T H E   N I H   C A T A L Y S T    F E B R U A R Y  22, 2005



The Assembly of Scientists believes there must be secure safeguards to ensure that financial interests do not compromise the design of research, the safety and well-being of patients, the collection and interpretation of research data, and the dissemination of research results, as well as funding and contract decisions. Strong restrictions on financial interests are necessary to protect the public trust in and the integrity and professionalism of the NIH and its staff. However, the DHHS supplemental regulations substantially overreach and will severely and irreparably compromise the NIH’s mission.

These new regulations will discourage talented, innovative scientists from staying at or being recruited to the NIH, and preclude scientists already at the NIH from participating as full members of the scientific community.

They will prohibit some outside activities by NIH employees with a wide variety of organizations that present no possible conflicts of interest. The restrictions on outside activities do not just apply to pharmaceutical companies, but could also inhibit interactions with scientists and others at universities, professional societies, and advocacy groups where the exchange cannot be approved as an official duty activity or as one of the permitted outside activities. Such barriers could make it harder to effectively and efficiently translate discoveries into therapies.

In addition, these regulations prohibit nearly 40% of NIH employees, their spouses and their children, including many who have no decision-making authority for grants or research, from holding any equity in any company that produces or sells pharmaceuticals, biotechnology products, or medical devices and could be extended to include food or beverage companies if NIH conducts coordinated research on obesity. They also limit the families of all other NIH employees, including secretaries, food handlers, elevator operators, lab technicians, electricians and others—clearly employees who cannot have relevant conflicts of interest—from holding more than $15,000 in these companies. Such expansive restrictions seem unnecessary and unlinked to preventing conflicts of interest, but they will have profoundly detrimental financial impacts on individual employees and hinder recruitment and retention.

More carefully crafted regulations that prohibit financial conflicts of employees who have decision-making authority and responsibility for the scientific direction of NIH, funding decisions, and grants management, and who conduct research can provide secure safeguards while promoting NIH’s mission of scientific advancement.

To ensure the NIH can continue to be a great research institution, the Assembly of Scientists is developing alternative proposals and exploring appropriate action to change these regulations. NIH employees interested in learning about the Assembly of Scientists’ activities in this area should contact one of the elected members of the Assembly’s Executive Committee. There is also a web site that will soon post additional information:

We welcome all suggestions.

—The Executive Committee:

Harvey Alter (CC), Karen Berman (NIMH), Cynthia Dunbar (NHLBI), Ezekiel Emanuel (CC), Lee Helman (NCI)

Steven Holland (NIAID), Elaine Jaffe (NCI), Hynda Kleinman (NIDCR), Edward Korn (NHLBI), Steven Libutti (NCI) 

William Paul (NIAID), Donald Rosenstein (NIMH), Alan Schechter (NIDDK), Earl Stadtman (NHLBI), Melanie Vacchio (NCI)

Lauren Wood (NCI), Kenneth Yamada (NIDCR), Howard Young (NCI)




Excerpts from the letter to to Michael Gottesman and Elias Zerhouni from the NIH Fellows Committee, representing more than 3,000 fellows at NIH.

NIH postdoctoral and clinical training programs attract highly qualified and motivated fellows. . . . It is imperative for the health of biomedical science and the nation that these productive, but temporary, researchers continue to be recruited and maintained at the NIH. . . .We are concerned that the proposed conflict-of-interest regulations will have an unanticipated and adverse effect on both current and future fellows. Our main issues of concern are as follows:

Conflict of Interest as defined in the current environment applies primarily to staff with the capacity to influence policy, stock prices, or public health matters. Like our peers in NIH funded extramural programs, NIH trainees do not have the same capacity for influence as do the permanent senior scientists and therefore it is unreasonable to hold them to the same level of scrutiny. By nature of the training position, fellows are supervised by senior staff and do not control any resources. We propose an exemption to these measures for trainees or, alternatively, regulations that better reflect their limited capacity for influence.

Trainees are often not considered employees for such positive benefits but could be held to the same restrictive standards as employees with full benefits. Indeed the majority of fellows (IRTA and CRTA) are not considered employees and do not qualify for Loan Repayment Program, Health Insurance, or Social Security Benefits. We suggest a separate category for trainees or at least consistency in the manner of determining who is an employee and who is not.

Regulations prohibiting biotech stock holdings for spouses and minor children will negatively impact recruitment of high quality fellows. The effectiveness and reputation of the NIH programs depend on its continued ability to recruit and support excellent trainees. Such applicants have many other prestigious options for training programs that do not have such restrictions. Scientists coming from industry may find this regulation particularly punitive. While a $15,000 limit will apply to many fellows, significant numbers of fellows have been asked to file Form 450 and will be subject to divestiture of all their holdings. Again, such problems could be solved with a separate category for trainees.

Proposed limitation of awards to approved listing of specific awards. Travel awards to conferences, workshops, and other professional development activities for fellows are an important means for career development and offset some of the costs incurred by the NIH for fellows to present data at national and international meetings. As proposed, the establishment and maintenance of a useful approved award list would be greatly complicated by the widely diverse and constantly changing nature of awards available to fellows. Even under the past rules there have been many inconsistencies in the ability of fellows to apply for awards or receive travel awards. We suggest that an umbrella category be created for trainees on the approved award list that would allow them to receive money toward travel to conferences, workshops, and other activities related to their professional development.

The application of stringent rules to this junior category of workers at the NIH does not appear to have any positive impact but rather several potential detrimental effects to fellows and the ability of NIH training programs to recruit and train high-caliber fellows for future placement in respected scientific centers. We therefore request that the proposed regulations are refined in a manner that mitigates the adverse consequences for the fellows.

We look forward to working with everyone concerned to create solutions that are reasonable, equitable, and allow the NIH to focus on its mission of fostering excellence in its fellows.






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