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When and how to include vulnerable subjects in clinical trials
1Department of Bioethics, National Institutes of Health, Bethesda, MD, USA.
Clinical Trials (London, England)
|August 19, 2020
Summary
Guidance is needed on including vulnerable populations in US clinical trials. A new six-step procedure helps institutional review boards include pregnant women, prisoners, and children while meeting regulations and protecting participant interests.
Area of Science:
- Clinical Trials and Regulatory Science
- Bioethics
- Public Health Research
Background:
- Limited literature exists on when and how to include vulnerable subjects in clinical trials.
- US regulations impose strict requirements for including pregnant women/fetuses, prisoners, and children.
- Excluding these groups from trials can reduce their value, particularly for pragmatic trials, and harm vulnerable populations.
Purpose of the Study:
- To provide guidance on including vulnerable subjects in US-regulated clinical trials.
- To develop a decision procedure for institutional review boards (IRBs).
- To balance regulatory compliance with the ethical inclusion of vulnerable populations.
Main Methods:
- A six-step decision procedure is proposed for IRBs.
- The procedure addresses when and how to include vulnerable subjects.
- Focus on compliance with US regulations and minimizing negative impacts.
Main Results:
- The manuscript outlines a structured approach for IRB decision-making.
- The procedure aims to facilitate the inclusion of vulnerable groups in clinical research.
- It offers a framework for satisfying regulatory requirements ethically.
Conclusions:
- A systematic procedure can help IRBs navigate the inclusion of vulnerable subjects in clinical trials.
- This approach supports the ethical conduct of research involving pregnant women, prisoners, and children.
- Minimizing exclusion enhances trial value and protects vulnerable populations' interests.
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