Prevalence of Industry Support and its Relationship to Research Integrity

Abstract

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research.

Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents' research.

Keywords:

• financial conflict of interest
• industry sponsorship
• research integrity

Acknowledgments

This work was supported by a grant from the National Institute of Neurological Disorders and Stroke, National Institutes of Health through the Office of Research Integrity, Department of Health AND Human Services #R01 NS 44523-01A1. We thank the staff at the UVA CSR for assistance with analysis and preparation of tables.

Notes

¹The sampling procedures for the medical school portion of the study are described here. Procedures used to sample nursing school faculty will be described elsewhere.

²An additional screener was included in the questionnaire. Respondents were instructed not to fill it out if they had not published any research in the previous five years.

³The overall sample also included about 500 nursing school researchers; results for the nurse subsample will be reported elsewhere. The estimated eligible respondents exclude those expressly disqualified, the unreachable (those for whom notice was received that the address was faulty), and the estimated number of disqualified and unreachable among the “open status” cases. The latter estimate was reached by first calculating the percentages of nonqualified and unreachable cases among those for which return mail was received, and then applying that percentage to those cases remaining in “open status.” We follow the conventional assumption that the percentage of ineligibles among cases whose eligibility is unknown is the same as it is among those whose eligibility is determined.

⁴Some respondents who answered “yes” to one or more of the research and publication support items in the Question 7 series skipped the long series of follow-up questions that applied to them. While 275 answered “yes” to one or more of the Question 7 items, only 231 answered the follow-ups. Most of those who skipped the follow-ups had reported little or no support that they considered important in the Question 7 series.

⁵ First hand is defined as: from the original source or personal experience; direct. Compact Oxford English Dictionary. Available at http://www.askoxford.com.

42 CFR Pt. 50 Subpart F.