Advance research directives: implementation issues.

Abstract

To the Editor: Three policy groups recently recommended that competent individuals be given authority to consent to research participation during future periods of decisional incapacity. Proposals by the National Bioethics Advisory Commission (NBAC)1 and state advisory groups in Maryland2 and New York3 call for legal recognition of “prospective authorization for research participation” (NBAC) or of a similar mechanism, the “research advance directive” (Maryland and New York). The proposals also recommend giving competent persons authority to designate a research agent to act as their decision-maker during future study participation. The proposals characterize research directives as a policy measure that promotes respect for individual autonomy. Moreover, the proposals take the position that advance consent is an appropriate basis for involving a decisionally incapable person in research that presents a relatively high level of risk and no prospect of direct benefit. This category of research is ethically controversial because it exposes vulnerable people to more than minimal risk purely to advance knowledge. In the absence of advance consent, the Maryland and New York proposals forbid this category of research, and the NBAC proposal permits it only after heightened ethical scrutiny by a national review panel. Persons at risk for dementia are a major target population for advance research directives. In this context, however, special attention to the information disclosure and discussion process will be necessary to ensure that research directives are genuine expressions of autonomy. Safeguards must also be adopted to meet the equally important moral requirement that vulnerable research participants be protected from harm. To make autonomous decisions about future dementia research, people must understand two important facts. One is that research participation will be experienced when cognitive abilities are diminished. People considering research directives must realize that by the time the study is carried out, they might be unable to comprehend why the interventions are being performed or remember their former consent to participate. Discussions of hypothetical cases and observations of dementia patients involved in research could help people imagine what future study participation might be like. The goal should be to help people evaluate different levels of future research burdens, including the maximal permissible level of future research risk. People must also understand the difference between an advance treatment directive and an advance research directive. It is vital that people realize that an advance research directive authorizes procedures aimed primarily at advancing knowledge for the benefit of future patients. This point should be emphasized because members of the general public are likely to confuse the research advance directive with the more familiar living will or healthcare power of attorney. Safeguards to promote the welfare of decisionally incapable individuals in the research process will be essential as well. Competent research participants have the right to withdraw from studies if they discover the burdens are more substantial than they had anticipated. Because people making research advance directives will be decisionally incapable when study procedures occur, it will be up to research agents and investigators to ensure that participants are protected from undue pain and distress. Safeguards in the research process must address three areas. First, research agents must be informed of and fulfill their responsibilities to maintain close contact with participants during the study. Second, coercion must never be applied to an individual who physically or verbally resists research participation. Third, investigators must develop a plan for monitoring the participant's well-being during the research. Attention to monitoring will be especially important when advance directives authorize participation in the higher-risk studies that are ordinarily prohibited for decisionally incapable persons. Without close attention to these areas, advance consent to research will not be truly informed, and vulnerable dementia patients will not be protected sufficiently in the research process. A superficial approach to advance research directives would undercut their moral justification and create suspicion that their true objective is to permit incapable individuals to be involved in burdensome research to benefit the broader society.