April 4, 2005
Office of the General Counsel
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
RE: Comments on Interim Final HHS Supplemental Ethics Rule
Dear Ms. Conte:
I am writing on behalf of the American Association for Cancer Research (AACR) to comment on the interim final rule regarding the “Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services (HHS),” as described in the Federal Register on February 3, 2005 (Volume 70, Number 22, Page 5543). Our comments pertain specifically to the interim final rule as it applies to the National Institutes of Health (NIH).
The AACR represents more than 23,000 scientists dedicated to the conquest of cancer. Our programs span the spectrum of basic, translational, and clinical cancer research, and include all aspects of the field, i.e., cancer etiology, diagnosis, treatment, and prevention. The AACR holds the premier scientific annual meeting in cancer research as well as more than 25 other scientific and educational conferences and workshops throughout the year. It also publishes five peer-reviewed scientific journals of high repute and engages in a variety of programs and activities that address the myriad scientific needs of the cancer field.
AACR members are NIH grantees, peer reviewers of papers submitted for consideration for publication, and study section members. They work in a variety of sectors, including the NIH, and they are dedicated to advancing the research mission of the NIH and to holding dear the public trust in them as scientists of integrity and ethics. Indeed the AACR understands and fully supports ethics regulations that protect public health and scientific integrity, and that have a positive impact on the conduct of cancer research.
We fully acknowledge that the articulation and enforcement of ethical standards are necessary and essential for maintaining the integrity and credibility of the research enterprise. Clearly, ethical safeguards are important for ensuring the safety and well-being of patients, and personal financial interests cannot in any way compromise the design of clinical trials and/or decisions about funding or contracts. The AACR believes strongly that rules must be in place at the NIH to protect against financial or other conflicts of interest and to adhere to the public trust.
The AACR recognizes the challenging context in which this stringent new rule was summarily implemented, but we deeply regret the lack of opportunity for public commentary prior to its imposition. In keeping with the opinions of other scientific societies, the AACR feels that many of the provisions in the new rule are broad and over-restrictive to the point of doing a serious disservice to the advancement of cancer and biomedical research.
Our mission is to facilitate and encourage cross-disciplinary scientific communications as one of the most efficient and effective ways to accelerate progress against cancer. As noted above, AACR fosters substantive scientific interchanges through its meetings and its prestigious scholarly scientific journals. Such dialogue also takes place in meetings of its committees, scientific working groups, and task forces, all of which are designed to foster the sharing of scientific knowledge and increased understanding about cancer. Thus we are very concerned that, as written, the regulations would prohibit, deter, and/or discourage many vital collaborations and scientific interactions by a major proportion of NIH employees with scientific societies like the AACR. Such prohibitions present no conflicts of interest, and yet they have the potential, under the new rule, to be devastating to scientific progress. We must find suitable ways to invoke rules against potential conflicts of interest while protecting the advancement of science and the important role of the AACR and NIH to promote public health. The NIH and the NCI share this important mission and have the duty and obligation to ensure that NIH scientists’ knowledge is conveyed to the scientific community at large.
The AACR is deeply concerned that the new rule will jeopardize these exchanges by preventing or reducing the involvement of NCI researchers in conferences, meetings, and editorial work. AACR believes that the overly broad prescription against prohibited activities will have the undesirable effect of undermining the recruitment and retention of top scientists at the NIH. The stream of senior leadership departures that began a few months ago has continued under the new rule and is not likely to slow until the rule is clarified and modified appropriately.
The new rule is particularly harsh with regard to the involvement by NIH employees in outside activities with “a supported research institution,” that is, “any educational institution or non-profit independent research institute” under Section 5501.109(c). While AACR believes that this definition is overly broad and does not apply to an organization of its nature, the provision should be clarified to specifically exempt organizations such as the AACR.
Further, the ambiguities and uncertainties raised by the language of Section 5501.109(c) are of particular concern in light of the (c)(1)(i) prohibition against “engaging in employment” with such an entity, the impact of which would be to compromise the ability of an NIH employee from serving as an elected member of the AACR Board of Directors. Example 2 accompanying this regulatory definition states clearly that “employment” includes service “with or without compensation” and also applies in the case of an HHS employee’s service on the board of directors of a non-profit corporation.
Even if the AACR is not considered to be one of the entities of concern defined in Section 5501.109(c), the new ethics rules would make an NIH employee’s service on the AACR Board of Directors subject to prior written approval under Section 5501.106(d)(2)(i). This is because any outside employment by NIH employees now is subject to the prior written approval requirement, which must be renewed annually. Thus, even where outside employment, such as service on a board of directors, is allowable because an organization of concern is not involved, the prior written approval requirement could have the negative effect of discouraging NIH employees from serving.
AACR notes that one mitigating provision retained from preexisting Section 5501.106(d)(5) is that the designated agency’s ethics official for HHS or a component agency may issue an instruction or manual entry exempting categories of employment or other activities from the prior written approval requirement, based upon a determination that it is unlikely to involved prohibited conduct. The AACR strongly recommends that HHS/NIH issue an instruction that covers and exempts service on a board of directors of an entity such as the Association in order to maintain the availability of NIH employees as potential AACR Board members.
While it appears that service by NIH employees – as journal editors, authors, speakers at conferences, and participants in meetings and committees – is generally prohibited if it involves a Section 5501.109 organization or compensation, the rule is not as clear with regard to the provision of these services to a non-profit organization such as the AACR. And while it may be allowable for NIH employees to engage in these activities for AACR, the very existence of these stringent and ambiguous rules is likely to have a chilling effect on the willingness of NIH employees to participate in outside activities that would benefit the cancer community and the public good. This must be specifically clarified in the rule.
The AACR appreciates the opportunity to offer constructive comments for the improvement of the new Interim Final HHS Supplemental Ethics Rule. AACR supports the recommendations of the Blue Ribbon Panel and believes that the proposals presented from that group can provide safeguards for avoiding real or perceived conflicts of interest while promoting NIH’s mission. AACR urges the NIH to solicit broad public input and to clarify, narrow, and modify the rule so that it meets the needs of both the NIH and the broader cancer community which it serves. The AACR believes that it is essential that the NIH operate within a strong ethical framework that balances the need for appropriate restrictions along with the obligation to fulfill its mission of free and open communication with the scientific community to further progress and the conquest of cancer.
Thank you for your consideration.
|Lynn M. Matrisian, Ph.D.
||Margaret Foti, Ph.D., M.D. (h.c.)
||Chief Executive Officer