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

Abstract

Biobanks are essential resources, and participation by individuals from diverse groups is needed. Various models of consent have been proposed for secondary research use of biospecimens, differing in level of donor control and information received. Data are needed regarding participant preferences for models of consent, particularly among minorities. We conducted qualitative semi-structured interviews with 60 women to examine their attitudes about different models of consent. Recruitment was stratified by race (Black/White) and prior biobank participation (yes/no). Two coders independently coded interview transcripts. Qualitative thematic analysis was conducted using NVivo 10. The majority of Black and White participants preferred Bbroad^consent (i.e., blanket permission for secondary research use of biospecimens), and the second most preferred model for both groups was Bstudyspecific^consent (i.e., consent for each future research study). The qualitative analysis showed that participants selected their most preferred model for 3 major reasons: having enough information, having control over their sample, and being asked for permission. Least preferred was notice model (i.e., participants notified that biospecimens may be used in future research). Attitudes toward models of consent differed somewhat by race and prior biobank participation. Participants preferred models of consent for secondary research use of biospecimens that provided them with both specific and general information, control over their biospecimens, and asked them to give permission for use. Our findings suggest that it will be important for researchers to provide information about future uses of biospecimens to the extent possible and have an explicit permission step for secondary research use.

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

“…We found that participants generally understood information on topics such as privacy and return of individual results. These topics were the subjects of the most common queries related to secondary research use of biospecimens found in our previous research[37]. We also found that topics such as possible risks of the use of biospecimens were least understood, which was similarly found in a prior study by Klima and colleagues[34].…”

“…We developed the content based on prior research by ourselves and others highlighting particularly difficult topics related to biobanks[33-35, 37] and integrated our prior findings about difficult terms in developing the wording of the text[37]. Each of the three brochures contained the following elements: Title page introducing the topic of the brochure; back page with information on the affiliated institution; a Frequently Asked Questions section; a graphic illustrating what happens when a sample is donated to a biobank (Figure 1); and sections describing the purpose of the research, the process of biospecimen donation, timing of consent process, and information about future research that might be conducted using stored biospecimens (Table 1).…”

“…All participants in the cognitive interviews were female because they were the target audience for the brochures; the brochures were intended to be used in a randomized experiment focused on women considering participation in a research study and biobank[37]. Recruitment for this study was stratified between Black and White females because we found in a prior study that participants’ perceptions of various models of consent differed by race[37].…”

“…Recruitment for this study was stratified between Black and White females because we found in a prior study that participants’ perceptions of various models of consent differed by race[37]. Women were eligible to participate in the cognitive interviews if they self-identified as either non-Hispanic White or Black; we recruited 7 Black women and 7 White women.…”

An empirical assessment of the short-term impacts of a reading of Deborah Zoe Laufer's drama Informed Consent on attitudes and intentions to participate in genetic research

“…Many key stakeholders commented on the Notice of Proposed Rule Making against obtaining consent due to the minimal risk nature of biospecimen research and the logistics of obtaining informed consent from populations within the context of clinical care and competing clinical needs (Health and Human Services 2015). Some published research with varied populations supports these comments, indicating that the public does not want to be refer each research project that uses their biospecimens (Simon et al 2011; Brown et al 2016; Garrison et al 2016). Yet, additional evidence supports a conclusion that the public wants to know about research with their biospecimens and more importantly, they want to be asked for their permission (Hendrix et al 2013; Javitt 2013; Botkin et al 2014, Hayeems et al 2016).…”