Developing model biobanking consent language: what matters to prospective participants?

Abstract

Background Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation. Methods We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions. Results Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful. Conclusions These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

“…A few studies (3/31, 9.7%) suggested providing participants considered to be “high information seekers” with the option or ability to drill down on information elements within a consent form (ie, supplementary information and click to expand) [ 44 , 49 , 65 ]. Information elements deemed most important to participants included the purpose of the proposed initiative, duration of the study, permitted uses and access, data handling and control, safeguards and security measures, and the risks and benefits of consenting [ 49 , 60 , 65 , 97 , 98 ].…”

“…At the most rudimentary level, individuals require specific and easily comprehensible information on who their PHI is being shared with, for what purpose their PHI will be used, and how the privacy and security of their PHI will be ensured [ 10 , 117 ]. Providing individuals with adequate information to make an informed choice fosters transparency—the moral and ethical obligation to enable meaningful consent [ 72 , 97 , 117 , 118 ]. The insights gathered and summarized in this review highlight the need to recognize individual behaviors and preferences when designing and implementing the consent processes of digital health initiatives and the importance of building and sustaining trust and transparency.…”

Becoming a research participant: Decision-making needs of individuals with neuromuscular diseases

“…Being part of the solution, not the problem, is an important element for individuals because many of them live with the guilt of being a carrier of an inherited disease. Helping others was a theme observed in recent literature [61,62]. This aspect is important to highlight, because it can strongly influence a person's decision to participate in a research project.…”

Alignment between expectations and experiences of egg donors: what does it mean to be informed?

“…Ensuring fully informed consent can be challenging, there is a natural asymmetry of knowledge between lay individuals and clinical experts, patients and research participants do not always retain all of the information communicated during this process, and there are often gaps between information communicated and information retained (Beskow and Weinfurt, 2019). This has led to increased efforts to determine what type of information matters to prospective research participants (Beskow et al, 2020).…”