Report of the Ethics Committee, 2008

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American Psychologist, 2009

2009-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. In 2008, ethics adjudication, ethics education and consultation, convention programs, ethics publications,…

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

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Pedersen, Reidar; Akre, Victoria; Førde, Reidun

2009-10-01

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

Rebuilding a Research Ethics Committee

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Biggs, John S. G.; Marchesi, August

2013-01-01

The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

[Accreditation of Independent Ethics Committees].

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Ramiro Avilés, Miguel A

According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

[Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics].

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Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel

2008-08-01

To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

Report of the Ethics Committee, 2010

Science.gov (United States)

American Psychologist, 2011

2011-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics matters investigated and the major programs undertaken. In 2010, ethics adjudication, ethics education and consultation, and special projects were activities of the Ethics…

Report of the Ethics Committee, 2009

Science.gov (United States)

American Psychologist, 2010

2010-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. This article is a summary of the talks and workshops of 2009, ethics adjudication, ethics education and…

Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

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Russ, Hagen

2009-07-01

Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

Mock Hospital Ethics Committee: An Innovative Simulation to Teach Prelicensure Nursing Students the Complexities of Ethics in Practice.

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Hagedorn Wonder, Amy

Limited opportunities exist for prelicensure nursing students to observe the interprofessional process required to resolve complex ethical cases in practice. Therefore, a mock hospital ethics committee (MHEC) was assembled to teach the application of ethics in practice through simulation. The MHEC meeting is an example of how nursing education and practice can partner to create meaningful learning experiences.

The job of 'ethics committees'.

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Moore, Andrew; Donnelly, Andrew

2015-11-13

What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

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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

ETHICAL AND LEGAL ASPECTS OF FUNCTIONING OF ETHIC COMMITTEES IN BULGARIA

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Mariela Deliverska

2017-06-01

Full Text Available Scientific research has to be based on ethical standards that promote the protection of human rights. On a national level, the domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials in order to introduce a substantial change in a clinical trial and non-interventional study. The procedure aims to evaluate the compliance of the planned clinical trial with the norms of good clinical practice, the requirements of the Medicinal Products in Human Medicine Act. On European Union level, standards have been set down in Regulation (EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. The licensing regime that has been introduced on a national level requires the performance of documentation evaluation that addresses a major change in a clinical trial and non-interventional research. Legal definitions of the terms "principal investigator" and "coordinating investigator" have been introduced. The "principal investigator" is the medical doctor or the dentist, designated by the sponsor, who leads the overall execution of the clinical trial in accordance with the approved protocol and good clinical practice guidelines and is responsible for the researchers. The "coordinating researcher" is a researcher appointed to coordinate researchers from different centres participating in a multicentre trial. Ethic committees performing review have to provide independent advice on the extent to which a biomedical research proposal complies with recognized ethical standards. Scientific research must necessarily conform to commonly accepted scientific principles and be based on thorough knowledge of scientific literature and other relevant sources of information.

Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

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Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto

2017-07-01

The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

The Evolution of American Hospital Ethics Committees: A Systematic Review.

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Courtwright, Andrew; Jurchak, Martha

2016-01-01

During the 1970s and 1980s, legal precedent, governmental recommendations, and professional society guidelines drove the formation of hospital ethics committees (HECs). The Joint Commission on Accreditation of Health Care Organization's requirements in the early 1990s solidified the role of HECs as the primary mechanism to address ethical issues in patient care. Because external factors drove the rapid growth of HECs on an institution-by-institution basis, however, no initial consensus formed around the structure and function of these committees. There are now almost 40 years of empirical studies on the composition, administration, and activities of HECs in the United States. We conducted a systematic review of the available empirical literature on HECs to describe their evolution. As HECs changed over time, they increased their total number of members and percentage of members from nursing and the community. Although physicians increasingly chaired these committees, their presence as a percentage of overall members declined. The percentage of administrative members remained steady, although committees became increasingly likely to have at least one administrative member. HECs were also increasingly likely to report to an administrative body or to the board of trustees or directors rather than to the medical staff. Finally, consultation volume increased steadily over time. There has not, however, been a national survey of the composition of ethics committees, their administration, or volume of consultation in more than 10 years, despite increasing calls for professional standards and quality improvement assessments among HECs. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

Co-design and implementation research: challenges and solutions for ethics committees.

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Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

2015-11-16

Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with

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

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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

Ethical challenges within Veterans Administration healthcare facilities: perspectives of managers, clinicians, patients, and ethics committee chairpersons.

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Foglia, Mary Beth; Pearlman, Robert A; Bottrell, Melissa; Altemose, Jane K; Fox, Ellen

2009-04-01

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions.

Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

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Hoecht, Andreas

2011-01-01

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…

Knowledge about the research and ethics committee at Makerere ...

African Journals Online (AJOL)

Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect ...

Ethics committees in India: Facing the challenges!

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Kadam, Rashmi; Karandikar, Shashikant

2012-04-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Ethics committees in India: Facing the challenges!

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Rashmi Kadam

2012-01-01

Full Text Available The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC. The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Ethical Competence Training for Members on Clinical Ethics Committees (CEC)

DEFF Research Database (Denmark)

Knox, Jeanette Bresson Ladegaard

2017-01-01

To address the moral questions in patient care and medical practice, Danish hospitals are starting to solicit clinical ethics committees (CEC). As in other places around the world, CECs in Denmark is an interdisciplinary group that includes physicians, nurses, social workers, psychologists, lawyers...... lingering moral quandaries. Thus, the creation of CECs in Denmark has raised the question of qualifications for those who serve on a committee. When the Danish Society of Clinical Ethics was formed in 2012, it was therefore at the forefront of its agenda to establish a training program that would offer...... valuable contributions to the ethical aspect of medical decision making and to serve as an important resource for health care providers, patients and their families. This article describes the history, development and preliminary results of the current training program as well as reflects on future ideas...

Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary.

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Petrini, Carlo; Ricciardi, Walter

2017-01-01

The issue addressed in the paper published by the Italian National Bioethics Committee (NBC) entitled "Clinical ethics committees", is highly significant for many reasons. One of these is the fact that the ethics committees charged with assessing clinical trials have so much responsibility and such a heavy work-load that they have little time available for other tasks such as engaging directly with patients "at the bedside", as a result of which the role of committees responsible for assessing clinical cases is especially important. According to the NBC, the opinions of clinical ethics committees should be formulated jointly and are non-binding. The NBC offers practical proposals not only for the Italian context. While the Italian National Institute of Health (Istituto Superiore di Sanità - ISS) is not involved directly in treating patients, its role in providing guidance is crucial to the national health service and it has always paid special attention to these issues.

Bridging problems and models in medical ethics: four images of local ethics committees.

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Incorvati, G

In the context of the continuing debate about how ethics committees in Italy should be structured (see Bulletin 160) Professor Incorvati, from the Comitato Nazionale per la Bioetica in Rome, considers four theoretical models of how such committees may be arranged, and why one in particular looks better placed to face the growing ethical problems that are emerging as a result of current developments in medicine.

Human Research Ethics Committees in Technical Universities

NARCIS (Netherlands)

Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.

2014-01-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although

A cross-sectional survey to investigate community understanding of medical research ethics committees.

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Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C

2015-07-01

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.

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Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

2015-01-01

The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

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Bouësseau Marie-Charlotte

2008-03-01

Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of

Do ethics committees need a legal framework?

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Byk, Christian

2007-01-01

The question "do ethics committees need a legal framework" may then raise fundamental discussion in the case of developing countries: will an ethical framework bring them a better capacity to assume their task? And what should this task be if we consider the particularities of clinical research conducted in developing countries?

Can non-regulators audit Independent Ethic Committees (IEC), and if so, how?

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Dent, N J; Sweatman, W J

A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical Practice (EFGCP). Auditing requirements in these recent guidelines and the EU Clinical Trial Directive are discussed as well as the methodology and type of documentation and SOPs that should be present at an audit. It is argued that both inspectorates and independent auditors need to conduct such audits to improve the overall global standard.

Qualitative analysis of healthcare professionals' viewpoints on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas.

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Marcus, Brian S; Shank, Gary; Carlson, Jestin N; Venkat, Arvind

2015-03-01

Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

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Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Novel Paths to Relevance: How Clinical Ethics Committees Promote Ethical Reflection.

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Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

How may clinical ethics committees (CECs) inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics.

Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

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de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.

2012-01-01

Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We

Committees for Ethics in Research involving human subjects.

Science.gov (United States)

Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

2008-01-01

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

Science.gov (United States)

Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

2011-09-01

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

An ethics for the living world: operation methods of Animal Ethics Committees in Italy

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Mariano Martini

2015-09-01

Full Text Available INTRODUCTION AND OBJECTIVES. Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific purposes", the Authors would like to analyse the topic of the introduction of ethical committees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU. RESULTS AND DISCUSSION. The implementation of the recent Italian law (Decreto Legislativo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protection of animals used for scientific purposes leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Italian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects. CONCLUSIONS. What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26. This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

Science.gov (United States)

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

A "next generation" ethics committee. St. Joseph Health system has integrated performance-improvement features into its ethics work.

Science.gov (United States)

Murphy, Kevin

2006-01-01

Understanding the limitations that accompany the traditional model of ethics committees, St. Joseph Health System (SJHS), Orange, CA, has been working to integrate ethics expertise and quality-improvement methodology into its "Next Generation Model" (NG Model) for such committees. However, moving from a traditional structure to the NG Model (introduced to SJHS facilities in 1999) brought some challenges, not the least of which was a deep-rooted culture of resistance to change. Following a 2004 audit of how the NG model was working, some common challenges were identified. To deal with those challenges, SJHS developed some tools and techniques that have helped ease the ongoing transition. These tools have helped the system's ethics committees address such issues as collaboration for the sake of organizational integration, setting goals, and measuring performance of various ethics roles.

Ethical assessment of research protocols: the experience of the Research Ethics Committee of the Hospital Israelita Albert Einstein (HIAE

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Sonia Maria Oliveira de Barros

2005-03-01

Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.

78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-08-08

...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...

Stating the Case for Nursing Research Ethics Committees: A Discussion Paper.

Science.gov (United States)

Mitchell, Theresa; Fletcher, Ian

1998-01-01

Nurse-led research ethics committees are generally more tolerant of diversity in research proposals than are medical committees steeped in empirical traditions. However, national trends in nursing in Britain may influence a preference for multidisciplinary over nurse-led committees. (SK)

Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

NARCIS (Netherlands)

Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

2006-01-01

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the

EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

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Oberbichler, S; Hackl, W O; Hörbst, A

2017-10-18

Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the

Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

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Gorman, Susanna M

2011-09-01

Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

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Begum, Rasheda; Kolstoe, Simon

2015-07-25

Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

Publication Ethics: A Case Series with Recommendations According to Committee on Publication Ethics (COPE).

Science.gov (United States)

Fazly Bazzaz, Bibi Seddigheh; Sadeghi, Ramin

2012-09-01

Ethical misconduct is not a new issue in the history of science and literature. However, ethical misconducts in science have grown considerably in the modern era which is due to emphasis on the scientific proliferation in research institutes and gauging scientists according to their publications. In the current case series, several misconducts occurring over the previous years in Mashhad University of Medical Sciences (Mashhad, Iran) either for Journals or Faculty members were gathered and specific recommendations were provided to avoid similar events in the future. All recommendations are according to Committee on Publication Ethics (COPE).

AWARENESS OF MEDICAL SPECIALISTS AND PATIENTS IN BULGARIA OF ETHICS COMMITTEES AND THE BENEFITS OF THEIR WORK

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Neli Gradinarova

2018-02-01

Full Text Available In today’s healthcare, the role of morality emerges to the forefront as a result of the high degree of uncertainty in our modern environment. Ethically responsible behaviour is therefore perceived as a prerequisite for preventing and counteracting a number of moral risks in society. With regard to moral hazard and responsibility, ethical codes represent a rational control mechanism, lowering the extent of the probability of moral peril. Ethics committees are also founded based on such ethical codes, the purpose of such committees being the proclamation and observation of the principles and norms set forth. At the healthcare institutions of the Republic of Bulgaria, ethics committees are established that are based on the principles of medical ethics and medical law. The significance with which ethics committees are charged regarding the sustainable development of the healthcare system consists of protecting the patients, the medical professionals and the institution itself. Awareness of the significance, functions and benefits of ethics committees and their impact on the medical practice and patients in Bulgaria is, however, insufficiently low. In a questionnaire survey conducted among 149 medical specialists employed at three medical establishments for hospital care in the country, and 269 patients under treatment at them, at being asked “Do you think that ethics committees contribute to protecting and respecting patients’ rights?”, 26.2% of the respondents among the medical professionals replied that they are not sure, while 25.7% of did not provide an answer to the question thus asked due to being unfamiliar with ethics committees as an institutionalized body and their functions. The analysis of the results of the abovementioned survey among medical professionals and patients evidences a low level of awareness of the ethics committees and their work on the territory of the Republic of Bulgaria. It is essential for healthcare

Research Award: Advisory Committee on Research Ethics Deadline ...

International Development Research Centre (IDRC) Digital Library (Canada)

Jean-Claude Dumais

2012-09-12

Sep 12, 2012 ... Research Award: Advisory Committee on Research Ethics. Deadline: ... The Research Awardee will spend one year at IDRC and work approximately 50% of the time on her/his own research and 50% on ACRE-related tasks.

South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

Science.gov (United States)

Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

Science.gov (United States)

Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew

2017-06-28

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster

Ethics committees in Italy--a time for change?

Science.gov (United States)

Wray, E

2000-01-01

The Comitato Nazionale per la Bioetica (CNB) in Italy has recently produced an unprecedented discussion document on the state of ethics committees in Italy, with an invitation to interested parties to comment on proposed changes to their fundamental structure. After this consultation, and taking note of relevant official publications and the most recent national and international literature on the subject, the CNB proposes to produce a final, definitive document that will consider options for the future development of such committees.

The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

Science.gov (United States)

Strech, Daniel; Hurst, Samia; Danis, Marion

2013-01-01

Background Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Results Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. Conclusion This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindvidual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures. PMID:20706163

Payment of research participants: current practice and policies of Irish research ethics committees.

LENUS (Irish Health Repository)

Roche, Eric

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.

Ethics in research

International Nuclear Information System (INIS)

Grass, Guido

2014-01-01

Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.

Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.

Science.gov (United States)

Kubar, Olga

2005-01-01

The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.

Doing the right thing! A model for building a successful hospital-based ethics committee in Nunavut

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Madeleine Cole

2013-08-01

Full Text Available Background. There exists a need throughout the North to increase capacity to address issues of health ethics and for community members to better understand and share their perspectives on this topic. Ethics comes down to weighing rights and wrongs, evaluating differing needs and understandings, acknowledging the many shades of grey and doing our best to come up with the just, fair and moral approach to the question at hand. Northern regions must collaborate to share capacity, successes and experiences in order to meet the unique needs of northern health care institutions and move forward on this issue. While guidelines for ethical research with indigenous populations exist, little has been published about an Inuit approach to health ethics more broadly. Design . To fill a critical need and to meet accreditation standards, the Qikiqtani General Hospital (QGH in Iqaluit, Nunavut, Canada, is in the process of building an Ethics Committee. Capitalizing on partnerships with other bodies both in northern and southern Canada has proved an efficient and effective way to develop local solutions to challenges that have been experienced both at QGH and other jurisdictions. Methods . The Ottawa Hospital Ethics Office and the active ethics committee at Stanton General Hospital in Yellowknife, NT, contributed expertise and experience, and helped provide some direction for the QGH ethics committee. At the local level, based on our shared commitment to health care ethics, the Qaujigiartiit Health Research Centre is an invaluable partner whose parallel efforts to develop a northern Health Research Ethics Board (REB gives great synergy to the QGH Ethics Committee. Results . Passion and commitment, as well as administrative support and endorsement from health care leaders, are the aspects of successful initiatives that we have identified to date. Using the information from both the experiences of other partners, as well as information gathered at a retreat held in

Retrospective research: What are the ethical and legal requirements?

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Junod, V; Elger, B

2010-07-25

Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.

Research governance: new hope for ethics committees?

Science.gov (United States)

Frew, Deborah; Martlew, Ainsley

2007-01-01

For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.

Evaluation of the work of hospital districts' research ethics committees in Finland.

Science.gov (United States)

Halila, Ritva

2014-12-01

The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PROFESSIONAL CODES OF CONDUCT IN PSYCHOLOGY: DESCRIPTIVE STUDY OF COMPLAINTS REVIEWED BY THE COPC ETHICS COMMITTEE

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Mila Arch

2013-09-01

Full Text Available In recent decades a significant increase has been observed in the number of complaints filed with ethical committees. The possibility of being the subject of a complaint is therefore a growing concern for professionals. However, research on ethics and codes of conduct in psychology is still very limited and real data on the complaints filed with Ethics Committees against psychologists are practically nonexistent. This article describes the results of a descriptive analysis of the complaints reviewed by the COPC Ethics Committee from 1998 to 2011. A total of 324 complaints were filed, but only 20% led to opening disciplinary proceedings, the judicial context being the professional area in which the highest percentage of complaints were filed (85%. Among the most prevalent reasons for complaints were making assessments without prior examination and partiality.

A Hospital-Based Committee of Moral Philosophy to Revive Ethics.

Science.gov (United States)

Illy, Margaux; Le Coz, Pierre; Mege, Jean-Louis

2017-08-15

The Méditerranée Infection Foundation's primary goal is supporting a research hospital for the treatment of infectious diseases in Marseille. The main objective of this innovative center is to understand the mechanisms of contagion and face them. The Foundation will include a committee on moral philosophy that will accompany and supervise biomedical research. This is not a conventional ethics committee, frequently giving rise to a board's bureaucratic excesses, which might slow down creative biomedical clinical research without necessarily restricting abuses. Moral philosophy, however, can handle contemporary biomedical issues. In all its diversity, this discipline is able to enrich the debate on medical issues, thanks to many philosophical currents such as deontological ethics and consequentialism. The purpose of this committee is therefore to advance reflection on the bioethical issues encountered in biomedical research in infectious diseases, while respecting the precepts of moral philosophy. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

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Matthew Hunt

Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be

Evaluation in health promotion: thoughts from inside a human research ethics committee.

Science.gov (United States)

Allen, Judy; Flack, Felicity

2015-12-01

Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.

Science.gov (United States)

Adams, Pornpimon; Prakobtham, Sukanya; Limphattharacharoen, Chanthima; Vutikes, Pitchapa; Khusmith, Srisin; Pengsaa, Krisana; Wilairatana, Polrat; Kaewkungwal, Jaranit

2015-09-14

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand. Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members' reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk-benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population. All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not

Early Childhood Special Educators and the Hospital Ethics Committee.

Science.gov (United States)

Lowenthal, Barbara

1989-01-01

The paper discusses issues of concern to early childhood special educators serving on hospital ethics committees to assist families with seriously ill and handicapped infants in neonatal intensive care units. Issues include infant euthanasia and the right to life, child abuse legislation, and possible effects on families. (Author/JDD)

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

Science.gov (United States)

Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F

2017-06-26

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to

Members of research ethics committees accepted a modification of the randomized consent design

NARCIS (Netherlands)

Schellings, Ron; Kessels, Alfons G.; ter Riet, Gerben; Kleijnen, Jos; Leffers, Pieter; Knottnerus, J. André; Sturmans, Ferd

2005-01-01

Background and Objective: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what

Why to audit to research ethics committees?

OpenAIRE

Quiroz, Estela; Médica oftalmóloga, docente de ética y metodología de la investigación, Coordinadora de la Red Peruana de Comités de Ética de la Investigación. Hospital Nacional Hipólito Unanue. Lima, Perú.

2010-01-01

Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created. Los comités de ét...

Why should ethics approval be required prior to publication of health promotion research?

Science.gov (United States)

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment.

Science.gov (United States)

Marcus, Brian S; Carlson, Jestin N; Hegde, Gajanan G; Shang, Jennifer; Venkat, Arvind

2016-03-01

We sought to evaluate whether health care professionals' viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108-tertiary care center, 92-large community hospitals, 40-small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.

Italian ethical committee intervention in a case of embryo-fetal medicine.

Science.gov (United States)

Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane

2011-06-01

Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

Science.gov (United States)

Smith, T; Moore, E J; Tunstall-Pedoe, H

1997-05-31

To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

77 FR 34046 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2012-06-08

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs... ethics standards to the accreditation process for public health departments; ethical considerations...

Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

Science.gov (United States)

Yanar, Zeynep M; Fazli, Mehria; Rahman, Jahanara; Farthing, Rys

2016-04-01

Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines. © The Author(s) 2016.

77 FR 58397 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

Science.gov (United States)

2012-09-20

... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. Matters To Be Discussed: Agenda items will include the following topics: Ethical considerations...

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

Science.gov (United States)

De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

2016-01-01

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

Directory of Open Access Journals (Sweden)

Elisabeth De Smit

2016-02-01

Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently

Ethics in research; Ethik in der Forschung

Energy Technology Data Exchange (ETDEWEB)

Grass, Guido [Koeln Univ. (Germany). Ethik-Kommission der Medizinischen Fakultaet

2014-07-01

Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.

An evaluation of a data linkage training workshop for research ethics committees.

Science.gov (United States)

Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A

2015-03-04

In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

75 FR 30409 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

Science.gov (United States)

2010-06-01

... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In... to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... address public health ethics issues and coordination of these efforts with the CDC Office of State, Tribal...

13 CFR 120.851 - CDC ethical requirements.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false CDC ethical requirements. 120.851... Company Loan Program (504) Other Cdc Requirements § 120.851 CDC ethical requirements. CDCs and their Associates must act ethically and exhibit good character. They must meet all of the ethical requirements of...

76 FR 29755 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-05-23

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... of public health ethics questions and issues arising from programs, scientists and practitioners... April 28, 2011, ACD, CDC meeting; discussion of next steps on addressing potential public health ethical...

77 FR 2549 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2012-01-18

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and... territorial health departments in their efforts to address public health ethics challenges, approaches for...

75 FR 57044 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2010-09-17

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and...; efforts to support state, tribal, local and territorial health departments address ethical issues in the...

76 FR 3909 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-01-21

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and... submitted on the ethical considerations document for the allocation of ventilators during a severe pandemic...

The Virtues of National Ethics Committees.

Science.gov (United States)

Montgomery, Jonathan

2017-05-01

The United Kingdom has many bodies that play their part in carrying out the work of national ethics committees, but its nearest equivalent of a U.S. presidential bioethics commission is the Nuffield Council on Bioethics, established in 1991. The Council is charged with examining ethical questions raised by developments in biological and medical research, publishing reports, and making representations to appropriate bodies in order to respond to or anticipate public concern. It is a nongovernment organization with no defined or guaranteed channels of influence. It has no authority merely by virtue of the position it holds. Rather, it has established relational authority based on its reputation. Unlike the U.S. bioethics commission, it is not part of executive government, nor is it constituted to contribute to the legislative branch, as does the French Comité Consultatif National d'Ethique. Its nongovernmental status notwithstanding, the Nuffield Council's work affects the U.K. government and the British public, and the Council has achieved international recognition for its reports. I was the chairperson from 2012 to 2017 and draw on my experience in this piece to consider three key audiences: governments, publics, and the international community. © 2017 The Hastings Center.

76 FR 55678 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-09-08

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues... in their efforts to address public health ethics challenges. The agenda is subject to change as...

Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

OpenAIRE

Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

2018-01-01

Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

Young people's views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study.

Science.gov (United States)

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-09-02

Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which 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. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance

75 FR 72831 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2010-11-26

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... strategy for addressing its charge to provide a preliminary overview to the ACD on ethical issues related...

Human somatic cell nuclear transfer and reproductive cloning: an Ethics Committee opinion.

Science.gov (United States)

2016-04-01

This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804-7. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Navigating the Process of Ethical Approval: A methodological note

Directory of Open Access Journals (Sweden)

Eileen Carey, RNID, BSc. (hons, MSc.

2010-12-01

Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

Ethics Requirement Score: new tool for evaluating ethics in publications

Science.gov (United States)

dos Santos, Lígia Gabrielle; Fonseca, Ana Carolina da Costa e; Bica, Claudia Giuliano

2014-01-01

Objective To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Methods Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author’s guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. Result The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Conclusion Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal. PMID:25628189

Ethics Requirement Score: new tool for evaluating ethics in publications.

Science.gov (United States)

Santos, Lígia Gabrielle dos; Costa e Fonseca, Ana Carolina da; Bica, Claudia Giuliano

2014-01-01

To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author's guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal.

75 FR 4830 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

Science.gov (United States)

2010-01-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES..., CDC, regarding a broad range of public health ethics questions and issues arising from programs...

A 'good' ethical review: audit and professionalism in research ethics

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2015-01-01

How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....

Impact of three years training on operations capacities of research ethics committees in Nigeria.

Science.gov (United States)

Folayan, Morenike Oluwatoyin; Adaranijo, Aisha; Durueke, Florita; Ajuwon, Ademola; Adejumo, Adebayo; Ezechi, Oliver; Oyedeji, Kola; Akanni, Olayide

2014-04-01

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants' knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. © 2012 John Wiley & Sons Ltd.

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

Science.gov (United States)

Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

2014-12-01

Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

Reporting ethics committee approval in public administration research.

Science.gov (United States)

Jordan, Sara R; Gray, Phillip W

2014-03-01

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

Nurses serving on clinical ethics committees: A qualitative exploration of a competency profile

NARCIS (Netherlands)

dr. Bart Cusveller

2014-01-01

The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two

International Perspectives of Ethical Approval: The New Zealand scene

Directory of Open Access Journals (Sweden)

Antoinette McCallin Ph.D.

2010-12-01

Full Text Available The paper “Navigating the process of ethical approval” (Carey, 2010 raises many issues about the influence Institutional Ethics Committees have on research methodology and what can or cannot take place in research. Carey draws attention to the ethical challenges classic grounded theory researchers face when an ethical proposal that follows the principles of the methodology is presented to an Ethics Committee, whose main responsibility is the protection of participants. Ethics committees not only guide researchers on acceptable ethical practice, but are charged with monitoring ethical standards and ensuring researchers act in accordance with professional expectations for researchers within the jurisdiction. These committees aim to ensure consistency of ethical practice in research. While there is generally some flexibility in the review process researchers often find ethical requirements constraining, as guidelines are primarily prescriptive and are designed to ensure consistency in the application of universal ethical principles in research. In New Zealand, consistency includes paying attention to broader socio-cultural responsibilities to society that includes promoting awareness of the Code of Health and Disability Services Consumer Rights 1996, the Health Information Privacy Code 1994, and promoting ethical practices which involve Maori (the local indigenous people in research proposals as much as possible (Ministry of Health, 2006. So while researchers in training assume that their prime interest concerns the management of a research topic and methodology, they quickly find out that ethical guidelines influence research design. Even though there is an international code of ethics (Universal Declaration of Human Rights, 2005 that defines ethical standards for researchers around the world, each country has its own specific requirements depending on the context. In this paper, ethical drivers in the New Zealand context are outlined and

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

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Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

2017-01-01

Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

Under the shelter of ethics.

Science.gov (United States)

Lichterman, Boleslav L

2005-01-01

Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

Consensus, contracts, and committees.

Science.gov (United States)

Moreno, J D

1991-08-01

Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this level of analysis than about the ethics committee phenomenon itself.

The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

Directory of Open Access Journals (Sweden)

Caroline A. Smith

2011-01-01

Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.

[Presumptive organ donations for transplants agreement of the Ethics Committee of the University of Chile Medical School].

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Roa, A; Rosselot, E

1995-04-01

The ethics committee of the Faculty of Medicine, University of Chile was consulted about the ethical aspects of presumptive organ donation for transplantation. After analyzing the problem, the committee concluded that every human being has the right to make use of his organs freely, voluntarily and according to his own discernment. The society has no right to make obligatory this donation, even after death. The foundations of this agreement were laid in a series of reasons. In fact, the corpse is not a juridical but a ethical asset and deserves respect for whom it was. It cannot be commercialized and is the only non-religious object susceptible of profanation. It is also object of popular affective and religious manifestations. Beliefs and affects must be respected. Organ donation is an act of charity and cannot be compulsory. The organ donation consent must be explicit, voluntary and solemn.

A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

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Chenneville, Tiffany; Menezes, Lynette; Kosambiya, Jayendrakumar; Baxi, Rajendra

2016-12-01

Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion.

Science.gov (United States)

2016-10-01

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6). Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

13 CFR 120.140 - What ethical requirements apply to participants?

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false What ethical requirements apply to... LOANS Policies Applying to All Business Loans Ethical Requirements § 120.140 What ethical requirements... “Participants”), must act ethically and exhibit good character. Ethical indiscretion of an Associate of a...

Payment of research participants: current practice and policies of Irish research ethics committees.

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Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

Health Research Ethics Committees in South Africa 12 years into democracy

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Myer Landon

2007-01-01

Full Text Available Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56% are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

"The Project Cannot Be Approved in Its Current Form": Feminist Visual Research Meets the Human Research Ethics Committee

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Pitt, Penelope

2014-01-01

This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…

Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

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Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

2018-01-11

Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

Ethical issues in using data from quality management programs.

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Nerenz, David R

2009-08-01

Since the advent of formal, data-driven quality improvement programs in health care in the late 1980s and early 1990s, there are have been questions raised about requirements for ethical committee review of quality improvement activities. A form of consensus emerged through a series of articles published between 1996 and 2007, but there is still significant variation among ethics review committees and individual project leaders in applying broad policies on requirements for committee review and/or written informed consent by participants. Recent developments in quality management, particularly the creation and use of multi-site disease registries, have raised new questions about requirements for review and consent, since the activities often have simultaneous research and quality improvement goals. This article discusses ways in which policies designed for local quality improvement projects and data bases may be adapted to apply to multi-site registries and research projects related to them.

A role for research ethics committees in exchanges of human biospecimens through material transfer agreements.

Science.gov (United States)

Chalmers, Donald; Nicol, Dianne; Nicolás, Pilar; Zeps, Nikolajs

2014-09-01

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.

Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

Science.gov (United States)

2014-01-01

Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

[Ethical issue in animal experimentation].

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Parodi, André-Laurent

2009-11-01

In the 1970s, under pressure from certain sections of society and thanks to initiatives by several scientific research teams, committees charged with improving the conditions of laboratory animals started to be created, first in the United States and subsequently in Europe. This led to the development of an ethical approach to animal experimentation, taking into account new scientific advances. In addition to the legislation designed to provide a legal framework for animal experimentation and to avoid abuses, this ethical approach, based on the concept that animals are sentient beings, encourages greater respect of laboratory animals and the implementation of measures designed to reduce their suffering. Now, all animal experiments must first receive ethical approval--from in-house committees in the private sector and from regional committees for public institutions. Very recently, under the impetus of the French ministries of research and agriculture, the National committee for ethical animal experimentation published a national ethical charter on animal experimentation, setting the basis for responsible use of animals for scientific research and providing guidelines for the composition and functioning of ethics committees. Inspired by the scientific community itself this ethical standardization should help to assuage--but not eliminate--the reticence and hostility expressed by several sections of society.

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

Directory of Open Access Journals (Sweden)

Siriwardhana Chesmal

2008-02-01

Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

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Dainesi, Sonia Mansoldo; Goldbaum, Moisés

2012-12-01

The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

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Langat, Simon K

2005-10-01

There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

[Disability, inability and vulnerability: on ableism or the pre-eminence of ableist and biomedical approaches of the Human Subjects Ethics Committee of UFSC].

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Mello, Anahi Guedes de

2016-10-01

Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis. In this ethnographic experience, in the light of Crip theory, I observed how the "disability," "vulnerability" and "inability" categories are articulated to reveal the ableism and the primacy of the biomedical model in the case of an ethics review at UFSC regarding the participation and legal capacity of persons with disabilities as subjects of research.

The end of the nuclear power generation. On the recommendations of the ethics committee according to the 13th amendment to the Atomic Energy Act

International Nuclear Information System (INIS)

Becker, Peter

2011-01-01

With the 13th Amendment to the Atomic Energy Act the nuclear consequences of the earthquake disaster in Japan will result in an end to nuclear power generation in Germany. Here, the legislature resorted to unusual methods. For the first time, the legislature received advices from the ''ethics committee reliable energy supply''. This Ethics Commission adopted its recommendations ''on behalf of the Chancellor'' in the period from 4th April to 28th May, 2011. The understanding of this development, its epochal character and speed of decision-making requires an excursion into the economic history and the establishment of nuclear power generation with their legal protection.

Ethics review in compassionate use.

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Borysowski, Jan; Ehni, Hans-Jörg; Górski, Andrzej

2017-07-24

Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.

Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

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Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

2015-05-08

UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

75 FR 7483 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

Science.gov (United States)

2010-02-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES); Correction AGENCY: Centers for Disease Control and Prevention (CDC), HHS. ACTION: Notice of meeting; meeting...

A Study on the Directed Living Non-Related Donor Kidney Transplantation Submitted to the Hospital Transplant Ethics Committee at the National Kidney and Transplant Institute.

Science.gov (United States)

Suguitan, G; Arakama, M-H I; Danguilan, R

2017-03-01

In the latter part of 2009, the Department of Health of the Philippines prohibited kidney transplantation with non-related kidney donors. Hence, the National Kidney and Transplant Institute created a Hospital Transplant Ethics Committee. This study describes directed non-related kidney donation at the National Kidney and Transplant Institute. This retrospective study reviewed the profiles of recipients and directed living non-related kidney transplant donors submitted to the Hospital Transplant Ethics Committee. A total 74 recipients and donors were reviewed by the Hospital Transplant Ethics Committee in 2014. Donors initiated the talks about being a donor (75%) to repay the good deeds that were done by the recipient for them or their families; examples of which are: sometime in their lives they needed financial assistance for hospitalization for their relatives and it was the patient who paid the hospital bill; or because they pitied the recipient, whom they found to be a good person, thus they would want to give one of their kidneys. Seventy-four (100%) said that they were not expecting anything in return for this act but wanted to be of help to the recipient. Of these 74 cases, 70 cases (95%) were approved and the others were disapproved. With a Hospital Transplant Ethics Committee in place, directed kidney donation is a valuable tool as an additional source of kidney donor without violating any ethical issues. Copyright © 2016. Published by Elsevier Inc.

From "a Fair Game" to "a Form of Covert Research": Research Ethics Committee Members' Differing Notions of Consent and Potential Risk to Participants Within Social Media Research.

Science.gov (United States)

Hibbin, R A; Samuel, G; Derrick, G E

2018-04-01

Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.

76 FR 57744 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-09-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES) Correction: This notice was published in the Federal Register on September 8, 2011, Volume 76, Number 174...

A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

Science.gov (United States)

Hedgecoe, Adam

2014-02-01

Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

Czech Academy of Sciences Publication Activity Database

Altavilla, A.; Giaquinto, C.; Giocanti, D.; Manfredi, C.; Aboulker, J.-P.; Bartoloni, F.; Cattani, E.; Giudice, M. L.; Mellado Peňa, M.J.; Nagler, R.; Peterson, C.; Vajnerová, Olga; Bonifazi, F.; Ceci, A.

2009-01-01

Roč. 11, 1-2 (2009), s. 79-87 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : ethic committees * clinical trials * pediatrics Subject RIV: FP - Other Medical Disciplines

Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

Science.gov (United States)

Greeff, Minrie; Rennie, Stuart

2016-04-01

Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

Activities of an ethics consultation service in a Tertiary Military Medical Center.

Science.gov (United States)

Waisel, D B; Vanscoy, S E; Tice, L H; Bulger, K L; Schmelz, J O; Perucca, P J

2000-07-01

The Joint Commission on Accreditation of Healthcare Organizations requires hospitals to have a mechanism to address issues of medical ethics. Most hospitals, especially those in the military, have an ethics committee composed solely of members who serve as an additional duty. To enhance the ethics consultation service, the 59th Medical Wing created a position under the chief of the medical staff for a full-time, fellowship-trained, medical ethicist. After establishment of this position, the number of consultations increased, a systematic program for caregiver education was developed and delivered, and an organizational presence was achieved by instituting positions on the institutional review board, the executive committee of the medical staff, and the credentials committee. Issues in medical care are becoming increasingly complicated, due in large part to financial stresses and technological advancements. Ethics consultation can help prevent and resolve many of these problems. This report discusses the activities of the first year of a full-time ethicist in a tertiary military medical center.

Do committees ru(i)n the bio-political culture? On the democratic legitimacy of bioethics committees.

Science.gov (United States)

Friele, Minou Bernadette

2003-08-01

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.

78 FR 15682 - Notice of Public Meeting of the Texas Advisory Committee

Science.gov (United States)

2013-03-12

..., TX 77027. The purpose of the meeting is for the Committee to receive orientation and ethic training and plan future activities. Orientation and ethics training is the first item on the agenda. After... Office at (213) 894- 3437. Hearing-impaired persons who will attend the meeting and require the services...

[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

Science.gov (United States)

de Lecuona, Itziar

2013-01-01

The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in

Perspectives of Egyptian research ethics committees regarding their effective functioning.

Science.gov (United States)

Matar, Amal; Silverman, Henry

2013-02-01

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

[Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].

Science.gov (United States)

Jeong, Ihn Sook

2015-06-01

This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

Ethical Delphi Manual

NARCIS (Netherlands)

Millar, K.; Tomkins, S.; Thorstensen, E.; Mepham, B.; Kaiser, M.

2006-01-01

An ethical Delphi is an iterative participatory process between experts for exchanging views and arguments on ethical issues. The method is structured around the notion of a virtual committee where the exchange of ideas is conducted remotely through a series of opinion exchanges. The ethical Delphi

Unintended consequences of human research ethics committees: au revoir workplace studies?

Science.gov (United States)

Bamber, Greg J; Sappey, Jennifer

2007-07-01

To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) are in conflict with an important stream of industrial sociological research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a 'good news story' guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences.

Legal and medical aspects of the ethics committee’s work relating to abortion

Directory of Open Access Journals (Sweden)

Ponjavić Zoran

2011-01-01

Full Text Available This paper analyses the legal and medical aspects of the work of ethics committees on abortion. According to the legislation of the Republic of Serbia, these committees are competent to determine justifiable terms for abortion after the twentieth week of the fetus. It is well known that abortion is not only a medical but a legal, ethic, social and demographic problem as well. A liberal solution in view of abortion in the first trimester has been accepted in most European countries, as by the legislature of the Republic of Serbia. Since prenatal diagnosis cannot always determine the fetus state with certainty but at times may do so at a later stage, abortion is then required when the child is already capable of extrauterine life. The necessity for performing abortion in the third trimester is thus a result of good knowledge of techno-medicine but also from the limited information it provides. In such situations, the physician needs confirmation and justification of his standpoint with respect to abortion through a legal formulation which should contain "minimum moral". Society has found a way to protect and help him through moral and ethic forms of prevention without anybody’s emotions being affected. Ethics committees should thus help the physician in view of determining the terms for performing late abortion, since the rules of doctor’s ethics are not sufficient in this case. The article especially analyses the work of the Ethics Committee of the Clinical Center in Kragujevac in the period 2000-2010. It is stated that the largest number of cases referred to determined diseases or fetus anomalies while only a negligible number (11.29% to the illness of the mother. There were no requests for abortions due to legal reasons (pregnancies from criminal offences. A significant number (40.28% of requests submitted to the Ethics Committee related to pregnancies under the 24th week of pregnancy. Since a pregnancy of 24 weeks represents a boundary

Four Roles of Ethical Theory in Clinical Ethics Consultation.

Science.gov (United States)

Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout.

Nurses' knowledge, attitudes and willingness to participate officially in workplace Healthcare Ethics Committees (HEC).

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Rubinstein, Dorit; Tabak, Nili

2012-03-01

This research was designed to assess nurses' perceptions, knowledge, attitudes and intentions in relation to nurse participation in Healthcare Ethics Committees (HECs). A convenience sample of 87 nurses from five Israeli hospitals completed a self-administered questionnaire, whose data were then analyzed by quantitative statistics. The main findings were that large percentages of nurses were totally ignorant of the existence and functioning of the HEC in their workplaces. Nurses in managerial roles were (a) much more knowledgeable on these matters than staff nurses and (b) regarded more positively the idea that nurses had an obligation to sit on such committees. Workplace role and rank in the organizational hierarchy had a stronger impact on nurse attitudes to HEC work than level of education. Overall, nurse willingness to sit on an HEC and to take special training in preparation for such a role were high.

Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

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Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R

2014-12-01

The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.

The Ethics and Politics of Ethics Approval

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Battin, Tim; Riley, Dan; Avery, Alan

2014-01-01

The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

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Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training

Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

Science.gov (United States)

Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri

2015-12-02

The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals

[Continuing education in ethics: from clinical ethics to institutional ethics].

Science.gov (United States)

Brazeau-Lamontagne, Lucie

2012-01-01

The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

Ethnographic Intimacy: Thinking Through the Ethics of Social Research in Sex Worlds

OpenAIRE

Maria Pérez-y-Pérez; Tony Stanley

2011-01-01

Ethnographic researchers entering sensitive fields of research become entangled in ethical dilemmas when they encounter 'sticky' questions, situations and issues. In undertaking research within two distinct sex worlds: female sex work and male sexual negotiation/risk and HIV, we struggled to manage the contingent links between our relationships with the people who inhabit these worlds, the ethical requirements of our institutional ethics committees, and our hybrid selves. In the context of 'd...

One step forward, two steps back – requiring ministerial approval for ...

African Journals Online (AJOL)

It will require that low-risk research without direct benefits, which might be adequately reviewed by an accredited research ethics committee (REC), must also be reviewed by the Minister. As it currently stands this requirement serves no plausible ethical purpose, will cause delays and discourage essential research on the ...

Closing unprofitable services: ethical issues and management responses.

Science.gov (United States)

Summers, James W

1985-01-01

Closing unprofitable services often requires as much analysis, public relations, marketing, and planning as any expansion. Further, issues about ethics, indigents, and the hospital mission force the consideration of values explicitly if a marketing fiasco is to be avoided. By integrating values analysis with more traditional management tasks, the challenges of service closure can be converted into opportunities to demonstrate how your institution has met or exceeded its ethical obligations. A case involving OB is developed to show how ethical and management issues blend into one another. Specific strategies for consensus building and marketing of the legitimacy of the hospital's position are given. Institutional ethics committees are one primary mechanism for developing a plan to benefit from unpleasant decisions.

Ethics issues in security hospitals.

Science.gov (United States)

Weinstein, Henry C

2002-01-01

The term 'security hospital' is used for a variety of facilities including forensic hospitals and prison hospitals, which, because of their mission, the nature of their work, and the populations they serve-or because of the authority under which they operate-place the staff at considerable risk of ethical violations related to either clinical care or to forensic activities. The problem of divided loyalties is of special concern in security hospitals. Ethics principles particularly at risk are confidentiality and informed consent. Where there are cultural disparities between the staff and the patients, differences in background, socioeconomic class, education, and other types of diversity, cultural awareness is required and must be reflected in appropriate treatment and evaluation. To counteract the risks of ethical violations, a security hospital should create an ethical climate and develop means to anticipate, prevent, and deal with ethical violations. These might include detailed and specific policies and procedures, programs of orientation, education, consultation, and liaison as well as its own ethics committee. Copyright 2002 John Wiley & Sons, Ltd.

Exploring perceptions and experiences of Bolivian health researchers with research ethics.

Science.gov (United States)

Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S

2015-04-01

In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.

Council Adopts New AERA Code of Ethics: Ethics Committee to Emphasize Ethics Education

Science.gov (United States)

Herrington, Carolyn D.

2011-01-01

At its February 2011 meeting, the AERA Council adopted unanimously a new Code of Ethics. The Code articulates a set of standards for education researchers in education and provides principles and guidance by which they can build ethical practices in professional, scholarly, and scientific activities. The Code reflects the Association's strong…

DRIVING CORPORATE SOCIAL RESPONSIBILITY (CSR THROUGH THE COMPANIES ACT: AN OVERVIEW OF THE ROLE OF THE SOCIAL AND ETHICS COMMITTEE

Directory of Open Access Journals (Sweden)

Henk J Kloppers

2013-04-01

policy requiring the implementation of socially responsible practices by the entire private sector is a necessity. Governments in general are increasingly beginning to view CSR as cost-effective means to enhance their sustainable development strategies, and as a part of their national competitiveness strategies to attract foreign direct investment. Given South Africa's history, legislation should be viewed as one of the main instruments enabling the Government to address the private sector's social, environmental and economic outreach activities.Against this background, this contribution identifies the regulations released in terms of the Companies Act 71 of 2008 in which the issue of the social and ethics committee is dealt with, as an important measure taken by Government to create a possible CSR platform. This contribution argues that the requirements regarding the creation of a social and ethics committee have the potential to embed the CSR notion in the corporate conscience. The aim of the contribution is to provide an overview of the role of the social and ethics committee, as envisaged by the Companies Regulations, 2011, as a potential driver of CSR.

The Ethical Problems of Reserach : An empirical study of ethics in research practice

OpenAIRE

Colnerud, Gunnel

2013-01-01

Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts and problems in research. They were all researchers at the post-doctoral l...

A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

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Klaus Rose

2015-05-01

Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

Ethics review of health research on human participants in South Africa.

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van Wyk, Christa

2010-06-01

In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

Institutional Ethics Resources: Creating Moral Spaces.

Science.gov (United States)

Hamric, Ann B; Wocial, Lucia D

2016-09-01

Since 1992, institutions accredited by The Joint Commission have been required to have a process in place that allows staff members, patients, and families to address ethical issues or issues prone to conflict. While the commission's expectations clearly have made ethics committees more common, simply having a committee in no way demonstrates its effectiveness in terms of the availability of the service to key constituents, the quality of the processes used, or the outcomes achieved. Beyond meeting baseline accreditation standards, effective ethics resources are requisite for quality care for another reason. The provision of care to the sick is a practice with profound moral dimensions. Clinicians need what Margaret Urban Walker has called "moral spaces," reflective spaces within institutions in which to explore and communicate values and ethical obligations as they undergird goals of care. Walker proposed that ethicists needed to be concerned with the design and maintenance of these moral spaces. Clearly, that concern needs to extend beyond ethicists to institutional leaders. This essay uses Walker's idea of moral space to describe individuals and groups who are actual and potential ethics resources in health care institutions. We focus on four requisite characteristics of effective resources and the challenges to achieving them, and we identify strategies to build them. In our view, such moral spaces are particularly important for nurses and their colleagues on interprofessional teams and need to be expanded and strengthened in most settings. © 2016 The Hastings Center.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

Science.gov (United States)

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-01-01

Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832

Ethics, Ethical Human Research and Human Research Ethics Committees

Science.gov (United States)

Lindorff, Margaret

2010-01-01

Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…

The ethics in qualitative health research: special considerations.

Science.gov (United States)

Peter, Elizabeth

2015-09-01

A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1) participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2) naturalistic observation can raise concerns regarding privacy and consent; 3) the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.

The ethics in qualitative health research: special considerations

Directory of Open Access Journals (Sweden)

Elizabeth Peter

2015-09-01

Full Text Available Abstract A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1 participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2 naturalistic observation can raise concerns regarding privacy and consent; 3 the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.

[Experience of a research Ethics Committee and the challenges of the new Chilean legislation on research in human beings].

Science.gov (United States)

Oyarzún G, Manuel; Pinto C, María Eugenia; Raineri B, Gina G; Amigo, Hugo; Cifuentes O, Lucía; González, María Julieta; Horwitz, Nina; Marshall F, Claudia; Orellana V, Gricel

2014-07-01

The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.

Confessions of an Ethics Committee Chair

Science.gov (United States)

Halse, Christine

2011-01-01

This essay examines the possibilities of being/becoming an ethical researcher in the academy. It tackles this task through the lens of an ethics application by Mary [pseudonym], a PhD student in sociology whose research thesis was investigating the reasons why married men with children use prostitutes. Two analyses are offered of Mary's story. The…

Report of the Committee to review safeguards requirements at power reactors

International Nuclear Information System (INIS)

1983-05-01

In October 1982, NRC's Executive Director for Operations appointed a five-member Committee to review NRC security requirements at nuclear power plants with a view toward evaluating the impact of these requirements on operational safety. During visits to five power reactor sites and more than a dozen days of meetings over a period of four months, the Committee observed plant operating conditions and obtained views from abut 100 persons representing 16 nuclear utilities and industry organizations. They also interviewed about 40 NRC employees, including Resident Inspectors, and members of the Regional and Headquarters staffs. Overall, the Committee did not identify any clear operational safety problems associated with implementation of the NRC's security requirements. However, they did find that the potential existed, to varying degrees, at licensed facilities. The Committee's report, dated February 28, 1983, contains five basic findings and a number of associated recommendations intended to minimize the potential impact of security on safety

Methods of legitimation: how ethics committees decide which reasons count in public policy decision-making.

Science.gov (United States)

Edwards, Kyle T

2014-07-01

In recent years, liberal democratic societies have struggled with the question of how best to balance expertise and democratic participation in the regulation of emerging technologies. This study aims to explain how national deliberative ethics committees handle the practical tension between scientific expertise, ethical expertise, expert patient input, and lay public input by explaining two institutions' processes for determining the legitimacy or illegitimacy of reasons in public policy decision-making: that of the United Kingdom's Human Fertilisation and Embryology Authority (HFEA) and the United States' American Society for Reproductive Medicine (ASRM). The articulation of these 'methods of legitimation' draws on 13 in-depth interviews with HFEA and ASRM members and staff conducted in January and February 2012 in London and over Skype, as well as observation of an HFEA deliberation. This study finds that these two institutions employ different methods in rendering certain arguments legitimate and others illegitimate: while the HFEA attempts to 'balance' competing reasons but ultimately legitimizes arguments based on health and welfare concerns, the ASRM seeks to 'filter' out arguments that challenge reproductive autonomy. The notably different structures and missions of each institution may explain these divergent approaches, as may what Sheila Jasanoff (2005) terms the distinctive 'civic epistemologies' of the US and the UK. Significantly for policy makers designing such deliberative committees, each method differs substantially from that explicitly or implicitly endorsed by the institution. Copyright © 2014 Elsevier Ltd. All rights reserved.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Directory of Open Access Journals (Sweden)

Ignacio Segarra

2017-07-01

Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

Science.gov (United States)

Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

2013-03-01

As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.

Ethics, big data and computing in epidemiology and public health.

Science.gov (United States)

Salerno, Jennifer; Knoppers, Bartha M; Lee, Lisa M; Hlaing, WayWay M; Goodman, Kenneth W

2017-05-01

This article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to "big data." This article presents a summary and further discussion of that symposium session. Three topic areas were presented: the policy implications of big data and computing, the fallacy of "secondary" data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy. To address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences. Copyright © 2017 Elsevier Inc. All rights reserved.

Navigating the ethics of cross-cultural health promotion research.

Science.gov (United States)

Haintz, Greer Lamaro; Graham, Melissa; McKenzie, Hayley

2015-12-01

Health promotion researchers must consider the ethics of their research, and are usually required to abide by a set of ethical requirements stipulated by governing bodies (such as the Australian National Health and Medical Research Council) and human research ethics committees (HRECs). These requirements address both deontological (rule-based) and consequence-based issues. However, at times there can be a disconnect between the requirements of deontological issues and the cultural sensitivity required when research is set in cultural contexts and settings etic to the HREC. This poses a challenge for health promotion researchers who must negotiate between meeting both the requirements of the HREC and the needs of the community with whom the research is being conducted. Drawing on two case studies, this paper discusses examples from cross-cultural health promotion research in Australian and international settings where disconnect arose and negotiation was required to appropriately meet the needs of all parties. The examples relate to issues of participant recruitment and informed consent, participants under the Australian legal age of consent, participant withdrawal when this seemingly occurs in an ad hoc rather than a formal manner and reciprocity. Although these approaches are context specific, they highlight issues for consideration to advance more culturally appropriate practice in research ethics and suggest ways a stronger anthropological lens can be applied to research ethics to overcome these challenges.

Ethics Education and Adjudication within Psychology.

Science.gov (United States)

Mills, David H.

1984-01-01

Provides an overview of the formal ethics system within psychology. Describes the structure of the American Psychological Association (APA) and state ethics systems, functions of APA's Committee on Scientific and Professional Ethics and Conduct, and its procedures for handling complaints. (Author/CMG)

The role of religious beliefs in ethics committee consultations for conflict over life-sustaining treatment.

Science.gov (United States)

Bandini, Julia I; Courtwright, Andrew; Zollfrank, Angelika A; Robinson, Ellen M; Cadge, Wendy

2017-06-01

Previous research has suggested that individuals who identify as being more religious request more aggressive medical treatment at end of life. These requests may generate disagreement over life-sustaining treatment (LST). Outside of anecdotal observation, however, the actual role of religion in conflict over LST has been underexplored. Because ethics committees are often consulted to help mediate these conflicts, the ethics consultation experience provides a unique context in which to investigate this question. The purpose of this paper was to examine the ways religion was present in cases involving conflict around LST. Using medical records from ethics consultation cases for conflict over LST in one large academic medical centre, we found that religion can be central to conflict over LST but was also present in two additional ways through (1) religious coping, including a belief in miracles and support from a higher power, and (2) chaplaincy visits. In-hospital mortality was not different between patients with religiously versus non-religiously centred conflict. In our retrospective cohort study, religion played a variety of roles and did not lead to increased treatment intensity or prolong time to death. Ethics consultants and healthcare professionals involved in these cases should be cognisant of the complex ways that religion can manifest in conflict over LST. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Ethical Issues in Cross-Cultural Research

Science.gov (United States)

Honan, Eileen; Hamid, M. Obaidul; Alhamdan, Bandar; Phommalangsy, Phouvanh; Lingard, Bob

2013-01-01

The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and…

Making Room for Ethics

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2017-01-01

This article examines the work that goes in to ‘making room’ for ethics, literally and figuratively. It follows the activities of a capacity building Asia-Pacific NGO in training and recognising ethics review committees, using multi-sited field materials collected over 12 months between 2009...

Ethical considerations for field research on fishes

Directory of Open Access Journals (Sweden)

Rhett H. Bennett

2016-12-01

field research to minimise impacts on fish populations. It is envisaged that this review will be a useful resource for journal editorial committees intending to introduce ethical requirements for publication and for researchers, managers, conservation practitioners and research organisations when designing field studies on fishes, applying for ethical clearance and developing institutional ethical guidelines.

HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

Science.gov (United States)

Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

2011-09-01

We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

Science.gov (United States)

Abdulrahman, Mahera; Nair, Satish Chandrasekhar

2017-04-01

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

Science.gov (United States)

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-08-31

Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. This study was a non-randomised comparison cohort study. Some data were missing. An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. Published by the BMJ Publishing Group Limited. For permission to use (where not

Security and privacy of EHR systems--ethical, social and legal requirements.

Science.gov (United States)

Kluge, Eike-Henner W

2003-01-01

This paper addresses social, ethical and legal concerns about security and privacy that arise in the development of international interoperable health information systems. The paper deals with these concerns under four rubrics: the ethical status of electronic health records, the social and legal embedding of interoperable health information systems, the overall information-requirements healthcare as such, and the role of health information professionals as facilitators. It argues that the concerns that arise can be met if the development of interoperability protocols is guided by the seven basic principles of information ethics that have been enunciated in the IMIA Code of Ethics for Health Information Professionals and that are central to the ethical treatment of electronic health records.

Building Capacity in Ethical Review

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2017-01-01

review to ensure the protection of human subjects participating in research. Drawing on fieldwork with the Forum for Ethical Review Committees in the Asian and Western Pacific Region, I explore two distinct forms taken by capacity building within that organization to support and train members of ethics...... review committees. The first, with an emphasis on standards and measurability, takes as its priority international accountability for clinical trial research. e second explores how the organization goes about persuading trainees to see and do ‘ethics’ differently. is distinction between forms of capacity...

Locating Ethics

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2013-01-01

Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...

[Surgery and the zeitgeist: what happened to ethics and moral?].

Science.gov (United States)

Schneider, L; Tuffs, A; Büchler, M W

2014-03-01

Ethical and moral topics have always been an integral part of surgery. The rapid progress of highly advanced medicine has induced public discussions about medico-ethical problems as well as respective legislation. Interdisciplinary ethical committees, appointed by political as well as professional associations, have published guidelines concerning current ethical topics. However, what about the doctor's attitude and the influence of the ever changing "Zeitgeist"? With the surplus of unproven health information on the web, modern information technologies have changed the doctor-patient relationship. Active leadership of the doctor is still required. For the benefit of the patient the physician should confront increasing economic pressures and the requirements of higher performance levels with competence. Indications have to be based on the results of valid quality controls. Special moral standards should be applied for working within the surgical community and for the pursuit of a career in academic surgery. By strengthening mutual respect and the community spirit surgery will remain attractive for aspiring young doctors.

[Reporting ethics board approval in German medical theses and journals].

Science.gov (United States)

Zenz, Michael; Zenz, Julia; Grieger, Maximilian

2018-06-05

Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

Ethical and legal challenges associated with disaster nursing.

Science.gov (United States)

Aliakbari, Fatemeh; Hammad, Karen; Bahrami, Masoud; Aein, Fereshteh

2015-06-01

In disaster situations, nurses may face new and unfamiliar ethical and legal challenges not common in their everyday practice. The aim of this study was to explore Iranian nurses' experience of disaster response and their perception of the competencies required by nurses in this environment. This article discusses the findings of a descriptive study conducted in Iran in 2012. This research was conducted in Iran in 2012. Participants included 35 nurses who had experience in healthcare delivery following a disaster event in the past 10 years, either in a hospital or out-of-hospital context. This research study was approved by the Ethics Committee of the Isfahan University of Medical Sciences. From this study, five themes emerged as areas that nurses require competence in to work effectively in the disaster setting. This article focusses on one theme, the ethical and legal issues that arise during disaster response. Within the theme of ethical and legal issues, two sub-themes emerged. (1) Professional ethics explores professional responsibility of nurses as well as sense of ethical obligation. (2) Adherence to law refers to nurses' familiarity with and observation of legal requirements. This article adds to a growing pool of literature which explores the role of nurses in disasters. The findings of this study emphasize the need for nurses working in the disaster setting to be aware of professional responsibilities and familiar with legal requirements and the challenges related to observing ethical responsibilities. In highlighting these issues, this article may provide a useful starting point for the development of an educational framework for preparing nurses and other health professionals to work in the disaster setting. © The Author(s) 2014.

Brief report : ethical problems in research practice

OpenAIRE

Colnerud, Gunnel

2013-01-01

Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral ...

The "Ethics Committee": A Practical Approach to Introducing Bioethics and Ethical Thinking

Science.gov (United States)

Goodwin, Mark; Kramer, Cas; Cashmore, Annette

2012-01-01

Bioethics is an increasingly important part of the biosciences curriculum at school and in higher education, but few science teachers have much experience of teaching the subject in an engaging or interactive manner. This article sets out a session that allows students to practise the skills of ethical thinking and ethical debate in a relevant…

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

Directory of Open Access Journals (Sweden)

Subhrojyoti Bhowmick

2014-01-01

Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

Science.gov (United States)

Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena

2015-10-01

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was 89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.

Resolving the ethical dilemma of nurse managers over chemically-dependent colleagues.

Science.gov (United States)

Chiu, W; Wilson, D

1996-12-01

This paper addresses the nurse manager's role regarding chemically-dependent nurses in the workplace. The manager may intervene by: terminating the contract of the impaired colleague; notifying a disciplinary committee; consulting with a counselling committee; or referring the impaired nurse to an employee assistance programme. A dilemma may arise about which of these interventions is ethically the best. The ethical theories relevant to nursing involve ethical relativism, utilitarianism, Kantian ethics, Kohlberg's justice, and Gilligan's ethic of care. Nurse managers first need to understand these theories in order to clarify their own perceptions and attitudes towards chemical dependency, and then satisfactorily resolve this ethical dilemma. Education and social learning are routes to a better understanding of chemical dependency and to broadening the ethical dimensions of nurse managers.

[Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

Science.gov (United States)

Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

2013-01-01

To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

The science of ethics: Deception, the resilient self, and the APA code of ethics, 1966-1973.

Science.gov (United States)

Stark, Laura

2010-01-01

This paper has two aims. The first is to shed light on a remarkable archival source, namely survey responses from thousands of American psychologists during the 1960s in which they described their contemporary research practices and discussed whether the practices were "ethical." The second aim is to examine the process through which the American Psychological Association (APA) used these survey responses to create principles on how psychologists should treat human subjects. The paper focuses on debates over whether "deception" research was acceptable. It documents how members of the committee that wrote the principles refereed what was, in fact, a disagreement between two contemporary research orientations. The paper argues that the ethics committee ultimately built the model of "the resilient self" into the APA's 1973 ethics code. At the broadest level, the paper explores how prevailing understandings of human nature are written into seemingly universal and timeless codes of ethics. © 2010 Wiley Periodicals, Inc.

Research ethics in physical education

Directory of Open Access Journals (Sweden)

Júlio César Schmitt Rocha

2009-06-01

Full Text Available The objective here is to point out ethics in Physical Education research against a backdrop of individual and collective human conduct. Since Plato, the question of ethics in the Western world has been an incessant search for the virtues to harmonize personal and social wellbeing and for the absolute principles of conduct: Autonomy, Beneficence and Justice. Physical Education cannot exempt itself from these and its countless areas of research. In addition to the moral education that develops and solidifies within social groups, the characteristic of which is action on an individual level, we must also consider ethical principles such as those defended by the Physical Education World Manifesto and those that regulate the professional activities of Physical Education professionals. Irrespective of the area investigated, Research in Physical Education will always clash with institutionalized ethical principles enforced by ethics committees, councils and the values accepted by the researchers. Committees strive to preserve the integrity and dignity of the people enrolled on research studies while the researchers challenge the limits of knowledge at an uncomfortable frontier between the acceptable and the unacceptable within a given context of academic vision and needs.

药物临床试验伦理委员会运作实践%The Operation of Ethics Committees in Drug Clinical Trials

Institute of Scientific and Technical Information of China (English)

鲁瑞萍; 单志桂; 申洁

2013-01-01

在药物临床试验的过程中,必须对受试者的个人权益给予充分的保障,并确保试验的科学性和可靠性.伦理委员会与知情同意书是保障受试者权益的主要措施.为确保临床试验中受试者的权益,须成立独立的伦理委员会,并向国家食品药品监督管理局备案.介绍了某医院药物临床试验伦理委员会的组成及备案、规范伦理委员会运作、存在的问题以及解决的对策与方法.%In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects'rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.

Committee on Scientific Values | Initiatives | Indian Academy of ...

Indian Academy of Sciences (India)

Academy Committee on Scientific Values. The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should follow. The Committee submitted its report to the Council, which at its meeting in December 2005 approved this report ...

Control of Antimicrobial Resistance Requires an Ethical Approach

Directory of Open Access Journals (Sweden)

Ben Parsonage

2017-11-01

Full Text Available Ethical behavior encompasses actions that benefit both self and society. This means that tackling antimicrobial resistance (AMR becomes an ethical obligation, because the prospect of declining anti-infectives affects everyone. Without preventive action, loss of drugs that have saved lives over the past century, will condemn ourselves, people we know, and people we don’t know, to unacceptable risk of untreatable infection. Policies aimed at extending antimicrobial life should be considered within an ethical framework, in order to balance the choice, range, and quality of drugs against stewardship activities. Conserving availability and effectiveness for future use should not compromise today’s patients. Practices such as antimicrobial prophylaxis for healthy people ‘at risk’ should receive full debate. There are additional ethical considerations for AMR involving veterinary care, agriculture, and relevant bio-industries. Restrictions for farmers potentially threaten the quality and quantity of food production with economic consequences. Antibiotics for companion animals do not necessarily spare those used for humans. While low-income countries cannot afford much-needed drugs, pharmaceutical companies are reluctant to develop novel agents for short-term return only. Public demand encourages over-the-counter, internet, black market, and counterfeit drugs, all of which compromise international control. Prescribers themselves require educational support to balance therapeutic choice against collateral damage to both body and environment. Predicted mortality due to AMR provides justification for international co-operation, commitment and investment to support surveillance and stewardship along with development of novel antimicrobial drugs. Ethical arguments for, and against, control of antimicrobial resistance strategies are presented and discussed in this review.

Ethics in Early Childhood Special Education.

Science.gov (United States)

Bowe, Frank G.

1995-01-01

This article discusses ethical questions in providing prenatal services, including testing and genetic engineering, and medical interventions with neonates and other very young children who have severe disabilities. It explores ways to enhance ethical decision making, including recruitment for multidisciplinary teams or other committees of adults…

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

Science.gov (United States)

Astaneh, Behrooz; Khani, Parisa

2017-11-10

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

Implications of the ethical-legal framework for adolescent HIV ...

African Journals Online (AJOL)

Nicky

Fourthly, the institutional framework for establishing research priorities and regulation of ethical review is being strengthened with the establishment of new institutions such as the National. Health Research Ethics Committee. The South African ethical-legal framework and its implications for adolescent HIV vaccine trials ...

Ethical dimensions of paediatric nursing: A rapid evidence assessment.

Science.gov (United States)

Bagnasco, Annamaria; Cadorin, Lucia; Barisone, Michela; Bressan, Valentina; Iemmi, Marina; Prandi, Marzia; Timmins, Fiona; Watson, Roger; Sasso, Loredana

2018-02-01

Paediatric nurses often face complex situations requiring decisions that sometimes clash with their own values and beliefs, or with the needs of the children they care for and their families. Paediatric nurses often use new technology that changes the way they provide care, but also reduces their direct interaction with the child. This may generate ethical issues, which nurses should be able to address in the full respect of the child. Research question and objectives: The purpose of this review is to describe the main ethical dimensions of paediatric nursing. Our research question was, 'What are the most common ethical dimensions and competences related to paediatric nursing?' A rapid evidence assessment. According to the principles of the rapid evidence assessment, we searched the PubMed, SCOPUS and CINAHL databases for papers published between January 2001 and March 2015. These papers were then independently read by two researchers and analysed according to the inclusion criteria. Ethical considerations: Since this was a rapid evidence assessment, no approval from the ethics committee was required. Ten papers met our inclusion criteria. Ethical issues in paediatric nursing were grouped into three areas: (a) ethical issues in paediatric care, (b) social responsibility and (c) decision-making process. Few studies investigate the ethical dimensions and aspects of paediatric nursing, and they are mainly qualitative studies conducted in critical care settings based on nurses' perceptions and experiences. Paediatric nurses require specific educational interventions to help them resolve ethical issues, contribute to the decision-making process and fulfil their role as advocates of a vulnerable population (i.e. sick children and their families). Further research is needed to investigate how paediatric nurses can improve the involvement of children and their families in decision-making processes related to their care plan.

[Is a strategy of bio-socio-ethic necessary?].

Science.gov (United States)

Alonso Trujillo, Federico; López Medel, Raquel; Asensio Fernández, Inmaculada; Pinzón Pulido, Sandra; González Montero, M Carmen

2016-01-01

The aim of this paper is to assess the need for a common ethics strategy shared by 2 of the cornerstones of human welfare: the healthcare and social services sectors. An observational cross-sectional descriptive study was performed by surveying social services and healthcare professionals. A purposive sampling technique was used. The questionnaire consisted of 10 questions about ethical conflicts in professional practice and respondents' views on a proposed shared approach to bioethics and ethics in social intervention. 124 professionals completed the questionnaire, 56% of the health sector and 44% of the social services sector. About 90% professionals surveyed had had to make difficult ethical decisions in their work and would welcome a common approach to ethics in the social services and healthcare sectors. 75% said that conflicts are occurring more frequently in both sectors simultaneously and that they were resolved preferably individually and independently. The survey respondents believe that a common approach to tackling ethical conflicts in professional practice is required. Nevertheless, it is still rare for ethics committees to intervene in the conflict resolution process and for decision-making support and evaluation tools to be used. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

The role of national ethics commissions in Finland.

Science.gov (United States)

Halila, Ritva

2003-08-01

There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub-Committee on Medical Research Ethics in 1999. The Co-operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub-Committee on Medical Research Ethics acts a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi-professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years.

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

Science.gov (United States)

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

Science.gov (United States)

Farajkhoda, Tahmineh

2017-01-01

Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

Science.gov (United States)

Farajkhoda, Tahmineh

2017-02-01

Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

NARCIS (Netherlands)

Alfonso, Fernando; Adamyan, Karlen; Artigou, Jean-Yves; Aschermann, Michael; Boehm, Michael; Buendia, Alfonso; Chu, Pao-Hsien; Cohen, Ariel; Cas, Livio Dei; Dilic, Mirza; Doubell, Anton; Echeverri, Dario; Enç, Nuray; Ferreira-González, Ignacio; Filipiak, Krzysztof J.; Flammer, Andreas; Fleck, Eckart; Gatzov, Plamen; Ginghina, Carmen; Goncalves, Lino; Haouala, Habib; Hassanein, Mahmoud; Heusch, Gerd; Huber, Kurt; Hulín, Ivan; Ivanusa, Mario; Krittayaphong, Rungroj; Lau, Chu-Pak; Marinskis, Germanas; Mach, François; Moreira, Luiz Felipe; Nieminen, Tuomo; Oukerraj, Latifa; Perings, Stefan; Pierard, Luc; Potpara, Tatjana; Reyes-Caorsi, Walter; Rim, Se-Joong; Rødevand, Olaf; Saade, Georges; Sander, Mikael; Shlyakhto, Evgeny; Timuralp, Bilgin; Tousoulis, Dimitris; Ural, Dilek; Piek, J. J.; Varga, Albert; Lüscher, Thomas F.

2017-01-01

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical

[Project for the Creation of a Medical or Hospital Ethical Committee at a Local Level in the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama. Year 2013].

Science.gov (United States)

Díaz Rivera, Yashiro A

2015-01-01

The next project was based on the design on the creation of a medical ethical Committee at a hospital. It was developed at the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama, in 2013. Insomuch as the creation of social projects requires unified international parameters, format is taken from the Unesco's guides for the establishing and working of bioethics committees; adapted to the socio-economic, political and cultural context of the San Miguelito District, Panama Province. Furthermore to adapting to socio-ecological aspect where the research project is carried out, the theoretical aspect includes from the ontological personalistic bioethics, where the cornerstone is the dignity of the human person. A study of perceptions of medical staff and nursing was developed on the management of the most common ethical dilemmas in the Hospital San Miguel Arcángel. The instrument used was a previously validated perception survey through a pilot test. Reliability was measured using Cronbach's alpha coefficient, and validity was obtained from the content. Satisfactory statistical results, that verify the working hypotheses on the recognition of the importance of autonomy, confidentiality, protection of vulnerable population, occupational health staff welfare and integration of bioethics at the institutional agenda, were obtained. However, there were particular aspects that indicate some doubt as to the management of some realities that are presented in the context of health care.

Ethics of reproductive technology: AFS recommendations, dissent.

Science.gov (United States)

McCormick, R A

1987-03-01

The Ethics Committee of the American Fertility Society recently released its report, "Ethical Considerations of the New Reproductive Technologies." The report examines general ethical, legal, and biological aspects of and makes ethical recommendations on procreative technologies, from standard in vitro fertilization, through all its possible variations and accompaniments, including donor gametes and preembryos, surrogate mothers, and cryopreservation. The judgment of ethical acceptability of third-party involvement in reproductive technology is the report's weakest aspect. The potential impact of such participation was not sufficiently weighed because of primacy given to a single value: the provision of a baby to an individual couple, or even an individual, who could not otherwise have one. A dissent to the report is based on two analyses: Third-party involvement itself violates the marriage covenant, independent of any potential damaging effects or benefits, and relaxation of marital exclusivity could harm the marriage (and marriage in general) and the prospective child. The committee also failed to resolve the problem of preembryo status. Instead, it recommended that local programs offering reproductive assistance draw up their own policies.

78 FR 15110 - Aviation Rulemaking Advisory Committee; Engine Bird Ingestion Requirements-New Task

Science.gov (United States)

2013-03-08

... Committee; Engine Bird Ingestion Requirements--New Task AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of new task assignment for the Aviation Rulemaking Advisory Committee (ARAC). SUMMARY: The FAA assigned ARAC a new task to review and assess the adequacy of certain portions of the existing...

A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making

Directory of Open Access Journals (Sweden)

Steven P. McCulloch

2018-06-01

Full Text Available Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE,~foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Committee and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an “Ethics Council for Animal Policy” to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs and examine some widely used ethical frameworks (e.g., Banner’s principles and the ethical matrix. The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i Problematisation of the policy issue, (ii utilitarian analysis, (iii animal rights analysis, (iv virtue-based analysis, (v animal welfare ethic analysis, and (vi integrated ethical analysis. The~paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

The rose of Sharon: what is the ideal timing for palliative care consultation versus ethics consultation?

Science.gov (United States)

La Via, Jennifer; Schiedermayer, David

2012-01-01

Ethics committees and palliative care consultants can function in a complementary fashion, seamlessly and effectively. Ethics committees can "air" and help resolves issues, and palliative care consultants can use a low-key, longitudinal approach.

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

OpenAIRE

Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.

1997-01-01

OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...

The end of the nuclear power generation. On the recommendations of the ethics committee according to the 13th amendment to the Atomic Energy Act; Das Ende der Atomverstromung. Zu den Empfehlungen der Ethik-Kommission, zur 13. Atomgesetz-Novelle

Energy Technology Data Exchange (ETDEWEB)

Becker, Peter [Kanzlei Becker Buettner Held, Berlin (Germany)

2011-11-15

With the 13th Amendment to the Atomic Energy Act the nuclear consequences of the earthquake disaster in Japan will result in an end to nuclear power generation in Germany. Here, the legislature resorted to unusual methods. For the first time, the legislature received advices from the ''ethics committee reliable energy supply''. This Ethics Commission adopted its recommendations ''on behalf of the Chancellor'' in the period from 4th April to 28th May, 2011. The understanding of this development, its epochal character and speed of decision-making requires an excursion into the economic history and the establishment of nuclear power generation with their legal protection.

Evidence and Ethics (Editorial

Directory of Open Access Journals (Sweden)

Alison Brettle

2012-12-01

discipline the research takes place in, and should be something that we are aware of as consumers of evidence. Within LIS in the UK, ethical principles have been put to the fore within a new professional framework (CILIP Chartered Institute of Library and Information Professionals, 2012a. The framework outlines the broad range of skills required by workers across the LIS profession, placing these on a wheel with ethics and values in the centre, as they underpin the profession. Placing ethics and values at the core in this way helps us set our knowledge into a wider context and, I believe, is one of the ways that we can make a difference as LIS professionals. At the same time, our ethical values and principles help to differentiate us from other professions and help to define what we do as LIS professionals. These ethical principles are outlined in a code (CILIP Chartered Institute of Library and Information Professionals, 2012b, which sets out professional responsibilities in relation to users, colleagues, and the information community and society. The elements which are particularly relevant to EBLIP, and which are espoused in the scope and mission of the journal, include maintaining and enhancing professional knowledge and competence, sharing results of research and development, encouraging best practice, and promoting equitable access to information. There are also ethical codes of practice for journal editors, these include one for LIS editors (Library and Information Science Editorial Committee, 2010 and a more general one which originated in the medical and health domain (Committee on Publication Ethics: COPE, 2011. Both of these guide journal editors in relating to readers, authors, reviewers, and publishers, and both seek to establish best practice for journal publishing. For the EBLIP journal, these codes of practice provide a useful framework for ensuring the journal operates in a professional and ethical way. A recent example where the codes have been used in

Assessment of orientation practices for ethics consultation at Harvard Medical School-affiliated hospitals.

Science.gov (United States)

Zaidi, Danish; Kesselheim, Jennifer C

2018-02-01

Few studies have been conducted to assess the quality of orientation practices for ethics advisory committees that conduct ethics consultation. This survey study focused on several Harvard teaching hospitals, exploring orientation quality and committee members' self-evaluation in the American Society of Bioethics and Humanities (ASBH) ethics consultation competencies. We conducted a survey study that involved 116 members and 16 chairs of ethics advisory committees, respectively (52% and 62.5% response rates). Predictor variables included professional demographics, duration on committees and level of training. Outcome variables included familiarity with and preparedness in the ASBH competencies and satisfaction with orientations. We hypothesised that responses would be associated with both the aforementioned predictors and whether or not participants had encountered the ASBH competencies in training. A majority of respondents found their orientation curricula to be helpful (62%), although a significant portion of respondents did not receive any orientation (24%) or were unsatisfied with their orientation (14%). Familiarity with ASBH competencies was a statistically significant predictor of respondents' self-evaluation in particular categories (54% had heard of the competencies). Standard educational materials were reported as offered during orientation, such as readings (50%) and case studies (41%); different medium resources were less evidenced such as videos on ethics consultation (19%). Institutions should re-evaluate orientation practices for ethics committee members that perform ethics consultation. Integrating ASBH competencies and useful methods into a resourceful pedagogy will help improve both member satisfaction with orientation and preparation in consultation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Patient decision-making: medical ethics and mediation.

OpenAIRE

Craig, Y J

1996-01-01

A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part of an eirenic ethic alr...

41 CFR 105-54.204 - Advisory committee membership.

Science.gov (United States)

2010-07-01

... particular individual or group to obtain different points of view relevant to committee business. The... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting...

Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

Science.gov (United States)

2013-01-01

Background Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively. Methods The study data were extracted from proposals and amendments submitted to the FTM-EC during the period October 2009 – September 2012, and then analyzed qualitatively and quantitatively. The main issues for clarification/revision were analyzed by thematic content analysis. Results 373 proposals were submitted; 44 studies involved minority groups with 21 extra-vulnerable minorities. All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review. For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles. The main issues needing clarification/revision differed between all studies and those involving minorities: participant information sheet (62.2% vs. 86.4%), informed consent/assent form (51.2% vs. 86.4%), and research methodology (80.7% vs. 84.1%), respectively. The main ethical issues arising during the meetings, regarding studies involving minorities, included ensuring no exploitation, coercion, or pressure on the minority to participate; methodology not affecting their legal status; considering ethnicity and cultural structure; and providing appropriate compensation. Conclusion Delays in the approval or non

The Just War Tradition: A Model for Healthcare Ethics.

Science.gov (United States)

Connolly, Chaplain John D

2018-06-01

Healthcare ethics committees, physicians, surgeons, nurses, families, and patients themselves are constantly under pressure to make appropriate medically ethical decisions concerning patient care. Various models for healthcare ethics decisions have been proposed throughout the years, but by and large they are focused on making the initial ethical decision. What follows is a proposed model for healthcare ethics that considers the most appropriate decisions before, during, and after any intervention. The Just War Tradition is a model that is thorough in its exploration of the ethics guiding a nation to either engage in or refuse to engage in combatant actions. In recent years, the Just War Tradition has expanded beyond the simple consideration of going to war or not to include how the war is conducted and what the post-war phase would look like ethically. This paper is an exploration of a healthcare ethics decision making model using the tenets of the Just War Tradition as a framework. It discusses the initial consult level of decision making prior to any medical intervention, then goes further in considering the ongoing ethical paradigm during medical intervention and post intervention. Thus, this proposal is a more holistic approach to healthcare ethics decision making that encourages healthcare ethics committees to consider alternate models and ways of processing so that ultimately what is best for patient, family, staff, and the environment is all taken into consideration.

Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States.

Science.gov (United States)

Hemminki, Elina

2016-01-19

The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries - England, Canada, the United States of America (USA) - in the late 2000s. Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized. In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland. The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.

Institutional ethical review and ethnographic research involving injection drug users: a case study.

Science.gov (United States)

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

Ethics and health promotion practice: exploring attitudes and practices in Western Australian health organisations.

Science.gov (United States)

Reilly, T; Crawford, G; Lobo, R; Leavy, J; Jancey, J

2016-04-01

Issue addressed Evidence-informed practice underpinned by ethics is fundamental to developing the science of health promotion. Knowledge and application of ethical principles are competencies required for health promotion practice. However, these competencies are often inconsistently understood and applied. This research explored attitudes, practices, enablers and barriers related to ethics in practice in Western Australian health organisations. Methods Semistructured, in-depth interviews were conducted with 10 health promotion practitioners, purposefully selected to provide a cross-section of government and non-government organisations. Interviews were recorded, transcribed and then themed. Results The majority of participants reported consideration of ethics in their practice; however, only half reported seeking Human Research Ethics Committee (HREC) approval for projects in the past 12 months. Enablers identified as supporting ethics in practice and disseminating findings included: support preparing ethics applications; resources and training about ethical practice; ability to access HRECs for ethics approval; and a supportive organisational culture. Barriers included: limited time; insufficient resourcing and capacity; ethics approval not seen as part of core business; and concerns about academic writing. Conclusion The majority of participants were aware of the importance of ethics in practice and the dissemination of findings. However, participants reported barriers to engaging in formal ethics processes and to publishing findings. So what? Alignment of evidence-informed and ethics-based practice is critical. Resources and information about ethics may be required to support practice and encourage dissemination of findings, including in the peer-reviewed literature. Investigating the role of community-based ethics boards may be valuable to bridging the ethics-evidence gap.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

Science.gov (United States)

Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

Ethics in clinical research: the Indian perspective.

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Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

The ethics of in vivo calibrations in oral health surveys.

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Andrade, Flávia Reis de; Narvai, Paulo Capel; Montagner, Miguel Ângelo

2016-01-01

To analyze the ethics of in vivo calibration, using the discourse of the administrators of the National Oral Health Survey (SBBrasil 2010) as a starting point. This is a qualitative research involving semi-structured individual interviews with 12 members of the Steering Group and Technical Advisory Committee of the Ministry of Health, and two coordinators, one State and the other Municipal. The discourse of the collective subject technique was used for data analysis. When asked about the experiences of SBBrasil 2010, which included ethical aspects, respondents identified the forms of standardization and training of teams who collected field data. For them, there is little scientific evidence to ethically support the way the training stage, including calibration, is carried out in oral health epidemiological surveys, as a certain unease can be predicted in participants of these studies. The ethics of a research also derives from its methodological rigor; the training process; and calibration in particular, is a fundamental technical and ethical requirement in surveys such as the SBBrasil 2010. The unease of the volunteers in face of test repetition does not ethically invalidate the in vivo calibration, but mechanisms to minimize it must be developed.

Discussing End-of-Life Decisions in a Clinical Ethics Committee: An Interview Study of Norwegian Doctors' Experience.

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Bahus, Marianne K; Førde, Reidun

2016-09-01

With disagreement, doubts, or ambiguous grounds in end-of-life decisions, doctors are advised to involve a clinical ethics committee (CEC). However, little has been published on doctors' experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors' experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients' relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs' discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs' discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians.

An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

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Tahmineh Farajkhoda

2017-08-01

Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening

2010 Amendments to the 2002 "Ethical principles of psychologists and code of conduct".

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2010-01-01

The following amendments to the 2002 "Ethical Principles of Psychologists and Code of Conduct" (the Ethics Code; American Psychological Association, 2002) were adopted by the APA Council of Representatives at its February 2010 meeting. The changes involve the last two sentences of the final paragraph of the Introduction and Applicability section and Ethical Standards 1.02 and 1.03. The amendments became effective June 1, 2010. A history of these amendments to the Ethics Code is provided in the "Report of the Ethics Committee, 2009" in this issue of the American Psychologist (American Psychological Association, Ethics Committee, 2010). Following are a clean version of the revisions and a version indicating changes from the 2002 language (inserted text is underlined; deleted text is crossed out). 2010 APA, all rights reserved.

Social Representations on ethical and bioethic aspects in research

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Maísa Araujo Costa

2017-03-01

Full Text Available Objective: the study aims to analyze the social representations on the ethical and bioethical aspects in the research elaborated by academics of the Dentistry Course. Methods: it is a qualitative research based on the Theory of Social Representations carried out with 80 academics of the Dentistry course. The data were collected through a semi-structured interview script, processed in the IRaMuTeQ and analyzed by the Descending Hierarchical Classification. The study followed the ethical standards recommended by Resolution n. 466/2012, obtaining approval from the Ethics Committee of UNINOVAFAPI University Center. Results: The corpus analyzed in the study is composed of 79 units of initial context (UCI with use of 62%. The results are presented in four classes, namely: 4. The understanding of Ethics and Bioethics in research; 3. Researcher's social position; 1. Legal responsibilities of the researcher and 2. Normative aspects of research ethics - legal basis. Conclusion: Scholars represent ethical and bioethical aspects in research as essential to respect human dignity and protect the lives of research participants, with a focus on normative aspects of research ethics through Research Committees. Their attitudes are guided by their conditions of life, their beliefs and cultures of different social contexts. Keywords: Bioethics, ethics, social psychology.

Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

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Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

2013-05-01

This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

Ethical considerations in biomedical research: a personal view.

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Dahlöf, Carl

2013-06-01

Ethical considerations are made when an experiment is planned and take a regulatory system of moral principles into account. Ethical considerations should first and foremost be made in order to protect the individual subject/animal from being exposed to any unethical and perhaps even illegal intervention and to ensure that the experimental conditions used are appropriate. The main role of research ethics committees is to assess the scientific and ethical aspects of submitted protocols and follow up the trial until its closure.

Ethics of sharing scientific and technological data: a heuristic for coping with complexity & uncertainty

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J E Sieber

2006-01-01

Full Text Available Data sharing poses complex ethical questions for data management. Manifold conflicting and shifting values need to be reconciled in pursuing viable data-management policies. For example, how does one make data available in useable form to stakeholders including scientists, governments and businesses worldwide, while assuring confidentiality, satisfying one's research ethics committee, protecting intellectual property and national security, and containing costs? Increasingly, ethical problem solving requires integration of ethics with technological "know how" and empirical research on the presenting problem. Each problem is highly contextual; broad application of general ethical principles such as always practice openness, or prepare all data for sharing, may have harmful unintended consequences. Chaos theory provides a heuristic or vision for understanding and coping with complexity and uncertainty. It does not provide answers to problems of data management, but frames the issues, and provides appropriate expectations and heuristics for considering data management problems.

IDRC's Advisory Committee on Research Ethics | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

ACRE observes IDRC's Corporate Principles on Research Ethics. ... various published statements on the management of environmental research. ... equity while remaining sensitive to the cultural norms and practices of the localities where the ...

Care-givers' reflections on an ethics education immersive simulation care experience: A series of epiphanous events.

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Gallagher, Ann; Peacock, Matthew; Zasada, Magdalena; Coucke, Trees; Cox, Anna; Janssens, Nele

2017-07-01

There has been little previous scholarship regarding the aims, options and impact of ethics education on residential care-givers. This manuscript details findings from a pragmatic cluster trial evaluating the impact of three different approaches to ethics education. The focus of the article is on one of the interventions, an immersive simulation experience. The simulation experience required residential care-givers to assume the profile of elderly care-recipients for a 24-hr period. The care-givers were student nurses. The project was reviewed favourably by a university ethics committee, and participants provided informed consent. Data from six postsimulation experience focus groups were analysed thematically and three themes were identified: the experience of vulnerability, dignity in care and the organisation of care. Findings suggest that the immersive simulation experience had a powerful immediate impact as participants described epiphanous insights relating to their care experiences. It is suggested that reflecting on and recording epiphanous events has the potential to sustain ethical care practices. Further research is required to evaluate the impact of different ethics education interventions in different cultural contexts. Exploration is also required regarding the meaning and significance of care epiphanies, those "most delicate and evanescent of moments," for the sustainability of ethical care. © 2016 John Wiley & Sons Ltd.

Ethics Leadership in Research, Healthcare and Organizational Systems: Commentary and Critical Reflections

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Gabriele, Edward F.

2011-01-01

In the last decades there has arisen a greater awareness of the ever present need for critical academic reflection on the nature of ethics leadership and committees in research, healthcare, and organizational systems. Yet what is meant by ethics itself? How is ethics understood as a historical phenomenon? What challenges must ethics leaders face…

Justice in human research ethics. A conceptual and practical guide.

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Pieper, Ian; Thomson, Colin J H

2013-03-01

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

Real-time Responsiveness for Ethics Oversight During Disaster Research.

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Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew

2015-11-01

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.

When to consult the institutional bioethics committee? The deliberative method for resolving possible dilemmas

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Alejandra T Rabadán

2017-12-01

Full Text Available In healthcare, an ethical concern that arises during the decision making process is considered to be a bioethical dilemma. It is often the case that in the absence of proper deliberation, the problem is transferred to a bioethics committee, not even representing precisely a dilemma. Bioethics emerged as a discipline in the mid-20th century. It is defined as a support to decision-making in ethical dilemmas centered on two aspects: ethics of clinical investigation, focused on protecting the rights of research subjects, and bioethics in medical practice, of an advisory nature. To recognize the difference among difficult or complex clinical circumstances and ethical dilemmas could allow knowing when it is necessary to request for advice of a committee. It is not so much a question of deciding what is right or wrong, but which is the most advisable solution to a problem. We review the history of Bioethics Committees in Argentina that are facing today the challenge of promoting social responsibility and opening deliberations to community and health professionals. In the 20th century two historical moments are recognized: a pioneering and slow first period, and a second one of legal regulatory framework. Considering deliberation as a method of ethics, this article proposes a case analysis procedure and the deliberative method to elucidate dilemmas, with or without the help of a Committee.

[When to consult the institutional bioethics committee? The deliberative method for resolving possible dilemmas].

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Rabadán, Alejandra T; Tripodoro, Vilma A

2017-01-01

In healthcare, an ethical concern that arises during the decision making process is considered to be a bioethical dilemma. It is often the case that in the absence of proper deliberation, the problem is transferred to a bioethics committee, not even representing precisely a dilemma. Bioethics emerged as a discipline in the mid-20th century. It is defined as a support to decision-making in ethical dilemmas centered on two aspects: ethics of clinical investigation, focused on protecting the rights of research subjects, and bioethics in medical practice, of an advisory nature. To recognize the difference among difficult or complex clinical circumstances and ethical dilemmas could allow knowing when it is necessary to request for advice of a committee. It is not so much a question of deciding what is right or wrong, but which is the most advisable solution to a problem. We review the history of Bioethics Committees in Argentina that are facing today the challenge of promoting social responsibility and opening deliberations to community and health professionals. In the 20th century two historical moments are recognized: a pioneering and slow first period, and a second one of legal regulatory framework. Considering deliberation as a method of ethics, this article proposes a case analysis procedure and the deliberative method to elucidate dilemmas, with or without the help of a Committee.

Written institutional ethics policies on euthanasia: an empirical-based organizational-ethical framework.

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Lemiengre, Joke; Dierckx de Casterlé, Bernadette; Schotsmans, Paul; Gastmans, Chris

2014-05-01

As euthanasia has become a widely debated issue in many Western countries, hospitals and nursing homes especially are increasingly being confronted with this ethically sensitive societal issue. The focus of this paper is how healthcare institutions can deal with euthanasia requests on an organizational level by means of a written institutional ethics policy. The general aim is to make a critical analysis whether these policies can be considered as organizational-ethical instruments that support healthcare institutions to take their institutional responsibility for dealing with euthanasia requests. By means of an interpretative analysis, we conducted a process of reinterpretation of results of former Belgian empirical studies on written institutional ethics policies on euthanasia in dialogue with the existing international literature. The study findings revealed that legal regulations, ethical and care-oriented aspects strongly affected the development, the content, and the impact of written institutional ethics policies on euthanasia. Hence, these three cornerstones-law, care and ethics-constituted the basis for the empirical-based organizational-ethical framework for written institutional ethics policies on euthanasia that is presented in this paper. However, having a euthanasia policy does not automatically lead to more legal transparency, or to a more professional and ethical care practice. The study findings suggest that the development and implementation of an ethics policy on euthanasia as an organizational-ethical instrument should be considered as a dynamic process. Administrators and ethics committees must take responsibility to actively create an ethical climate supporting care providers who have to deal with ethical dilemmas in their practice.

Sources of bias in clinical ethics case deliberation.

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Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2014-10-01

A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods

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Bernabe Rosemarie D L C

2012-04-01

Full Text Available Abstract Background Research ethics committees (RECs are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision. Conclusion As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task.

Partnering with patients in translational oncology research: ethical approach.

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Mamzer, Marie-France; Duchange, Nathalie; Darquy, Sylviane; Marvanne, Patrice; Rambaud, Claude; Marsico, Giovanna; Cerisey, Catherine; Scotté, Florian; Burgun, Anita; Badoual, Cécile; Laurent-Puig, Pierre; Hervé, Christian

2017-04-08

The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses

[Consent and confidentiality in occupational health practice: balance between legal requirements and ethical values].

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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.

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

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Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

2017-12-01

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

Beyond Compliance Checking: A Situated Approach to Visual Research Ethics.

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Lenette, Caroline; Botfield, Jessica R; Boydell, Katherine; Haire, Bridget; Newman, Christy E; Zwi, Anthony B

2018-03-19

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous.

76 FR 21382 - Pediatric Ethics Subcommittee; Notice of Meeting

Science.gov (United States)

2011-04-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0184] Pediatric Ethics Subcommittee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Ethics Subcommittee of...

Research Award: Advisory Committee on Research Ethics

International Development Research Centre (IDRC) Digital Library (Canada)

IDRC CRDI

ACRE seeks a Research Awardee to study research ethics in an ... The following topics are examples of issues that could be ... advance their career goals, and recognize the dual nature of the position—applied research activity and general ...

Research ethics consultation: ethical and professional practice challenges and recommendations.

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Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-05-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

Justice and care: decision making by medical school student promotions committees.

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Green, Emily P; Gruppuso, Philip A

2017-06-01

The function of medical school entities that determine student advancement or dismissal has gone largely unexplored. The decision making of 'academic progress' or student promotions committees is examined using a theoretical framework contrasting ethics of justice and care, with roots in the moral development work of theorists Kohlberg and Gilligan. To ascertain promotions committee members' conceptualisation of the role of their committee, ethical orientations used in member decision making, and student characteristics most influential in that decision making. An electronic survey was distributed to voting members of promotions committees at 143 accredited allopathic medical schools in the USA. Descriptive statistics were calculated and data were analysed by gender, role, institution type and class size. Respondents included 241 voting members of promotions committees at 55 medical schools. Respondents endorsed various promotions committee roles, including acting in the best interest of learners' future patients and graduating highly qualified learners. Implementing policy was assigned lower importance. The overall pattern of responses did not indicate a predominant orientation toward an ethic of justice or care. Respondents indicated that committees have discretion to take individual student characteristics into consideration during deliberations, and that they do so in practice. Among the student characteristics with the greatest influence on decision making, professionalism and academic performance were paramount. Eighty-five per cent of participants indicated that they received no training. Promotions committee members do not regard orientations of justice and care as being mutually exclusive and endorse an array of statements regarding the committee's purpose that may conflict with one another. The considerable variance in the influence of student characteristics and the general absence of committee member training indicate a need for clear delineation of the

Public titles of clinical trials should have ethics review.

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Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

2015-09-01

A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

Monitoring 'monitoring' and evaluating 'evaluation': an ethical framework for monitoring and evaluation in public health.

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Gopichandran, Vijayaprasad; Indira Krishna, Anil Kumar

2013-01-01

Monitoring and evaluation (M&E) is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to institutionalise the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees.

Research Ethics with Undergraduates in Summer Research Training Programs

Science.gov (United States)

Cheung, I.; Yalcin, K.

2016-02-01

Many undergraduate research training programs incorporate research ethics into their programs and some are required. Engaging students in conversations around challenging topics such as conflict of interest, cultural and gender biases, what is science and what is normative science can difficult in newly formed student cohorts. In addition, discussing topics with more distant impacts such as science and policy, intellectual property and authorship, can be difficult for students in their first research experience that have more immediate concerns about plagiarism, data manipulation, and the student/faculty relationship. Oregon State University's Research Experience for Undergraduates (REU) in Ocean Sciences: From Estuaries to the Deep Sea as one model for incorporating a research ethics component into summer undergraduate research training programs. Weaved into the 10-week REU program, undergraduate interns participate in a series of conversations and a faculty mentor panel focused on research ethics. Topics discussed are in a framework for sharing myths, knowledge and personal experiences on issues in research with ethical implications. The series follows guidelines and case studies outlined from the text, On Being A Scientist: Responsible Conduct In Research Committee on Science, Engineering, and Public Policy, National Academy of Sciences.

[ETHICAL CONDUCT FOR RESEARCH INVOLVING INDIGENOUS PEOPLE IN FRANCE: A COMMENT OF THE CNRS ETHICS COMMITTEE OPINION ON THE IMPERATIVE OF FAIRNESS IN THE RELATIONSHIP BETWEEN RESEARCHERS AND INDIGENOUS PEOPLES].

Science.gov (United States)

Burelli, Thomas; Bambridge, Tamatoa

2015-12-01

Historically, scientific research and colonization process have maintained very close ties. In order to frame research involving indigenous peoples and to avoid situations of abuse, some States have developed very detailed ethicalframeworks. In France, there are no ethicalframework comparable to those observed in particular in Anglo-Saxon countries like Canada. Extensive discussions were conducted by the Ethics Committee of the CNRS leading to the adoption of an opinion of a high quality but which appears largely unknown and under-exploited. This opinion deals with "the delicate question of the rights of local and indigenous populations during the research projected conducted with their support in developed and developing countries (DCs)". In this paper, we propose to analyze how this opinion can be considered remarkable because it recognizes the current challenges of research projects involving indigenous people, but also because of his recommendations. We still see that the scope of its recommendations is however limited so far although some encouraging experiences like the recent adoption of the CRIOBE centre code of ethics in French Polynesia can be observed.

Guyana - How Do You Know Where to Get the Information You Need? Determining Ethics Approval Requirements in a Developing Country

OpenAIRE

Gloria Song

2018-01-01

Determining the process for obtaining local research ethics approval, or whether such a requirement even exists, may not always be straightforward in the context of some developing countries where such information may not be easily accessible to overseas researchers. How far do a researcher's ethical obligations extend in determining whether there is a requirement for local research ethics approval, and what form this would take (e.g., institutional or centralised ethics review)? In other wor...

Interim report of the Advisory Committee on human radiation experiments

International Nuclear Information System (INIS)

1994-01-01

The Advisory Committee on Human Radiation Experiments was created by President Clinton to advise the Human Radiation Interagency Working Group on the ethical and scientific criteria applicable to human radiation experiments carried out or sponsored by the U.S. Government. The Committee seeks to answer several fundamental question: What ethics criteria should be used to evaluate human radiation experiments? What was the Federal Government's role in human radiation experiments? What are the criteria for determining appropriate Federal responses where wrongs or harms have occurred? What lessons learned from studying past and present research standards and practices should be applied to the future? The Committee has been gathering vast amounts of information and working to render it orderly and accessible. In the next six months, the Committee will continue with the tasks of data gathering and organizing. The focus of the work, however, will be developing criteria for judging historical and contemporary experiments, policies, and procedures, as well as criteria for remedies that may be appropriate where harms or wrongs have ocurred. Based on findings, the Committee will make specific recommendations regarding policies for the future

Interim report of the Advisory Committee on human radiation experiments

Energy Technology Data Exchange (ETDEWEB)

1994-10-21

The Advisory Committee on Human Radiation Experiments was created by President Clinton to advise the Human Radiation Interagency Working Group on the ethical and scientific criteria applicable to human radiation experiments carried out or sponsored by the U.S. Government. The Committee seeks to answer several fundamental question: What ethics criteria should be used to evaluate human radiation experiments? What was the Federal Government`s role in human radiation experiments? What are the criteria for determining appropriate Federal responses where wrongs or harms have occurred? What lessons learned from studying past and present research standards and practices should be applied to the future? The Committee has been gathering vast amounts of information and working to render it orderly and accessible. In the next six months, the Committee will continue with the tasks of data gathering and organizing. The focus of the work, however, will be developing criteria for judging historical and contemporary experiments, policies, and procedures, as well as criteria for remedies that may be appropriate where harms or wrongs have ocurred. Based on findings, the Committee will make specific recommendations regarding policies for the future.

Implicit and explicit clinical ethics support in The Netherlands: a mixed methods overview study

NARCIS (Netherlands)

Dauwerse, L.; Weidema, F.C.; Abma, T.; Molewijk, A.C.; Widdershoven, G.

2014-01-01

Internationally, the prevalence of clinical ethics support (CES) in health care has increased over the years. Previous research on CES focused primarily on ethics committees and ethics consultation, mostly within the context of hospital care. The purpose of this article is to investigate the

Communicating Qualitative Research Study Designs to Research Ethics Review Boards

Science.gov (United States)

Ells, Carolyn

2011-01-01

Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…

Historical Roots and Future Perspectives Related to Nursing Ethics.

Science.gov (United States)

Freitas, Lorraine

1990-01-01

This article traces the evolution of the development and refinement of the professional code from concerns about the ethical conduct of nurses to its present state as a professional code for all nurses. The relationship of the Ethics Committee of the American Nurses' Association to the development of the code is also discussed. (Author/MLW)

Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

Science.gov (United States)

Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-01-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

[Implementation of ethics services. Opportunities and obstacles].

Science.gov (United States)

Salomon, F

2015-04-01

Medical success in the last century has caused situations, in which the question arises whether therapy is right. In the same time autonomy has become more and more important. Furthermore, human beings want to decide on health, life and dying. Experience of limitations of life and desire of autonomy in healthcare lead to ethical questions. Different ethical services were established to deal with and to solve problems. Ethics committees with multiprofessional members and different qualifications will give guidance in critical decision making. Ethics services do not receive responsibility for the decision, but helps those who are responsible by structured reflection, estimation of values and including all concerned. Implementing ethics services also encounters obstructions and scepticism. Time, responsibility for therapy and criticism of customs and structures must be considered to perpetuate success. Instructions for implementing ethics services are presented.

Why Are There So Few Ethics Consults in Children's Hospitals?

Science.gov (United States)

Carter, Brian; Brockman, Manuel; Garrett, Jeremy; Knackstedt, Angie; Lantos, John

2017-10-03

In most children's hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children's hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are (1) ethics committee meetings, (2) Nursing Ethics Forum, (3) ethics Brown Bag workshops, (4) PICU ethics rounds, (5) Grand Rounds, (6) NICU Comprehensive Care Rounds, (7) Palliative Care Team (PaCT) case conferences, (8) multidisciplinary consults in Fetal Health Center, and (9) ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of "core competencies" than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple "moral spaces" in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set

Ethics consultation on demand: concepts, practical experiences and a case study

OpenAIRE

Reiter-Theil, S.

2000-01-01

Despite the increasing interest in clinical ethics, ethics consultation as a professional service is still rare in Europe. In this paper I refer to examples in the United States. In Germany, university hospitals and medical faculties are still hesitant about establishing yet another "committee". One of the reasons for this hesitation lies in the ignorance that exists here about how to provide medical ethics services; another reason is that medical ethics itself is not yet institutionalised at...

Nurses' contributions to the resolution of ethical dilemmas in practice.

Science.gov (United States)

Barlow, Nichola Ann; Hargreaves, Janet; Gillibrand, Warren P

2018-03-01

Complex and expensive treatment options have increased the frequency and emphasis of ethical decision-making in healthcare. In order to meet these challenges effectively, we need to identify how nurses contribute the resolution of these dilemmas. To identify the values, beliefs and contextual influences that inform decision-making. To identify the contribution made by nurses in achieving the resolution of ethical dilemmas in practice. An interpretive exploratory study was undertaken, 11 registered acute care nurses working in a district general hospital in England were interviewed, using semi-structured interviews. In-depth content analysis of the data was undertaken via NVivo coding and thematic identification. Participants and context: Participants were interviewed about their contribution to the resolution of ethical dilemmas within the context of working in an acute hospital ward. Participants were recruited from all settings working with patients of any age and any diagnosis. Ethical considerations: Ethical approval was obtained from the local National Research Ethics Committee. Four major themes emerged: 'best for the patient', 'accountability', 'collaboration and conflict' and 'concern for others'. Moral distress was also evident in the literature and findings, with moral dissonance recognised and articulated by more experienced nurses. The relatively small, single-site sample may not account for the effects of organisational culture on the results; the findings suggested that professional relationships were key to resolving ethical dilemmas. Nurses use their moral reasoning based on their beliefs and values when faced with ethical dilemmas. Subsequent actions are mediated though ethical decision-making frames of reference including deontology, consequentialism, the ethics of care and virtue ethics. Nurses use these in contributing to the resolution of these dilemmas. Nurses require the skills to develop and maintain professional relationships for addressing

Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation.

Science.gov (United States)

Northway, Ruth; Howarth, Joyce; Evans, Lynne

2015-02-01

The aim of this paper is to explore how making reasonable adjustments to the process of securing ethical approval for research can facilitate the meaningful involvement of people with intellectual disabilities as members of a research team. This is achieved through critical reflection upon the approach taken within one participatory research study whose objective was to explore how people with intellectual disabilities understand abuse. Internationally participatory research studies (in which active involvement of community members in all stages of the research process is sought) are becoming increasingly common in the context of health care and, more specifically, within research involving people with intellectual disabilities. However, whilst it is acknowledged that participatory research gives rise to specific ethical challenges, how (or if) involvement in securing ethical approval is facilitated, is not discussed in most research reports. The significance of this paper is that it seeks to address this gap by exploring how meaningful participation can be promoted by making reasonable adjustments. Within the study, the research team worked in collaboration with the ethics committee to identify potential barriers that could prevent the participation of members of the research team who had intellectual disabilities. Reasonable adjustments (such as redesigning forms) were made to the processes involved in securing ethical approval. This study demonstrated that it is possible to ensure that ethical standards are upheld and the requirements of ethics committees met whilst also facilitating the meaningful involvement of people with intellectual disabilities. The reasonable adjustments approach explored within this paper can be translated into the context of clinical practice: making changes to the way that services are delivered can promote greater involvement of people with intellectual disabilities in their own health care. © 2014 John Wiley & Sons Ltd.

Ethics curriculum for emergency medicine graduate medical education.

Science.gov (United States)

Marco, Catherine A; Lu, Dave W; Stettner, Edward; Sokolove, Peter E; Ufberg, Jacob W; Noeller, Thomas P

2011-05-01

Ethics education is an essential component of graduate medical education in emergency medicine. A sound understanding of principles of bioethics and a rational approach to ethical decision-making are imperative. This article addresses ethics curriculum content, educational approaches, educational resources, and resident feedback and evaluation. Ethics curriculum content should include elements suggested by the Liaison Committee on Medical Education, Accreditation Council for Graduate Medical Education, and the Model of the Clinical Practice of Emergency Medicine. Essential ethics content includes ethical principles, the physician-patient relationship, patient autonomy, clinical issues, end-of-life decisions, justice, education in emergency medicine, research ethics, and professionalism. The appropriate curriculum in ethics education in emergency medicine should include some of the content and educational approaches outlined in this article, although the optimal methods for meeting these educational goals may vary by institution. Copyright © 2011 Elsevier Inc. All rights reserved.

Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk).

Science.gov (United States)

Sharkey, Siobhan; Jones, Ray; Smithson, Janet; Hewis, Elaine; Emmens, Tobit; Ford, Tamsin; Owens, Christabel

2011-12-01

The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a 'report' button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them.

An overview of the major changes in the 2002 APA Ethics Code.

Science.gov (United States)

Knapp, Samuel; VandeCreek, Leon

2003-06-01

This article summarizes the major changes that were made to the 2002 Ethical Principles and Code of Conduct of the American Psychological Association. The 2002 Ethics Code retains the general format of the 1992 Ethics Code and does not radically alter the obligations of psychologists. One goal of the Ethics Committee Task Force was to reduce the potential of the Ethics Code to be used to unnecessarily punish psychologists. In addition, the revised Ethics Code expresses greater sensitivity to the needs of cultural and linguistic minorities and students. Shortcomings of the 2002 Ethics Code are discussed.

Ethical evaluation of research proposals by ethics panels advising the European Commission.

Science.gov (United States)

Kolar, Roman

2004-06-01

Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.

Employer Requirements to Work during Emergency Responses: Key Ethics Considerations.

Science.gov (United States)

Rutkow, Lainie; Taylor, Holly A; Powell, Tia

2017-03-01

Local health departments and their employees are at the forefront of emergency preparedness and response. Yet, recent studies have found that some local public health workers are unwilling to report to work in a variety of disaster scenarios. This can greatly compromise a response, as many local health departments need "all hands on deck" to effectively meet increased demands. To address these concerns, local health departments have employed varied policy strategies to ensure that employees do report to work. After describing different approaches taken by local health departments throughout the United States, we briefly identify and explore key ethics considerations that arise for local health departments when employees are required to report to work for emergency responses. We then discuss how these ethics considerations may inform local health department practices intended to promote a robust emergency response.

[Ethics of research in psychiatry. Comparison of France and the United States].

Science.gov (United States)

Lemoine, P; Pacault-Legendre, V

1983-01-01

This article presents a comparison of research ethics in psychopharmacology in France and the United States. The authors present some elements of definition, etymology and of history. In addition, they study how this very specific research is actually done. Many questions are discussed, including the right of the patient, and the problem of normal volunteers. Other aspects are more technical i.e. remuneration, protocol, and the product. Finally the role of the ethics committees is investigated. These committees comprise the third component of the trial that consists of the research and the subject.

Guyana - How Do You Know Where to Get the Information You Need? Determining Ethics Approval Requirements in a Developing Country

Directory of Open Access Journals (Sweden)

Gloria Song

2018-02-01

Full Text Available Determining the process for obtaining local research ethics approval, or whether such a requirement even exists, may not always be straightforward in the context of some developing countries where such information may not be easily accessible to overseas researchers. How far do a researcher's ethical obligations extend in determining whether there is a requirement for local research ethics approval, and what form this would take (e.g., institutional or centralised ethics review? In other words, how far should a researcher be expected to go in seeking out local ethics approval, especially where such information is not readily available? As part of this discussion, this case study describes the steps that I took as the principal researcher, before I was able to reasonably conclude that no national ethics approval requirement existed in Guyana for my particular research, which involved interviewing justice service providers about the implementation of Guyana's Domestic Violence Act. Drawing on this experience, I discuss various considerations that an international development researcher should bear in mind when planning and conducting research that seeks to meet leading international norms of research ethics.

Research on prisoners - a comparison between the IOM Committee recommendations (2006) and European regulations.

Science.gov (United States)

Elger, Bernice S; Spaulding, Anne

2010-01-01

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki.

Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

Science.gov (United States)

Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

2015-12-01

Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

Analysis of time to regulatory and ethical approval of SATVI TB ...

African Journals Online (AJOL)

Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...

The effect of nurses' ethical leadership and ethical climate perceptions on job satisfaction.

Science.gov (United States)

Özden, Dilek; Arslan, Gülşah Gürol; Ertuğrul, Büşra; Karakaya, Salih

2017-01-01

The development of ethical leadership approaches plays an important role in achieving better patient care. Although studies that analyze the impact of ethical leadership on ethical climate and job satisfaction have gained importance in recent years, there is no study on ethical leadership and its relation to ethical climate and job satisfaction in our country. This descriptive and cross-sectional study aimed to determine the effect of nurses' ethical leadership and ethical climate perceptions on their job satisfaction. The study sample is composed of 285 nurses who agreed to participate in this research and who work at the internal, surgical, and intensive care units of a university hospital and a training and research hospital in İzmir, Turkey. Data were collected using Ethical Leadership Scale, Hospital Ethical Climate Scale, and Minnesota Satisfaction Scale. While the independent sample t-test, analysis of variance, Mann-Whitney U test, and Kruskal-Wallis test were used to analyze the data, the correlation analysis was used to determine the relationship between the scales. Ethical considerations: The study proposal was approved by the ethics committee of the Faculty of Medicine, Dokuz Eylül University. The nurses' mean scores were 59.05 ± 14.78 for the ethical leadership, 92.62 ± 17 for the ethical climate, and 62.15 ± 13.46 for the job satisfaction. The correlation between the nurses' ethical leadership and ethical climate mean scores was moderately positive and statistically significant (r = +0.625, p = 0.000), was weak but statistically significant between their ethical leadership and job satisfaction mean scores (r = +0.461, p = 0.000), and was moderately positive and statistically significant between their ethical climate and job satisfaction mean scores (r = +0.603, p = 0.000). The nurses' ethical leadership, ethical climate, and job satisfaction levels are moderate, and there is a positive relationship between them. The nurses' perceptions of ethical

Ethnographic research with adolescent students: situated fieldwork ethics and ethical principles governing human research.

Science.gov (United States)

Hemmings, Annette

2009-12-01

This paper explores ethical dilemmas in situated fieldwork ethics concerning ethnographic studies of adolescent students. While consequentialist and deontological ethics form the basis of the ethical stances shared by ethnographers and research ethics committees, the interpretation of those principles may diverge in school-based ethnography with adolescent students because of the particular role of the adult ethnographer vis-à-vis developmentally immature adolescents not held legally responsible for many of their actions. School ethnographers attempt to build trust with adolescent participants in order to learn about their hidden cultural worlds, which may involve activities that are very harmful to the youths involved. They face many difficult and sometimes unexpected choices, including whether to intervene and how to represent events and adolescents in published findings. Scenarios with examples drawn from research conducted in public high schools are used to illustrate and explicate dilemmas in formal research and latent insider/outsider roles and relations involving harmful adolescent behaviors, advocacy, and psychological trauma. Also examined are analytical procedures used to construct interpretations leading to representations of research participants in the resulting publication.

[Centenary of the Health Council of the Netherlands. V. Ethical-social issues

NARCIS (Netherlands)

Have, H.A.M.J. ten

2002-01-01

Since its inception, the Health Council of the Netherlands has included normative aspects in its reports. Over the past decades, ethics and rights have received increasing attention, particularly since the establishment of the Standing Committee on Medical Ethics and Health Law in 1977. In

Power supply and ethics

International Nuclear Information System (INIS)

Anon.

2004-01-01

The 'Power Supply and Ethics' workshop was designed on the basis of a recommendation by the Nuclear Technology Committee (FA-KT) of VDI-GET. The topic is part of a series of events and publications by VDI in an area where engineering and the humanities converge. The Workshop comprised presentations and thorough discussions of seven papers on 'Power Supply and Ethics', reflecting a variety of contents and points of view of the different disciplines participating. The Workshop offered another opportunity to take the initiative and influence the public, especially politics. Other activities are planned which also the participants increasingly consider an obligation to the public. (orig.) [de

Review: Will van den Hoonaard (Ed. (2002. Walking the Tightrope: Ethical Issues for Qualitative Researchers

Directory of Open Access Journals (Sweden)

Rod Gerber

2004-05-01

Full Text Available This publication basically represents a collection of former conference papers and some other contributions mainly by North American social scientists on the dilemmas that qualitative researchers encounter when they submit research applications to research ethics committees. Collectively, the contributions demonstrate the tensions that exist in the policy and practice of applied research ethics in qualitative research. Thirteen chapters are included in this volume. They focus on the themes of: differentiating between ethics and morality; dealing with ethics committees and policies; research processes; research ethics trends; and, ethical issues when submitting research applications. The emphasis is on research policy in a North American context (Canada and the United States, but can be relevant for qualitative researchers in other parts of the world. One challenge to this context is that it does not capture the essence of some European perspectives, especially those from Continental Europe. However, it does raise the issue of ethics in qualitative research to a high level. URN: urn:nbn:de:0114-fqs040214

48 CFR 2803.104-70 - Ethics program training requirements.

Science.gov (United States)

2010-10-01

... contracting officers and procurement officials. The Ethics Official should be contacted directly to schedule... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Ethics program training... General IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 2803.104-70 Ethics...

Opportunity to discuss ethical issues during clinical learning experience.

Science.gov (United States)

Palese, Alvisa; Gonella, Silvia; Destrebecq, Anne; Mansutti, Irene; Terzoni, Stefano; Morsanutto, Michela; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Canzan, Federica; Ponte, Adriana Dal; De Biasio, Laura; Fascì, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Nicotera, Raffaela; Randon, Giulia; Tollini, Morena; Saiani, Luisa; Grassetti, Luca; Dimonte, Valerio

2018-01-01

Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues

The value of respect in human research ethics: a conceptual analysis and a practical guide.

Science.gov (United States)

Pieper, I J; Thomson, C J H

2014-01-01

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

Hazy Boundaries: Virtual Communities and Research Ethics

Directory of Open Access Journals (Sweden)

Helena Kantanen

2016-10-01

Full Text Available This paper examines ethical issues specific to research into virtual communities. Drawing on an empirical case with online forums of education experts, we identify the following key issues: publicity versus privacy of the community; the definition of human subjects research; participant recruitment; informed consent; and ethical questions associated with observing virtual communities, and with reporting and disseminating research results. We maintain that different research cultures in different countries can present challenges when studying global forums. Acknowledging the ephemeral characteristics of Internet contexts, this paper argues that ethical considerations should be more case-based, instead of relying on one model for all solutions. We suggest that local ethics committees or institutional review boards could, with their expert knowledge of ethics, provide valuable support for researchers operating in the complex and dynamic terrain of Internet research, as well as in fields and research settings where an ethical review is not a standard part of the research process.

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Ethical issues in personality assessment in forensic psychology.

Science.gov (United States)

Knapp, S; VandeCreek, L

2001-10-01

In this article we address several ethical issues of concern for psychologists who are engaged in personality assessment in forensic settings such as for courts or attorneys. The ethical issues reviewed include the role of the psychologist as an expert witness, matters of competence, informed consent, confidentiality, multiple relationships, and special issues related to billing. Emphasis is placed on how psychologists can provide useful information to the courts in a manner consistent with the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct, the Committee on Ethical Guidelines for Forensic Psychologist's Specialty Guidelines for Forensic Psychologists, and the APA's Guidelines for Child Custody Evaluations in Divorce Proceedings. The practical recommendations made in this article are consistent with the APA's Ethical Principles of Psychologists and Code of Conduct.

Ethics of orthodontic clinical research based on Helsinki declaration

Directory of Open Access Journals (Sweden)

Eka Erwansyah

2016-06-01

Full Text Available Declaration of Helsinki code of ethics on human experimentation, states that the desin and peformance of experimental procedures involving human should be clearly formulated in an experimental protocol, Todeterminewhetheraninvestigationin accordancewiththe code of conductin a researchthen letusconsider the contentofthe declarationhelsinkiasour referencein conductingaclinicalstudyusinghuman subjects. In journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian.

Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

Science.gov (United States)

McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

2010-03-21

Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

Focus on the Activity of a Local Ethics Committee in Italy

Directory of Open Access Journals (Sweden)

Pamela Barbadoro

2008-06-01

Full Text Available

Background: The continuing evolution of medical treatments and the loss of neutrality of medicine with respect to morality of human values have represented the major tracking elements towards settings of sharing of choices between society and medicine. Several concerns have been raised upon links between pharmaceutical corporations and researchers. Moreover, being in a learning environment, we must pay even more attention to these items because students appear to be at risk for unrecognized influence by marketing efforts. The aim of this study is to focus on the activities of a local ethics committee (LEC and the characteristics of the protocols discussed in an Italian LEC during a three year period (2001-2003.

Methods: Three years of activity of a LEC were analysed by a questionnaire registering: main sponsorship, setting, technical characteristics of trials, outcome of the submission to the LEC, state of progress. Approved trials were followed-up until April 30th, 2005.

Results: A total of 345 protocols were discussed. 67.8% (n = 198 of approved protocols were submitted by a pharmaceutical corporation. 72.6% (n = 212 of studies approved in 2001 were still in progress in 2005. 91.3% (n = 73 of closed trials had a pharmaceutical corporation as their main sponsor. None of the submitted studies focused on prevention strategies.

Conclusions: These results show how important grants offered by pharmaceutical industries are, the efforts spent on therapy and the lack of investors in prevention.

AGU Committees

Science.gov (United States)

Administrative Committees are responsible for those functions required for the overall performance or well-being of AGU as an organization. These committees are Audit and Legal Affairs, Budget and Finance*, Development, Nominations*, Planning, Statutes and Bylaws*, Tellers.Operating Committees are responsible for the policy direction and operational oversight of AGU's primary programs. The Operating Committees are Education and Human Resources, Fellows*, Information Technology, International Participation*, Meetings, Public Affairs, Public Information, Publications*.

Research ethics and approval process: A guide for new GP researchers.

Science.gov (United States)

Liaw, Siaw-Teng; Tam, Chun Wah Michael

2015-06-01

The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.

Innovations in research ethics governance in humanitarian settings.

Science.gov (United States)

Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome

2015-02-26

Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out

Ethical issues in action-oriented research in Indonesia.

Science.gov (United States)

Rachmawaty, Rini

2017-09-01

Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies

Ethical considerations in implementing a biometric co-enrol- ment ...

African Journals Online (AJOL)

The biometrics co-enrolment prevention system (BCEPS) is a novel ... capture participant's identification details in real time was approved by the SAMRC Ethics Committee. ... for guidelines and standard operating procedures (SOPs) for the.

Ethical challenges facing veterinary professionals in Ireland: results from Policy Delphi with vignette methodology

Science.gov (United States)

Magalhães-Sant'Ana, M.; More, S. J.; Morton, D. B.; Hanlon, A.

2016-01-01

Ethics is key to the integrity of the veterinary profession. Despite its importance, there is a lack of applied research on the range of ethical challenges faced by veterinarians. A three round Policy Delphi with vignette methodology was used to record the diversity of views on ethical challenges faced by veterinary professionals in Ireland. Forty experts, comprising veterinary practitioners, inspectors and nurses, accepted to participate. In round 1, twenty vignettes describing a variety of ethically challenging veterinary scenarios were ranked in terms of ethical acceptability, reputational risk and perceived standards of practice. Round 2 aimed at characterising challenges where future policy development or professional guidance was deemed to be needed. In round 3, possible solutions to key challenges were explored. Results suggest that current rules and regulations are insufficient to ensure best veterinary practices and that a collective approach is needed to harness workable solutions for the identified ethical challenges. Challenges pertaining mostly to the food chain seem to require enforcement measures whereas softer measures that promote professional discretion were preferred to address challenges dealing with veterinary clinical services. These findings can support veterinary representative bodies, advisory committees and regulatory authorities in their decision making, policy and regulation. PMID:27613779

Women, children and advertising - legal and ethical aspects

OpenAIRE

Stejskalová, Radka

2012-01-01

The thesis titled "Women, children and advertising - legal and ethical aspects" deals with the portrayal of women and children in advertising. The aim of the thesis is to analyze advertising with a focus on the portrayal of women and children present to Arbitration Committee in the reporting period and propose recommendations for the future. The work also deals with the importance of legal and ethical rules that regulate advertising and focuses on content regulation of women and children.

Do organizational and clinical ethics in a hospital setting need different venues?

Science.gov (United States)

Førde, Reidun; Hansen, Thor Willy Ruud

2014-06-01

The structure of ethics work in a hospital is complex. Professional ethics, research ethics and clinical ethics committees (CECs) are important parts of this structure, in addition to laws and national and institutional codes of ethics. In Norway all hospital trusts have a CEC, most of these discuss cases by means of a method which seeks to include relevant guidelines and laws into the discussion. In recent years many committees have received more cases which have concerned questions of principle. According to Ellen Fox and co-authors the traditional CEC model suffers from a number of weaknesses. Therefore, in their organization a separate body deals with organizational matters. In this paper, we discuss what is gained and what is lost by creating two separate bodies doing ethics consultation. We do this through an analysis of detailed minutes of CEC discussions in one CEC during a 6-year period. 30 % of all referrals concerned matters of principle. Some of these discussions originated in a dilemma related to a particular patient. Most of the discussions had some consequences within the hospital organization, for clinical practice, for adjustment of guidelines, or may have influenced national policy. We conclude that a multiprofessional CEC with law and ethics competency and patient representation may be well suited also for discussion of general ethical principles. A CEC is a forum which can help bridge the gap between clinicians and management by increasing understanding for each others' perspectives.

76 FR 18800 - NASA Advisory Council; Information Technology Infrastructure Committee; Meeting

Science.gov (United States)

2011-04-05

... Network Support IT Security Risk Management Ethics Briefing IT Committee Work Plan Actions/Assignments..., company affiliation (if applicable) to include address, telephone number, and their title, place of birth...

An Educational Program of Engineering Ethics and Its Dissemination Activity

Science.gov (United States)

Muramatsu, Ryujiro; Nagashima, Shigeo

Education on ethics for corporate employees, especially for engineers, seems to become increasingly important for most of companies in Japan, because some affairs or scandals caused by ethical problem in many companies were likely to subject them to operational disadvantages. Even in Hitachi, Ltd., we have worked on education of engineering ethics for two years. In this paper, we describe some activities of committees on engineering ethics, an e-learning training course which is usable on our intranet e-learning system, and a short-term in-house training course operated regularly in our training institute. And we also refer to its dissemination activities to employees in each division and some subsidiaries.

Preliminary ethical appraisal of a trial - what's it all about?

Science.gov (United States)

Siipi, Helena

Preliminary ethical appraisal of medical trials is often based on the following four principles: respect for autonomy, beneficence, non-maleficence, and justice. Preliminary ethical appraisal should, however, not be understood solely as application of these four principles to practice. Ethical committees will inevitably interpret the principles and make decisions about their reciprocal importance in connection with each trial. Reasoning does not always proceed from above towards practical recommendations of action, but can instead also be based on a moral rule or practice relating to a certain action. A good preliminary ethical appraisal will also take into account everyday standards of morality, law and shared moral values of the society.

[Ethic review on clinical experiments of medical devices in medical institutions].

Science.gov (United States)

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

Science.gov (United States)

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

THE CHALLENGES OF BUSINESS ETHICS: THE BASIC PRINCIPLES OF BUSINESS ETHICS - ETHICAL CODEX IN BUSINESS

Directory of Open Access Journals (Sweden)

Anton Jamnik

2017-09-01

Full Text Available Past several decades management has become a vital concern to society. If we look at pools, we notice that the public does not have good opinion about management ethics and business. For the management community to turn this situation around, significant efforts are required. It should be understood what management ethics means, why it is important and how it should be integrated into decision making. Principles of ethics from moral philosophy and management theory are available to inform interested managers. Further requires that managers understand, and be sensitive to, all the stakeholders of the organization and their stakes. If the moral management model is to be achieved, managers need to integrate ethical wisdom with their managerial wisdom and to take steps to create and sustain an ethical climate in their organizations. When all that will be done, the desirable goals of moral management will be achievable.

External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE pilot trial

Directory of Open Access Journals (Sweden)

Sheila M. Bird

2017-03-01

Full Text Available The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released.

INDIAN ACADEMY OF SCIENCES Scientific Values: Ethical ...

Indian Academy of Sciences (India)

vedamurthy

Science has many applied ... activities pursued by the Fellows not only involve conducting research and publishing its results, but ... See for example, the announcements on “ethical guidelines for biomedical research on human .... therefore it is important for the selection committee members to study each case carefully.

Comités de ética independientes para la investigación clínica en la Argentina: Evaluación y sistema para garantizar su independencia Independent ethics committees for clinical research in Argentina: An evaluation and a system to guarantee their independence

Directory of Open Access Journals (Sweden)

Sergio E. Gonorazky

2008-04-01

Full Text Available La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT exige para la ejecución de protocolos de investigación de nuevos fármacos en seres humanos, que éstos sean previamente evaluados y aprobados por un denominado comité de ética independiente de los patrocinadores e investigadores. Sin embargo, esta evaluación es lucrativa y la elección del comité de ética independiente es realizada por el patrocinador y/o investigador, lo que convierte la supuesta independencia en una relación del tipo "prestador de servicio - cliente". El Consejo de Revisión Institucional de Estudios de Investigación del Hospital Privado de Comunidad de Mar del Plata evaluó, entre los años 2005 y 2006, treinta y tres protocolos (con sus correspondientes hojas de información al paciente y consentimientos informados aprobados previamente por un comité de ética independiente no institucional. La mediana de objeciones relevantes realizadas por este Consejo de Revisión a los mencionados protocolos, que obligaron a que sean modificados para luego ser aprobados, fue de tres por protocolo. La acreditación de los Comités de Ética Independiente exige un sistema que garantice la real independencia de éstos de los patrocinadores y/o investigadores a la vez que mecanismos de control de gestión que incluyan una eventual pérdida de la acreditación. Este trabajo propone algunas medidas concretas para corregir las deficiencias del sistema actual.The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the

77 FR 50985 - National Advisory Committee for Implementation of the National Forest System Land Management...

Science.gov (United States)

2012-08-23

... following business will be conducted: (1) Determine the scope and initial tasks of the committee, (2) ethics... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of... Management Planning Rule will meet in Washington, DC. The committee operates in compliance with the Federal...

Sunk cost and work ethic effects reflect suboptimal choice between different work requirements.

Science.gov (United States)

Magalhães, Paula; White, K Geoffrey

2013-03-01

We investigated suboptimal choice between different work requirements in pigeons (Columba livia), namely the sunk cost effect, an irrational tendency to persist with an initial investment, despite the availability of a better option. Pigeons chose between two keys, one with a fixed work requirement to food of 20 pecks (left key), and the other with a work requirement to food which varied across conditions (center key). On some trials within each session, such choices were preceded by an investment of 35 pecks on the center key, whereas on others they were not. On choice trials preceded by the investment, the pigeons tended to stay and complete the schedule associated with the center key, even when the number of pecks to obtain reward was greater than for the concurrently available left key. This result indicates that pigeons, like humans, commit the sunk cost effect. With higher work requirements, this preference was extended to trials where there was no initial investment, so an overall preference for the key associated with more work was evident, consistent with the work ethic effect. We conclude that a more general work ethic effect is amplified by the effect of the prior investment, that is, the sunk cost effect. Copyright © 2013 Elsevier B.V. All rights reserved.

Impact of the economic crisis on the activity of a clinical research ethics committee

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Paula Arcenillas

2014-11-01

Full Text Available Purpose: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT and observational studies (ES from the activity of an Research Ethics Committee (REC. Method: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1 promoted by pharmaceutical industry, 2 by scientific societies with industry support, 3 by scientific societies with government support and 4 unfunding.Two periods were compared: pre-crisis (2003-2007 and crisis (2008-2012. Results: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Conclusions: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

International Capacity-Building Initiatives for National Bioethics Committees.

Science.gov (United States)

Gefenas, Eugenijus; Lukaseviciene, Vilma

2017-05-01

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy-makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise ethical dilemmas that traverse national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity-building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low- and middle-income countries. © 2017 The Hastings Center.

Ethical Implications of the Electronic Health Record: In the Service of the Patient.

Science.gov (United States)

Sulmasy, Lois Snyder; López, Ana María; Horwitch, Carrie A

2017-08-01

Electronic health records (EHRs) provide benefits for patients, physicians, and clinical teams, but also raise ethical questions. Navigating how to provide care in the digital age requires an assessment of the impact of the EHR on patient care and the patient-physician relationship. EHRs should facilitate patient care and, as an essential component of that care, support the patient-physician relationship. Billing, regulatory, research, documentation, and administrative functions determined by the operational requirements of health care systems, payers, and others have resulted in EHRs that are better able to satisfy such external functions than to ensure that patient care needs are met. The profession has a responsibility to identify and address this mismatch. This position paper by the American College of Physicians (ACP) Ethics, Professionalism and Human Rights Committee does not address EHR design, user variability, meaningful use, or coding requirements and other government and payer mandates per se; these issues are discussed in detail in ACP's Clinical Documentation policy. This paper focuses on EHRs and the patient-physician relationship and patient care; patient autonomy, privacy and confidentiality; and professionalism, clinical reasoning and training. It explores emerging ethical challenges and concerns for and raised by physicians across the professional lifespan, whose ongoing input is crucial to the development and use of information technology that truly serves patients.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Ética e investigación Ethics and investigation

Directory of Open Access Journals (Sweden)

Salomón Zavala

2011-12-01

Full Text Available Los autores hacen una evaluación crítica de los aspectos éticos de la investigación en base a su experiencia como docentes universitarios y como miembros de Comités de Ética en Investigación. Invitan a la discusión de temas que consideran polémicos. Comienzan mencionando el rol regulador de las Normas Éticas Internaciones y Locales y de los Comités de Ética en Investigación. Comentan la postura de bioeticistas sudamericanos respecto del llamado "doble estándar" ético y sobre la liberalización del uso del placebo. Critican el perjuicio que ocasiona a los pacientes de bajos recursos el sistema de patentes así como la falta de interés en el desarrollo de nuevos medicamentos para tratar enfermedades raras o propias de países pobres, y la excesiva extensión de los Consentimientos Informados. Terminan opinando acerca de la distribución de los ensayos clínicos entre los investigadores, los problemas que afectan a los Comités de Ética en Investigación y sobre algunos contenidos del Reglamento de Ensayos Clínicos del Instituto Nacional de Salud.The authors make a critical evaluation of the ethical aspects of research based on their experience as university teachers and members of Ethics Committees. They invite to the discussion on topics that they consider polemic. They begin by mentioning the regulatory role of the International and Local Ethical Norms and of the Ethics Committees. They comment on the position of South American bioethicists regarding the so-called ethical "double standard" and on the liberalization of the use of the placebo. They criticize the damage that the system of patents causes on low- resources patients, as well as the lack of interest in the development of new medications to treat neglected diseases or those diseases which are only prevalent in poor countries, and the excessive length of the Informed Consents. They finish giving their opinion about the distribution of the clinical trials among the

Ethics in Online Publications.

Science.gov (United States)

Vervaart, Peter

2014-10-01

Journals have been publishing the results of scientific investigations since the founding of Philosophical Transactions in 1665. Since then we have witnessed a massive expansion in the number of journals to the point that there are now approximately 28,000 active, peer reviewed journals collectively publishing more than 1.8 million articles per year. Before the mid-1990s, these journals were only available on paper but by the end of the 20th century, most journals had moved to online platforms. Online publication has also served as the impetus for the move to 'open-access' to the information contained in journals. The fact that a publication is 'on-line' and 'open-access' does not negate the responsibility of the author and the publisher to publish in an ethical way. [1] The document produced by the IFCC Ethics Task Force (TF-E) on publication ethics states that 'Ethics in Science at its broadest level encompasses research ethics, medical ethics, publication ethics, conflicts of interest, ethical responsibilities as educator, plus many other areas.' Thus publication ethics is a continuum from the first step of research design through to the information being read by the reader. In general terms 'publication ethics' includes the ethical behaviour of the authors in writing and submitting a scientific manuscript to a publisher for the purpose of publication, thus any discussion of publication ethics must include the role of the authors, referees, publisher and reader and the issues of authorship (and the use of 'ghosts'), plagiarism, duplicate publication (including in different languages), image manipulation (particularly in the era of digitisation), and conflict of interest [2]. To aid the authors, and others involved in the process of publication, a number of resources are now available particularly those from the Committee on Publication Ethics (COPE) [3] and the World Association of Medical Editors (WAME) [4]. More recently the issue of 'publisher ethics' has

Methodologic and ethical ramifications of sex and gender differences in public health research.

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Lawrence, Kitty; Rieder, Anita

2007-01-01

Experience and investigative studies have shown that inequalities still exist between the sexes as well as in how public health policies and strategies approach the needs of the sexes. Sufficient attention has not been given to gender in public health research. Gender-based differences and similarities need to be promoted, and more structured guidelines are needed to build gender into public health research models. The aim of this review was to investigate and discuss public health research and to answer several related questions on gender biases, ethics and methodologies, and the establishment of guidelines. Using the search terms public health research and gender , or ethics , gender , and public health, a literature search was conducted predominately with, but not limited to, the PubMed database. English- or German-language articles were identified that examined the current status of gender in public health research as well as any relevant ethical guidelines. A review of the current literature showed that much work has been undertaken to promote the inclusion of gender in health research. However, deficiencies in the extent of gender-oriented research have been found in a number of key areas, including ethics committees and public health research methodology. Women were found to be underrepresented in ethics committees, which lack clear guidance, particularly in the European Union, to ensure the inclusion of gender issues in public health research. Data are often not sex disaggregated, and information on gender and social circumstances are frequently lacking. Furthermore, some methodologies, such as those used in the field of occupational health, underestimate men's or women's burden of disease. Recommendations include establishing guidelines for researchers on how to incorporate gender in health research, ensuring that the composition of ethics committees is more representative of society, and recommending that data collection systems or bodies ensure that data

[Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

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Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

2015-01-01

Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

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Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

2018-02-15

There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

Ethics of safety reporting of a clinical trial

Directory of Open Access Journals (Sweden)

Amrita Sil

2017-01-01

Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

78 FR 55692 - Electricity Advisory Committee

Science.gov (United States)

2013-09-11

... amended, 5 U.S.C., App. 2, to provide advice to the U.S. Department of Energy (DOE) in implementing the....-1:00 p.m. Swearing in Ceremony and Ethics Briefing--For New EAC Members 12:00 p.m.-1:00 p.m. EAC Leadership Committee Meeting 12:00 p.m.-1:00 p.m. Registration 1:00 p.m.-1:15 p.m. Welcome and Developments...

Ethical review in Pakistan: the credibility gap.

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Jafarey, Aamir Mustafa; Iqbal, Saima Pervaiz; Hassan, Mariam

2012-12-01

The concept of mandatory ethical review of research involving human participants is gradually taking root in Pakistani institutions. Based on the opinions of Institutional Review Board (IRB) members from institutions across the country, the process faces several challenges which threaten its integrity. The lack of registration or accreditation for IRBs has resulted in a wide variation in the calibre and working of such Boards. Despite the recent growth in numbers of people with formal bioethics degrees in the country, a majority of membership remains without any formal training for the work expected from them in ethical review. External pressures to influence deliberations, conflict of interest issues within board leadership and inconsistent application of review requirements all contribute in undermining the reliability of the process. Some of the most significant threats to independent and uninfluenced functioning of such boards arise from institutional leadership itself. In the opinions of IRB members, the review process has to be uniform, consistent and trustworthy if it is to gain the respect of researchers, and IRB need to be given the autonomous space to make independent decisions. Otherwise there is a real danger of IRBs being relegated to being no more than rubber stamping committees.

Ethical bodies: are they possible under democratic systems? The Turkish example.

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Arda, Berna

2009-09-01

In this article, the relationship between ethics bodies and democratic concepts will be introduced. One should bear in mind that the relationship between the flourishing of ethics committees (EC) and democracy is by no means undirectional. The line of causation can easily be reversed as a higher level of democracy is likely to lead to a spurt in such committees at different levels of society. It is not a coincidence that they appear in larger numbers in relatively more open and democratic societies. In this sense, their sheer existence might be taken as a sign of a higher level of awareness for openness and democracy. EC seems to have some functions theoretically: To contribute to the eradication of corruption in society; To increase the accountability of different sections of the population; To play an important part in increasing the awareness about the rights and duties; To contribute to the spread of self-disciplining behavior in society; One final point to be emphasized is that for ethical committees to fulfill the above functions they should have a clear set of guidelines, powers to enforce them and effective deterrents to prevent wayward behavior. The principal question of how it does works in Turkey--a country located at the junction of Europe and Asia--ought to be perceived from the point of view of a medical ethicist from a developing country.

A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making.

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McCulloch, Steven P; Reiss, Michael J

2018-06-07

Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE, foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Council and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an "Ethics Council for Animal Policy" to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs) and examine some widely used ethical frameworks (e.g., Banner's principles and the ethical matrix). The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i) Problematisation of the policy issue, (ii) utilitarian analysis, (iii) animal rights analysis, (iv) virtue-based analysis, (v) animal welfare ethic analysis, and (vi) integrated ethical analysis. The paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

Compassionate use programs in Italy: ethical guidelines.

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De Panfilis, Ludovica; Satolli, Roberto; Costantini, Massimo

2018-03-09

This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP. The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case (proposing physician and palliative physician) and with 3 components of the EC who played a major role in the EC internal discussion. In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient's quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the "simultaneous care" approach must be preferred. Secondly, 2) the EC's assessment must be part of the decision-making process

Clinical governance and research ethics as barriers to UK low-risk population-based health research?

Directory of Open Access Journals (Sweden)

Douglas Flora

2008-11-01

Full Text Available Abstract Background Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom. Methods Our paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research. Results Our mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers. Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case! Conclusion Research ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s, and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low

Ethical considerations in implementing a biometric co-enrolment ...

African Journals Online (AJOL)

The use of this web-based system to capture participant's identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their ...

Instrumental and ethical aspects of experimental research with animal models

Directory of Open Access Journals (Sweden)

Mirian Watanabe

2014-02-01

Full Text Available Experimental animal models offer possibilities of physiology knowledge, pathogenesis of disease and action of drugs that are directly related to quality nursing care. This integrative review describes the current state of the instrumental and ethical aspects of experimental research with animal models, including the main recommendations of ethics committees that focus on animal welfare and raises questions about the impact of their findings in nursing care. Data show that, in Brazil, the progress in ethics for the use of animals for scientific purposes was consolidated with Law No. 11.794/2008 establishing ethical procedures, attending health, genetic and experimental parameters. The application of ethics in handling of animals for scientific and educational purposes and obtaining consistent and quality data brings unquestionable contributions to the nurse, as they offer subsidies to relate pathophysiological mechanisms and the clinical aspect on the patient.

[Impact of the economic crisis on the activity of a clinical research ethics committee].

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Redondo Capafons, S; Arcenillas, Paula; Giménez, Nuria; March López, Pablo; Soriano, Laura; Pla, Ramon; Quintana, Salvador

2014-11-03

Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Ethical leadership outcomes in nursing.

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Barkhordari-Sharifabad, Maasoumeh; Ashktorab, Tahereh; Atashzadeh-Shoorideh, Foroozan

2017-01-01

Leadership style adopted by nursing managers is a key element in progress and development of nursing and quality of healthcare services received by the patients. In this regard, the role of ethical leadership is of utmost importance. The objective of the study was to elaborate on the ethical leadership and its role in professional progress and growth of nurses in the light of work condition in health providing institutes. The study was carried out as a qualitative study following conventional content analysis method. In total, 14 nursing faculty members and nursing managers at different levels were selected through purposive sampling method. Semi-structured interviews were used for data gathering. The data were analyzed using latent content analysis and constant comparison analysis. Ethical considerations: This study was conducted in accordance with ethical issues in research with human participants and national rules and regulations related to informed consent and confidentiality. The study was approved by the Committee of Ethics in Research at the Shahid Beheshti University of Medical Sciences in Tehran, Iran, under the code: sbmu.rec.1393.695 on 15 February 2015. Five subcategories were obtained based on the analysis, which constituted two main categories including "all-inclusive satisfaction" and "productivity." Nursing leaders highlighted the point that their ethical behavior creates "inner satisfaction of the leader," "employees' job satisfaction," and "patients' satisfaction." Improvement of productivity was another outcome of ethical behavior of the leaders. This kind of behavior resulted in "providing better services" and "inspiring ethical behavior in the employees." It has great influence on progress and growth of the nursing profession. By creating an ethical climate, ethical leadership leads to positive and effective outcomes-for the patients as well as for the nurses and the leaders-and professional progress and development of the nursing profession

The Role of the Theological Ethical Task Force in the University of Minnesota Program in Human Sexuality

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Yates, Wilson

1976-01-01

Describes the evolution of the Committee on Religion and Ethics, an interdisciplinary committee of theological and medical professors at the University of Minnesota. Its Sexual Attitude Reassessment seminars are the subject of much controversy. This article explains the purpose of the seminars. (HMV)

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

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Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Physician-Rating Web Sites: Ethical Implications.

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Samora, Julie Balch; Lifchez, Scott D; Blazar, Philip E

2016-01-01

To understand the ethical and professional implications of physician behavior changes secondary to online physician-rating Web sites (PRWs). The American Society for Surgery of the Hand (ASSH) Ethics and Professionalism Committee surveyed the ASSH membership regarding PRWs. We sent a 14-item questionnaire to 2,664 active ASSH members who practice in both private and academic settings in the United States. We received 312 responses, a 12% response incidence. More than 65% of the respondents had a slightly or highly unfavorable impression of these Web sites. Only 34% of respondents had ever updated or created a profile for PRWs, although 62% had observed inaccuracies in their profile. Almost 90% of respondents had not made any changes in their practice owing to comments or reviews. One-third of respondents had solicited favorable reviews from patients, and 3% of respondents have paid to improve their ratings. PRWs are going to become more prevalent, and more research is needed to fully understand the implications. There are several ethical implications that PRWs pose to practicing physicians. We contend that it is morally unsound to pay for good reviews. The recourse for physicians when an inaccurate and potentially libelous review has been written is unclear. Some physicians have required patients to sign a waiver preventing them from posting negative comments online. We propose the development of a task force to assess the professional, ethical, and legal implications of PRWs, including working with companies to improve accuracy of information, oversight, and feedback opportunities. It is expected that PRWs will play an increasing role in the future; it is unclear whether there will be a uniform reporting system, or whether these online ratings will influence referral patterns and/or quality improvement. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Ill-placed democracy: ethics consultations and the moral status of voting.

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Fiester, Autumn M

2011-01-01

As groups around the country begin to craft standards for clinical ethics consultations, one focus of that work is the proper procedure for conducting ethics consults. From a recent empirical look into the workings of ethics consult services (ECSs), one worrisome finding is that some ECSs rely on a committee vote when making a recommendation. This article examines the practice of voting and its moral standing as a procedural strategy for arriving at a clinical ethics recommendation. I focus here on the type of clinical ethics conflicts that are most likely to lead an ECS to vote, namely, conflicts involving ethical uncertainty--or, in the Greek, aporia. I argue that in cases of aporia, voting on an ethics conflict is not a morally justifiable procedure. Then on the same grounds that I use to show that voting is ethically problematic, I raise broader concerns about the common practice of making recommendations by other procedures. In contrast to the standard approach of adjudicating between moral claims, I argue that ECSs can best resolve aporetic conflict through the process of clinical ethics mediation.

THE ETHICS OF SHAM SURGERY IN PARKINSON'S DISEASE: BACK TO THE FUTURE?

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Swift, Teresa; Huxtable, Richard

2013-01-01

Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinson's Disease is provided here, followed by an analysis of the key ethical issues which such trials raise. PMID:22150772

Scepticism about the virtue ethics approach to nursing ethics.

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Holland, Stephen

2010-07-01

Nursing ethics centres on how nurses ought to respond to the moral situations that arise in their professional contexts. Nursing ethicists invoke normative approaches from moral philosophy. Specifically, it is increasingly common for nursing ethicists to apply virtue ethics to moral problems encountered by nurses. The point of this article is to argue for scepticism about this approach. First, the research question is motivated by showing that requirements on nurses such as to be kind, do not suffice to establish virtue ethics in nursing because normative rivals (such as utilitarians) can say as much; and the teleology distinctive of virtue ethics does not transpose to a professional context, such as nursing. Next, scepticism is argued for by responding to various attempts to secure a role for virtue ethics in nursing. The upshot is that virtue ethics is best left where it belongs - in personal moral life, not professional ethics - and nursing ethics is best done by taking other approaches.

Interactive Poster Survey Study of ACS Members' Knowledge and Needs on Research Ethics

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Mabrouk, Patricia Ann; Schelble, Susan M.

2018-01-01

An interactive poster exhibited at two poster sessions at the Fall 2016 American Chemical Society (ACS) National Meeting was used as a vehicle to learn about ACS members' concerns and needs related to research ethics and to identify opportunities for engagement of the Society by the Committee on Ethics (ETHX) and others in terms of ethics…

Ethics consultation on demand: concepts, practical experiences and a case study.

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Reiter-Theil, S

2000-06-01

Despite the increasing interest in clinical ethics, ethics consultation as a professional service is still rare in Europe. In this paper I refer to examples in the United States. In Germany, university hospitals and medical faculties are still hesitant about establishing yet another "committee". One of the reasons for this hesitation lies in the ignorance that exists here about how to provide medical ethics services; another reason is that medical ethics itself is not yet institutionalised at many German universities. The most important obstacle, however, may be that medical ethics has not yet demonstrated its relevance to the needs of those caring for patients. The Centre for Ethics and Law, Freiburg, has therefore taken a different approach from that offered elsewhere: clinical ethics consultation is offered on demand, the consultation being available to clinician(s) in different forms. This paper describes our experiences with this approach; practical issues are illustrated by a case study.

Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

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Glass, Kathleen Cranley; Kaufert, Joseph

2007-06-01

CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.

The Environmental and ethical basis of the geological disposal of long-lived radioactive waste. A collective opinion by the Radioactive Waste Management Committee (RWMC) of the OECD Nuclear Energy Agency

International Nuclear Information System (INIS)

1995-01-01

The report presents a consensus position of the national authorities in their search for appropriate solutions in the safe disposal of radioactive wastes in the form of a Collective Opinion of the Radioactive waste Management Committee (RWMC) of the OECD Nuclear Energy Agency. The Collective Opinion addresses the strategy for the final disposal of long-lived radioactive wastes seen from an environmental and ethical perspective, including considerations of equity and fairness within and between generations. (7 refs.)

Ethics, transplantation, and the changing role of anatomists.

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Satyapal, K S

2005-03-01

Anatomists are regarded as custodians of cadaveric material donated to science. Almost every facet of medical science has experienced explosive advances. This has impacted directly on anatomists and their role. Increasingly, anatomists are raising concerns with regard to the treatment of human tissue (Jones,2002, Clin. Anat. 15:436-440). The Korperwelten (Bodyworlds) of Gunther von Hagens et al. (1987, Anat. Embryol. 175:411-421) has evoked considerable debate about the treatment of human cadavers. Thus far clinical anatomists have had little role to play in policy formulation, legislation, and ethical imperatives as applied to cadaveric donation for organ transplantation. Anatomists play an even more negligible role in the raging ethical controversy around live related/unrelated organ transplantation. Due to the critical international shortage of cadaveric donors, boundaries are being pushed to meet the needs of potential recipients (Ohler,2001, Prog. Transplant. 11:160-161). Constant reappraisal of these ethical and moral issues is therefore appropriate. Issues that relate to cultural and economic imperialism and pronouncements of international transplant societies may also require re-evaluation. The legislature governing the donation of human tissue in various countries is usually governed by a Human Tissue Act or its equivalent. In general, such acts are congruent with the Human Tissue Act (South Africa: Government Gazette 9, November 2001; No. 22824) that states "It is an offense to charge a fee in relation to the donation of human organs." In many countries, however, various lay press report that "the sale of body parts is now coming of age." Terms such as "rewarded gifting" and "donors" being transformed into "vendors" are opening a Pandora's Box (Nelson et al.,1993, "Financial incentives for organ donation: a report on the UNOS ethics committee payment subcommittee"). Cameron and Hoffenberg (1999, Kidney Int. 55:724-732) feel strongly that arguments in

Teaching medical ethics and law.

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Parker, Malcolm

2012-03-01

The teaching of medical ethics is not yet characterised by recognised, standard requirements for formal qualifications, training and experience; this is not surprising as the field is still relatively young and maturing. Under the broad issue of the requirements for teaching medical ethics are numerous more specific questions, one of which concerns whether medical ethics can be taught in isolation from considerations of the law, and vice versa. Ethics and law are cognate, though distinguishable, disciplines. In a practical, professional enterprise such as medicine, they cannot and should not be taught as separate subjects. One way of introducing students to the links and tensions between medical ethics and law is to consider the history of law via its natural and positive traditions. This encourages understanding of how medical practice is placed within the contexts of ethics and law in the pluralist societies in which most students will practise. Four examples of topics from medical ethics teaching are described to support this claim. Australasian medical ethics teachers have paid less attention to the role of law in their curricula than their United Kingdom counterparts. Questions like the one addressed here will help inform future deliberations concerning minimal requirements for teaching medical ethics.

[The role of bioethics committees in the systems protecting scientific biomedical research participants in France and in Poland].

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Czarkowski, Marek; Sieczych, Alicja

2013-08-01

Bioethics committees are along with ethic regulations and rules of law one of three main pillars in the system of protection of scientific biomedical research participants. Although principal directives for bioethics committees are established by international guidelines, detailed regulations may differ in particular states. The aim of this article was to compare two bioethic committees systems: French and Polish one. Historical beginnings of the bioethics committees system in France and in Poland are briefly mentioned, Subsequently, the networks of bioethics committees in both countries are compared. Although the number of bioethics committees (Research Ethic Committees) in both countries is comparable, the procedure of their establishment varies. French committees are based on administrative division of the country and divide on regional and interregional committees. In Poland, bioethics committees are established by medical universities, medical research and development units or regional chambers of physicians and dentists. In France there is no equivalent of Appeal Bioethics Committee, however one could appeal from the negative bioethics committee's opinion. The composition of French bioethics committees is more diverse and half of the members are not related to medical professions. Members of French committees are named on indefinite term by headmaster of Regional Health Agency after having been chosen in competition for the post. In Poland members are called on three-year-term but the rotation of members is not overwhelming since there is no limit of terms for one member. French legal solutions seems more secure for scientific bioethics research participants. For this reason, a detailed research on legislation in other countries is necessary before introducing any new regulations in Polish law.

Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

Science.gov (United States)

Carr, Caleb T.

2015-01-01

Bullying, often considered an interpersonal or intergroup behaviour, has not been explored as an unintended artefact of organisational structure. Institutional review boards (IRBs), the 'human research ethics committees' at US universities, help oversee the protection of human research subjects, particularly in the social sciences within…

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

Science.gov (United States)

Coleman, Carl H; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, Francois; Colonna, Pierre; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, Marie-France; Maoundé, Dionko; Martinent, Eric; Ntsiba, Honoré; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie-Christine; Sarr, Samba Cor; Sepou, Abdoulaye; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Van Nieuwenhove, Simon; Strub-Wourgaft, Nathalie

2015-12-01

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. © 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.

Paper use in research ethics applications and study conduct.

Science.gov (United States)

Chakladar, Abhijoy; Eckstein, Sue; White, Stuart M

2011-02-01

Application for Research Ethics Committee (REC) approval and the conduct of medical research is paper intensive. This retrospective study examined all applications to a single REC in the south of England over one year. It estimated the mass of paper used, comparing the proportional paper consumption of different trial types and during different stages of the research process, quantifying the consumption in terms of carbon dioxide emissions. In 2009, 68 trials were submitted to the REC. Total paper consumption for the REC process and study conduct was 176,150 sheets of A4 paper (879 kg), equivalent to an estimated 11.5 million sheets (88 tonnes, 2100 trees) a year for the U.K.; the REC process accounted for 26.4%. REC applications and the conduct of approved trials generate considerable environmental impact through paper consumption contributing to the NHS's carbon footprint. Paper use might be reduced through the implementation of digital technologies and revised research methods, namely changing attitudes in both researchers and ethics committees.

Current trends in medical ethics education in Japanese medical schools.

Science.gov (United States)

Kurosu, Mitsuyasu

2012-09-01

The Japanese medical education program has radically improved during the last 10 years. In 1999, the Task Force Committee on Innovation of Medical Education for the 21st Century proposed a tutorial education system, a core curriculum, and a medical student evaluation system for clinical clerkship. In 2001, the Model Core Curriculum of medical education was instituted, in which medical ethics became part of the core material. Since 2005, a nationwide medical student evaluation system has been applied for entrance to clinical clerkship. Within the Japan Society for Medical Education, the Working Group of Medical Ethics proposed a medical ethics education curriculum in 2001. In line with this, the Japanese Association for Philosophical and Ethical Research in Medicine has begun to address the standardization of the curriculum of medical ethics. A medical philosophy curriculum should also be included in considering illness, health, life, death, the body, and human welfare.

(The Ethics of) Teaching Science and Ethics: A Collaborative Proposal.

Science.gov (United States)

Kabasenche, William P

2014-12-01

I offer a normative argument for a collaborative approach to teaching ethical issues in the sciences. Teaching science ethics requires expertise in at least two knowledge domains-the relevant science(s) and philosophical ethics. Accomplishing the aims of ethics education, while ensuring that science ethics discussions remain grounded in the best empirical science, can generally best be done through collaboration between a scientist and an ethicist. Ethics as a discipline is in danger of being misrepresented or distorted if presented by someone who lacks appropriate disciplinary training and experience. While there are exceptions, I take philosophy to be the most appropriate disciplinary domain in which to gain training in ethics teaching. Science students, who must be prepared to engage with many science ethics issues, are poorly served if their education includes a misrepresentation of ethics or specific issues. Students are less well prepared to engage specific issues in science ethics if they lack an appreciation of the resources the discipline of ethics provides. My collaborative proposal looks at a variety of ways scientists and ethicists might collaborate in the classroom to foster good science ethics education.

(The Ethics of Teaching Science and Ethics: A Collaborative Proposal

Directory of Open Access Journals (Sweden)

William P. Kabasenche

2014-10-01

Full Text Available I offer a normative argument for a collaborative approach to teaching ethical issues in the sciences. Teaching science ethics requires expertise in at least two knowledge domains—the relevant science(s and philosophical ethics. Accomplishing the aims of ethics education, while ensuring that science ethics discussions remain grounded in the best empirical science, can generally best be done through collaboration between a scientist and an ethicist. Ethics as a discipline is in danger of being misrepresented or distorted if presented by someone who lacks appropriate disciplinary training and experience. While there are exceptions, I take philosophy to be the most appropriate disciplinary domain in which to gain training in ethics teaching. Science students, who must be prepared to engage with many science ethics issues, are poorly served if their education includes a misrepresentation of ethics or specific issues. Students are less well prepared to engage specific issues in science ethics if they lack an appreciation of the resources the discipline of ethics provides. My collaborative proposal looks at a variety of ways scientists and ethicists might collaborate in the classroom to foster good science ethics education.

45 CFR 73.735-902 - Reporting requirements for certain employees not covered by the Ethics in Government Act of 1978.

Science.gov (United States)

2010-10-01

... covered by the Ethics in Government Act of 1978. 73.735-902 Section 73.735-902 Public Welfare DEPARTMENT... Interests § 73.735-902 Reporting requirements for certain employees not covered by the Ethics in Government... decision-making responsibility for the following matters: (i) Contracting or procurement, (ii...

Contesting the science/ethics distinction in the review of clinical research

Science.gov (United States)

Dawson, Angus J; Yentis, Steve M

2007-01-01

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389

[Research Ethics in Partnership with Benin : A call for Solidarity].

Science.gov (United States)

Bergeron, Michel

2017-05-22

Over the last decade, research ethics has developed in Benin partly through a partnership with Quebec. This partnership has evolved using TCPS2, the Canadian framework in research ethics. In doing so, three main values were put forward : respect for human dignity, respect for cultural diversity and solidarity. Over that time period, research ethics in Benin has structured through new Research Ethics Committees (REC) and though participation of those involved in research with human beings. REC members, researchers and students have acquired the needed tools to resolve most of the ethical dilemmas that could arise in the future making it one of the positive results of this partnership. Retrospectively, it has also been a situation where the Van Rensselaer Potter's perspective on bioethics has emerged in a French-speaking context where the spoken language and the French cultural approach is of great importance.

How not to argue against mandatory ethics review.

Science.gov (United States)

Hunter, David

2013-08-01

There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion.

Ethik in der Medizinischen Ausbildungsforschung [Ethics in medical education research

Directory of Open Access Journals (Sweden)

Marienhagen, Jörg

2009-02-01

Full Text Available [english] Research ethics criteria that are used for reviewing clinical trials are also applicable to research designs used within the field of medical education. Especially the principles of nonmaleficence, informed consent, and freedom to participate are relevant in this area of research. Due to the high impact of university education on tomorrow’s doctors, high-quality ethical and methodological standards are essential in medical education research. A responsible handling of ethical problems in the area of medical education research requires careful handling of issues concerning participants, informed consent, and the methodology used. As it is obligatory in clinical trials, risk-benefit and cost-performance analyses have to be a part of the complete process, from the planning phase onwards, to avoid potential harm to the participants. Every publication of study results should contain information about the methodology used and the reliability of the data. It is important that the contribution of all mentioned co-authors becomes clear. The authors recommend the constitution of an ethics committee within the German Association for Medical Education (Gesellschaft für Medizinische Ausbildung, GMA to support researchers and to meet the interests of all groups involved. Additionally, more and more journals dealing with publications in the area of medical education demand an ethical statement as part of their publication requirements. The GMA is called on to establish such a committee to secure ethical standards for medical education research. [german] Es zeigt sich, dass forschungsethische Kriterien wie in medikamentösen Interventionsstudien auch in der Ausbildungsforschung sinnvoll und ohne große Einschnitte ins Studiendesign applizierbar sind. Das Nichtschadensprinzip, die informierte Einwilligung und Freiwilligkeit der Teilnahme stehen hierbei im Vordergrund. Aus dem hohen Stellenwert der Ausbildung für Studierende begründet sich ein

Ethical Issues Surrounding the Use of Modern Human Remains for Research in South Africa.

Science.gov (United States)

Briers, N; Dempers, J J

2017-02-01

Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains. Queries relating to science (22.2%) and administration (18.9%) were the most common, whereas queries relating to legal issues constituted only 10.2%. Ethical issues centered on informed consent regarding sensitive topics such as HIV, DNA, and deceased children. The change in legislation did not change the number or type of legal issues identified by the REC.

A Swedish perspective on research ethics review

Directory of Open Access Journals (Sweden)

Hans Thulesius, M.D., G.P., Ph.D.

2010-12-01

Full Text Available I have participated in writing ethical approval applications for research projects in Sweden a dozen times. I am also since some years a member of the local ethics advisory board in a mostly rural area serving 180.000 people. From that position I advise on what types of local project applications will have to be sent further to the regional ethics committee, REPN in Sweden. With that background I will try to give a brief Swedish perspective on research ethics reviews in general and regarding CGT (classic grounded theory studies using qualitative data in particular.The most famous Swedish example of unethical research is the 1947-1951 Vipeholm sugar trial (Krasse, 2001. Several hundred intellectually and mentally challenged persons at the Vipeholm institution were for years given an excess amount of sugar, mostly in the shape of candy. This resulted in caries that totally ruined the teeth of 50 persons. Of course participants did not give informed consent. Yet, at the time the research was not considered unethical. At least there was no debate about it.

Global Ethics Applied: Global Ethics, Economic Ethics

OpenAIRE

Stückelberger, Christoph

2016-01-01

Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...

Opening the black box of ethics policy work: evaluating a covert practice.

Science.gov (United States)

Frolic, Andrea; Drolet, Katherine; Bryanton, Kim; Caron, Carole; Cupido, Cynthia; Flaherty, Barb; Fung, Sylvia; McCall, Lori

2012-01-01

Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the "black box" of this health care ethics practice by providing two detailed case examples of ethics policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews.

Secretary's Business Ethics

Institute of Scientific and Technical Information of China (English)

曾玉丹

2017-01-01

Secretary is a comprehensive, service, auxiliary and political job with high requests. The so-called secretary's business ethics refers to the sum of all the secretary's acts required to comply with professional responsibility, professional emotion, role orientation, discipline-obeying and ethics-obeying. The purpose of this paper is to present a good way to know the ethics that a secretary should own to act out perfectly.

Overview of psychiatric ethics V: utilitarianism and the ethics of duty.

Science.gov (United States)

Robertson, Michael; Morris, Kirsty; Walter, Garry

2007-10-01

The aim of this paper is to describe the ethical theories of utilitarianism and the ethics of duty (Kant's ethics) and to evaluate their value as theoretical bases of psychiatric ethics. Utilitarianism is a well-established moral philosophy and has significant instrumental value in dealing with common ethical problems faced by psychiatrists. Despite its capacity to generate solutions to ethical problems, utilitarianism requires a process of what Rawls described as 'reflective equilibrium' to avoid morally repugnant choices, based on utility. The criticisms of utilitarianism, such as the problems of quantifying utility and the responsibility for consequences, are very relevant for psychiatry. Singer's model of utilitarian thinking is particularly problematic for our profession. Kant's ethics provides the pretext for duty bound codes of ethics for psychiatrists, but suffers from problems of flawed claims to the universalizability prescribed by Kant's 'categorical imperative'. Kant's valorization of reason as the core of the autonomy of persons is a valuable insight in understanding psychiatrists' ethical obligations to their patients.

Research ethics committee decision-making in relation to an efficient neonatal trial.

Science.gov (United States)

Gale, C; Hyde, M J; Modi, N

2017-07-01

Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The ethics of interrogation and the American Psychological Association: A critique of policy and process

OpenAIRE

Olson, Brad; Soldz, Stephen; Davis, Martha

2008-01-01

Abstract The Psychological Ethics and National Security (PENS) task force was assembled by the American Psychological Association (APA) to guide policy on the role of psychologists in interrogations at foreign detention centers for the purpose of U.S. national security. The task force met briefly in 2005, and its report was quickly accepted by the APA Board of Directors and deemed consistent with the APA Ethics Code by the APA Ethics Committee. This rapid acceptance was unusual for a number o...

Einstein, Ethics and the Atomic Bomb

Science.gov (United States)

Rife, Patricia

2005-03-01

Einstein voiced his ethical views against war as well as fascism via venues and alliances with a variety of organizations still debated today. In 1939, he signed a letter to President Roosevelt (drafted by younger colleagues Szilard, Wigner and others) warning the U.S.government about the danger of Nazi Germany gaining control of uranium in the Belgian-controlled Congo in order to develop atomic weapons, based on the discovery of fission by Otto Hahn and Lise Meitner. In 1945, he became a member of the Princeton-based ``Emergency Committee for Atomic Scientists'' organized by Bethe, Condon, Bacher, Urey, Szilard and Weisskopf. Rare Einstein slides will illustrate Dr.Rife's presentation on Albert Einstein's philosophic and ethical convictions about peace, and public stance against war (1914-1950).

Embryo politics: ethics and policy in Atlantic democracies

National Research Council Canada - National Science Library

Banchoff, Thomas F

2011-01-01

... States, the United Kingdom, Germany, and France have grappled with these questions so far. In setting out an argument about the intersection of politics, ethics, and policy, I focus on national bioethics committees, elected leaders, and their efforts to reconcile the moral status of the embryo and the imperative of biomedical progress in practice. In order to st...

Ethical values in nurse education perceived by students and educators.

Science.gov (United States)

Boozaripour, Mahsa; Abbaszadeh, Abbas; Shahriari, Mohsen; Borhani, Fariba

2018-03-01

Education is considered the first function and mission of the university, and observing educational ethics guarantees the health of the teaching-learning process in the university. The aim of this study was to explore ethical values in nursing education from the perspective of Iranian nursing students and educators. This qualitative study was conducted using the Thematic Content Analyses method. The data were collected from seven semi-structured individual interviews and three focus group discussions from July to November 2015. Participants and research context: The participants were faculty educators of nursing and nursing students in Tehran, capital of Iran, who were selected through purposive sampling. They were recruited gradually. Sampling was continued until data saturation when no new codes were extracted. Ethical committee: This study was conducted after obtaining the approval of Shahid Beheshti University of Medical Sciences Ethics Committee, and informed consent were ensured before conducting the research. The principles of voluntariness, confidentiality, and anonymity were respected during the research process. Seven major themes emerged: human dignity, constructive human relations, educational justice, competency enhancement, excellence view, wisdom, and commitment and accountability. The results of this study indicated that although many of the values, as universal values, were similar to those of other countries-which can be a reflection of the globalization process in the nursing profession and the presence of humanistic and spiritual approaches at the roots of the discipline, some differences could be found in the content of values due to factors such as the people's beliefs, culture, and religion. Iranian nursing students and educators revealed a unique and culture-based set of ethical values.

Ethics of Immunization

NARCIS (Netherlands)

Verweij, M.F.; Quah, S.R.; Cockerham, W.C.

2017-01-01

Collective immunization can be highly effective in protecting societies against infectious diseases, but policy decisions about both the character and the content of immunization policies require ethical justification. This article offers an overview of ethical aspects that should be taken into

Ethics for Management.

Science.gov (United States)

Jaques, Elliott

2003-01-01

Notes that it is essential that business organizations establish organizational systems that require satisfactory ethical business behaviors from everyone concerned, regardless of differences in personal outlooks. Outlines what needs to be done in order to effectively teach business ethics. (SG)

5 CFR 2635.107 - Ethics advice.

Science.gov (United States)

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Ethics advice. 2635.107 Section 2635.107 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH General Provisions § 2635.107 Ethics advice. (a) As required by §§ 2638.201...

Ethics in radiation protection

International Nuclear Information System (INIS)

Corbett, R.H.

2002-01-01

Ethics is a branch of philosophy. Its object is the study of both moral and immoral behaviour in order to make well founded judgements and to arrive at adequate recommendations. The Collins English Dictionary provides the following definitions of the word ethic: Ethic: a moral principle or set of moral values held by an individual or group; Ethics(singular): the philosophical study of the moral value of human conduct and of the rules and principles that ought to govern it; Ethics(pleural): a social, religious or civil code of behaviour considered correct, especially that of a particular group, profession or individual; Ethics(pleural): the moral fitness of a decision, course of action, etc. Ethics has a two-fold objective: Firstly it evaluates human practices by calling upon moral standards; it may give prescriptive advice on how to act morally in a specific kind of situation. This implies analysis and evaluation. Sometimes this is known as Normative ethics. The second is to provide therapeutic advice, suggesting solutions and policies. It must be based on well-informed opinions and requires a clear understanding of the vital issues. In the medical world, we are governed by the Hippocratic Oath. Essentially this requires medical practitioners (doctors) to do good, not harm. There is great interest and even furore regarding ethics in radiation protection

Compliance with National Ethics Requirements for Human-Subject Research in Non-biomedical Sciences in Brazil: A Changing Culture?

Science.gov (United States)

de Albuquerque Rocha, Karina; Vasconcelos, Sonia M R

2018-02-06

Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country.

Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

Science.gov (United States)

Mathews, D J H; Sugarman, J; Bok, H; Blass, D M; Coyle, J T; Duggan, P; Finkel, J; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Siegel, A W; Smith, K; Solter, D; Song, H; Vescovi, A; Young, W; Gearhart, J D; Faden, R

2008-07-22

Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

The Brewsters: A new resource for interprofessional ethics education.

Science.gov (United States)

Rozmus, Cathy L; Carlin, Nathan; Polczynski, Angela; Spike, Jeffrey; Buday, Richard

2015-11-01

One of the barriers to interprofessional ethics education is a lack of resources that actively engage students in reflection on living an ethical professional life. This project implemented and evaluated an innovative resource for interprofessional ethics education. The objective of this project was to create and evaluate an interprofessional learning activity on professionalism, clinical ethics, and research ethics. The Brewsters is a choose-your-own-adventure novel that addresses professionalism, clinical ethics, and research ethics. For the pilot of the book, a pre-test/post-test design was used. Once implemented across campus, a post-test was used to evaluate student learning in addition to a student satisfaction survey. A total of 755 students in six academic schools in a health science center completed the activity as part of orientation or in coursework. The project was approved as exempt by the university's Committee for the Protection of Human Subjects. The pilot study with 112 students demonstrated a significant increase in student knowledge. The 755 students who participated in the project had relatively high knowledge scores on the post-test and evaluated the activity positively. Students who read The Brewsters scored well on the post-test and had the highest scores on clinical ethics. Clinical ethics scores may indicate issues encountered in mass media. The Brewsters is an innovative resource for teaching interprofessional ethics and professionalism. Further work is needed to determine whether actual and long-term behavior is affected by the activity. © The Author(s) 2014.

Application of the Commission’s recommendations: the activities of ICRP Committee 4

International Nuclear Information System (INIS)

Lochard, Jacques

2012-01-01

Committee 4 of the International Commission on Radiological Protection (ICRP) is responsible for developing principles, recommendations, and guidance on the protection of man against radiation exposure; and considering their practical application in all exposure situations. The Committee also acts as a major point of contact between ICRP and other international organisations and professional bodies concerned with protection against ionising radiation. The current work of the Committee involves the development of a series of reports on implementation of the 2007 Recommendations, and a reflection on the ethical foundations of the radiological protection system. Following the accident in Fukushima, Committee 4 also initiated an analysis of management of the consequences of the accident, with the objective of revising, if necessary, the Commission’s publications on emergency and post-accident situations.

Employers Assessment of Work Ethics Required of University Business Education Graduates in South-South Nigeria

Science.gov (United States)

Okoro, James

2014-01-01

This study examined the employers assessment of work ethics required of university Business Education graduates in south south Nigeria. One research question and three hypotheses guided the study. The design of this study was a descriptive survey. The population of the study comprised 318 identified employers of Business Education graduates in…

Research Ethics: Reforming Postgraduate Formation

Science.gov (United States)

Vallance, Roger J.

2005-01-01

Research ethics is not only a matter of doing no harm, or even abiding by the guidelines of the Ethics Review Board of the institution. While these matters are important and legal requirements, there is much more at stake in discussions of research ethics. Research ethics establish the foundation upon which research rests. Taking the social…

Machine medical ethics

CERN Document Server

Pontier, Matthijs

2015-01-01

The essays in this book, written by researchers from both humanities and sciences, describe various theoretical and experimental approaches to adding medical ethics to a machine in medical settings. Medical machines are in close proximity with human beings, and getting closer: with patients who are in vulnerable states of health, who have disabilities of various kinds, with the very young or very old, and with medical professionals. In such contexts, machines are undertaking important medical tasks that require emotional sensitivity, knowledge of medical codes, human dignity, and privacy. As machine technology advances, ethical concerns become more urgent: should medical machines be programmed to follow a code of medical ethics? What theory or theories should constrain medical machine conduct? What design features are required? Should machines share responsibility with humans for the ethical consequences of medical actions? How ought clinical relationships involving machines to be modeled? Is a capacity for e...

Integrating Ethics across the Curriculum: A Pilot Study to Assess Students' Ethical Reasoning

Science.gov (United States)

Willey, Susan L.; Mansfield, Nancy Reeves; Sherman, Margaret B.

2012-01-01

At Georgia State University (GSU), undergraduate and graduate business students are introduced to ethical theory and decision making in the required legal environment of business course, but ethics instruction in the functional areas is sporadic and uncoordinated. After a broad overview of the history of ethics in the business curriculum in Part…

Computer Ethics and Neoplatonic Virtue

DEFF Research Database (Denmark)

Stamatellos, Giannis

2011-01-01

attempts for application to computer ethics and cyberethics. In this paper, the author argues that current trends and behaviours in online communication require an ethics of self-care found in Plotinus’ self-centred virtue ethics theory. The paper supports the position that Plotinus’ virtue ethics......n normative ethical theory, computer ethics belongs to the area of applied ethics dealing with practical and everyday moral problems arising from the use of computers and computer networks in the information society. Modern scholarship usually approves deontological and utilitarian ethics...... as appropriate to computer ethics, while classical theories of ethics, such as virtue ethics, are usually neglected as anachronistic and unsuitable to the information era and ICT industry. During past decades, an Aristotelian form of virtue ethics has been revived in modern philosophical enquiries with serious...

Scientific Publication Ethics

Directory of Open Access Journals (Sweden)

Osman İnci

2015-06-01

showing conscious deceptive intention. Duplication, salamislicing, publications aiming partiality, partiality in choice of sources, authorship rights violations (Author concealment, Gift Autorship, Honory Autorship or Ghost Autorship,author addition changing the order of author list, and not thanking to the contributers are other irregular applications. Innocent faults and carelessness should not be evaluated as irregular applications. It is the task and responsibility of administrators of academic committee, editors and publication committees, referees, supporting institutions, and mainly academic readers and writers to avoid irregular applications in academic publications. It is of vital importance to give ‘an academic ethics’ instructions just at the very beginning of academic life. The ones who do not know principles and rules of academic ethics are not efficient for academic research and publications. Besides sanctions should be applied against approved irregular applications.

Ethical aspects of registry-based research in the Nordic countries.