To share or not to share: A randomized trial of consent for data sharing in genome research

Abstract

Purpose Despite growing concerns toward maintaining participants’ privacy, individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing. To assess the effect on research enrollment and data sharing decisions of three different consent types (traditional, binary, or tiered) with varying levels of control and choices regarding data sharing. Methods A single blind, randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston, Texas between January 2008 and August 2009. Participants were randomly assigned to one of three experimental consent documents (traditional, n=110; binary, n=103; tiered, n=110). Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation. Results Before debriefing, 83.9% of participants chose public data release. After debriefing, 53.1% chose public data release, 33.1% chose restricted (controlled access database) release, and 13.7% opted out of data sharing. Only one participant declined genome study participation due to data sharing concerns. Conclusion Our findings indicate that most participants are willing to publicly release their genomic data, however, a significant portion prefer restricted release. These results suggest discordance between existing data sharing policies and participants’ judgments and desires.

Pediatric Data Sharing in Genomic Research: Attitudes and Preferences of Parents

“…When not constrained by a particular consent form (after debriefing, Table 2), parents selected no release and restricted release at 2.59 and 1.4 times adults, respectively, with public release, the most common choice of adults (62.8%), being selected only 38.1% of the time by consenting parents. These differences in final DS option were significant (P , .001) and previously reported by McGuire et al 12 Parents start with more restrictive choices before debriefing and then choose more restrictive options when freed from randomized consent at an approximately equal rate to adults, with 1 exception. Parents originally assigned to traditional consent egress from public release (Table 3) at a higher rate than adults when presented with other options (ordinal OR 4.75; 95% CI, 1.45-15.55).…”

“…Full study design, enrollment rates, randomization procedure, and debriefing details can be found in McGuire et al 12 Participants recruited to 1 of 6 ongoing genomic studies (pediatric brain tumor and controls, pediatric autism, adult and pediatric epilepsy, adult and pediatric liver cancer, and adult pancreatic cancer) were randomly assigned to 1 of 3 experimental informed consent documents (ICDs) with a waiver of consent at Baylor College of Medicine in Houston, Texas between January 2008 and August 2009. The experimental ICDs provided varying options for breadth of genomic DS (traditional consent, meaning public release or withdraw from study; binary consent, public release or no release; and tiered consent, public release, restricted release, or no release).…”

“…11 Data sharing (DS) preferences of this group are not well studied, and the factors influencing parental permission need additional characterization if we are to maximize the efficiency of future pediatric genomics studies while protecting our young patients. We previously reported that adults were more likely to agree to public data release than parents, 12 but the reasons underlying these differences have not been explored. Toward this end, the current study seeks to explore the attitudes and preferences of parents of pediatric patients and adult patients enrolled in genomic research studies.…”

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

“…37,40,48 Preferences for data sharing: data-sharing options. Despite positive attitudes towards data sharing, [40][41][42]49 most respondents in quantitative as well as in qualitative studies stressed the importance of being informed about data-sharing practices and privacy protection measures during the informed consent process. 30,[39][40][41][42][43] In several studies, Table 1 Informed consent requirements in biobank-based genomic research: main findings…”

“…37,40,48 Preferences for data sharing: data-sharing options. Despite positive attitudes towards data sharing, [40][41][42]49 most respondents in quantitative as well as in qualitative studies stressed the importance of being informed about data-sharing practices and privacy protection measures during the informed consent process. 30,[39][40][41][42][43] In several studies, Table 1 Informed consent requirements in biobank-based genomic research: main findings Informed consent requirements in biobank-based genomic research (a) The majority of patients accepted one-time-general consent as appropriate type of consent; reconsent for every future research project was regarded as a waste of time, effort and money [22][23][24] (b) Up to 44% of respondents from the public requested reconsent for each new study [28][29][30] (c) Patients and public wanted to know the aim of the of research [25][26][27][30][31][32] (d) General requirements for participations in research were study approval by REC and trust in authorities 31,32 Articles excluded n=693…”