5 Questions: Harry Greenberg on NIH’s revised conflict rules

Harry Greenberg

Substantial new regulations on financial conflicts of interest will require researchers who receive grants from the National Institutes of Health to more thoroughly disclose personal payments and equity received from companies, foundations and medical societies.

Finalized on Sept. 26 by the U.S. Department of Health and Human Services, this 144-page amendment to its 1995 “Objectivity in Research” regulations will enable research institutions and stakeholders to better understand the influences that pharmaceutical and medical device companies have on health-related research conducted at universities and research institutions. These institutions collectively receive 83 percent of the $30 billion NIH budget.

Most significantly, these new regulations will require that academic medical centers take a more active role in managing researchers’ potential financial conflicts of interest. Rather than conducting annual reviews of researchers’ industry relationships, university officials will be required to review new outside financial interests as acquired, then submit a conflict mitigation plan to the NIH within 60 days. Because the NIH reporting threshold for “significant financial interests” has been lowered and the definition has been widened, many more researchers will be subject to institutional review.

While the School of Medicine has one of the most extensive conflicts-of-interest policies in academic medicine, there are a number of important changes that researchers need to be aware of before these regulations go into effect on Aug.t 24, 2012.

In this interview, Kris Newby, Spectrum’s communications manager, asks Harry Greenberg, MD, senior associate dean for research at the medical school, why these
regulations are important, and how the university will help researchers comply with the new rules.

Q; Why were the NIH conflict-of-interest rules revised?

Greenberg: The main rationale behind the new rules is to better ensure the objectivity of government-funded research. While the vast majority of researchers conduct their work with honesty and integrity, several episodes recently came to light — through media and Congressional reports — where academic investigators had financial relationships with industry that were not disclosed and that could potentially influence research results or the way the results were reported.

Q; Why don’t universities ban private-sector consulting among faculty?

Greenberg: Stanford and most academic medical institutions are highly supportive of private-sector collaborations because it’s the most efficient way of transferring basic medical discoveries into mainstream patient care. Applying faculty brainpower to our society’s biggest challenges is an integral part of the university’s mission, as stated in the faculty handbook, "to promote public good by fostering the transfer of knowledge gained through University research and scholarship to the private sector.” Two ways of accomplishing this are through faculty consulting and the commercialization of technologies developed from university research. A ban could negatively impact the speed and extent of this important information and technology transfer to the private sector and the public.

Q: What are the most significant changes in the new NIH regulations?

Greenberg: NIH-funded researchers will have to provide their institutions with a more complete disclosure of industry relationships. The dollar threshold for reporting “significant financial interests” will be lowered from $10,000 to $5,000 and has been expanded to include things like travel reimbursements from non-academic entities and payments from certain foundations and medical societies. Payments related to clinical and teaching duties, such as authorship fees from medical societies, will also have to be reported. Assets identified as “financial conflicts of interest” that have a direct and significant effect on the NIH-funded research will now have to be publicly disclosed, either on an institution’s website or upon written request. Overall, many more researcher-industry interactions will be subject to evaluation of financial conflicts and their effect on the research by a researcher’s institution.

Q: How will the university help researchers comply with these rules?

Greenberg: All the schools at Stanford, in conjunction with the School of Medicine, are working hard to put in place a more automated system to minimize the additional reporting tasks that the new regulations will require. In addition, a variety of societies, such as the Association of American Medical Colleges, are putting together tools and recommendations to help medical centers deal with these regulations in a uniform and consistent way.

Q: How good do you think these new transparency regulations will be at limiting researcher bias?

Greenberg: While we can all get behind the spirit and intent of these new regulations — it’s essential that the medical research from our major academic centers is free from bias — we need to make sure that our precious research investments are going toward advancing medical knowledge, not unnecessary administrative overhead. I think it would be prudent, given the extent of these new regulations, to put in place some form of review to determine if they lead to the improvements in research integrity that they were designed to provide.