Researchers reluctant to disclose financial information

AORN Journal,  March, 2007  

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Researchers and institutional officials responsible for the ethical oversight of human clinical trials often are reluctant to reveal financial interests to potential study participants, according to a Sept 11, 2006, news release from Duke University Medical Center News, Durham, NC. Financial interests in a study may include corporate support for the costs of the trial and its personnel consulting contracts with companies who have a vested interest in the study's outcome, or researchers' ownership of stock in the sponsoring company. Air of these relationships could be perceived as conflicts of interest.

A survey of researchers who conduct clinical trials indicated that most respondents believe that disclosure of financial interests contributes to informed consent, reduces liability, and promotes trust in the researchers. Some researchers, however, are concerned that potential study participants who are told the exact dollar amounts involved in the study will overestimate the value and influence of the money involved. They believe potential participants also may tack the appropriate background or education to fully understand whether a financial conflict of interest exists, which may lead to misunderstandings. In addition, some researchers are concerned that the complexity of the information required by full disclosure would shift the potential participant's attention away from making the decision of whether to participate in the study. Others believe, however, that full disclosure should be made in a straightforward and simple manner to minimize confusion for participants.

Overall, respondents in this survey thought that it was difficult to decide what potential study participants should be told, when, in many cases, the patients may have a poor idea of what informed decision making actually means. This study's researchers believe the next step is to gather information on how potential research participants would use such disclosure information when making decisions about participating in clinical trials.

Study Reveals Reluctance to Financial Disclosures in Research Involving Humans [news release]. Durham, NC: Duke University Medical Center News; September 11, 2006. Available at: http://dukemednews.org/news/article.php?id=9862. Accessed January 8, 2007.

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