In this Proof Over Precedent episode, the third show in the ‘Demystifying IRBs’ series, host Jim Greiner meets with IRB expert Shannon Sewards to answer the tricky question: Who counts as a ‘human subject’? Medical fields can easily point to human subjects in their research; but in social sciences, the definition relies heavily on federal regulations from Institutional Review Boards that require consent from human subjects to participate in research. So, legal researchers need to know about IRBs and how they define ‘human subjects’ and IRBs need to know about legal research and the role of participants in the studies. While the previous episode in the ‘Demystifying IRBs’ series addressed human subject research versus medical research, this third episode discusses:
- Legal regulations that define human subjects in social science research
- Ethical considerations in applying research to human subjects
- Hypothetical scenarios to illustrate IRB challenges in interpreting and applying federal regulations
- Risk assessments for human subjects
Read the corresponding blog post.
Speakers:
- Shannon Sewards, Director of the Human Research Protection Program, Dartmouth Health; former Director, Harvard University Area IRB
- Jim Greiner, Honorable S. William Green Professor of Public Law at Harvard Law School; Faculty Director of the Access to Justice Lab at Harvard Law School
Resources mentioned:
- Institutional Review Board FAQs
- 45 Code of Federal Regulations Part 46, Subpart A [“Common Rule”]
- Office of Human Research Protection
Share feedback and relevant topics you would like the A2J Lab to discuss: a2jlab@law.harvard.edu
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Proof Over Precedent cover art by Courtney Chrystal