Research participants want to be asked before their data are added to federal database
MONDAY, Sept. 13 (HealthDay News) -- Most research participants want to be asked for secondary consent -- referred to as re-consent -- before their existing personal genetic data are added to the federal database of Genotypes and Phenotypes (dbGaP), according to research published in the September issue of the Journal of Empirical Research on Human Research Ethics.
Evette J. Ludman, Ph.D., of the Group Health Research Institute in Seattle, and colleagues asked 1,340 study participants for re-consent for submission of their de-identified data to dbGaP. The first 400 of the 86 percent of subjects who agreed were asked to complete a telephone survey about the reasoning for their decision and their satisfaction with the process; 365 participants completed the survey.
The authors write that survey respondents felt it was very important (69 percent) or somewhat important (21 percent) to be asked for re-consent before submission of their existing data to the federal database. Alternatives to re-consent were presented, such as an opt-out process (unacceptable to 40 percent of the respondents) and a notification-only policy (unacceptable to 67 percent).
"Our results suggest that re-consent may be advisable in certain cases to anticipate and honor participant preferences. The cost of seeking re-consent from Adult Changes in Thought Study participants averaged approximately US$50 per participant. Researchers should be prepared for re-consenting study participants when feasible, and the National Institutes of Health should be prepared to provide researchers the time and money that this step requires," the authors conclude.