Journal
ACCOUNTABILITY IN RESEARCH-POLICIES AND QUALITY ASSURANCE
Volume 29, Issue 1, Pages 55-62Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/08989621.2021.1880902
Keywords
IRB; evidence; standard of evidence; research ethics on human subjects
Categories
Funding
- Clinical and Translational Science Award [UL1TR001439]
- National Center for Advancing Translational Sciences, National Institutes of Health
Ask authors/readers for more resources
Increasing the use of evidence to meet a higher standard for decision making by IRBs is ideal for transparency, but would require significant modifications for researchers and IRBs. Researchers would need to include appropriate scientific and ethics evidence, while IRB members and professionals would need to discuss the importance and value of evidence to make collective decisions. Helping to bring rigor and transparency to the system, this change would necessitate time, training, research, and education.
This commentary is a critical response to the article written by David Resnik regarding the use of a standard of evidence for Institutional Review Board (IRB) decision making. Resnik suggests that IRBs should not only base decisions on evidence, but that this evidence should be sufficient to ensure a clear and convincing standard similar to that used by juries for legal proceedings. We agree that the increased use of evidence to meet this standard would be ideal since this provides clear guidance and could allow for a more transparent IRB review. However, to effectively meet this standard, significant modification would be required for researchers as well as for IRBs' processes. First, researchers would be required to identify, understand and include appropriate scientific and ethics evidence in support of their protocol. IRB members and IRB professionals would need to discuss the importance, value, and significance of evidence in order to come to a collective decision regarding each protocol. Such responsibilities are justifiable and could bring much needed rigor and transparency to the system but they would require time, training, research, and education. While Resnik's suggestion seems to incorporate a small change with respect to a standard, in application it would actually require a novel system.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available