title: Assessing the understanding of biobank participants.
abstract: Biobanks have been developed as a tool to better understand the genetic basis of disease by linking DNA samples to corresponding medical information. The broad scope of such projects presents a challenge to informed consent and participant understanding. To address this, 200 telephone interviews were conducted with participants in the NUgene Project, Northwestern University's biobank. Interviews included a modified version of the "quality of informed consent measure" (QuIC) and semi-structured questions which were analyzed thematically for 109 of the interviews. The QuIC, originally applied to cancer clinical trials, objectively assessed some of the components of informed consent for a biobank, and interview questions provided rich data to assist in interpreting participant understanding. The best understood domains included: the nature of the study, benefit to future patients, and the voluntary nature of participation. Lower knowledge scores included: potential risks and discomforts, experimental nature of the research, procedures in the event of study-related injury, and confidentiality issues. Qualitatively, confidentiality protections of the study were described as good by most (>50%). Although some cited concerns with employer (12%) or insurance discrimination (25%), most considered the risks to privacy low (25%) or none (approximately 60%). Only 10% of participants explicitly stated they had no expectation for personal benefit, and when asked whether they expected to be contacted with study results, respondents were split between having no expectation (39%), being hopeful for results (37%) and expecting to be contacted with results (12%). These findings are informative to those establishing and implementing biobanks, and to the IRBs reviewing such studies.
authors.affiliation: Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. kormond@stanford.edu
authors.forename: K E
authors.initials: KE
authors.lastname: Ormond
authors.forename: A L
authors.initials: AL
authors.lastname: Cirino
authors.forename: I B
authors.initials: IB
authors.lastname: Helenowski
authors.forename: R L
authors.initials: RL
authors.lastname: Chisholm
authors.forename: W A
authors.initials: WA
authors.lastname: Wolf
mesh_terms: D016208:Databases, Factual; D030561:Databases, Nucleic Acid; D028744:Ethics Committees, Research / Q000941:ethics; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D007407:Interviews as Topic