Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent

Abstract

Dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation. Although the argument for dynamic consent has been made on theoretical grounds, empirical studies evaluating the potential utility of dynamic consent are needed to enhance deliberations about the merits of dynamic consent. Few studies have assessed such considerations as whether donor preferences may change over time or if participants would use a dynamic consent mechanism to modify preferences when they change. We administered a 66-item survey to participants in a large DNA biobank. The survey sought to gauge the stability of donor preferences specified at the time of biobank enrollment, specifically the stability of donors’ preference regarding posthumous availability of biospecimens to next-of-kin. We received 1164 completed surveys for a response rate of 72%. Forty percent of respondents indicated a preference regarding sample availability on the survey (T2) that was inconsistent with the preference they had expressed when they enrolled in the biobank (T1). Most (94%) individuals with inconsistent preferences regarding sample availability had initially restricted sample availability at T1 but were comfortable with broader availability when asked at the time of the survey (T2). Our findings demonstrate that preferences regarding sample use expressed at the time of enrollment in a DNA biobank may not be reliable indicators of donor preferences over time. These findings lend empirical support to the case for a dynamic consent model in which biobank participants are approached over time to clarify their views regarding sample use.

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

“…Furthermore, in a survey with CHRIS participants conducted in 2014, participants highly endorsed the study and valued the possibility to change their consent choices over time, the possibility to choose among different options, and the ongoing regular communication (Supplementary Information, Table S2 ). This echoes the findings of other empirical studies that found that biobank participants’ preferences over samples availability changed over time, suggesting that dynamic consent, designed as an informed consent model that provides the strategy to address the possible changes in values and wishes that participants may experience through time, is relevant for participants [ 24 ]. Additionally, another empirical study with biobank participants investigating the experience of participating in biobanking research and of using a dynamic consent interface sample showed that the possibility of revising the consent given and the possibility of being informed about the research development through a dynamic consent tool represented for participants an opportunity for reciprocity and engagement [ 25 ].…”

Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers

“…Tiered consent has also been preferred in other African countries [ 51 ]. Dynamic consent represents another model in which donors can choose their preferences about sample use through web-based interfaces [ 52 ]. This type of consent is controversial, primarily due to costs that might make it prohibitive in LMICs.…”

“…This engagement can be done in different ways, including community advocates and forums and community advisory boards [ 52 , 53 ]. An interesting example of community engagement is the one that involved the United States biobanks in the eMERGE Network.…”

Informed consent, genomic research and mental health: A integrative review

“…The importance of a written information is emphasized. 33 As the research of genomics and genes has expanded, 38 it is time to investigate the current information on informed consent practices in the context of genomic studies on mental health. The purpose of this study was to provide information to the large education program developed for health care professionals on genomics and genetic studies.…”