Vulnerability as a Regulatory Category in Human Subject Research

2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Research ◽  
Human Subject Protection ◽  
Research Ethics Review ◽  
Institutional Review ◽  
Research Regulations ◽  
Vulnerable Subjects ◽  
The Common

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

Upholding “Colonial Unknowing” Through the IRB: Reframing Institutional Research Ethics

2018 ◽  
Vol 25 (9-10) ◽  
pp. 1056-1064 ◽  
Author(s):  
Sheeva Sabati
Keyword(s):  
Research Ethics ◽  
Academic Research ◽  
Institutional Review Boards ◽  
Institutional Research ◽  
Origin Stories ◽  
History Of Research ◽  
Institutional Review ◽  
History Of ◽  
The Common ◽  
A Site

This article considers the institutionalization of research ethics as a site of “colonial unknowing” in which the racial colonial entanglements of academic research and institutions are obscured. I examine the origin stories situating Institutional Review Boards (IRBs) as a response to cases of exceptional violence, most notably the Tuskegee syphilis experiment, within an otherwise neutral history of research. I then consider how the 2018 revisions to the Common Rule extend “colonial unknowing” by decontextualizing the forms of risk involved in social and behavioral research. I situate these complicities as necessary starting points toward anticolonial research ethics of “answerability.”

Clinical Research From Proposal to Implementation

2008 ◽  
Vol 56 (8) ◽  
pp. 975-984 ◽  
Author(s):  
Suzanne M. Rivera
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Protection ◽  
Institutional Review ◽  
The Us ◽  
Complicated Process ◽  
Study Participants ◽  
Review Boards

ABSTRACTThe conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.

scholarly journals Research Ethics Training Needs in Thailand and Vietnam

2019 ◽  
Author(s):  
C Jason Wang ◽  
Uma Palam Pulendran ◽  
Diana Wise ◽  
Monika Thomas-Uribe ◽  
Punkae Mahaisavariya ◽  
...  
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Online Survey ◽  
Human Subjects ◽  
Significant Proportion ◽  
Research Area ◽  
Ethics Training ◽  
Institutional Review Boards ◽  
Formal Training ◽  
Institutional Review

Abstract Background To describe the types of research being conducted and the availability of research ethics training and research ethics review in Thailand and Vietnam. Methods An English survey with four major domains, Research Area, Societal Conditions, Research Ethics, and Basic Information was translated into Thai and Vietnamese by native training partners from the NIH Fogarty Research Ethics Training Program. Setting/Participants The survey was administered in two modes - an online survey distributed via an email link in Thailand, and an onsite paper survey in Vietnam. Participants were Thai and Vietnamese trainees and investigators from prestigious universities. Results In Thailand, there were 363 respondents (9.3% online response rate); in Vietnam there were 117 survey participants. Among those who conduct research, 81% in Thailand and 92% percent in Vietnam reported that their research involves human subjects. Among human subject researchers, 83% in Thailand reported having ethics training, and among these, only 44% reported having formal training. In Vietnam, 66% reported having research ethics training; among them, 72% had formal training. Human subject research reported include clinical observations (26% from Thailand and 26% from Vietnam) and clinical interventions (29% from Thailand and 26% from Vietnam). Significant proportion of respondents reported that their institutions have guidelines (97% in Thailand; 89% from Vietnam) and have established Institutional Review Boards (92% in Thailand; 77% in Vietnam). 76% and 79% of respondents in Thailand and Vietnam respectively reported no experience in teaching research ethics. Lack of trained research ethics teachers (38% in Thailand and 59% in Vietnam), training materials (34% in Thailand; 43% in Vietnam), and an adequate curricular “delivery platform” (58% in Thailand; 49% in Vietnam) are most pressing issues. Conclusions We identified gaps in research ethics training in these two South East Asian countries undergoing rapid socioeconomic transition and identified future curricular focus opportunities.

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 Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

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.

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