PROXIES DECISIONS ABOUT CLINICAL RESEARCH PARTICIPATION FOR THEIR CHARGES

OBJECTIVE: To examine the process by which proxies decide about their charges' participation in clinical research. DESIGN: Using eight hypot hetical research studies encompassing a variety of risks and benefits, we interviewed 315 competent persons greater than or equal to 65 year s old (charges) and, separately, the individuals who would be designat ed as their proxies if the charges were to become incompetent. The pro xies were asked what they thought their charges would decide and what decisions they would make for their charges and for their own particip ation. SETTINGS: A medical house-call program, two apartment complexes , and three nursing homes. PARTICIPANTS: Charges greater than or equal to 65 years old and their proxies.MAIN OUTCOME MEASURE: Comparison of decisions made by charges and by proxies for their charges. RESULTS: The agreement between the proxies' and charges' decisions was not sign ificantly different from random agreement (range of kappa statistics, 0.05-0.15). Rather, proxies' decisions for their charges were signific antly related to the proxies' decisions for themselves (kappas, 0.52-0 .86). When the paired proxies' and charges' decisions differed, the pr oxies were protective, more frequently refusing their charges' partici pation in the perceived riskier research studies. CONCLUSIONS: Proxies did not know what their charges would decide. Their choices for the c harges related more to the proxies' decisions about their own particip ation (which they knew) than to the decisions of their charges (which they didn't know). This is similar to the process of a reasonable pers on making the decision, a characteristic of decisions made in the best interests of the patient.