WHEN SHOULD RISKIER SUBJECTS BE EXCLUDED FROM RESEARCH PARTICIPATION

The exclusion of potential subjects based on increased risks is a comm on practice in human subjects research. However, there are no guidelin es to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a spec ific 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 f or assessing standard exclusions as well as more controversial ones su ch as the exclusion of pregnant women and women of childbearing potent ial from certain types of research.