Views of potential research participants on financial conflicts of interest barriers and opportunities for effective disclosure
BACKGROUND: There is little guidance regarding how to disclose researchers’ financial interests to potential research participants.
OBJECTIVE: To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement.
DESIGN AND PARTICIPANTS: Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer.
APPROACH: Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis.
RESULTS: Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know.
CONCLUSIONS: Financial interests are important to potential research participants, but obstacles to effective disclosure exist.
Key Wordsconflict of interest disclosure human experimentation
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- 1.Office of Extramural Research, National Institutes of Health. Financial Conflict of Interest: Objectivity in Research. Available at: http://grants.nih.gov/grants/policy/coi/nih_review.htm. Accessed November 18, 2005. 2002.Google Scholar
- 2.National Science Foundation. Chapter V: Grantee Standards. Available at http://www.nsf.gov/pubs/2002/nsf02151/gpm5.jsp. Accessed November 18, 2005. 2002.Google Scholar
- 3.American Society of Gene Therapy. Financial Conflict of Interest in Clinical Research. Available at: http://www.asgt.org/position_statements/conflict_of_interest.html. Accessed November 18, 2005. 2000.Google Scholar
- 5.Financial relationships and interests in research involving human subjects: guidance for human subject protection. Federal Register. 2004; 69:26393–7.Google Scholar
- 6.Food and Drug Administration. Guidance: Financial Disclosure By Clinical Investigators. Available at: http://www.fda.gov/oc/guidance/financialdis.html. Accessed November 18, 2005. 2001.Google Scholar
- 7.National Human Research Protections Advisory Committee, US Department of Health and Human Services. NHRPAC Recommendations on HHS’s Draft Interim Guidance on Financial Relationships in Clinical Research. October 2001. Available at http://www.hhs.gov/ohrp/nhrpac/documents/aug01a.pdf. Accessed November 18, 2005.Google Scholar
- 9.AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research. Acad Med. 2003;78:225–36.Google Scholar
- 10.AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution’s financial interests in human subjects research. Acad Med. 2003;78:237–45.Google Scholar
- 11.Food and Drug Administration. FDA issues public health advisory on Vioxx as its manufacturer voluntarily withdraws the product [press release]. Available at: http://www.fda.gov/bbs/topics/news/2004/NEW01122.html. Accessed February 28, 2006.Google Scholar
- 12.Food and Drug Administration. FDA announces withdrawal of fenfluramine and dexfenfluramine. Available at: http://www.fda.gov/cder/news/phen/fenphenpr81597.htm. Accessed February 28, 2006.Google Scholar
- 15.Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986.Google Scholar