Kennedy Institute of Ethics journal
When should "riskier" subjects be excluded from research participation?
Abstract
The exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulation is addressed by a specific account of a "condition on inclusion risks" (CIR), a condition under which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.
Source and rights
Published by Kennedy Institute of Ethics journal, 1998. The guideline itself is at the source linked here.
Prognia summarises this guideline for reference and education. It is not medical advice. Always check the official guideline and current local protocols before acting on it.
At a glance
- Published
- 1998
- Applies to
- 🌐 International
- Country of origin
- 🇺🇸 United States
- Scope
- International
- Journal
- Kennedy Institute of Ethics journal
- PubMed
- 11656935