In this episode, we interview Dr. Robert Steel about how we should assess the risks and benefits of research, what justifies research oversight, and whether there should be upper limits on the amount of risk research participants are exposed to.
(00:00) Our introduction
(05:06) Start of interview; IRB background
(13:34) The notion of minimal risk
(24:49) Justifying IRB risk evaluation: Initial discussion
(37:07) Justifying IRB risk evaluation: Group soft paternalism
(45:57) Justifying IRB risk evaluation: Maintaining social trust
(54:13) IRB assessment of social value
(56:25) Alternative justifications (beneficence, non-maleficence, non-exploitation)
(01:02:36) Implications: Benefits to society count; No upper limits on risk
(01:15:07) Robert’s future work on government policy trials
Mentioned:
- Survey of pediatric IRB chairs: “How do institutional review boards apply the federal risk and benefit standards for pediatric research?” by Shah et al. (2004)
- Exploitation by Alan Wertheimer (1996)
- “Facing up to paternalism in research ethics” by Franklin Miller and Alan Wertheimer (2007)
- Public Trust: “Is there an ethical upper limit on risks to study participants?” by Nir Eyal (2020)
- “What makes clinical research ethical?” by Ezekiel Emanuel, David Wendler, and Christine Grady (2000)
- “Reconceptualizing Risk-Benefit Analyses: the Case of HIV Cure Research” by Robert Steel (2020)
- “A framework for risk-benefit evaluations in biomedical research” by Annette Rid and David Wendler (2011)
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Bio(un)ethical is written and edited by Leah Pierson and Sophie Gibert, with production by Audiolift.co. Our music is written by Nina Khoury and performed by Social Skills. We are supported by a grant from Amplify Creative Grants.
Bio(un)ethical is a bioethics podcast written by Leah Pierson and Sophie Gibert, with editing and production by Ambedo Media (previous production support by Audiolift.co). Our music is written by Nina Khoury and performed by Social Skills. We are supported by a grant from Amplify Creative Grants.
