When Should "Riskier" Subjects Be Excluded From Research Participation?
Kennedy Institute of Ethics Journal. 1998 Sep; 8(3): 307-327.
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.
Age Factors; Autonomy; Decision Making; Drugs; Ethics; Ethics Committees; Females; Fetuses; Government; Government Regulation; Guidelines; Human Experimentation; Injuries; Investigators; Justice; Kidney Diseases; Literature; Males; Moral Policy; Patients; Preconception Injuries; Pregnant Women; Prenatal Injuries; Regulation; Research; Research Design; Research Ethics; Research Ethics Committees; Research Subjects; Rights; Risk; Risks and Benefits; Selection of Subjects; Volunteers;
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