Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects

A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid.  Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s.  The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.

The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study  may hinder efforts to conduct trials of Alzheimer’s drugs.  In 2010, an Institute of Medicine summary  of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in which they agreed to participate, and 90% of all clinical trials worldwide fail to enroll the target number of subjects on time and must extend their enrollment periods.  Though the federal Office for Human Research Protections and the Secretary’s Advisory Committee on Human Research Protections have considered the issue of participation of decisionally-impaired subjects in research in recent years, no guidance has been released.  Further, few states’ laws explicitly address who has authority to consent to research participation on behalf a decisionally-impaired individual.

In the absence of clear guidance, to be in the best position to participate in Alzheimer’s research and other research involving subjects who are or may become decisionally-impaired, institutions and their IRBs should develop their own policies on enrollment of and consent for decisionally-impaired subjects and subjects whose capacity may diminish over the course of a study.  Having policies in place before opportunities to participate in such studies arise will help ensure consistent and efficient review by institutions and IRBs.  Individuals who have a strong interest in participating in Alzheimer’s research studies should complete health care power of attorney documents, record their wishes in writing, and discuss them with their designated health care agents.

©2012 Drinker Biddle & Reath LLP

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