A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review

2012 ◽  
Vol 40 (4) ◽  
pp. 930-944 ◽  
Author(s):  
Alex John London
Keyword(s):  
Research Ethics ◽  
Political Correctness ◽  
Human Subjects ◽  
Current System ◽  
Ethics Committees ◽  
The United States ◽  
Institutional Review Boards ◽  
Iron Cage ◽  
Institutional Review ◽  
Exposed Population

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards (IRBs), sometimes called Research Ethics Committees (RECs), have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”

What the ANPRM Missed: Additional Needs for IRB Reform

2013 ◽  
Vol 41 (2) ◽  
pp. 390-396 ◽  
Author(s):  
Charles W. Lidz ◽  
Suzanne Garverich
Keyword(s):  
Data Collection ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Limited Time ◽  
Research Ethics Committees ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The World

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA
Keyword(s):  
United States ◽  
Research Ethics ◽  
Gold Standard ◽  
The United States ◽  
Institutional Review Boards ◽  
Scientific Review ◽  
Initial Development ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
A Current

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

Differences between research ethics committees

2007 ◽  
Vol 23 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Sarah J. L. Edwards ◽  
Tracey Stone ◽  
Teresa Swift
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Ethical Considerations ◽  
Local Conditions ◽  
Ethical Judgments ◽  
Risks And Benefits ◽  
The United Kingdom ◽  
Institutional Review

Objectives:To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).Methods:We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.Results:There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.Conclusions:The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

scholarly journals Negotiating Responsibility for Navigating Ethical Issues in Qualitative Research: A Review of Miller, Birch, Mauthner, and Jessop’s (2012) Ethics in Qualitative Research, Second Edition

2015 ◽  
Author(s):  
Michelle McCarron
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
The United Kingdom ◽  
Institutional Review ◽  
Technological Advances ◽  
Research Ethics Boards

Ethics in Qualitative Research (Miller, Birch Mauthner, & Jessop, 2012), now in its second edition, uses a feminist framework to present a variety of issues pertinent to qualitative researchers. Topics include traditional challenges for qualitative researchers (e.g., access to potential participants, informed consent, overlapping roles), as well as those that have garnered more attention in recent years, particularly with regard to uses and consequences of technological advances in research. The book is critical of committees whose function it is to review proposed research and grant research ethics approval (e.g., University Research Ethics Committees [URECs], Research Ethics Boards [REBs], and Institutional Review Boards [IRBs]). The authors of this book are situated within the United Kingdom. The editors take the position that ethics oversight by the researchers themselves is preferable and that such boards and committees are not well equipped to review qualitative research. A rebuttal to this position is presented within this review. Ethics in Qualitative Research provides a good overview of ethical issues that researchers face and is effective in merging theory with practice. It would be strengthened by avoiding the debate over URECs or by offering concrete suggestions for how URECs can improve their reviews of qualitative research.

In defence of a broad approach to public interest in health data research

2020 ◽  
pp. medethics-2020-106880
Author(s):  
Angela Ballantyne ◽  
G Owen Schaefer
Keyword(s):  
Research Ethics ◽  
Conceptual Understanding ◽  
Public Interest ◽  
Ethics Committees ◽  
Health Data ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Privacy Act ◽  
Institutional Review ◽  
Broad Approach

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs), we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

Indigenous Research Ethics Requirements: An Examination of Six Tribal Institutional Review Board Applications and Processes in the United States

2020 ◽  
Vol 15 (4) ◽  
pp. 279-291
Author(s):  
Nicole S. Kuhn ◽  
Myra Parker ◽  
Clarita Lefthand-Begay
Keyword(s):  
United States ◽  
Research Ethics ◽  
Management Practices ◽  
The United States ◽  
Institutional Review Boards ◽  
Indigenous Research ◽  
Cultural Appropriation ◽  
Building Relationships ◽  
Institutional Review ◽  
Indigenous Knowledge Systems

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB’s operating environment before seeking research approval, and issues related to tribal data management practices.

Research Ethics Committees in the Field of Health-Related Human Research — A European Perspective and the Case of Austria

2014 ◽  
Vol 21 (4) ◽  
pp. 387-400
Author(s):  
Verena Stühlinger ◽  
Michael Hackl
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Epidemiological Studies ◽  
Healthcare Research ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Research Committee ◽  
Institutional Review ◽  
Health Related Research ◽  
Health Related

Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (irbs or Research Ethics Committees (recs)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of eu Member States; and European laws differ widely. The article gives an overview of European regulations in the field of rec review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria — the Research Committee for Scientific and Ethical Questions (rcseq). Finally, important European initiatives for the future are pointed out.

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