Research While Impaired?

Have you (or a family member or friend) been involved as a research participant while your capacity to make decisions was impaired? If so, you have a unique opportunity to advise the federal government as it considers revising its regulations on research involving human subjects. There are 10 more days remaining for public comment - and yes, you are eligible to comment.

Normally, of course, potential research participants are provided with information about a clinical trial, in writing and usually also orally. If they decide they wish to be enrolled in the study, they are then required to read and sign an Informed Consent form. Some research necessarily involves participants who are decisionally-impaired. That is, due to long-term or temporarily low mental capacity, an individual is unable to adequately understand and weigh the risks and benefits of volunteering for the clinical trial. Examples of such research would include studies of behavior when someone is heavily under the influence of alcohol or drugs, studies of individuals with advanced Alzheimer's disease, and studies of the severely mentally disabled.

The Office for Human Research Protections is soliciting comments from the public through January 14. The original solicitation "Request for Information and Comments on Research That Involves Adult Individuals With Imparied Decision-making Capacity" may be found at http://www.hhs.gov/ohrp/documents/20070905.htm. This deadline represents an extension of the original December 4, 2007 deadline.

Many of the specific questions posted are directed at researchers themselves and at members of Institutional Review Boards (IRBs - the committees that review and approve clinical research at hospitals, universities and other research organizations). However, several of the questions solicit responses which should include those from actual research participants or their family or friends. I've listed some of those questions below, numbered as in the government posting:

1f. For research involving adult individuals with impaired decision-making capacity as subjects, how are subjects' potential or actual objections to enrollment or continued participation in research being addressed by investigators and IRBs?

1h. For studies that have included an assessment of potential subjects' capacity to consent, how has this assessment been used in the informed consent process? Are subjects notified when they have been found to lack capacity to consent? When informed consent is sought from such a subject's legally authorized representative, are potential subjects provided an opportunity to assent or object to their participation in the research?

1i. For research involving subjects who are able to provide informed consent, but are expected to have fluctuating, limited, or diminishing decision-making capacity during the course of the research study, what processes or procedures have investigators implemented, or have IRBs required, in order to ensure that the rights and welfare of such subjects remains adequately protected?

2. What problems or concerns have arisen for investigators, IRBs, or research subjects in the conduct or review of research involving decisionally impaired individuals as subjects?

2b. Please describe the process used when a legally authorized representative is asked to consent on behalf of a prospective research subject for research involving adult individuals with impaired decision-making capacity as subjects. Do the legally authorized representatives use substituted judgment (decisions that reflect the views of the individual expressed while decisionally capable) or the best interest standard? Which seems more ethically justified?

2c. How are advance directives for health care and for research used when a legally authorized representative is available?

2d. Have any problems or concerns arisen in regard to seeking consent from a legally authorized representative on behalf of a prospective research subject for research involving adult individuals with impaired decision-making capacity as subjects? If so, please describe the issues that have arisen.

4. How should the population of adults with impaired decision-making be defined for the purposes of guidance or regulation?

6a. If an adult with impaired decision-making capacity is capable of providing assent to participation in research, should the guidance or regulation indicate that the adult subject's assent should always be a condition for proceeding with the research? If there are circumstances when an adult subject's assent should not be necessary, what are those circumstances?

Your participation in this national dialogue may assist the federal government in hearing all sides of this issue. Your experience is at least as important as what researchers and IRBs will be telling the feds. And please, feel free to share your thoughts here as well.

-Joe

Related Topics:

• 12 Answers to Common Questions About Clinical Trials
• Alzheimer's Disease: Clinical Trials - A Guide for Patients

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