other harm, amount to “more than a minimal risk” of harm to the participant? As Dresser (this volume) suggests, the answer to this question probably turns on whether the research is undertaken in a clinical or social service setting in which the risk (of disclosure, especially under applicable reporting laws) inheres in the clinical or service interaction, not in the research itself. In such instances, the residual possibility that the researcher might disclose evidence of mistreatment does not present a material risk that must be disclosed in order to obtain informed consent. As Dresser observes:
In applying the Common Rule’s minimal risk and consent waiver provisions, the focus should be on whether research participation exposes older persons and caregivers to risks greater than those present in ordinary life and routine medical and social service encounters. For example, consider an interview study of family members caring for older individuals. If the study would expose participants to more detailed scrutiny than they would encounter in their usual interactions with the health care and social services systems, and if investigators planned to report suspected maltreatment to protective services authorities, the study would present more than minimal risk to study participants. The higher risk would exist because study participation would expose family members to reporting risks greater than those present in routine clinical and social services activities. If, however, data would be collected in interviews conducted as part of the ordinary activities of a social services agency, and the agency’s ordinary reporting practices would be followed, the research risks would appear not to exceed the minimal risk threshold.
Assuming that the risk is characterized as a minimal one, the second question is whether disclosing it would unduly compromise the scientific integrity of the study by skewing enrollment or the accuracy of responses. Obviously, this question must be addressed in the context of a particular study. However, waiver of the disclosure requirement would seem to be especially warranted in studies aiming to provide accurate estimates of the occurrence of elder mistreatment.
In general, it is the panel’s view that investigators and IRBs need clearer guidance (without rigid rules) concerning two issues that tend to recur in elder mistreatment research: conditions under which research can properly go forward with participants whose decisional capacity is impaired, and the proper responses to evidence of mistreatment elicited during the course of the study. In the absence of better guidance, IRBs are left setting their own criteria, leading to inconsistencies and confusion—the same IRB often interprets the governing rules differently with each rotation of its chair. Co-