Dementia is one of the most serious public health challenges of the coming decades. To respond to these challenges, research is needed that often requires the participation of subjects who are themselves demented. But ethical norms limit the participation of demented persons who are not able to consent to become a research subject. Research advance planning (RAP) may provide a way to balance the competing needs to advance knowledge and protect these vulnerable subjects. RAP means that a person -- prior to the loss of their capacity to make an enrollment decision - expresses their willingness to participate or not to participate in research that involves noncompetent subjects. But as valuable as RAP may be, we know very little about how the people for whom it is designed to protect view it. The goal of this project is to understand elderly persons' attitudes about RAP. We are focusing on ethically challenging research: research that does not offer the prospect of direct medical benefit to the subject. Using both quantitative and qualitative techniques, we will examine the willingness of elderly persons to designate a proxy for research decision making, to provide an advance consent, and their willingness to allow their proxy freedom, or leeway, to overturn their advance decision-in other words, to choose the opposite of their research advance directive. To assure the generalizability of our results, we will study elderly persons with a broad range of social, demographic and attitudinal characteristics. The results of this research will help national, state and institutional review board policies better reflect the views of the subjects; better define what is the appropriate content and specificity of a research proxy's substituted judgment; and identify demographic, attitudinal, and behavioral characteristics that explain differences in views about RAP and proxy decision making. These results will assist researchers and proxies in conducting subject-centered informed consent discussions. ? ? ?
| Rubright, Jonathan D; Cary, Mark S; Karlawish, Jason H et al. (2011) Measuring how people view biomedical research: Reliability and validity analysis of the Research Attitudes Questionnaire. J Empir Res Hum Res Ethics 6:63-8 |
| Karlawish, Jason; Rubright, Jonathan; Casarett, David et al. (2009) Older adults' attitudes toward enrollment of non-competent subjects participating in Alzheimer's research. Am J Psychiatry 166:182-8 |
| Jefferson, Angela L; Lambe, Susan; Moser, David J et al. (2008) Decisional capacity for research participation in individuals with mild cognitive impairment. J Am Geriatr Soc 56:1236-43 |
