Public preferences regarding informed consent models for participation in population-based genomic research

Abstract

Purpose Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, while others re-consent for specific new studies. Understanding research participants’ attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support. Methods An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy, the value of research, and the perceived trustworthiness of researchers. Results Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among Black non-Hispanic respondents, and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those that would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved. Conclusion These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent.

Differences in preferences for models of consent for biobanks between Black and White women

“…However, some participants also viewed the study-specific model as time-consuming, wasteful, and burdensome, as also observed in prior studies (Hoeyer et al 2004;Master et al 2013;Murphy et al 2009;Platt et al 2013). We found some differences in qualitative themes about the study-specific model by race, with White participants in particular believing that this model would lead to too much contact, while having specific information about secondary research uses and being asked permission for each study were particularly important among Black participants.…”

“…Our study also adds an indepth exploration of women's reasons for these preferences. Prior studies have identified the importance of participants' feelings of control over their sample (Platt et al 2013;Simon et al 2011) and the importance of being asked permission (Murphy et al 2009;Simon et al 2011); our study adds that feeling informed as a result of the consent process is an essential characteristic of participants' most preferred consent model. Prior empirical studies that have examined preferences for different models of consent for secondary research use of Wouldn't know details of every future study before giving one-time permission "I would wanna know each time you wanna sample or whatever, I would like you to give-like, don't just tell me anything.…”

“…Thiel et al (2014) found that participants preferred a study-specific consent model while other studies have found a preference for a broad model of consent (Platt et al 2013;Platt et al 2014;Simon et al 2011;Vermeulen et al 2009). In one such study, believing that a particular research study might lead to improved treatments or cures was associated with preference for a broad model of consent (Platt et al 2013), although we did not observe this reason for participants' preferences in our study. We did find, however, that participants were concerned that a broad model of consent might slow down research progress compared with models using an optout process.…”

“…In 2011, the US Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM), seeking public perspective to guide possible changes to policies regarding human subjects' research protection (U.S. Department of Health and Human Services 2011). The current policy is that research using biospecimens previously collected for research or clinical use can be conducted without additional consent if certain conditions are met, including if any personal identifying information is removed or not recorded or if the research meets requirements for waiver of consent (Platt et al 2013 (2014) recently finalized a revised Genomic Data Sharing policy which details that funding applications submitted on or after January 25, 2015 should, among other things, include informed consent wording detailing that samples will be used for broad biomedical purposes without specific data use limitations.…”

Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process

“…Previous research shows that participants consider a multitude of topics important when reviewing consent forms and making a decision to participate in research studies[11, 14, 51, 52]. Our findings demonstrate the importance of utilizing plain language guidelines to clearly communicate information to participants and using brochures to improve participants’ understanding of all aspects of the study.…”