Published 10/1/2011
Terry Stanton

HHS tightens conflict-of-interest rules for researchers

New rules cut reporting threshold in half, increase transparency

New rules covering conflicts of interest (COI) for researchers receiving federal funding lower the dollar threshold for disclosure of significant financial interests from the current $10,000 to $5,000. The rules, which replace regulations originally issued in 1995, also expand the accessibility of disclosure information to the public. (See Table 1.)

The updated rules were issued by the U.S. Department of Health and Human Services (HHS) and go into effect in August 2012. They apply to individuals and institutions conducting research supported by agencies within HHS.

In addition to the lower monetary trigger and the access provision—requiring institutions to make public certain information concerning identified significant financial interests held by senior or key personnel—the revised regulations include the following provisions:

  • Investigators must disclose all significant financial interests related to their institutional responsibilities.
  • Institutions must report additional information on identified financial COIs and how they are being managed.
  • Investigators must complete training related to the regulations and their institution’s financial COI policy.

The new regulations were announced in the wake of increasing concern about undisclosed conflicts and lack of transparency in industry-sponsored research. As reported in the September 2011 AAOS Now, The Spine Journal published an entire issue devoted to questions about industry-sponsored research on the use of recombinant bone morphogenetic protein-2 in spine surgery.

New definitions
Under the revised rules, “investigator” is now more broadly defined as not only the project director or principal investigator but any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the funded or proposed research. So, for example, collaborators or consultants might be considered investigators.

The rules also specify new definitions of “key personnel” and “senior/key personnel,” who are also subject to public disclosure of information. As subsets of the broader term “investigator,” both key and senior/key personnel must disclose financial COIs and the grantee organization must post that information on a publicly available website.

Several changes in the definition of “significant financial interest” were also made. For example, salaries, royalties, and other remuneration are now excepted only if the investigator is employed or otherwise appointed by the institution. Income from government agencies or institutions of higher learning for seminars, lectures and teaching engagements, or service on advisory or review panels is excluded.

Kristy L. Weber, MD, chair of the Academy’s Council on Research and Quality, has become familiar with the new rules as a professor on the Committee on Outside Interests at her institution, Johns Hopkins. She notes the following points:

  • The lowering of the monetary threshold to $5,000 “will greatly increase paperwork for many individuals and institutions.”
  • The $5,000 relates to income or equity related to the investigator’s “institutional responsibilities,” potentially including research, teaching, clinical practice, institutional committee membership, and institutional review boards.
  • Honorariums from grand rounds at teaching or academic institutions are excluded unless the payment comes from industry.
  • The institution is responsible for determining whether a financial COI exists.
  • The institution must post COI information on a public website or make it available within five business days of a request. The information must be available for 3 years from last update and include details such as a management plan, the investigator’s agreement to comply, and monitoring plans.

Dr. Weber advises all researchers who have obtained or hope to obtain funding from the National Institutes of Health (NIH) to carefully read the new regulations and talk with the COI group at their institution to ensure compliance.

The rules will require institutions to spend more time and money on compliance, according to Dr. Weber, but they may have a positive effect in shaping the public perception of orthopaedic surgery.

“In general I think orthopaedics is more susceptible to conflict-of-interest problems,” said Dr. Weber, “given our heavy reliance on the device industry and our procedure-oriented specialty. Such transparency will help address fears of bias and enable outsiders to judge the impact of industry support on the research.”

The right direction
Charles Carroll IV, MD, chair of the Academy’s Ethics Committee, says the revised rules “are a good thing.” He acknowledges that some unknowns may lurk, but that “all of this is going in the right direction. As a step for the public, this is the right way to go.”

Dr. Carroll, an associate professor at Northwestern University, notes that the rules “will apply more to the academic side than to the average surgeon. But if you look at all of our activities, this goes beyond research, because many universities will require everyone to list conflicts.

“From the ethics standpoint, it starts to take away the potential for bias and the issue of conflict of interest when you receive ‘soft’ money or ‘hard’ money from industry,” he continues. “This is a real issue for federal authorities. For those of us in orthopaedics who have peer-review grants from federal organizations, this will make it more apparent as to what our bias might be. We may not like having information on websites that we don’t have controlled access to, but that is more of a personal conundrum than a systemic drawback.”

William R. Martin III, MD, AAOS medical director, says that among the noteworthy new requirements is one requiring COI training for each investigator. The training must be completed before the researcher can engage in research funded by any HHS grant; it must be repeated at least every 4 years or immediately if the institution changes its conflict policies or finds the researcher is noncompliant with its management plan.

Coupled with mandatory reporting information that manufacturers must provide beginning in 2013 and a variety of voluntary programs, including the Academy’s disclosure database, the new HHS rules put the public, patients, and the profession in good standing with regard to disclosure and transparency, Dr. Martin said.

“The AAOS has a strong commitment to the disclosure of COIs by physicians, whether in their practices or in research endeavors,” added Dr. Martin.

Peter C. Amadio, MD, chair of the Academy’s Research Development Committee and a professor at Mayo Clinic, notes that the new rule continues a trend of requiring disclosure of increasingly small conflicts.

“I think that the medical profession is doing a good job of staying ahead of the curve. The relevant American Medical Association and AAOS committees are doing a good job in setting ethical standards for the profession in general and with regard to conflicts of interest in particular,” he said. “Orthopaedics in particular has been very focused on making sure that conflicts are both disclosed and managed appropriately.”

Victor Goldberg, MD, professor of orthopaedic surgery at Case Western Reserve University and University Hospital in Cleveland, Ohio, says the new rules “were a long time coming.” Despite the extra burden of compliance, he welcomes them.

“They may seem draconian, but they have to be,” he said. “Transparency is the key element. A conflict of interest is not necessarily a bad thing.”

“This adds further credibility to what we say,” added Dr. Carroll.

Disclosure information: Dr. Amadio—Johnson & Johnson, Merck, Journal of Bone and Joint Surgery–American; Dr. Carroll—American Society for Surgery of the Hand, AAOS; Dr. Martin—National Board of Medical Examiners; Dr. Weber—AAOS Now, Musculoskeletal Tumor Society, Ruth Jackson Orthopaedic Society. Dr. Goldberg—Osteotech, Astrazenica, TissueLink, Sultzer, NIH, Zimmer, Elsevier, OASRI, Bioinnovations Institute, AAOS Now, Journal of Bone and Joint Surgery–American, Journal of Orthopaedic Research, Clinical Orthopaedics and Related Research, Osteoarthritis and Cartilage.

Terry Stanton is senior science writer for AAOS Now. He can be reached at tstanton@aaos.now

Additional Link:
HHS Tightens Financial Conflict of Interest Rules for Researchers

Additional details about the major changes to the regulations

Full text of Final Rule