Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey

Abstract

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket—or broad—consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using “real-time”—or study-by-study—consent, but this policy places a significant burden on biobanks. In order to better understand the public’s preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

Effect of deliberation on the public’s attitudes toward consent policies for biobank research

“…We also found that for >70% of respondents, willingness to give broad consent was adversely affected by at least one scenario and that lower levels of trust in biomedical research was a strong predictor of this effect [8]. Further, when our respondents were asked to evaluate alternative forms of consent, substantial minorities found both broad and 'real-time' specific consent (in which the biobank asks for donor consent for each specific project) to be 'unacceptable' policies (43.6% and 43%, respectively) or to be the 'worst' policies (37.8%, 45%) among five options [9].…”

“…The survey administered to participants was the same one used in our previous national study [9]. It starts with a brief description of a fictional biobank and an explanation of the process of donating to a biobank.…”

The Ethics of Medical Data Donation

“…Questions around what constitutes an optimal model for the consent of health research participants, and the limits of that consent, have been closely and extensively scrutinised in the academic literature. There remains disagreement on terminology as between broad and blanket consents (De Vries et al 2016) and in particular as to whether broad consent can, or cannot, be sufficiently informed in ethically robust terms Kaye et al 2014). A comprehensive review of this ongoing debate falls outside of the scope of this chapter.…”

“…The authors further suggest that this interactive aspect of broad consent may be improved though the use of some of the communication methods used in dynamic consent (see also Kaye et al 2014 for a description of this model). De Vries et al (2016) suggest that the challenge in broad consent is to combine 'transparency about sponsored research together with governance models that assure the donor community and the public that their interests and moral concerns are being respected'. In the case of live donors to biobanks, they note that this can be achieved through access to information -for example by providing up-to-date descriptions of projects.…”

Medical Data Donation, Consent and the Public Interest After Death: A Gateway to Posthumous Data Use

“…Questions around what constitutes an optimal model for the consent of health research participants, and the limits of that consent, have been closely and extensively scrutinised in the academic literature. There remains disagreement on terminology as between broad and blanket consents (De Vries et al 2016) and in particular as to whether broad consent can, or cannot, be sufficiently informed in ethically robust terms (Sheehan 2011;Kaye et al 2014). A comprehensive review of this ongoing debate falls outside of the scope of this chapter.…”