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Why IRBs should protect bystanders in human research
1Studies of Translation, Ethics, and Medicine (STREAM), Department of Biomedical Ethics, McGill University, Montreal, Quebec, Canada.
Bioethics
|September 25, 2020
Summary
Human research can pose risks to bystanders. Institutional Review Boards (IRBs) should ensure bystander protections are considered during research review to safeguard individuals not directly participating in studies.
Area of Science:
- Human subjects research ethics
- Public health policy
- Risk assessment in research
Background:
- Human research activities frequently create risks and burdens for individuals not directly involved in the study, referred to as bystanders.
- Existing human protection policies offer limited direct guidance on safeguarding research bystanders.
- The ethical considerations for bystanders in human research remain an under-addressed area in current regulatory frameworks.
Purpose of the Study:
- To articulate the ethical justifications for protecting research bystanders.
- To establish the primary role of Institutional Review Boards (IRBs) in ensuring bystander protection.
- To outline mechanisms through which IRBs can facilitate bystander welfare in research protocols.
Main Methods:
- Review of existing human research protection policies and ethical principles.
- Analysis of the ethical basis for bystander protections.
- Proposal of a framework for IRB oversight of bystander protection strategies.
Main Results:
- Bystanders possess valid ethical claims to protection from research-related risks and burdens.
- Institutional Review Boards (IRBs) are optimally positioned to oversee and enforce bystander protection measures.
- IRB review can involve direct evaluation of bystander protection plans or certification of existing regulatory safeguards.
Conclusions:
- IRBs play a crucial role in extending ethical protections to research bystanders.
- A proactive approach by IRBs is necessary to address the welfare of bystanders in human research.
- Integrating bystander protection into IRB review processes enhances the overall ethical conduct of research.
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