Journal of General Internal Medicine

, Volume 21, Issue 9, pp 901–906

Views of potential research participants on financial conflicts of interest barriers and opportunities for effective disclosure

  • Kevin P. Weinfurt
  • Joëlle Y. Friedman
  • Jennifer S. Allsbrook
  • Michaela A. Dinan
  • Mark A. Hall
  • Jeremy Sugarman
Original Articles

Abstract

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 Words

conflict of interest disclosure human experimentation 

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References

  1. 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. 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. 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
  4. 4.
    American Society of Clinical Oncology. American society of clinical oncology: revised conflict of interest policy. J Clin Oncol. 2003;21:2394–6.CrossRefGoogle Scholar
  5. 5.
    Financial relationships and interests in research involving human subjects: guidance for human subject protection. Federal Register. 2004; 69:26393–7.Google Scholar
  6. 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. 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
  8. 8.
    Kim SY, Millard RW, Nisbet P, et al. Potential research participants’ views regarding researcher and institutional financial conflicts of interest. J Med Ethics. 2004;30:73–9.PubMedCrossRefGoogle Scholar
  9. 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. 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. 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. 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
  13. 13.
    Cain DM, Loewenstein G, Moore DA. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud. 2005;34:1–25.CrossRefGoogle Scholar
  14. 14.
    Hibbard J, Slovic P, Jewett J. Informing consumer decisions in health care: implications from decision-making research. Milbank Q. 1997;75:395–414.PubMedCrossRefGoogle Scholar
  15. 15.
    Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986.Google Scholar
  16. 16.
    Hall MA, Kidd KE, Dugan E. Disclosure of physician incentives: do practices satisfy purposes? Health Aff. 2000;19:156–64.CrossRefGoogle Scholar

Copyright information

© Society of General Internal Medicine 2006

Authors and Affiliations

  • Kevin P. Weinfurt
    • 1
    • 2
  • Joëlle Y. Friedman
    • 1
  • Jennifer S. Allsbrook
    • 1
  • Michaela A. Dinan
    • 1
  • Mark A. Hall
    • 3
  • Jeremy Sugarman
    • 4
  1. 1.Center for Clinical and Genetic Economics, Duke Clinical Research InstituteDuke University Medical CenterDurhamUSA
  2. 2.Department of Psychiatry and Behavioral SciencesDuke University School of MedicineDurhamUSA
  3. 3.Wake Forest University School of LawWinston-SalemUSA
  4. 4.The Phoebe R. Berman Institute of Ethics, and Department of MedicineThe Johns Hopkins UniversityBaltimoreUSA

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