Assembly continues to fight COI rules
NIH director supports changes
A group of NIH researchers known as the Assembly of Scientists (AOS) is continuing organized opposition to implementation of stringent new conflict-of-interest rules slated for full implementation late this year.
The group recently dropped a planned court challenge following statements by NIH director Elias Zerhouni and Health and Human Services Secretary Mike Leavitt that indicate they are open to amending the rules. But they have retained the services of law firm Arent Fox to lobby Congress and the public in support of the assembly’s position.1,2
"We do believe some regulation is necessary to prevent conflict of interest and ensure the integrity of federally sponsored research," Ezekiel Emanuel, MD, chief of clinical bioethics at the NIH’s Warren G. Magnuson Clinical Center and chair of the AOS executive committee tells IRB Advisor. "But the current rules are so broad and overreaching that they will hurt the ability of the NIH to attract and retain top scientists and impede the collaborations with industry and outside organizations that are necessary to ensure the sound dissemination and interpretation of research findings."
Many media reports have characterized the AOS as opposing any restriction on paid private relationships between NIH scientists on the federal payroll and companies in the pharmaceutical and biomedical industries.
That’s not true, Emanuel says, adding that the rules are far broader than most people realize.
In addition to requiring top scientists to forego outside consulting, and divest of stock in pharmaceutical and biomedical companies, the rules require all NIH employees and their immediate family members to divest of stock worth more than $15,000 in any pharmaceutical, biomedical, food, and beverage company.
The new rules also bar employees from consulting with or accepting any payments from pharmaceutical, biotech, and medical device companies as well as universities, hospitals, and research institutes that receive NIH funds. This can prohibit accepting paid speaking engagements at health care organizations that receive NIH money, whether related to that person’s area of work or not. Work with advocacy groups and service in leadership positions in many professional organizations also are affected, Emanuel says.
Since the rules were announced, some noted scientists have announced they will reconsider taking positions at the NIH or will leave the positions they currently have.
James Battey, director of the National Institute for Deafness and Other Communication Disorders, has said he intends to quit before the requirement for stock divestiture takes effect.
Pulmonary researcher David Schwartz of Duke University told The Washington Post that the new rules caused him to rethink taking the helm at the National Institute of Environmental Health Sciences.
The AOS has proposed alternative regulations that, Emanuel says, will effectively prevent researcher conflicts while preserving their ability to work collaboratively with academic institutions and private organizations, he says.
Among the differences:
• Researchers would be prohibited from holding stock in companies or organizations that support studies in that person’s field, or in any area in which they have oversight at the NIH. However, they would be permitted to consult or serve on advisory boards for companies unrelated to their area of research.
• Payment for outside writing and editing would be permitted as would service with professional organizations, but those in leadership and grants administration positions at the NIH could not be paid for doing so, and such employees would be barred from holding stock in any drug, biotech, or medical device company.
The level of restriction should vary based on the influence the particular employee has over funding decisions or pursuit of specific types of research within the institutes, Emanuel states.
The group submitted their recommendations more than two months ago, but have yet to receive any response, he says. Meanwhile, the current rules are in force, with the exception of the requirement for stock divestiture, which has been postponed until October.
References
- Willman D. Scientists add clout in NIH fight. Los Angeles Times, April 21, 2005. Page A1. Assembly of Scientists. Summary of executive committee activities as of May 9, 2005. Accessed on the web at: http://homepage.mac.com/assemblyofscientists/FileSharing24.html.
- Assembly of Scientists. Alternative COI Regulations Proposal. Accessed on-line at: http://homepage.mac.com/assemblyofscientists/FileSharing20.html.
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