishments which keep, use, produce or store radioactive materials and radiation sources must obtain a licence from the Turkish Atomic Energy Authority (TAEA). In addition, the import, export and transport of all radioactive materials must be approved by TAEA and a valid permit issued by TAEA must be presented to customs authorities for all importation and exportation. (NEA) [fr
-
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...
-
International Nuclear Information System (INIS)
1972-01-01
This Decree was made in implementation of Decree-Law no. 49398 of 24 November 1969 establishing the licensing system for nuclear activities of an industrial nature in Portugal; it determines the licensing procedure for nuclear electricity-generating plants. The Decree lays down the conditions to be complied with for obtaining a licence, which is issued in three stages, prior to the activity. The three stages are: site approval; construction licence and operating licence. The operating licence is delivered by the competent authorities after they are satisfied that the final safety report conforms to requirements. (NEA) [fr
-
Consented Autopsy and the Middle-East.
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.
-
Informed Consent and Capacity to Give Consent in Mental Disorders
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.
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.
-
Risk assessment in gas activities according to legislative decree No. 626/94
International Nuclear Information System (INIS)
Del Gaudio, P.; Andreani, A.; Brindani, A.; Capizzi, F.; Cervi, G.; Gandausio, C.; Savio, S.; Rossi, G.P.; Viola, M.
1998-01-01
Among the latest measures on health and safety (H and S) at work, Legislative Decree 626/94 is the most important step ever taken until now. Following the implementation of a long series of European Directives, the Decree gives the guidelines to be followed in order to safeguard the workers' H and S. Since gas distribution companies are deeply involved in these activities, the Italian Technical Gas Association (ATIG) has issued a paper on D and S focused on the activities of construction, maintenance and management of gas distribution networks. In a series of tables, the article summarizes a long list of the possible actions to be taken during various interventions, detects the sources of potential risks and suggests the main operational precautions. Besides, criteria for risk assessment, a scale of occurrence probabilities and a scale for damage evaluation are given [it
-
International Nuclear Information System (INIS)
1984-01-01
This Decree amends and replaces several tables of occupational diseases annexes to the Decree of 31 December 1946 made under the Social Security Code. In particular it amends Table 6 now entitled: ''Diseases caused by ionizing radiation'' to take account of the latest status of knowledge in this field. (NEA) [fr
-
International Nuclear Information System (INIS)
1970-01-01
Under the Nuclear Energy Act, any fissionable materials or ores held without due authorization shall be seized and handed over to an establishment designated by Decree. This Decree designates the establishment to which such materials or ores shall be transferred. (NEA) [fr
-
International Nuclear Information System (INIS)
1973-01-01
This Decree provides that the Central Reinsurance Fund may cover, with the State guarantee, risks for which operators of nuclear ships and installations are liable and concerning which State intervention is provided for by legislation. These operations relate in particular to goods carried, nuclear installations and property on the site of such installations. The Decree sets up an Advisory Commission for the Central Reinsurance Fund regarding security for exceptional and nuclear risks and repeals a 1967 Decree on insurance of exceptional risks. (NEA) [fr
-
Informed consent in surgical trials.
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.
-
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.
-
Decree no 77-974 of 19 August 1977 on information to be supplied in relation to harmful waste
International Nuclear Information System (INIS)
1977-01-01
Under this Decree the services in charge of controlling classified installations are responsible for policing undertakings whose work involves certain types of harmful wastes; the undertakings concerned may be required to keep records, to send periodic statements or, in the case of waste transport, to establish a loading statement specifying the planned methods of disposal. Wastes containing radioactive substances are included in the categories of waste covered by this Decree. (NEA) [fr
-
Oberlandesgericht Hamm confirms decree against power price boycotters
International Nuclear Information System (INIS)
Anon.
1981-01-01
With the interim decree of July 1, 1981 - 70VGA 1/79 - the OVG Lueneburg has decided in favour of the action of a plaintiff living at a distance of 6.5 km from KKU Unterweser (KKU) to set aside the 3rd partial license under water law granted to KKU by the district of Wesermarsch for discharge of the KKU waste water into the Weser river. The grounds for the decision are rendered in full wording. (orig./HP) [de
-
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.
-
International Nuclear Information System (INIS)
1980-01-01
Under Section 83 of Presidential Decree No. 185 of 13 February 1964 on radiation protection, this Decree authorizes Agip Nucleare to undertake physical and medical surveillance in the field of radiation protection. (NEA) [fr
-
Decree N0 81-978 of 29 October 1981 setting up a Higher Council for Nuclear Safety
International Nuclear Information System (INIS)
1981-01-01
This Decree amends the Decree of 13 March 1973 setting up a High Council for Nuclear Safety and a Central Service for the Safety of Nuclear Installations. The High Council, which is attached to the Ministry of industry, is competent to advise on all questions involving the safety of nuclear installations. Henceforth, the National Assembly, the Senate and the regional or general Councils concerned may request the Minister to submit for consideration by the High Council all important matters within its competence. (NEA) [fr
-
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].
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.
-
International Nuclear Information System (INIS)
1975-01-01
This Decree lays down the licensing system for nuclear installations in Turkey and also sets up a Nuclear Safety Committee whose duty is to ensure that the requirements of this Decree are met. The Committee is made up of members of the Atomic Energy Commission specialized in reactors, nuclear safety, health physics, reactor physics as well as two experts respectively appointed by the Ministry of Health and Social Welfare and the Ministry of Energy and National Resources. (NEA) [fr
-
International Nuclear Information System (INIS)
2013-01-01
The decree is about an adaptation of the integration of the national committee on oncologic o including representatives of the Faculty of Medicine of the University of the Republic and representatives of the National Board of Health and Honorary Commission to Fight Cancer that is proposed.Creating a Standing Advisory Group is also suggested
-
Decree No. 67/77 of 6 May establishing a National Uranium Undertaking as a public body
International Nuclear Information System (INIS)
1977-01-01
This Decree, promulgated on 29 March 1977, sets up a National Uranium Undertaking (ENU). The ENU Statute which is attached to the Decree lays down that its main purpose is to prospect for and inventory uranium deposits, to explore known deposits, to set up facilities for recovery and treatment of uranium ores, and finally, to market the products obtained. The ENU has taken over the work which, until now, had been carried out in that field by the Junta de Energia Nuclear and it is placed under the authority of the Minister of Industry and Technology. (NEA) [fr
-
Informed consent in psychotherapy.
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.
-
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.
-
International Nuclear Information System (INIS)
1977-01-01
Further to Decree-Law No. 358/76 of 14 May 1976 establishing the general reorganisation of the Ministry of Industry and Technology, this Decree-Law creates new departments and decides the abolition of others, including the Junta de Energia Nuclear. The JEN's activities are henceforth to be redistributed to other departments in the Ministry. (NEA) [fr
-
Decree No 87-137 of 2 March 1987 concerning the High Council for nuclear safety and information
International Nuclear Information System (INIS)
1987-01-01
This Decree amends the Decree of 13th March 1973 setting up a High Council for Nuclear Safety. Its purpose is to widen the terms of reference of the High Council for Nuclear Safety. In addition to its responsibilities as regards the safety of nuclear installations, it is now competent in the field of information. The Council is now charged with informing the media as well as the public not only on questions of safety proper but also on incidents and accidents occurring in nuclear installations. (NEA) [fr
-
Use of informed consent with therapeutic paradox.
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.
-
Case summary of the first amended consent decree with Intel Corporation and Raytheon Company to address trichloroethylene (TC) contamination in residential and commercial buildings in Mountain View, California
-
32 CFR 634.8 - Implied consent.
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.
-
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.
-
USign--a security enhanced electronic consent model.
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.
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.
-
Health Ministry - Decree-law no 72/91 of 8 february
International Nuclear Information System (INIS)
1991-01-01
This Decree-Law No 72/91 was brought into force retroactively since 1 January 1991. It lays down regulations for the marketing, quality control and fabrication of medical products and apparatus for human use. The regulations take into account a series of Directives in this respect issued by the Council of the European Communities and establish a licensing system for medicines and apparatus, including those containing radioisotopes [fr
-
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
-
International Nuclear Information System (INIS)
1977-01-01
This Decree, amended in 1980 and 1985 implements the 1976 Act and contains provisions applying specifically to installations subject to licensing and others which apply solely to installations subject to declaration; also, certain provisions apply to all classified installations. As regards installations subject to licensing, the Decree details the licensing procedure: information to be contained in the application, accompanying documents, conditions of the hearing for issuance of the licensing decree, etc. In addition, it specifies for installations subject to declaration, the particulars to be contained in the declaration, the accompanying documents, the conditions for publicising it as well as the conditions for modifying the general specifications applicable to the installation declared. The provisions of the Decree common to both types of installation mainly concern inspections, conditions to be observed if there is a change in the operator or cessation of activities, and fines in case of non-compliance with the Decree (NEA) [fr
-
Energy Technology Data Exchange (ETDEWEB)
Hing, K. [CDF Energie, Charbonnages de France, 92 - Rueil-Malmaison (France)
1997-12-31
The impacts of the new French decree 2910 concerning the classification of all combustion equipment with regards to their energy sources, energy efficiency and pollution control, on 2 to 20 MW coal-fired boilers, are discussed, with emphasis on their pollutant emissions (SO{sub 2}, NO{sub x} and ashes). The compositions of several coals is presented and the various types of coal-fired boilers adapted to the new decree are presented: automatic boilers, dense fluidized bed boilers, vibrating and chain grids with fume tubes and water tubes
-
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
-
Informed consent comprehension in African research settings.
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
-
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.
-
International Nuclear Information System (INIS)
2009-08-01
This decree aims at making compulsory the presence of a skilled medical radio-physics specialist in the medical centre during the whole duration of the radiotherapy treatment given to patients. The planning of presence of this specialist must take into account the schedule of patients treatment. The decree specifies the conditions of deputizing in case of absence of this specialist. (J.S.)
-
Dynamic axes of informed consent in Japan.
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.
-
International Nuclear Information System (INIS)
Ayrault, Jean-Marc; Batho, Delphine
2013-01-01
While referring to various legal European and French texts (treaty, codes, decrees, and so on), this decree indicates modifications to a previous decree. These modifications notably concern the fuel type, and arrangements concerning the operator. These modifications are also made, based on a text published by the ASN (nuclear safety authority)
-
International Nuclear Information System (INIS)
1978-01-01
This Decree was made by the Italian Minister for Industry, Commerce and Crafts; it lays down that nuclear installations governed by Act No. 1860 of 31 December 1962 on the Peaceful Uses of Nuclear Energy and by Presidential Decree No. 185 of 13 February 1964 on Radiation Protection and excluded from the scope of are Royal Order No. 824 of 12 May 1927 on combustion control. (NEA) [fr
-
International Nuclear Information System (INIS)
Miller, L.
2004-01-01
The decree refers to intervention level values for particular types of intervention activity, such as evacuation, order to leave in closed rooms, application of preparations containing stabile iodine, prohibition or limiting to consume contaminated food or water, temporary or permanent displacement. The intervention level values refer to contamination level values refer to contamination with strontium 90, iodine 131, plutonium 239, americium 241, cesium 134 and cesium 137 of drinking water, milk and food for men and domestic animals. The decree replaces the decrees of 6 August 2002 (Dz. U. no 145, item 1218, 2002 and no 151, item 1463, 2003)
-
International Nuclear Information System (INIS)
1978-01-01
This 1978 Circular by the Minister of Industry, Commerce and Crafts lays down the licensing procedure to be complied with for construction and operation of nuclear installations, determined by a Ministerial Decree of 4 January 1977 subjecting certain installations to Section 55 of Presidential Decree no.185 of 13 February 1964. It lists the documents to be supplied by applicants for a licence and describes the technical enquiry to be undertaken by the Comitato Nazionale per l'Energia Nucleare (CNEN). (NEA) [fr
-
Decree No. 85-140 of 28 January 1985 on the Higher Council for Nuclear Safety
International Nuclear Information System (INIS)
1985-01-01
The Council set up in 1973 under the supervision of the Minister responsible for energy matters, is charged with all questions dialing with nuclear safety. This Decree expands membership in the Council. (NEA) [fr
-
Franco, G; Mora, Erika
2009-01-01
Ethical behaviour consists ofindividual choices inspired by knowledge and professional experience derived from the universally acknowledged ethical principles of beneficience/nonmaleficience, autonomy and justice. However, in spite of the unanimous consent on their universal importance, such principles do not usually have the strength of a law. The recently introduced Italian law on the protection of workers' health represents a novelty because it gives the Ethics Code of the International Commission on Occupational Health legal strength. This paper aims at examining article 25 of legislative decree 81/2008 by comparing the points of the Ethics Code and the Deontology Code of the Italian medical profession. The relationships between the 12 points of paragraph 1 of article 25, the 26 points ofthe Code ofEthics and the 75 articles of the Deontology Code are described with regard to the occupational health physician's duties (i) of collaboration with other occupational health professionals, (ii) of organization and execution of health surveillance, (iii) of recording, securing, transmitting of medical files on workers' health and (iv) of employee and employer information on the importance and meaning of health surveillance.
-
International Nuclear Information System (INIS)
1978-01-01
This Ministerial Decree was made in implementation of Decree No. 185 of 13 February 1964 of the President of the Republic on the safety of installations and the health protection of workers and the population against the hazards of ionizing radiation. It determines the methods for evaluating environmental contamination doses in mines which contain radioactive substances, and more generally, as regards mining research or exploitation implying a risk of exposure to ionizing radiaton. (NEA) [fr
-
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
-
International Nuclear Information System (INIS)
1984-01-01
This Decree amends and replaces a series of tables of occupational diseases annexed to Decree No. 46-2959 of 31 December 1946. Table no. 6 which concerns nuclear activities, already amended in 1963, has now been given a new title. The original title ''diseases created by X-rays or radioactive substances'' is replaced by ''diseases created by ionizing radiation''. Other modifications concern the diseases and time-period for taking certain of them in charge to take account of the evolution of knowledge. (NEA) [fr
-
International Nuclear Information System (INIS)
Anon.
2001-01-01
The decree of the 27. July 2001 defines the organization of nuclear safety concerning nuclear military systems (SNM) and secret basic nuclear installations (INBS). The responsibility of nuclear safety is shared between 3 authorities: 1) the synthetic authority, this authority defines the organization required to reach and maintain the adequate level of safety set by the ministry of defence, the synthetic authority can change according to the state in which SNM or INBS is (designing, fabrication, operation and dismantling); 2) the authority that is responsible for the material and staff resources that are required to operate the SNM or INBS according to the rules and regulations of nuclear safety; and 3) the military territorial authority, this authority manages the actions made by the state services concerning the prevention of accidents, or the measures to take in case of accidents. (A.C.)
-
Royal Decree 1157/1982 of 30 April approving the Statute of the Nuclear Safety Council
International Nuclear Information System (INIS)
1982-01-01
This Decree, made in implementation of the Act of 1980, setting up the Nuclear Safety Council, lays down the statutes, responsibilities, structure and rules of procedure of the Council as well as its staff rules. (NEA) [fr
-
Improving the Proficiency of Research Consent Administrators
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
-
Guidance: Strategies to Achieve Timely Settlement and Implementation of RD/RA at Superfund Sites
Memorandum recommends strategies to encourage PRPs to enter into a settlement using the model RD/RA Consent Decree; discusses the current model UAO; and suggests practical alternatives to expedite Superfund settlements and the cleanup process.
-
International Nuclear Information System (INIS)
2012-01-01
This decree regulates the establishment of electricity conduction in Florida, Cerro Largo, Maldonado, Flores, San Jose and Tacuarembo towns. These electrical lines are necessary to provide the public service by UTE
-
12 CFR 980.6 - Finance Board consent.
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.
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.
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.
-
Obtaining consent to oral and maxillofacial surgery.
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.
-
International Nuclear Information System (INIS)
2003-01-01
This decree allows the entry into force the safe exercise regulation of the packing activities and the distribution of liquefied petroleum gas (LPG) that will dictate the URSEA (The regulatory unit of energy and water service)
-
International Nuclear Information System (INIS)
Hollande, Francois; Valls, Manuel; Royal, Segolene
2016-01-01
In its first part, this official document describes the objectives and contents of the different chapters and articles of a decree which is related to the application of some articles contained by the law on energy transition and for a green growth (the decree builds up the second part of the document). It notably addresses the transposition of the 2011/70/EURATOM, directive, the adaptation of existing laws to this transposition, the definition of a procedure of reclassification of materials into radioactive wastes, and the strengthening of administrative and penal sanctions, measures related to nuclear safety and transparency, the creation of a system for the safety control of radioactive sources by the ASN, activities related to the Public Health Code
-
Decree No 82-531 of 22 June 1982 on the Higher Council for Nuclear Safety
International Nuclear Information System (INIS)
1982-01-01
This Decree lays down the composition of the Higher Council for Nuclear Safety which comprises representatives of parliament and of various ministries and scientific, technical, economic circles covering industry, energy, environment, defense, labour, as well as health and safety. (NEA) [fr
-
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.
-
Directory of Open Access Journals (Sweden)
Oscar Torres Yarzagaray
2018-05-01
Full Text Available Colombia as a developing country and outstanding nation in its gross domestic production in South America, has accepted the international accounting standards, financial information and information security as of Act 1314 of 2009 as a requirement of international commitments to encourage foreign investment and update the national accounting information system of public and private companies. Therefore, the current research aims to establish the effects of regulatory change in the statement of changes in equality as one of those that is part of the group of general purpose financial statements. Thus, the research is considered documentary and the bibliographic analysis is made by comparative law technique, between Decree 2649 of 1993 as a local rule in accounting matters until the entry in to force of the regulatory decrees of law 1314 of 2009, and the IFRS for SMEs version 2009 appended in the Single Regulatory Decree 2420 and 2496 of 2015.
-
Prospects of development of the court decrees enforcement system
Directory of Open Access Journals (Sweden)
Kristina Sergeyevna Morkovskaya
2015-06-01
Full Text Available Objective the relevance of the topic the insufficient level of its scientific elaboration predetermined the research objectives which consist in the analysis of the institution of enforcement proceedings the identification of key challenges trends and ways to improve the current system of court decrees enforcement. Methods the methodological basis of the undertaken research is scientific method of cognition in conjunction with certain specific scientific methods the laws of formal logic historical method comparative legal method and systematic analysis of theoretical works studied in this work. Results the emerging trends in the enforcement proceedings reform in the country cannot be considered to be satisfactory in general although some initiatives seem quite appropriate in case of the proper performance. If you the situation cannot be rectified with the execution of judicial decrees basing on own experience only it is necessary to pay attention to foreign practices and to provide citizens with the right to an effective judicial protection. Of all approaches to reforming of the enforcement institution analyzed in the article the preferred for the Russian legal reality is modernization of the existing nonjudicial system of enforcement through civil procedural means. Scientific novelty at present neither the civil procedure nor the general theory of law has not developed a unified understanding of the civil procedural tools for improving the efficiency of enforcement proceedings. Practical value the main provisions and conclusions of the article can be used in research and teaching when viewing the issues of the effectiveness of enforcement proceedings. nbsp
-
Unanimous Constitutional Consent and the Immigration Problem
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 ...
-
International Nuclear Information System (INIS)
1981-01-01
The purpose of this Decree is to provide a framework for aid and assistance at a local level, taking into account the decentralization following the creation in 1972 of autonomous administration in the regions. The provisions of thid Decree are of general application, and therefore cover nuclear emergencies, although they are not explicitly mentioned (NEA) [fr
-
Decree 120/12. It regulate the servitudes prescribed by law 17,389
International Nuclear Information System (INIS)
2012-01-01
This decree regulates the monitoring, control, maintenance and operation of the oil pipeline territory in charge of Ancap. This pipeline connects the Eastern Terminal Jose Ignacio with La Teja refinery which simultaneously is connected with La Tablada plant. The Administracion Nacional de Combustibles Alcohol y Portland (Ancap) establish the prohibitions and limitations on the land use as well as the explosive charge circulation in the zone.
-
International Nuclear Information System (INIS)
1982-01-01
This Decree further determines the competence of the Minister delegate for energy questions and provides that he will discharge the duties in that field given previously to the then Minister of Industry by Decree No 81-730 of 30 July 1981. (NEA) [fr
-
Ministry of Industry and Energy - Regulatory Decree No. 7/93 of 19 March
International Nuclear Information System (INIS)
1993-01-01
This Decree reorganizes the General Directorate for Energy within the Ministry of Industry and Energy. Its services include a Nuclear Energy Division which is responsible for keeping under review the technical and economic tendencies in the development of fuel and equipment for nuclear power plants and the problems in the field of radioactive waste management. (NEA)
-
Royal Decree 441/1986 of 28 February 1986 on the establishment of new electricity tariffs
International Nuclear Information System (INIS)
1986-01-01
This Decree raises electricity tariffs and prescribes the use to be made of the funds obtained from the sale of electricity: electrical/technical R and D, constitution of uranium stocks and work on the terminal part of the nuclear fuel cycle. (NEA) [fr
-
Description of a Mobile-based Electronic Informed Consent System Development.
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.
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.
-
Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.
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.
-
Petrini, C
2014-01-01
The provisions contained in the Legislative Decree no.26 signed by Italy's President on 4th March 2014 will have a considerable impact on the future of experiments with animals. The article briefly describes the stages of the decree's complicated passage through Parliament and the resulting text, which includes bans on: the use of animals for xenotransplants or research on drugs of abuse; the breeding of dogs, cats and non-human primates for experimental use; research without anaesthetic or analgesics that causes pain to the animal, except when anaesthetics or analgesics are being investigated. There is widespread feeling in the scientific community that these provisions will hinder the advancement of biomedical research in Italy.
-
International Nuclear Information System (INIS)
2009-01-01
On 9 May 2006, Electricite de France (EDF) submitted to the Ministers for Nuclear Safety an authorization decree application for an EPR-type reactor on the site of the Flamanville Nuclear Power Plant (NPP). Article 29 of Act No. 2006-686 of 13 June 2006 on Transparency and Security in the Nuclear Field prescribes that the creation of any basic nuclear installation shall be issued by a decree taken after consultation with the Nuclear Safety Authority (Autorite de surete nucleaire - ASN). The purpose of this report is to provide ASN's Board with a summary of the technical review led by ASN services and carried out by their technical support agencies, namely the IRSN, the GPR and the Standing Nuclear Section of the CCAP between 2001 and 2006. After summing up the conclusions of the review on the safety options of the European Pressurized Reactor (EPR) Project, as carried out between 1993 and 2000, this report describes the process and modalities of the review conducted from 2001 to 2006. Besides providing the opinion of ASN's services on the creation-licence application, it also outlines the further review to be carried out, if the authorization decree is issued. (authors)
-
The characteristics and use patterns of all-terrain vehicle drivers in the United States.
Rodgers, G B
1999-07-01
The consent decrees between the US Consumer Product Safety Commission and the major distributors of all-terrain vehicles (ATV), which were designed to address ATV-related injuries and deaths, expired in April, 1998. While national estimates of nonfatal and fatal injuries involving ATVs declined after the consent decrees went into effect 10 years ago, the injury estimates have stabilized in recent years. To gain a better understanding of current ATV use patterns, the CPSC sponsored a national probability survey of ATV drivers in the fall of 1997. The survey was designed to collect information about the characteristics and use patterns of ATV drivers and to quantify the numbers and types of ATVs in use. It employed a single stage list-assisted random-digit-dial sample design. This article describes the results of the survey, and discusses long term ATV usage trends.
-
Decree No. 89-85 of 8 February 1989 setting up a Council on Technological Risk Prevention
International Nuclear Information System (INIS)
1989-01-01
The Council set up by this Decree contributes to the assessment of collective risks arising from industrial activities, in particular nuclear activities, through its opinions, recommendations, studies, and proposes the relevant preventive actions to the Government. (NEA) [fr
-
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.
-
Bontemps, G; Daver, C; Ecoffey, C
2014-12-01
Day surgery is often considered as a marker of the necessity of reorganizing the hospital to take care globally and so better meet the expectations of improvement of the management of patients. But the actual deployment of day surgery can also act as a real revelation of the stakes of conciliation between the regulations, which supervise professional practices and organization, and the functioning of hospitals. Between the regulations supervising hospitals and professional practices and the place of the recommendations, between the general legal framework of the medical activity and specific legal framework (decree of anesthesia of 1994) and the Evidence-Based Medicine, the pretext of the improvement of the patient flow in day surgery, recommended by several institutions (Sfar, ANAP, HAS), questions about the legal obligation of the passage of all the patients in the postanesthesia care unit (PACU). Seen under the angle of a legal action against a medical doctor, the study of the French jurisprudence reveals that every practitioner has to respect the recommendations and the Evidence-Based Medicine, and this in the standardized frame of the MD's activity and the respect for a very strict legal environment. The question of an obvious conciliation between all these measures arises today clearly. In the case of a potential conflict, the key of resolution, based only on legal standards (constitution, laws, decrees), is not enough for arbitrating. Applying that the only respect for the decree of anesthesia would be enough for exempting itself from any contentious risk does not satisfy more. There is a real difficulty defining the legal precise nature of the recommendations, so best practices as better organization, which are more and more frequently. Even if these recommendations originally had not their place in the hierarchy of the legal standards, they are brought in there today. There is a real brake in the deployment of the day surgery because the strict respect for
-
Competence for Contract and Competence to Consent to Treatment
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.
-
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
-
[The informed consent in international clinical trials including developing countries].
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.
-
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
-
Testing an alternate informed consent process.
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.
-
2010-12-20
... under Iowa Code section 455B.186(1); 567 Iowa Admin. Code 38.3(1) and 51.6 with respect to the GM AC... examined on the following Department of Justice Web site, http://www.usdoj.gov/enrd/Consent_Decrees.html...
-
International Nuclear Information System (INIS)
2005-01-01
This Decree provides for the organisational structure of the Ministry of Mines and of Energy.which consists of a central administration, adjunct services and decentralized services. The central administration includes the cabinet of the Minister, the general Secretariat, the General Inspection of services, national directorates and consultatives organs. Decentralized services includes regional directorates departmental directorates, and communal services of Mines and energy. Adjunct Services include services under the supervision of the Minister of Mines and and Energie. This decree is engaged in cabinets [fr
-
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].
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.
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.
-
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.
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.
-
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.
-
Ministry of Industry and Energy - Decree Law No. 122/93 of 16 April
International Nuclear Information System (INIS)
1993-01-01
The Directorate for Geology and Mines was restructured into a public boy by this Decree-Law and named the Geological and Mining Institute. The Institute is placed under the authority of the Ministry of Industry and Energy and is generally responsible for the management of mineral resources, for establishing and implementing the national policy regarding extractive industries and for proposing and implementing the related regulations. (NEA)
-
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
-
Non-completion and informed consent.
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.
-
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.
-
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
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.
-
International Nuclear Information System (INIS)
1980-01-01
Section 83 of Decree No. 185 of 13 February 1964 on protection against ionizing radiation provides that institutions previously authorised by the Minister of Labour and Social Security may, on condition that they are adequately equipped for such services, be authorised to undertake health physics and medical supervision of personnel. This Decree accordingly authorises the Agip Nucleare Company to carry out this work. (NEA) [fr
-
Changing trends in informed consent
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...
-
Decree No. 2967 of 7 December 1979 on the regulation of activities in the nuclear fuel cycle
International Nuclear Information System (INIS)
1980-01-01
Within the framework of the national energy plan, and for the purpose of ensuring the supply of uranium for nuclear power plants in Spain, this Decree reorganises and develops the duties and responsibilities of the National Uranium Undertaking (ENUSA) set up by Decree No. 3322 of 23 December 1971. ENUSA is a public undertaking, wholly controlled by the State, with a majority capital held by the National Institute for Industry and participation by the Junta de Energia Nuclear, which advises it in connection with research and development. ENUSA is responsible for the development of industrial and commercial activities related to the nuclear fuel cycle. While the Junta de Energia Nuclear remains responsible for final storage of radioactive waste, ENUSA is henceforth in charge of other activities in execution of the national plan for prospection for and investigation of uranium. (NEA) [fr
-
Value of informed consent in surgical orthodontics
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
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.
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
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.
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.
-
International Nuclear Information System (INIS)
1971-01-01
This Decree contains the values in radioactivity, concentration and weight to which, under Act No. 1008, the system of notification and licensing does not apply. The Decree exempts from this system certain special fissile materials, source materials and other radioactive materials (NEA) [fr
-
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.
-
Decree 53/1963 of 10 January on the establishment of a radioactivity alarm network
International Nuclear Information System (INIS)
1963-01-01
This Decree provides for the setting up of a radioactivity alarm network by the Directorate General for Public Protection to prevent hazards arising from possible incidents originating in nuclear installations. The Duty stations are located in specified police stations and with fire brigades within a radius ranging from 15 to 20 km from planned reactors or nuclear power plants. (NEA) [fr
-
International Nuclear Information System (INIS)
1995-01-01
The Decree stipulates that manufacturers and users of equipment for radioactive waste transportation, storage and disposal are obliged to have the equipment tested. This duty concerns radioactive waste transport casks, shielding containers, etc., except for nuclear fuel transporting facilities. Authorization to act as the national testing body was granted to the Institute for Research, Production and Application of Radioisotopes. The Decree entered into force on 1 July 1981. (J.B.)
-
Informed Consent: An Ethical Obligation or Legal Compulsion?
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.
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 ...
-
International Nuclear Information System (INIS)
1966-01-01
This Decree was made to determine the quantity of radioactivity which constitutes the threshold for classifying commercial operations into a less or more hazardous category, namely A and B categories respectively. The IAEA criteria in this field were used as a basis for this classification. (NEA) [fr
-
An Alternative Consent Process for Minimal Risk Research in the ICU.
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.
-
International Nuclear Information System (INIS)
1976-01-01
This Royal Decree implements the national Regulations for the transport of dangerous goods by road, based on the European Agreement concerning International Carriage of Dangerous Goods by Road (ADR) to which Spain became a party on 22nd November 1972. The implementing provisions lay down that the national regulations do not apply to transport not exceeding 50 km or to loads below one tonne. Furthermore, the Decree prescribes the period within which vehicles and their markings as well as packaging conditions for dangerous goods must comply with its requirements. It is recalled that radioactive materials are classified as dangerous goods in Class 7. (N.E.A.) [fr
-
International Nuclear Information System (INIS)
1964-01-01
This Decree is the basic legislative text on radiation protection in Italy. It was made under Act No. 1860 of 31 December 1962. A series of decrees were subsequently made in implementation of this decree and together with Act No. 1860, it provides the basic framework for the regulation of nuclear activities in Italy. (NEA) [fr
-
Decree no. 2004-251 from March 19, 2004 relative to public utility obligations in the gas sector
International Nuclear Information System (INIS)
2004-03-01
This decree defines the public utility obligations that gas suppliers and gas facility operators (transportation and distribution networks, underground storage facilities, LNG facilities) have to fulfill in order to ensure without interruption the continuity of gas supplies to their clients. (J.S.)
-
Decree No 81-858 of 15 September 1981 on the organization of the Ministry of Industry
International Nuclear Information System (INIS)
1981-01-01
This is an extract of the Decree on the organization of the Ministry of Industry and covers questions related to the Ministry's responsibilities in connection with the Atomic Energy Commission (CEA). This concerns in particular the CEA's activities in energy production, nuclear materials supply and nuclear safety. (NEA) [fr
-
International Nuclear Information System (INIS)
1975-01-01
This Decree prescribes the licensing procedure for the release of liquid wastes from nuclear installations as well as the technical supervision of such operations. It does not apply to the transport of radioactive effluents which is governed by the regulations on the transport of dangerous goods. (NEA) [fr
-
Consent, ethics and genetic biobanks: the case of the Athlome project.
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.
-
Value of informed consent in surgical orthodontics.
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?
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.
-
Informed consent in Malaysia: an overview.
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.
-
International Nuclear Information System (INIS)
1980-01-01
This Decree is important as respects nuclear energy insofar as the tasks of the Institute which are mainly of an advisory nature, also concern radiation protection and safety in connection with nuclear activities. It provides for an advisory role to be played by the Institute as regards health protection in the field of nuclear power generation and radioactive materials, including use of and trade in such materials. On the other hand, it does not affect the regulations governing the use of nuclear energy, in particular as concerns Act N 0 1240 of 1971 reorganising the CNEN, Act N 0 1860 of 1962 on the peaceful uses of nuclear energy, Presidential Decree N 0 185 of 1964 on radiation protection and the decrees implementing these tests (NEA) [fr
-
International Nuclear Information System (INIS)
2004-01-01
This decree approve the transport regulation in the national jurisdiction routes. Is prohibited the transport of dangerous good with contamination risk in food, medication or articles intended for human or animal use
-
The accompanying adult: authority to give consent in the UK.
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.
-
Blockchain protocols in clinical trials: Transparency and traceability of consent
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.
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
-
Informed consent in neurosurgery--translating ethical theory into action.
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
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
-
Informed consent in Sri Lanka: a survey among ethics committee members.
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.
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
-
1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order
This document announces that EPA has signed an enforceable testing Consent Order with the Dow Chemical Co, Vulcan Materials Co, Occidental Chemical Corp, Oxy Vinyls, LP, Georgia Gulf Corp, Westlake Chemical Corp, PPG Industries, Inc., and Formosa Plastics.
-
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.
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.
-
International Nuclear Information System (INIS)
1977-01-01
Under this Decree, works and projects must be preceded by an environmental impact study which includes a site assessment, environmental effects and the measures planned by the person in charge of the works. When there is a public enquiry pocedure, the impact study is included. Failing such procedure, the study must be published in the press. The Decree also applies to setting up of large nuclear installations. (NEA) [fr
-
Scientists' perspectives on consent in the context of biobanking research.
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.
-
Informed consent in paediatric critical care research--a South African perspective.
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
-
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.
-
2010-06-14
... the plant. The Department reviewed blueprints of the Menasha facility, visited and toured the plant... costly settlement through the consent decree process.'' 119 Cong. Rec. 24,598 (1973) (statement of..., (202) 616-3302, [email protected] . Certificate of Service I, Rachel J. Adcox, hereby certify that...
-
78 FR 34910 - Approval and Promulgation of Implementation Plans; Maryland; Revisions to the State...
2013-06-11
...; administrative change. SUMMARY: EPA is taking final action on administrative changes to the Maryland State... an obsolete Consent Decree for the Allegany County Board of Education, Beall Jr./Sr. High School. EPA has determined that this action falls under the ``good cause'' exemption in the Administrative...
-
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
-
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.
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
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.
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.
-
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.
-
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.
-
Informed consent and collaborative research: perspectives from the developing world.
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.
-
Improving participant comprehension in the informed consent process.
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
-
1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement and Testing Consent Order
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.
-
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?
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'?
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.
-
2013-07-29
.... California Regional Water Quality Control Board, Los Angeles Region v. City of Los Angeles, Civil Action No... of California ex rel. California Regional Water Quality Control Board, Los Angeles Region v. City of... written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree...
-
Evaluating nurse understanding and participation in the informed consent process.
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.
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.
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.
-
International Nuclear Information System (INIS)
1985-01-01
Act No. 83-630 of 19 July 1983 on democratisation of public inquiries and environmental protection prescribes a public inquiry procedure for work likely to affect the environment. This Decree was made in implementation of the Act. Its scope is set out in an annexed table which provides that this new procedure applies to major nuclear installations governed by Decree No. 63-1128 of 11 December 1963 on nuclear installations and their radioactive effluent releases. The definition of a major nuclear installation which, until now, was set out in orders, is henceforth included in the 1963 Decree which is amended by the above Decree. As regards substance, the main modifications concerning nuclear installations are those directly resulting from the 1983 Act: one month's duration at least for the inquiry, designation of an inquiry commissioner by the president of the administrative court, stay of execution decided ipso facto by the judicial authority in case of the inquiry commissioner's negative opinion. (NEA) [fr
-
Can children withhold consent to treatment?
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.
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.
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...
-
International Nuclear Information System (INIS)
1985-01-01
Based on the directives given in the National Energy Plan of 1983, this Decree provides that the National Uranium Undertaking (ENUSA) which must constitute a stockpile of nuclear fuels to meet the needs of Spanish nuclear power plants, should now keep a lower stock. Therefore, the contingency stock is to be reduced progressively and a so-called operating stock is to be kept by ENUSA. In addition, the safety stocks of uranium concentrates and uranium enrichment services ensured by ENUSA will be eliminated and replaced by safety stocks or fuel elements in operating power plants to guarantee them a measure of autonomy. (NEA) [fr
-
29 CFR 1921.8 - Consent findings and order.
2010-07-01
... 29 Labor 7 2010-07-01 2010-07-01 false Consent findings and order. 1921.8 Section 1921.8 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.8 Consent findings and order. (a) General. At any...
-
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.
-
International Nuclear Information System (INIS)
2004-03-01
This decree defines the charges imputable to the missions of electric public utility, the procedure of determination of their amount, the contribution to these charges by end-users and the operations of recovery and transfer, the processing of declaration defects and payment failures and some other various dispositions. (J.S.)
-
International Nuclear Information System (INIS)
Miller, L.
2004-01-01
The decree refers to conditions for to bring on the territory of Poland, to take away from the territory of Poland, and to transit through this territory nuclear materials, radioactive sources and devices containing such sources. They be bring to, take away and transit through Poland with documents and procedures determined in regulations. The decree replaces the decree of 5 November 2002 (Dz.U. no. 207, item 1754)
-
21 CFR 50.25 - Elements of informed consent.
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
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].
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.
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.
-
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
-
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].
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.
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.
-
International Nuclear Information System (INIS)
2003-01-01
This decree lists and explains in detail the procedures to follow in the case of radiological emergency situations such radiological incidents or accidents. The definitions of emergency cases, the interventions themselves and the persons susceptible to be committed in these interventions are detailed, information to the population if necessary is taken into account. (N.C.)
-
Ethical Issues Regarding Informed Consent for Minors for Space Tourism
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.
-
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.
-
Implications of the UK NHS consent policy for nuclear medicine practice.
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.
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.
-
Presuming consent in the ethics of posthumous sperm procurement and conception.
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.
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
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
-
No Understanding, No Consent: The Case Against Alternative Medicine.
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.
-
Informed Consent in Research on Second Language Acquisition
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…
-
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...
-
Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study
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
-
Atomic power engineering under falsified safety standards
International Nuclear Information System (INIS)
Ackerman, A.J.
1974-01-01
In July 1970 the United States Department of Justice accused the American Society of Mechanical Engineers (ASME) of violating the Sherman Antitrust Act and of acting in restraint of trade by restricting the ASME Certificate of Authorization and the use of the Code Symbol Stamps to boilers and pressure vessels manufactured in the United States and Canada. During the succeeding two years attorneys for the parties in the case formulated a Consent Decree without a public confrontation in the Court. Furthermore, the membership of ASME was kept uninformed until October of 1972, after the Consent and Final Judgment had become effective and new procedures had been developed for allowing foreign manufacturers to apply the ASME Code Symbol Stamps to their products. As a consequence, a breakdown in engineered safety standards has been sanctioned and this is undermining the engineering profession's overriding reponsibility to protect the public health and safety. This breakdown of professional responsibility is especially serious in the new technology of atomic power. American insurance companies, which have traditionally written 100% insurance coverage for property damage and third party liability against explosions of high pressure steam boilers bearing the ASME Code Stamp, have refused to write such insurance coverage on nuclear reactors. In the author's opinion there is evidence that the Consent was formulated under collusive proceedings and he calls on the members and the Council of ASME to appeal for dismissal of the Consent Decree. 24 refs
-
International Nuclear Information System (INIS)
1982-01-01
This Royal Decree-Law sets out the conditions of intervention by the State in the achievement of the Lemoniz nuclear power plant with a view to accelerating the work. It sets up an Intervention Council responsible for directing the work which is empowered to take the necessary measures for discharging its duties. (NEA) [fr
-
International Nuclear Information System (INIS)
1989-01-01
In compliance with the Czechoslovak State Surveillance over Nuclear Safety of Nuclear Installations Act No. 28/1984, the Decree specifies requirements for assuring security protection of nuclear installations (and their parts) and of nuclear materials with the aim to prevent their abuse for jeopardizing the environment and the health and lives of people. (P.A.)
-
International Nuclear Information System (INIS)
Leloup, Lea
2015-01-01
This article comments a recent decree which aims at struggling against artificial splitting of solar installations, i.e. the possibility for solar electricity producers to circumvent tariffs and ask for a better purchase tariff through requests for distinct contracts. The author describes this problem, and analyses how this struggle is strengthened by new legal arrangements. She also outlines that no more parcel division will be tolerated
-
International Nuclear Information System (INIS)
1978-01-01
This Decree by the Ministry for Industry, Commerce and Crafts and the Ministry for transport of Italy was made in implementation of Section 2 of the Decree No. 519 by the president of the Republic of 2 May 1975 amending Section 15 to 24 of Act No. 1860 of 31 December 1962 on the Peaceful Uses of Nuclear Energy. This present Decree approves the general conditions of third party liability insurance policies for operators of nuclear installations and for transport of radioactive materials. (NEA) [fr
-
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.
-
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.
-
2012-02-21
... New York City and Long Island areas. See the proposal to this rule for details (76 FR 63865, October... obligation, timeline, or other requirement of the utility consent decrees. None of the restrictions in the... effective in 2017 for the purpose of unit-level allocations. EPA notes that this timeline will provide...
-
Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.
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
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…
-
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.
-
International Nuclear Information System (INIS)
1977-01-01
Under this Decree, the Central Service for the Safety of Nuclear Installations is placed from now onwards within the Directorate of Mines which comes under the Ministry of Industry, Trade and Crafts. The Head of the Central Service for the Safety of Nuclear Installations and his deputy are appointed by Order of the Minister of Industry, Trade and Crafts, on the proposal of the Director of Mines. (NEA) [fr
-
International Nuclear Information System (INIS)
2007-11-01
This decree concerns the enforcement of articles 5, 17 and 36 of the law 2006-686 from June 13, 2006, relative to the transparency and safety in the nuclear domain. A consultative commission of basic nuclear facilities is established. The decree presents the general dispositions relative to basic nuclear facilities, the dispositions relative to their creation and operation, to their shutdown and dismantling. It precises the dispositions in the domain of public utility services, administrative procedures and sanctions. It stipulates also the particular dispositions relative to other facilities located in the vicinity of nuclear facilities, relative to the use of pressure systems, and relative to the transport of radioactive materials. (J.S.)
-
Futility, autonomy, and informed consent.
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.
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.
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...
-
International Nuclear Information System (INIS)
1989-01-01
By Royal Decree of 12 February 1976, Norway implemented the European Agreement concerning the International Carriage of Dangerous Goods by road (ADR). Its provisions govern both international and domestic transport by road of radioactive materials. A Royal Decree of 8 December 1989 lays down Regulations on the land transport of dangerous goods which replace the 1976 Decree [fr
-
Trends and Determinants of Familial Consent for Corneal Donation in Chinese.
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.
-
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.
-
International Nuclear Information System (INIS)
1969-01-01
In accordance with the Nuclear Energy Act, this Decree determines the amount of contributions required towards the costs incurred by the State in implementation of the Act. Contributions are required when licences are granted, when packaging must be approved and when materials are transported. (NEA) [fr
-
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.
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.
-
International Nuclear Information System (INIS)
1981-01-01
This Decree, which determines the competence of the Minister of Research and Technology, provides that the latter prepares the Governments' decisions on the distribution of funds for technological R and D for civilian uses. Therefore he is responsible for allocating funds for such activities to the Atomic Energy Commission (CEA). (NEA) [fr
-
Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study
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
-
International Nuclear Information System (INIS)
1969-01-01
This Decree concerns the conditions attached to the licences required under the Nuclear Energy Act. It provides for the procedure for lodging appeals against additional conditions which may be imposed upon applicants for a licence. (NEA) [fr
-
Sexual Consent as a Scientific Subject: A Literature Review
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
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…
-
International Nuclear Information System (INIS)
2004-06-01
The reactor EL4, implemented in december 1966, has definitely shutdown on the 31 july 1985. This reactor was an industrial prototype, built and exploited by Cea and EDF. In the framework of the partial dismantling of the installation, the decree 96-978 of the 31 october 1996 agreed the Cea to modify the installation to become a storage installation. (A.L.B.)
-
Children's competency to consent: an ethical dilemma.
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.
-
Access to special care dentistry, part 3. Consent and capacity.
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.
-
"Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.
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.
-
International Nuclear Information System (INIS)
1992-01-01
This Decree sets out the conditions for consultations with elected representatives and the population which must be held before preliminary research work is started for installing any underground laboratory project for radioactive waste management. The Decree provides for the designation of a mediator responsible for conducting these prior consultations and for proceeding with any such consultations with elected representatives, associations and populations concerned. The mediator must describe the management of the project, the purpose of the research programme, its integration in the radioactive waste management policy. Finally, he must provide information on any potential harmful effects caused by the work prior to achievement of the laboratory and the remedial actions to be undertaken. (NEA)
-
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)
-
Informed consent for and regulation of critical care research.
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.
-
CJD, Progress Report, 2010/2011, Summary of nuclear data activity by staff of the IPPE CJD
International Nuclear Information System (INIS)
Blokhin, A.I.; Demin, N.A.; Gay, E.V.; Ignatyuk, A.V.; Manokhin, V.N.; Mikhaylyukova, M.V.; Pronyaev, V.G.; Zolotarev, K.I.
2012-01-01
Since last NRDC-2011 meeting the compilation in the EXFOR and the work on fulfillment of meeting's Conclusions and Actions have been done in the center. But substantial part of CJD activity was related to the nuclear data evaluation. 1) Staff 2) EXFOR activity 3) NRDC2011 actions 4) Computer and software matters. WEB-site service 5) Nuclear data evaluation activity 6) Nuclear Data services 7) Journal YK 8) Publications 9) Acknowledgments
-
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
-
Remote preenrollment checking of consent forms to reduce nonconformity.
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
-
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.
-
Capacity to consent to research among patients with bipolar disorder.
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.
-
Ministry of the Environment and Natural Resources-Decree-Law No.425/91 of 30 October
International Nuclear Information System (INIS)
1991-01-01
This Decree-Law restructures the Nuclear Protection and Safety Bureau to take account of its new responsibilities. It has the following tasks: evaluates and monitors the radiological impact of nuclear and radioactive installations, the safe management of radioactive waste; safety of nuclear and radioactive installations; controls that measures in the field of third party liability and nuclear non-proliferation are complied with; and co-operates with national and international authorities to respond to nuclear and radiological emergencies. (NEA)
-
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.
-
Shut Out: Denial of Education to Homeless Children.
Friedman, Lorraine; Christiansen, Guy
The Stewart B. McKinney Act of 1987 was intended to remove barriers and ensure access to education for homeless children. But despite a 1988 consent decree, the United States Department of Education (DOE) has failed to comply with its statutory duties to implement the Act, the states have also failed to implement the Act adequately, and homeless…
-
Negligence in securing informed consent and medical malpractice.
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.
-
International Nuclear Information System (INIS)
1964-01-01
This Decree prescribes the procedure to be complied with for entering information in the special register for commercial operations concerning source materials, ores and radioactive materials. (NEA) [fr
-
"Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students
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.
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.
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.
-
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 ...
-
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.
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.
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.
-
75 FR 26275 - Notice of Lodging of Proposed Consent Decree
2010-05-11
... Oceanic and Atmospheric Administration and the Department of the Interior; the State of Washington; the.... 9607(a); section 311 of the Clean Water Act (CWA), 33 U.S.C. 1321; section 1002(b) of the Oil Pollution Act (OPA), 33 U.S.C. 2702(b); and the Model Toxics Control Act (MTCA), RCW 70.105D. Under the proposed...
-
International Nuclear Information System (INIS)
1969-01-01
In implementation of Section 1 of the Nuclear Energy Act, this Decree lays down the percentages of uranium, plutonium and thorium substances must contain to be classified as fissionable materials under the Act. It provides for more detailed definitions of non-irradiated materials, natural, enriched and depleted uranium and ionizing radiations. (NEA) [fr
-
Should informed consent be based on rational beliefs?
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 ...
-
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
-
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
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
-
International Nuclear Information System (INIS)
1992-01-01
The Decree lays down the rules enabling government authorities to monitor the proper functioning of such appliances. It takes account of the Council of European Communities' Directive 80/836/Euratom amended by Directive 84/466/Euratom on basic safety standards for the health protection of the general public and workers against the dangers of ionization and Directive 84/467/Euratom laying down basic measures for the radiation protection of persons undergoing medical examination or treatment. The Decree provides for a register of firms authorised to sell and maintain medical X-ray equipment, and a register of the equipment installed. It also sets out requirements relating to third party liability insurance, and to the qualifications and training of personnel operating the equipment. (NEA)
-
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
-
Decree of the 24 April 2016 related to the objectives of development of renewable energies
International Nuclear Information System (INIS)
Royal, Segolene
2016-01-01
This decree defines objectives by 2018 and 2023 in terms of installed power for ground-based wind energy, solar radiative energy, hydroelectricity, offshore wind energy, marine energies, electrical geothermal energy, wood energy, and methanization. It also indicates an agenda for bidding procedures related to these different renewable energies. It indicates objectives of heat and cold renewable production based on biomass, biogas, heat pumps, low and medium geothermal energy, and thermal solar energy. Targeted percentages of use of advanced biofuels are also defined
-
Decree-Law No. 189/93 of 24 May establishing the General Directorate for the Environment
International Nuclear Information System (INIS)
1993-01-01
This Decree-Law sets up a General Directorate for the Environment with the Ministry for the Environment and Natural Resources. The Protection and Nuclear Safety Bureau-GPSN which had first been transferred from the Ministry of Industry, has now been merged with other Directorates into this new General Directorate for the Environment. The tasks of this Directorate include assessing and examining the radiological impact of nuclear and radioactive installations, including radioactive waste management and the safety of nuclear installations. (NEA)
-
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.
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
-
Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond
Directory of Open Access Journals (Sweden)
Go Yoshizawa
2017-07-01
Full Text Available The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in
-
Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.
Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto
2017-01-01
The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More
-
Qualitative study of patient consent for health information exchange in an HIV clinic.
Ramos, S Raquel; Bakken, Suzanne
2014-01-01
Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.
-
17 CFR 230.263 - Consent to Service of Process.
2010-04-01
... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Consent to Service of Process... Consent to Service of Process. (a) If the issuer is not organized under the laws of any of the states of... [§ 239.42 of this chapter]. (b) Any change to the name or address of the agent for service of the issuer...
-
Opt-Out Parental Consent in Online Surveys: Ethical Considerations.
Harris, Jane; Porcellato, Lorna
2018-07-01
This article aims to foster discussion and debate around seeking parental consent from young people recruited online. The growth of social media, particularly for young people, has led to increased interest in young people's online activities as both a research topic and recruitment setting. In a health-related study, which sought to recruit young people aged 13 to 18 years old from YouTuber fan communities to an online survey, the question arose of how parental consent could be sought from young people below 16 when no link existed between researcher and parents/guardians. A practical strategy is proposed which combines novel communication methods for participant information, opt-out online consent and age verification to address this issue. Strengths and limitations of these approaches are discussed.
-
Applying a sociolinguistic model to the analysis of informed consent documents.
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.
-
Law on consent and confidentiality in India: a need for clarity.
Mathiharan, Karunakaran
2014-01-01
The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.
-
Influenza vaccination in Dutch nursing homes: is tacit consent morally justified?
Verweij, M F; van den Hoven, M A
2005-01-01
Efficient procedures for obtaining informed (proxy) consent may contribute to high influenza vaccination rates in nursing homes. Yet are such procedures justified? This study's objective was to gain insight in informed consent policies in Dutch nursing homes; to assess how these may affect influenza vaccination rates and to answer the question whether deviating from standard informed consent procedures could be morally justified. A survey among nursing home physicians. We sent a questionnaire to all (356) nursing homes in the Netherlands, to be completed by one of the physicians. We received 245 completed questionnaires. As 21 institutions appeared to be closed or merged into other institutions, the response was 73.1% (245/335). Of all respondents 81.9% reported a vaccination rate above 80%. Almost 50% reported a vaccination rate above 90%. Most respondents considered herd immunity to be an important consideration for institutional policy. Freedom of choice for residents was considered important by almost all. Nevertheless, 106 out of 245 respondents follow a tacit consent procedure, according to which vaccination will be administered unless the resident or her proxy refuses. These institutions show significantly higher vaccination rates (p tacit consent procedures can be morally justifiable. Such procedures assume that vaccination is good for residents either as individuals or as a group. Even though this assumption may be true for most residents, there are good reasons for preferring express consent procedures.
-
International Nuclear Information System (INIS)
1978-01-01
This Decree by the Minister of Labour and Social Welfare was published in the Italian Official Gazette of 30 August 1978 and implements Section 7 of Presidential Decree no. 1150 of 12 December 1972 fixing the conditions for inclusion of qualified experts and approved physicians in the list of persons authorised to be in charge of surveillance of radiation protection from the viewpoint of physics and medicine. The 1978 Decree determines the frequency of sessions for examination of the qualification of experts and physicians who wish to be included in the list, the procedures for application, the documents required, and the time within which successful candidates are notified of their inclusion in the list. (NEA) [fr
-
Consent for blood transfusion: do patients understand the risks and benefits?
Cheung, D; Lieberman, L; Lin, Y; Callum, J
2014-10-01
Blood transfusion is a frequent medical intervention in hospitals. The benefits of, risks of and alternatives to blood transfusions are not consistently understood by patients. The objective of this study was to assess gaps in knowledge and comfort with the current process of consenting patients for blood transfusions. A standardised video regarding the risk and benefits of blood transfusions was developed and feedback regarding this tool was assessed. After informed consent had been obtained, 25 patients receiving their first transfusion at a single academic centre were asked to complete a survey, watch a standardised educational video and complete a follow-up survey. The patient survey revealed that the information recollected from informed consent discussions was variable and incomplete. After the informed consent discussion, the majority of patients were comfortable with having a blood transfusion, although one-third did express concerns or worry about having a blood transfusion. After viewing the video, patients felt that the video improved their understanding of the risks (7·3 of 10), benefits (6·9 of 10) and alternatives (7·1 of 10) to transfusion, but it did not change their comfort with blood transfusion consent. Patients experienced a variable informed consent process prior to blood transfusion. Although the video improved their understanding of risks, it did not improve patient comfort towards giving consent for transfusion as the level of comfort was already high. The video is available online (http://www.youtube.com/watch?v=RxaPnLkgh-0) as an optional resource for patients (and physicians) who wish to receive standardised and accurate information about blood transfusions. © 2014 British Blood Transfusion Society.
-
2010-07-01
... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child... amend the child's education records to remove any references to the child's receipt of special education...
-
International Nuclear Information System (INIS)
Issoufou, Mahamadou; Brigi, Rafini; Foumakoye, Gado
2013-01-01
This decree provides for the organization of the Ministry of Energy and Oil. Thus the Ministry of Energy and Oil is composed of: the central administration, deconcentrated services and piecing services, administrations and decentralized services, programs and public projects. [fr
-
Qureshi, Adnan I; Gilani, Sarwat; Adil, Malik M; Majidi, Shahram; Hassan, Ameer E; Miley, Jefferson T; Rodriguez, Gustavo J
2014-01-01
Background Telephone consent and two physician consents based on medical necessity are alternate strategies for time sensitive medical decisions but are not uniformly accepted for clinical practice or recruitment into clinical trials. We determined the rate of and associated outcomes with alternate consenting strategies in consecutive acute ischemic stroke patients receiving emergent endovascular treatment. Methods We divided patients into those treated based on in-person consent and those based on alternate strategies. We identified clinical and procedural differences and differences in hospital outcomes: symptomatic ICH and favorable outcome (defined by modified Rankin Scale of 0–2 at discharge) based on consenting methodology. Results Of a total of 159 patients treated, 119 were treated based on in-person consent (by the patient in 27 and legally authorized representative in 92 procedures). Another 40 patients were treated using alternate strategies (20 telephone consents and 20 two physician consents based on medical necessity). There was no difference in the mean ages and proportion of men among the two groups based on consenting methodology. There was a significantly greater time interval incurred between CT scan and initiation of endovascular procedure in those in whom in-person consent was obtained (117 ± 65 min versus 101 ± 45 min, p = 0.01). There was no significant difference in rates of ICH (9% versus 8%, p = 0.9), or favorable outcome at discharge (28% versus 30%, p = 0.8). Conclusions Consent through alternate strategies does not adversely affect procedural characteristics or outcome of patients and may be more time efficient than in-person consenting process. PMID:25132906
-
Language cultural brokerage and informed consent will technological terms impede telemedicine use
Directory of Open Access Journals (Sweden)
Caron Jack
2014-04-01
Full Text Available Introduction. Telemedicine provides a solution to treatment of economically and geographically compromised patients and enhances the level of care. However, a problem has arisen in safeguarding patients’ rights to informed consent.Objective. To determine the impact of language, translation and interpretation barriers on gaining legally valid informed consent in telemedicine.Design. Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a telemedicine encounter were selected and sent for translation into isiZulu, the local indigenous language of KwaZulu-Natal, South Africa. A questionnaire with the list of words was developed with three domains covering information communication technology (ICT use, ICT terms and ethics terms. This was administered to patients at four outpatient departments in rural KwaZulu-Natal hospitals.Results. Of the 54 participants, 50 (92.6% did not know or understand the term ‘telemedicine’, 49 (90.7% the term ‘video conference’ and 49 (90.7% the term ‘electronic records’. Words such as ‘consent’ and ‘autonomy’ were understood by less than a third of the participants. Only 19 individuals (35.2% understood the word ‘consent’, and only 4 (7.4% understood both the words ‘consent’ and ‘telemedicine’.Conclusions. The results of this study show that obtaining informed consent for a telemedicine consultation is problematic. Alternative ways of gaining informed consent need to be investigated.
-
Organ donation in Switzerland--an analysis of factors associated with consent rate.
Directory of Open Access Journals (Sweden)
Julius Weiss
Full Text Available BACKGROUND AND AIM: Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased's next of kin (NOK for organ donation, which is a prerequisite for donation in Switzerland. METHODS AND ANALYSIS: During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. RESULTS: Of 266 NOK approached for consent, consent was given in 137 (51.5% cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46-6.54 and German language area (OR 0.31, 95% CI: 0.14-0.73. Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93-3.33 and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90-3.87. CONCLUSION: Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions.
-
International Nuclear Information System (INIS)
1990-01-01
The 1964 Decree on radiation protection (DPR No. 185 of 1964) provides that the competent authorities may lay down specific conditions for keeping documentation on physical and medical surveillance of workers exposed to ionizing radiation. This Decree establishes where such documents must be kept, the information they should provide on irradiation and contamination, the relevant obligations of qualified experts, and employers according to Euratom Directive No. 80/836 on the health protection of workers against ionizing radiation [fr
-
[Pediatric autopsy and informed parental consent].
Rambaud, C; Guilleminault, C
2005-10-01
In French legal terminology, the definition of autopsy is "organs'withholding". This phrase is ambiguous, meaning both removing the organs for their macroscopic exam and their retention for subsequent histology. The autopsy of a child requires an informed consent from both parents. The issue is that the pathologist who performs the autopsy is not the one who delivers the information and gets the parents' consent: therefore, he does not know what they were told and what they actually agreed upon. A questionnaire was sent to 3 groups of paediatricians (N=891) to approach their knowledge regarding autopsy. Among 362 paediatricians who answered the questionnaire, 57.2% never attended an autopsy and procedures were badly known. They did not know whether or not organs, were systematically sampled especially brain. Regarding the possibility of conservation of organs, a majority thought that one should not solely answer to parents'queries (63.8%) but rather that one should point out every possibility, without giving the ins and outs (60.8%). The majority favoured organs retention and use for research. We make 3 suggestions: to register autopsy in the Natioanal Securite Sociale nomenclature, to establish information and consent forms for organs'removal, retention and disposal, and to offer parents the possibility of an interview with the pathologist before and/or after the autopsy, in association with the paediatrician.
-
Informed consent: is it a myth?
Herz, D A; Looman, J E; Lewis, S K
1992-03-01
The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.
-
Placebo Effects and Informed Consent.
Alfano, Mark
2015-01-01
The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.
-
Universal donor education and consent: what we know and where we should go.
Wehrli, Gay; Sazama, Kathleen
2010-11-01
Each day thousands of blood donors across the country are given educational materials and sign a consent form, thus fulfilling two blood collection accreditation requirements. Very few donors will experience a documented adverse event, although a disproportionate number of these events occur in the youngest donor cohort. The literature reflects this disproportion and suggests mitigation strategies. Studies describe subjective, undocumented donor reactions and decreased donor return rates after a documented or subjective reaction. Additionally, studies have shown donor consent form variability among blood collection facilities and that donor comprehension of the educational materials and consent is limited. There are few standardized donor education materials or consent documents. Current accreditation standards for educational materials are limited to aspects of transfusion-transmitted diseases and for donor consent process and documentation are vague and nonspecific. Recent experiences with young donors and current research compel our community to engage in creating standardized, expanded donor educational materials and standardized donor consent processes and documents. © 2010 American Association of Blood Banks.
-
Informed consent for telemedicine in South Africa: A survey of ...
African Journals Online (AJOL)
Informed consent for telemedicine in South Africa: A survey of consent practices among healthcare professionals in Durban, KwaZulu-Natal. C Jack, M Mars. Abstract. Background. The Health Professions Council of South Africa is drafting guidelines to regulate the practice of telemedicine. These emphasise the need for ...
-
29 CFR 1905.24 - Consent findings and rules or orders.
2010-07-01
... UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 Hearings § 1905.24 Consent... 29 Labor 5 2010-07-01 2010-07-01 false Consent findings and rules or orders. 1905.24 Section 1905.24 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...
-
Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B; Lee-Kim, Youngna; Shah, Mona D
2018-01-01
Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to 90%.
-
Decree 2211: Standards to control the generation and handling of dangerous wastes
International Nuclear Information System (INIS)
1992-01-01
This Decree has for object to establish the conditions under which should be carried out the activities of generation and handling of dangerous waste, in order to prevent damages to health and to the atmosphere. It includes: definitions; a list of sources of waste; a list of constituent of dangerous waste; the characteristics of danger; a lists of maximum permissible concentrations in leachates, handling of dangerous waste, criterion for transport, monitoring form, storage areas, treatment and final disposition, storage, elimination, incineration, recycling, reuse and recovery, installation and operation of security backfilling, book of waste record, control of activities, obligations in charge of those who manage dangerous waste, and trans border movements of dangerous waste [es
-
Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J
2013-12-01
Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
-
Directory of Open Access Journals (Sweden)
H Miller MacSween
1997-01-01
Full Text Available Informed consent has undergone a transformation from an ethical concept to a legal doctrine. It is based on the ethical principles of self-determination and autonomy. Over the past several years, courts have established physician liability based on the failure to obtain adequate informed consent. It is the duty of all gastrointestinal endoscopists to obtain legally adequate informed consent before performing any endoscopic procedure.
-
Audit of the informed consent process as a part of a clinical research quality assurance program.
Lad, Pramod M; Dahl, Rebecca
2014-06-01
Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.
-
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.
-
Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...
African Journals Online (AJOL)
Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...
-
Current approaches for informed consent in pediatrics
Directory of Open Access Journals (Sweden)
Hatice Betül Gemici
2014-09-01
Full Text Available Today in medical practis; codes of ethic are becoming important. New aprroaches has emerged that about to participate with patient’s consent and child absent understand the own situation should be taken for treatment or process on child. Means of child informing is to given simple information about understandable language. Physicians should support to be shared with the patient’s medical decision according to the child’s age and understanding capacity. Informed consent in pediatric patients makes contribution to develepmont of future individuals; therefore that is an important ethic assignment for doctors. J Clin Exp Invest 2014; 5 (3: 496-503
-
Parental perspectives on consent for participation in large-scale, non-biological data repositories.
Manhas, Kiran Pohar; Page, Stacey; Dodd, Shawn X; Letourneau, Nicole; Ambrose, Aleta; Cui, Xinjie; Tough, Suzanne C
2016-01-01
Data sharing presents several challenges to the informed consent process. Unique challenges emerge when sharing pediatric or pregnancy-related data. Here, parent preferences for sharing non-biological data are examined. Groups (n = 4 groups, 18 participants) and individual interviews (n = 19 participants) were conducted with participants from two provincial, longitudinal pregnancy cohorts (AOB and APrON). Qualitative content analysis was applied to transcripts of semi-structured interviews. Participants were supportive of a broad, one-time consent model or a tiered consent model. These preferences were grounded in the perceived obligations for reciprocity and accuracy. Parents want reciprocity among participants, repositories and researchers regarding respect and trust. Furthermore, parents' worry about the interrelationships between the validity of the consent processes and secondary data use. Though parent participants agree that their research data should be made available for secondary use, they believe their consent is still required. Given their understanding that obtaining and informed consent can be challenging in the case of secondary use, parents agreed that a broad, one-time consent model was acceptable, reducing the logistical burden while maintaining respect for their contribution. This broad model also maintained participant trust in the research and secondary use of their data. The broad, one-time model also reflected parents' perspectives surrounding child involvement in the consent process. The majority of parents felt decision made during childhood were the parents responsibility and should remain in parental purview until the child reaches the age of majority.
-
An audit cycle of consent form completion: A useful tool to improve junior doctor training.
Leng, Catherine; Sharma, Kavita
2016-01-01
Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91-100%) and additional procedures (0-7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.
-
Ophthalmologists' awareness of informed consent and their compliance to its requirements.
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
-
Informed Consent in Pediatric Oncology: A Systematic Review of Qualitative Literature.
Alahmad, Ghiath
2018-01-01
Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship. Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary
-
Emergency Physicians, Beware of the Consent Standard of Care
Moore, Gregory P.; Matlock, Aaron G.; Kiley, John L.; Percy, Katherine D.
2018-01-01
Many emergency physicians view informed consent as a necessary component of treatments or procedures to be performed on their patients. When such procedures are necessary, often there is a discussion of risks, benefits and alternatives with forms signed to validate the discussion. Two Wisconsin emergency department medical-legal cases have expanded liability of the duty of informed consent. These cases have focused on withholding medication and diagnostic tests.
-
Informed consent and medical ordeal: a qualitative study.
Little, M; Jordens, C F C; McGrath, C; Montgomery, K; Lipworth, W; Kerridge, I
2008-08-01
Informed consent is a mainstay of clinical practice, with both moral and legal forces. Material disclosure about extreme treatments, however, is unlikely to convey the full impact of the experience of treatment. Informed consent may be flawed under such circumstances. The aims of this study were to compare expressed satisfaction with pretreatment information to satisfaction after experiencing autologous stem cell transplantation for recurrent lymphoma. A qualitative, narrative-based cohort study was conducted in a bone-marrow transplant unit of a teaching hospital at Westmead Hospital, Sydney, Australia. The cohort consisted of 10 transplant recipients and 9 of their nominated lay carers. The outcome measure was satisfaction expressed in narrative interviews at the time of transplantation and 3 months later. We used discourse-analytic techniques to examine the narratives. Both patients and carers expressed high satisfaction with the information given by individual clinicians and by speakers at a formal Information Day held before transplantation. At the first interview, neither patients nor carers commented much on the forthcoming ordeal of chemotherapy and bone marrow ablation, although all patients had undergone previous chemotherapy. At the second interview, the ordeal dominated the narratives and retrospective dissatisfaction with information was common. This study suggests that information about treatment theories and protocols can be satisfactorily communicated, but personal experience of suffering defies communication. This finding has serious implications for the practices involved in obtaining informed consent and for the very notion of informed consent.
-
Should informed consent be based on rational beliefs?
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.
-
Harle, Christopher A; Golembiewski, Elizabeth H; Rahmanian, Kiarash P; Krieger, Janice L; Hagmajer, Dorothy; Mainous, Arch G; Moseley, Ray E
2017-12-19
The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details. © The Author(s) 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
-
Conditions for Australian consent to reprocessing
International Nuclear Information System (INIS)
Anon.
1980-01-01
This article contains the text of the statement by the Australian Minister for Foreign Affairs to the House of Representatives, Noember 1980, on conditions for Australian consent to the reprocessing of nuclear material of Australian origin
-
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.
-
Kortram, Kirsten; Spoon, Emerentia Q. W.; Ismail, Sohal Y.; d'Ancona, Frank C. H.; Christiaans, Maarten H. L.; van Heurn, L. W. Ernest; Hofker, H. Sijbrand; Hoksbergen, Arjan W. J.; Homan van der Heide, Jaap J.; Idu, Mirza M.; Looman, Caspar W. N.; Nurmohamed, S. Azam; Ringers, Jan; Toorop, Raechel J.; van de Wetering, Jacqueline; Ijzermans, Jan N. M.; Dor, Frank J. M. F.
2016-01-01
Introduction: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed
-
International Nuclear Information System (INIS)
1973-01-01
This Decree by the Ministry of Labour implements Section 36 of DPR No. 1450 of 30 December 1970 (Regulations concerning the qualifications for technical operation of nuclear installations) made under Act no. 1860. (NEA) [fr
-
Time to Improve Informed Consent for Dialysis: An International Perspective.
Brennan, Frank; Stewart, Cameron; Burgess, Hannah; Davison, Sara N; Moss, Alvin H; Murtagh, Fliss E M; Germain, Michael; Tranter, Shelley; Brown, Mark
2017-06-07
The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: ( 1 ) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and ( 2 ) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: ( 1 ) the patient was competent, ( 2 ) the consent was made voluntarily, and ( 3 ) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike. Copyright © 2017 by the
-
Furyk, Jeremy; McBain-Rigg, Kristin; Watt, Kerrianne; Emeto, Theophilus I; Franklin, Richard C; Franklin, Donna; Schibler, Andreas; Dalziel, Stuart R; Babl, Franz E; Wilson, Catherine; Phillips, Natalie; Ray, Robin
2017-01-01
Background A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency...
-
Black Boxing Restraints: The Need for Full Disclosure and Consent
Mohr, Wanda K.; Nunno, Michael A.
2011-01-01
In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…
-
Testing Consent Order for Sodium Cyanide
This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).
-
Directory of Open Access Journals (Sweden)
Marilang Marilang
2016-12-01
Full Text Available In Indonesia, children born out of wedlock only have legal relationship or family lineage relationship with their mother and mother’s family, not with their biological father and biological father’s family. This provisions of law are arranged in Article 43 paragraph (1 of Marriage Law No. 1 of 1974 which is highly influenced by Shafi’ite School of Islamic jurisprudence. Through judicial review of Aisyah (Machica Mochtar and her son named M. Iqbal Ramadhan, Constitutional Court has agreed to waive the provisions by means of the Decree Number 46/PUU-VIII/2010 with legal consideration that the concerned article contravenes the Constitution, then it creates new legal norm which states those children have legal relationship and family lineage with their mother and mother’s family and also the man who is their father. The Decree sparks controversies concerning the term ‘children born out of wedlock’ and ‘legal relationship’ in the decree. Contrary to many law experts, the article argues that the term ‘children born out of wedlock’ simply means children born from zina (adultery or fornication. Thus, ‘legal relationship’ only refer to limited relationship between both parties.
-
Bioethics and power: Informed consent procedures in post-socialist Latvia.
Putniņa, Aivita
2013-12-01
This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. Copyright © 2013 Elsevier Ltd. All rights reserved.
-
Use of altered informed consent in pragmatic clinical research.
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.
-
The consent and counselling of patients for cataract surgery: a prospective audit.
Cheung, D; Sandramouli, S
2005-09-01
The aims of ideal preoperative informed consent include educating the patient adequately to enable an autonomous decision to be made without causing undue anxiety. We study how the paternalistic and nonpaternalistic approaches meet this ideal. The influence of the new patient consent forms is also assessed. Two cycles of a prospective clinical audit are presented. An assessment of relevant patient knowledge was performed by patient interview. Visual analogue scales were used to quantify patient anxiety. The first cycle, examining a paternalistic approach, demonstrated: 37% of patients understood what a cataract was and 48% understood what surgery involved. 48% misunderstood that cataract surgery was completely risk free. In total, 80% of patients undergoing second eye surgery believed that it was completely risk-free. Average anxiety visual analogue scores (VAS) for cataract surgery were low (2.89). The second cycle, examining the nonpaternalistic approach combined with the implementation of new consent forms showed that, despite more explicit repeated preoperative consent: 39% of patients understood correctly what a cataract was, 28% understood what surgery involved and 43% misunderstood that surgery was completely risk-free. All patients undergoing second eye surgery thought that it was risk-free. The average anxiety VAS for cataract surgery were moderate (5.00). Both paternalistic and non-paternalistic approaches to informed consent are inadequate in meeting the demands of the ideal informed consent. The new patient consent forms appear to have little effect in influencing patient knowledge about their surgery. Patients undergoing second eye surgery often have an overoptimistic view of cataract surgery.
-
Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia.
Vučemilo, Luka; Borovečki, Ana
2015-01-01
High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10-19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.
-
Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia
Vučemilo, Luka; Borovečki, Ana
2015-01-01
Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183
-
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
-
Young people's views about consenting to data linkage: findings from the PEARL qualitative study.
Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John
2016-03-21
Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings
-
Directory of Open Access Journals (Sweden)
Leonardo Carnut
2016-12-01
Full Text Available To empty the right to health in the name of Reserve of the Possible Principle, lawmakers are editing the right to health in its regulations based on managerial thinking. The objective was to demonstrate this thesis through the critical analysis of the notion of performance in Decree 7508/2011, which regulates the regional health systems in the Unified Health System. The purpose was built a theoretical path to the post-positivist interpretation of this infraconstitucional dispositive. For this, we used the narrative review technique described by Rother to have sufficient theoretical framework that expose the values underlying the law text. It was possible to see that the logic had been concretized in performance incentives that contradict the systemic organization advocated for the achievement of comprehensive care in a health region. It can be concluded that the Decree has strong managerial connotation and may restrict the right to users' access to health services within their interpretation going against the canons of the theoretical foundation of Public Health.
-
Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.
Mamotte, Nicole; Wassenaar, Douglas
2017-09-01
Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.
-
Variability in the Perception of Informed Consent for IV-tPA during TeleStroke Consultation
Directory of Open Access Journals (Sweden)
Lisa Elizabeth Thomas
2012-08-01
Full Text Available OBJECTIVE: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving IV-tPA.METHODS: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by 5 raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. RESULTS: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all 5 raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k< 0.20. Similarly, the quality of the physician consent process was poor for agreement between all 5 raters (k=0.07 or between the subgroup of the 3 non-physician raters (k=-0.06 and fair between the 2 physician raters (k=0.24. The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. CONCLUSION: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.
-
Compilation status and research topics in Hokkaido University Nuclear Reaction Data Centre
International Nuclear Information System (INIS)
Aikawa, M.; Furutachi, N.; Katō, K.; Ebata, S.; Ichinkhorloo, D.; Imai, S.; Sarsembayeva, A.; Zhou, B.; Otuka, N.
2015-01-01
Nuclear reaction data are necessary and applicable for many application fields. The nuclear reaction data must be compiled into a database for convenient availability. One such database is the EXFOR database maintained by the International Network of Nuclear Reaction Data Centres (NRDC). As a member of the NRDC, the Hokkaido University Nuclear Reaction Data Centre (JCPRG) compiles charged-particle induced reaction data and contributes about 10 percent of the EXFOR database. In this paper, we show the recent compilation status and related research topics of JCPRG. (author)
-
Informed Consent Decision-Making in Deep Brain Stimulation.
Mandarelli, Gabriele; Moretti, Germana; Pasquini, Massimo; Nicolò, Giuseppe; Ferracuti, Stefano
2018-05-11
Deep brain stimulation (DBS) has proved useful for several movement disorders (Parkinson’s disease, essential tremor, dystonia), in which first and/or second line pharmacological treatments were inefficacious. Initial evidence of DBS efficacy exists for refractory obsessive-compulsive disorder, treatment-resistant major depressive disorder, and impulse control disorders. Ethical concerns have been raised about the use of an invasive surgical approach involving the central nervous system in patients with possible impairment in cognitive functioning and decision-making capacity. Most of the disorders in which DBS has been used might present with alterations in memory, attention, and executive functioning, which may have an impact on the mental capacity to give informed consent to neurosurgery. Depression, anxiety, and compulsivity are also common in DBS candidate disorders, and could also be associated with an impaired capacity to consent to treatment or clinical research. Despite these issues, there is limited empirical knowledge on the decision-making levels of these patients. The possible informed consent issues of DBS will be discussed by focusing on the specific treatable diseases.
-
Informed Consent Decision-Making in Deep Brain Stimulation
Directory of Open Access Journals (Sweden)
Gabriele Mandarelli
2018-05-01
Full Text Available Deep brain stimulation (DBS has proved useful for several movement disorders (Parkinson’s disease, essential tremor, dystonia, in which first and/or second line pharmacological treatments were inefficacious. Initial evidence of DBS efficacy exists for refractory obsessive-compulsive disorder, treatment-resistant major depressive disorder, and impulse control disorders. Ethical concerns have been raised about the use of an invasive surgical approach involving the central nervous system in patients with possible impairment in cognitive functioning and decision-making capacity. Most of the disorders in which DBS has been used might present with alterations in memory, attention, and executive functioning, which may have an impact on the mental capacity to give informed consent to neurosurgery. Depression, anxiety, and compulsivity are also common in DBS candidate disorders, and could also be associated with an impaired capacity to consent to treatment or clinical research. Despite these issues, there is limited empirical knowledge on the decision-making levels of these patients. The possible informed consent issues of DBS will be discussed by focusing on the specific treatable diseases.
-
Modified informed consent in a viral seroprevalence study in the Caribbean.
Cox, Cheryl; Macpherson, CNL
1996-07-01
An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.
-
Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.
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.
-
[Evaluation and improvement of the management of informed consent in the emergency department].
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.
-
Directory of Open Access Journals (Sweden)
Gitanjali B
2003-01-01
Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.
-
The informed consent process in randomised controlled trials: a nurse-led process.
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.
-
International Nuclear Information System (INIS)
1988-01-01
This Decree concerns the compatibility of industrial installations and equipment - both public and private - with environmental protection. The Decree entered into force on the day following its publication. It specifies the conditions for performing environmental impact assessments and the information to be provided at the planning stage of the installations involved. Those include nuclear power plants and other reactors. The Decree further provides that facilities for the final storage and disposal of radioactive waste also require an environmental impact assessment. (NEA) [fr
-
47 CFR 76.65 - Good faith and exclusive retransmission consent complaints.
2010-10-01
... 47 Telecommunication 4 2010-10-01 2010-10-01 false Good faith and exclusive retransmission consent... § 76.65 Good faith and exclusive retransmission consent complaints. (a) Duty to negotiate in good faith. Television broadcast stations and multichannel video programming distributors shall negotiate in good faith...
-
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...
-
Organ procurement: let's presume consent
Moustarah, F
1998-01-01
IN WINNING FIRST PRIZE in the Logie Medical Ethics Essay Contest in 1997, Dr. Fady Moustarah made a strong and compelling argument in favour of presumed consent in the procurement of donor organs. He stressed that a major education campaign will be needed when such a policy is adopted lest some people begin to regard physicians as "organ vultures."
-
Cardiac imaging modalities with ionizing radiation: the role of informed consent.
Paterick, Timothy E; Jan, M Fuad; Paterick, Zachary R; Tajik, A Jamil; Gerber, Thomas C
2012-06-01
Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
-
Safety, identity and consent: a limited defense of reproductive human cloning.
Lane, Robert
2006-06-01
Some opponents of reproductive human cloning have argued that, because of its experimental nature, any attempt to create a child by way of cloning would risk serious birth defects or genetic abnormalities and would therefore be immoral. Some versions of this argument appeal to the consent of the person to be conceived in this way. In particular, they assume that if an experimental reproductive technology has not yet been shown to be safe, then, before we use it, we are morally obligated to get either the actual consent or the presumed consent of the person to be conceived. In this article, I attempt to explain the appeal of such consent-based arguments as deriving from a mistaken view of personal identity. I then argue that since this view is false, such arguments are unsound. Finally, I argue that even if reproductive cloning is unsafe, it may still be morally permissible in some circumstances.
-
International Nuclear Information System (INIS)
1986-01-01
This Decree, amending Article R 233-83 of the Labour Code, applies to gamma-ray industrial radiography equipment whether mobile or fixed. It contains specific technical conditions concerning the equipment, in particular, safety devices located at the entry and exit points of the source's shield. The equipment must carry a notice mentioning''Radioactive''prepared by the constructor or the importer of the source, which explains the conditions for handling, setting-up, use and maintenance of the source, including the frequency of revisions. The Decree entered into force on 1 June 1986. (NEA) [fr
-
Energy Technology Data Exchange (ETDEWEB)
Prestes, Madelon Rocha Ribeiro [Transportadora Brasileira Gasoduto Bolivia-Brasil S.A. (TBG), Rio de Janeiro, RJ (Brazil)
2008-07-01
This work examines the question of possible of use an electronic tool through internet, the Petronect, to facilitate the completion of procedures to carry through licitations for the PETROBRAS Group that is being debated in diverse instances in the Brazilian present time. This analysis should take into account the existing law on licitations, the constitutionality of Decree 2.745/98, as well as economic facts. Due to the understanding of TCU - expressed on several occasions - in the sense that PETROBRAS would be required to use the Law 8.666/93 in its bids, is being challenged the constitutionality of Decree 2.745/98 and their use for licitations procedures. They will be examined the conceptual and legal aspects of the decree, and the relationship and the importance of the function for the Group Purchases damage. Thus, the analysis will cover the new issues raised by EC 19/98, the constitutionality of the decree, the position of the Court of Auditors of the Union and the Federal Supreme Court (STF) and the legislation published on this subject. The existing conclusion in this work shows how right - under the optical legal and constitutional - the use of the portal Petronect to carry out the licitations of PETROBRAS under Decree 2.745/98 and non-use of Law 8.666/93, for this is not appropriate to the specific activity of company. (author)
-
The patient's opinion of informed consent
International Nuclear Information System (INIS)
Pinto, I.; Paul, L.; Chimeno, P.; Fernandez, J. L.; Vigil, D.
1999-01-01
To evaluate the quality of the information provided by informed consent forms for angiography and interventional radiology on the basis of the patients opinion. A descriptive study was performed based on an anonymous survey distributed among patients who were to undergo angiography and interventional radiology, and had previously been informed and provided with the corresponding informed consent form. A descriptive and analytical statistical study was carried out to compare the responses to the questions concerning different factors (Mann-Whitney U test). Of the 182 surveys completed 75.3% corresponded to diagnostic procedures and the remaining 24.7% to therapeutic procedures. When the responses to closed-ended questions were analyzed, 90.1% of respondents considered the amount of information provided by the document to be sufficient 75.3% declared that they found the form easy to comprehend and 34.1% responded that reading it had calmed their nerves. Statistically significant differences were observed, depending on whether the form corresponded to diagnostic or therapeutic procedures, concerning the questions related to comprehension of the document and to the feeling upon reading it, with those used for diagnostic procedures obtaining better scores. There was a statistically significant difference between the responses of the patients to the question concerning their feeling upon reading the document and the responses of family members, with the patients responding more favorably than their relatives. The consent forms prepared for angiography and interventional radiology procedures are acceptable to the patients concerned with respect to both the quantity and the quality of the information. (Author) 22 refs
-
Key factors in children's competence to consent to clinical research.
Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L
2015-10-24
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 including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that
-
Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.
Lawrence, Dana J
2011-11-01
To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby