Ethics and politics of research involving subjects with impaired decision-making abilities

In this issue of Neurology, Stocking et al.1 report a survey of 90 Alzheimer disease (AD) researchers who published articles prior to the flurry of policy debates of the late 1990s regarding the ethics of research with subjects lacking decision-making capacity. Thirty-eight (42%) returned usable data. Approximately two thirds of the respondents feel their institutional review boards (IRB) are now more exacting in their review, and a comparable number feel that the current climate makes research with decisionally impaired persons “harder to conduct.” Most of this more exacting review appears to be in the form of, sadly but not surprisingly, more stringent documentation; few of the researchers report making substantial changes in their informed consent procedures. Thus it appears that a large number of AD researchers are feeling more scrutiny from their IRB, and yet for many (perhaps including the 58% who did not respond) this scrutiny gives little reason for substantive changes in how they do their research.

This seemingly contradictory evidence mirrors the state of confused policy and practice in this arena. The majority of AD research is conducted with “double consent”—obtaining informed consent from both the person with AD and a surrogate who is typically a family caregiver. In many of these cases, the subject may lack capacity while the surrogate may lack the legal authority (as specified in 45CFR46.102c of the Federal regulations) to give permission. Historically, little legal scrutiny has been brought to bear on this …