Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research

2020 ◽  
Vol 173 (7) ◽  
pp. 558-562
Author(s):  
Holly Fernandez Lynch ◽  
Stephen Rosenfeld
Keyword(s):  
Private Equity ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Institutional Review

scholarly journals Is Safety in the Eye of the Beholder? Safeguards in Research With Adults With Intellectual Disability

2016 ◽  
Vol 11 (5) ◽  
pp. 424-438 ◽  
Author(s):  
Katherine E. McDonald ◽  
Nicole E. Conroy ◽  
Carolyn I. Kim ◽  
Emily J. LoBraico ◽  
Ellis M. Prather ◽  
...  
Keyword(s):  
Decision Making ◽  
Intellectual Disability ◽  
Service Providers ◽  
Human Subjects ◽  
Well Being ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Disability Service ◽  
Disability Service Providers ◽  
Institutional Review

Human subjects research has a core commitment to participant well-being. This obligation is accentuated for once exploited populations such as adults with intellectual disability. Yet we know little about the public’s views on appropriate safeguards for this population. We surveyed adults with intellectual disability, family members and friends, disability service providers, researchers, and Institutional Review Board (IRB) members to compare views on safeguards. We found many points of convergence of views, particularly for decision-making and participation. One trend is that adults with intellectual disability perceive greater safety in being engaged directly in recruitment, and recruitment by specific individuals. Researchers and IRB members need to consider community views to facilitate the safe and respectful inclusion of adults with intellectual disability.

A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity

2014 ◽  
Vol 42 (3) ◽  
pp. 383-388
Author(s):  
Valerie Gutmann Koch
Keyword(s):  
New York ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Cognitively Impaired ◽  
Conservative Approach ◽  
Important Research ◽  
Human Subjects Research ◽  
Institutional Review ◽  
Voluntary Informed Consent ◽  
Conducting Research

Despite existing federal and state law and regulation, new human subjects research (HSR) scandals involving “vulnerable” populations continue to surface. Although existing oversight mechanisms were enacted to ensure voluntary informed consent for participants and institutional review board (IRB) oversight of HSR, these laws and regulations do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults. The absence of rules to ensure consistently ethical conduct of research involving adults who lack consent capacity may either lead to exploitation of this vulnerable population or the dearth of important research into the broad range of diseases that impair cognition. In other words, while some institutions and investigators are conducting research with this group without guidance, others are taking an extremely conservative approach and are excluding these individuals from research. Without safeguards that are adequate and robust but not overly burdensome, conducting research involving this population is ethically and legally challenging.

scholarly journals SoTL and the Institutional Review Board: Considerations before navigating the application process for classroom research in higher education

2014 ◽  
pp. 1-14 ◽  
Author(s):  
Kathryn E. Linder ◽  
E. Deborah Elek ◽  
Lucia Calderon
Keyword(s):  
Teaching And Learning ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Application Process ◽  
Institutional Review ◽  
History Of ◽  
Research Protections ◽  
Faculty Developer ◽  
Research Compliance

One of the more challenging areas of Scholarship of Teaching and Learning (SoTL) research can be navigating the components of human subjects research protections implemented by the Institutional Review Board (IRB). The authors of this article, a faculty developer and a current and former research compliance coordinator, discuss the history of IRB in relation to SoTL research and explicate some of the foundational components of IRB protocols for SoTL projects. In particular, the authors explore what constitutes “research” for SoTL projects, explain the different IRB types of review, and offer some sample SoTL projects with respect to their IRB implications.

Comment on the Proposed Institutional Review Board Retrospective Review of Research

2020 ◽  
Vol 15 (3) ◽  
pp. 229-231 ◽  
Author(s):  
Min-Fu Tsan
Keyword(s):  
Retrospective Review ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Common Rule ◽  
Institutional Review ◽  
The Common

Investigators of nonexempt human subjects research conducted without prior institutional review board (IRB) approval often have difficulties in publishing data obtained from such research. Retrospective review and approval of such research has been suggested as a potential pathway for an IRB to help these investigators to publish those data. However, under the Common Rule, an IRB has no authority to retrospectively review and approve human subjects research. Prevention remains the best strategy to ensure that no nonexempt human subjects research is initiated prior to IRB approval.

scholarly journals Social and Behavioral Research with Undocumented Immigrants: Navigating an IRB Committee

2020 ◽  
Vol 42 (1) ◽  
pp. 3-17
Author(s):  
Elizabeth Jach ◽  
Gene Gloeckner ◽  
Colleen Kohashi
Keyword(s):  
Vulnerable Populations ◽  
Human Subjects ◽  
Undocumented Students ◽  
Institutional Review Board ◽  
Federal Regulations ◽  
Political Climate ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The U.S

When conducting human subjects research, social and behavioral researchers seeking to study current issues involving immigrants, refugees, and undocumented students must submit their research to an institutional review board (IRB). Research applications proposing to enroll these populations lie outside the scope of vulnerable populations named in the U.S. Code for Federal Regulations (45 CFR 46). Through a consideration of privacy, confidentiality, flexibility in providing protections, and case study examples, this article examines how researchers and IRBs can negotiate protecting participants who may be undocumented while supporting the advancement of research in the midst of the current, and uncertain, political climate.

Donor-funded research: permissible, not perfect

2018 ◽  
Vol 45 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Mike King ◽  
Angela Ballantyne
Keyword(s):  
Health Research ◽  
Human Subjects ◽  
Trial Participation ◽  
Ethical Standards ◽  
Human Subjects Research ◽  
The Public ◽  
Funded Research ◽  
Personal Liberty ◽  
Institutional Review ◽  
Trial Intervention

Donor-funded research is research funded by private donors in exchange for research-related benefits, such as trial participation or access to the trial intervention. This has been pejoratively referred to as ‘pay to play’ research, and criticised as unethical. We outline three models of donor-funded research, and argue for their permissibility on the grounds of personal liberty, their capacity to facilitate otherwise unfunded health research and their consistency with current ethical standards for research. We defend this argument against objections that donor-funded research is wrongly exploitative, unfair and undermines the public good of medical research. Our conclusion is that, like all human subjects research, donor-funded research should be regulated via standard health research legislation/guidelines and undergo Research Ethics Committee/Institutional Review Board and scientific peer-review. We expect that, measured against these standards, some donor-funded research would be acceptable.

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 Institutional Review Board and International Field Research in Conflict Zones

2014 ◽  
Vol 47 (04) ◽  
pp. 840-844 ◽  
Author(s):  
Srobana Bhattacharya
Keyword(s):  
Human Subjects ◽  
Social Science Research ◽  
Field Research ◽  
Science Research ◽  
Political Conflict ◽  
Institutional Review Board ◽  
Biomedical Sciences ◽  
Conflict Zones ◽  
Institutional Review ◽  
The Many

ABSTRACTResearch on political conflict can benefit immensely from fieldwork. However, the Institutional Review Board (IRB) process is elaborate and daunting that discourages rather than encourages this type of research. Existing policies often are insensitive to the many uncertainties related to field research abroad, especially in conflict zones. Three reasons for this are identified in this article. First, the federal regulations to protect human subjects of social science research are most suitable for biomedical sciences. Second, there is huge gap between “procedural ethics” and “ethics in practice.” Third, there is a lack of communication or dialogue between researchers and IRBs. After discussing these reasons, I offer the following suggestions: bridging the gap between the researcher and the IRB; reducing delays in the IRB approval and revision process; encouraging collaboration and dialogue among researchers; and advocating a proactive stance by academic associations.

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