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.

Understanding of informed consent by parents of children enrolled in a genetic biobank

“…This is consistent with prior studies of adult biobanking participants. Ormond et al 13 demonstrated that nearly half of the subjects enrolled in a biobanking study were unaware that their DNA would be stored at all, a finding that this study confirmed. It is possible that participants may not understand the connection between the samples they provide (blood or saliva) and the storage of DNA.…”

“…The Marshfield and Nugene studies demonstrated discrepancies between objective and subjective scores on the QuIC assessment. 13,14 Although the questions in this study are slightly different from those of the previously mentioned studies, it is apparent from these combined results that biobanking participants appear to think that they understand more than they do. Future research should include assessments of actual and perceived understanding immediately following consent to confirm these results.…”

“…This supports previous studies of informed consent understanding for adults consenting to participate in research studies. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] However, our study is the first to measure actual and perceived understanding of informed consent for parents who gave permission for their children to participate in a biobanking study. More than half of the parents were uncertain or responded incorrectly to the main questions of the study, including those regarding the use and storage of samples and the handling of results from the study.…”

“…[12][13][14] This brief measure assesses understanding of the following domains: (i) the purpose of the research; (ii) the expected duration of participation; (iii) the procedures; (iv) the experimental procedures; (v) the foreseeable risks or discomforts; (vi) the benefits that may be reasonably expected; (vii) the appropriate alternative procedures or treatments; (viii) the confidentiality of research records/participant information; (ix) the compensation and the medical treatment provided if injury results; (x) whom to contact if the participant has questions about the study, participants' rights, or a research-related injury; and (xii) the voluntary nature of research, including the right to refuse participation or withdraw without any penalty or loss of benefits.…”

La recherche biomédicale à l’ère des tumorothèques

“…Il est toutefois nécessaire de s'assurer de la qualité de la procédure. Des études, menées dans le contexte de biobanques destinées à la population générale ou à des patients diabétiques, ont mis en évidence la qualité insuffisante des consentements recueillis [19,20]. En cancérologie, la période de l'annonce du diagnostic de cancer est peu propice à la transmission d'informations dans le cadre du recueil du consentement à participer à un essai clinique [21], et les documents d'information complets sont souvent longs et difficiles à comprendre [22].…”