Excluding a Population: A Claim of Risks

Research on the neurotoxic nature of an aquatic food source in the Great Lakes region is developed in response to notification by public health officials of a possible link with a disease with high morbidity and mortality. As the research with human subjects is proposed, it appears that the sample of subjects who will be given larger doses of the suspected toxin will exclude women because of claims that there is a special risk (to reproductive systems) in them.

What are the consequences of excluding one sex from the research in terms of benefits, risks, research burden, generalizability of such research?