Institutional review board evaluation of neuroscience protocols involving human subjects

1994 ◽  
Vol 41 (2) ◽  
pp. 162-167 ◽  
Author(s):  
A.John Popp ◽  
Dale L. Moore
Keyword(s):  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review

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.

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.

The Role of the Institutional Review Board in Research Involving Human Subjects

1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Research Subjects ◽  
Basic Composition ◽  
Institutional Review ◽  
Policies And Procedures

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.

scholarly journals Setting Up Targeted Research Interviews: A Primer for Students and New Interviewers

2014 ◽  
Author(s):  
Darren Noy
Keyword(s):  
Human Subjects ◽  
Warning Signs ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research Interviews

This article analyzes key strategic considerations for setting up targeted research interviews, including human subjects and Institutional Review Board requirements, approaching respondents, the medium of contact, using technology, cultural conceptions of time and commitment, using networks, wading through bureaucracies, and watching for warning signs. By making these considerations explicit and conscious, we can better specify how to gain interviews for our research and how to ethically approach this task. This analysis will be most useful as a pedagogical explanation for students and for scholars newly approaching interviewing.

scholarly journals Regulatory flexibility for COVID-19 research

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Holly Fernandez Lynch ◽  
Neal W Dickert ◽  
Patricia J Zettler ◽  
Steven Joffe ◽  
Emily A Largent
Keyword(s):  
Human Subjects ◽  
Improve Patient Care ◽  
Institutional Review Board ◽  
Emergency Research ◽  
Regulatory Requirements ◽  
High Quality Evidence ◽  
Institutional Review ◽  
Research Oversight ◽  
Regulatory Flexibility ◽  
Improve Patient

Abstract Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.

Research on Human Subjects: Academic Freedom and the Institutional Review Board

Academe ◽  
2006 ◽  
Vol 92 (5) ◽  
pp. 95 ◽  
Author(s):  
Judith Jarvis Thomson ◽  
Catherine Elgin ◽  
David A. Hyman ◽  
Philip E. Rubin ◽  
Jonathan Knight
Keyword(s):  
Academic Freedom ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research On Human Subjects

scholarly journals Improving readability of informed consents for research at an academic medical institution

2017 ◽  
Vol 1 (6) ◽  
pp. 361-365 ◽  
Author(s):  
Kristie B. Hadden ◽  
Latrina Y. Prince ◽  
Tina D. Moore ◽  
Laura P. James ◽  
Jennifer R. Holland ◽  
...  
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Plain Language ◽  
Post Intervention ◽  
Consent Forms ◽  
Institutional Review ◽  
Final Rule ◽  
The Mean ◽  
Protection Of Human Subjects

IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Sign in / Sign up

Export Citation Format

Share Document