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Dual-Use Review and the IRB
1Bioethicist and IRB Chair at the National Institute of Environmental Health Science, National Institutes of Health.
Journal of Clinical Research Best Practices
|January 21, 2012
Summary
Institutional Review Boards (IRBs) face dual-use research concerns. A dedicated dual-use committee (DUC) or similar body should review these issues, not the IRBs themselves, to ensure proper oversight.
Area of Science:
- Biomedical research ethics
- Biosafety and biosecurity
Background:
- Growing threat of biomedical research misuse by malicious actors.
- Institutional Review Boards (IRBs) are increasingly encountering dual-use research concerns.
- Current IRBs may lack specialized expertise for comprehensive dual-use review.
Purpose of the Study:
- To define the appropriate role of IRBs in reviewing dual-use research.
- To recommend a specialized review process for research with dual-use implications.
- To enhance institutional oversight of potentially dangerous research.
Main Methods:
- Analysis of existing ethical review frameworks for research.
- Review of dual-use research of concern (DURC) case studies.
- Consultation with experts in biosafety, biosecurity, and research ethics.
Main Results:
- IRBs are not optimally structured to conduct in-depth dual-use reviews.
- Specialized committees are better equipped to assess dual-use risks.
- Clear delineation of responsibilities is needed for effective oversight.
Conclusions:
- IRBs should be informed but not solely responsible for dual-use research review.
- Establishment of dedicated Dual-Use Committees (DUC) or similar bodies is recommended.
- Findings and recommendations from specialized committees should inform institutional decisions.
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