Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

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Abstract:

Abstract Background:

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Method:

We conducted a survey of HREC chairpersons in New South Wales. Results:

HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. Conclusion:

These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Keywords: clinical trial; conflict of interest; pharmaceutical sponsorship; research ethics; research ethics committee

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1445-5994.2006.01234.x

Affiliations: Centre for Values Ethics and the Law in Medicine, University of Sydney, Sydney, New South Wales, Australia

Publication date: January 1, 2007

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