Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

Author:

Wolf Susan M.,Lawrenz Frances P.,Nelson Charles A.,Kahn Jeffrey P.,Cho Mildred K.,Clayton Ellen Wright,Fletcher Joel G.,Georgieff Michael K.,Hammerschmidt Dale,Hudson Kathy,Illes Judy,Kapur Vivek,Keane Moira A.,Koenig Barbara A.,LeRoy Bonnie S.,McFarland Elizabeth G.,Paradise Jordan,Parker Lisa S.,Terry Sharon F.,Van Ness Brian,Wilfond Benjamin S.

Abstract

Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem — how should incidental findings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant’s physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require?

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

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