As the nation’s biomedical research agency, the National Institutes of Health (NIH) must ensure that the research it funds on the behalf of US taxpayers is scientifically rigorous and free of bias. Over the course of more than 65 years and hundreds of thousands of awards, most researchers receiving funds from NIH have proved to be trustworthy stewards. Still, more must be done to retain, and in some instances regain, public trust in the biomedical and behavioral research enterprise. The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias. Plain and simple, Americans do not want financial conflicts of interest (FCOI) to influence the federally funded research they hope will yield better ways to fight disease and improve health. Managing FCOI in biomedical and behavioral research, however, can prove to be a major challenge because of the complex relationships among government, academia, and industry. Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside. These relationships manifest as consultant agreements, in published works, and through a variety of other productive alliances. However, such relationships can sometimes lead to FCOI that may compromise—or appear to compromise—the integrity of research supported by NIH. The US Public Health Service, of which NIH is a part, is the only federal agency to have regulations regarding FCOI in research.1 In addition to the individual responsibilities ascribed to NIH-funded investigators, institutions that receive NIH funding have responsibilities to develop policies to implement the regulations and to adhere to such policies. In recent years, it has become increasingly apparent that the existing federal regulations, which were promulgated in 1995, need to be clarified and strengthened to ensure greater transparency and accountability. Without such changes, even more instances of real or perceived FCOI will likely be encountered in the future. The following scenarios, which incorporate various elements of real-life cases, illustrate some of the many challenges that need to be addressed. University X. The principal investigator of an NIH-supported clinical trial at university X fails to disclose more than $750 000 in payments for serving on an advisory panel for a company involved in the trial. Although the researcher followed the university’s policies concerning financial disclosure, NIH suspends the trial and requires all grant applications from university X to include details of investigators’ FCOI. Subsequently, university X develops and implements new processes for managing FCOI. NIH lifts the special award conditions. Investigator Y. Because she is an NIH grantee, investigator Y discloses to her university that she received lecture fees of “more than $10 000” annually over the past decade from a company developing a drug based on her laboratory’s findings. In fact, investigator Y receives more than $500 000 annually in such fees. However, investigator Y does not violate her university’s policy or the current federal rules because they do not require researchers to identify the precise amounts received from drug makers. The university decides to revise its FCOI policy. Institution Z. NIH imposes special conditions on all grant awards to institution Z, citing deficiencies in its FCOI rules. The action follows institution Z’s failure to report to NIH more than $1 million in company payments that a researcher received for promoting a new diagnostic test. The NIH-supported investigator fulfilled institution Z’s disclosure requirements, but those requirements were not in compliance with federal regulations. An ensuing investigation by institution Z finds that the researcher had no actual FCOI related to his NIH-supported research. Still, institution Z works with NIH to revise its policy and procedures to ensure they are consistent with federal regulations.
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