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 hypothetical research studies encompassing a variety of risks and benefits, we interviewed 315 competent persons > 65 years old (charges) and, separately, the individuals who would be designated as their proxies if the charges were to become incompetent. The proxies were asked what they thought their charges would decide and what decisions they would make for their charges and for their own participation. SETTINGS: A medical house-call program, two apartment complexes, and three nursing homes. PARTICIPANTS: Charges > 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 significantly different from random agreement (range of kappa statistics, 0.05–0.15). Rather, proxies' decisions for their charges were significantly related to the proxies' decisions for themselves (kappas, 0.52–0.86). When the paired proxies' and charges' decisions differed, the proxies were protective, more frequently refusing their charges' participation in the perceived riskier research studies. CONCLUSIONS: Proxies did not know what their charges would decide. Their choices for the charges related more to the proxies' decisions about their own participation (which they knew) than to the decisions of their charges (which they didn't know). This is similar to the process of a reasonable person making the decision, a characteristic of decisions made in the best interests of the patient.