Emergency Research and Research Involving Subjects with Cognitive Impairment: Ethical Connections and Contrasts

n this issue, Doctors Karlawish and Sachs suggest that I recent analyses of emergency research could shed light on persistent ethical problems in geriatric, neurologic, psychiatric, and other research involving subjects with cognitive impairment. We agree that certain ethical considerations are relevant to both emergency and nonemergency research involving decisionally incapable subjects. However, we also believe that the two kinds of research differ in ethically relevant ways. We will first discuss differences between emergency and nonemergency research and then address the commona litics. Research in emergency situations and other forms of research involving subjects with cognitive impairment differ in the opportunities for deliberation about research participation, the capacities of subjects to give assent, and the risks individuals face if they fail to enter a study. Our comments on emergency research refer to the final federal rules issued in October 1996. ’ In both emergency research and research involving subjects with cognitive impairment, prospective participants are often incapable of independent decision-making about whether to enter a study. In the emergency situation, there is frequently a need for speedy intervention, sometimes before an i l l or injured person’s family can be consulted. This urgency is absent in most proposals to involve subjects with cognitive impairment. In the latter research situation, there is typically the opportunity to present relevant information to a family member or other surrogate, who may then decide whether to permit the cognitively impaired person’s participation. Outside the emergency situation, we see no justification for conducting research without obtaining surrogate consent on behalf of decisionally incapable subjects.