Enrolling subjects by exception from consent versus proxy consent in trauma care research.

STUDY OBJECTIVE

For clinical research, the consent process plays a critical role in protecting human subjects. In emergency research, proxy consent can impose substantial delays or even render a study infeasible if the intervention involves a highly time-sensitive treatment. The objective of this study is to compare the time required to enroll brain-injured trauma patients in a study with proxy consent versus exception from consent.

METHODS

We analyzed data from a clinical trial (Progesterone for Traumatic brain injury-Experimental Clinical Treatment-ProTECT) of a promising treatment for acute brain injury that used proxy consent for subject enrollment. Performance metrics using proxy consent (actual study) were compared to assumptions of what would have happened if the study had been conducted with exception from consent (hypothetical study). The total number and monthly rate of enrollees, mean time from injury to initiation of the study treatment, and number of subjects receiving unwanted treatment for any span of time were compared.

RESULTS

During the 30-month enrollment period, the actual study accrued 100 consenting subjects (3.3 per month) compared with 122 subjects (4.1 per month) for the hypothetical study. Mean time from injury to initiation of experimental treatment in the actual study was 379.2 standard deviation 118.0 minutes, approximately 6.3 hours, compared with 122 minutes in the hypothetical study.

CONCLUSION

Exception from consent can reduce mean time from injury to initiation of study treatment of trauma patients by 4 hours or more. For a time-critical trauma care intervention, this difference may justify elaborate efforts to comply with the Final Rule.