Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research
The effects of disclosing financial interests to potential research participants are not well understood.
To examine the effects of financial interest disclosures on potential research participants’ attitudes toward clinical research.
Design and Participants
Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements.
Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial.
Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments.
Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.
KEY WORDSclinical research disclosure financial interest
We thank Scott Y. Kim of the University of Michigan for commenting on an early draft of the manuscript; Diana B. McNeill, Mark N. Feinglos, and Peter S. Kussin of Duke University, and Peter B. Terry, Frederick L. Brancati, and Jerry A. Krishnan of The Johns Hopkins University for assistance with developing items with which to categorize disease severity among survey respondents; and Damon Seils of Duke University for editorial assistance and manuscript preparation.
This study was supported by grant R01HL075538-01 from the US National Heart, Lung, and Blood Institute to Dr Sugarman. This work was independent of the funding source. The sponsor had no involvement in the study design; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to submit the paper for publication.
Conflicts of interest
- 6.National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants, Vol. 1. Bethesda, Md: National Bioethics Advisory Commission; August 2001.Google Scholar
- 7.Department of Health and Human Services. Financial relationships and interests in research involving human subjects: guidance for human subject protection. Fed Regist. 2004;69:26393–7.Google Scholar
- 13.Weinfurt KP, Allsbrook JS, Friedman JY, et al. Developing model language for disclosing financial interests to potential clinical research participants. IRB Advis. 2007;29:1–5.Google Scholar
- 15.Cohen J. Statistical power analysis for the behavioral sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.Google Scholar
- 19.New survey shows public perception of opportunity to participate in clinical trials has decreased slightly from last year. Harris Interactive Healthcare News. 2005;5(6):1–14. Available at: http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=941. Accessed February 9, 2007.
- 20.Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress—Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research. Washington, DC: Association of American Medical Colleges; 2001:1–23.Google Scholar