eTable. The sociodemographics of survey respondents and non-respondents compared to the Current Population Survey
Tom Tomlinson, Raymond De Vries, Kerry Ryan, Hyungjin Myra Kim, Nicole Lehpamer, Scott Y. H. Kim. Moral Concerns and the Willingness to Donate to a Research Biobank. JAMA. 2015;313(4):417–419. doi:10.1001/jama.2014.16363
Research biobanks are increasing in number and importance, with great potential for advancing knowledge of human health, disease, and treatment.1 Recruitment of donors is vital to their success and relies largely on blanket consent, in which donors give one-time permission for any future research uses of their coded specimen. This approach to consent has been endorsed recently in proposed changes to federal regulations.2
Previous studies suggest that donors may have moral, religious, and cultural concerns about the use to which their specimens are put, which may affect their willingness to give blanket consent.3,4 These earlier studies, however, used convenience samples unrepresentative of the US population.
The institutional review boards at the University of Michigan and Michigan State University approved this study as exempt. Between June 18, 2014, and June 30, 2014, we used the GfK KnowledgePanel (a probability-based online panel of adults aged 18 years or older, designed to represent the civilian, noninstitutionalized US population) to field a survey examining associations between moral concerns and the willingness to donate to a biobank.
Respondents read an introductory description of a fictional biobank and then used a 6-point scale—from strongly agree to strongly disagree—to indicate their willingness to donate, first using blanket consent and then “even if” their samples might be used in each of 7 potential research scenarios presenting moral concerns. We then gave respondents short descriptions of the benefits and consequences of 5 methods of gaining consent and asked them to indicate which were the acceptable, best, and worst options.
All analyses were weighted to correct for the stratified sampling designs and other sources of survey errors including nonresponse and noncoverage. We used conditional logistic regression to compare willingness to consent with blanket consent vs other scenarios. Analyses were done using Stata version 13.1 (StataCorp); all tests were 2-sided, with a threshold of P = .05.
After excluding 39 surveys with nonresponses to at least half of the substantive survey questions, our final analysis included 1599 participants, resulting in a response rate of 60.2% (1599 of 2654 participants). Respondents were older (51 years vs 45 years for nonrespondents), were more commonly white (82% vs 75%), and had higher levels of education and household income (eTable in the Supplement). Using blanket consent, 68.0% (95% CI, 65.5%-70.5%) were willing to donate. In all but 1 scenario, moral concerns were associated with a significant reduction in willingness to donate (Table 1).
When asked about different approaches to gaining consent, 43.6% (95% CI, 41.1%-46.0%) of respondents found the blanket consent method to be unacceptable, and 37.8% (95% CI, 35.3%-40.4%) said blanket consent was the worst among 5 policy options. Specific consent, in which donors are asked to consent to each study using their specimen, was considered the worst option by 45.0% (95% CI, 42.4%-47.6%) (Table 2).
As shown in previous studies,5 this survey documented that members of the general population are willing to donate to biobank research. Most respondents were willing to donate using a blanket consent. However, willingness to donate waned when they were informed of possible uses of their specimens that raised moral concerns. As recruitment of donors becomes more widespread, such concerns may need to be addressed to moderate possible effects on donation rates.
Respondents’ preferences toward biobank consent options are also noteworthy. Specific consent, the option that gives donors the most control over potentially concerning uses, was the least preferred option. But blanket consent, the option currently in widespread use, was not far behind. This suggests that an adequate approach for dealing with donors’ moral concerns may lie between these 2 extremes.
Limitations include a response rate of 60%, with respondents and nonrespondents differing on some characteristics that may introduce bias. Because respondents may be more in favor of research, the association between moral concerns and decreased willingness to donate may be a conservative estimate. Also, respondents’ views were based on brief scenarios rather than on detailed understanding of the issues. Deliberative engagement with citizens may deepen understanding of public opinion regarding biobank policy.
Corresponding Author: Tom Tomlinson, PhD, Center for Ethics and Humanities in the Life Sciences, Michigan State University, 965 Fee Rd, East Lansing, MI 48824 (email@example.com).
Author Contributions: Dr Tomlinson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Tomlinson, De Vries, Ryan, H. Kim, S. Kim.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: All authors.
Critical revision of the manuscript for important intellectual content: Tomlinson, De Vries, S. Kim.
Statistical analysis: H. Kim.
Obtained funding: Tomlinson, S. Kim.
Administrative, technical, or material support: De Vries, Ryan, Lehpamer.
Study supervision: Tomlinson, De Vries.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: The work was supported by grant 1 R01 HG007172-01A1 from the National Human Genome Research Institute.
Role of the Funder/Sponsor: The National Human Genome Research Institute had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The ideas and opinions expressed by Dr S. Kim in this article are his own; they do not represent any position or policy of the National Institutes of Health, the Department of Health and Human Services, or the US government.