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Otherwise Approvable:

Research that CRP cannot approve under one of the above categories may be permitted if it meets the following stringent criteria. The first is that CRP finds the research to present a reasonable opportunity to further the understanding, prevention, or alleviation of a serous child health or welfare problem. In addition, the Secretary of DHHS, after consultation with a panel of experts from relevant disciplines and opportunity for public review and comment, must determine that the research in fact falls into one of the above categories or that it meets the following provisions:

a. The research presents a reasonable opportunity to further the understanding , prevention or alleviation of a serious child health or welfare problem;

b. The research will be conducted in accordance with sound ethical principles; and

c. The research makes adequate provisions for soliciting the children’s assent and permission of the parents or guardians.

This last category of research is extremely rare. Indeed, research with child subjects that involves more than minimal risk is uncommon at the University, and you should use special care in proposing such research to deploy all available protection measures to ensure the subject’s safety and well-being.

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