March 28, 2005 - ASM Comments on Interim Final HHS Supplemental Ethics Rule

Office of the General
Counsel, Ethics Division
Department of Health and Human Services
Room 700-E
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
Attention: Linda L. Conte

The American Society for Microbiology (ASM) is submitting comments on the February 3 interim final rule amending the Department of Health and Human Services (DHHS) regulation on standards of ethical conduct. The ASM is the largest single life science Society in the world with over 43,000 members who are involved in basic, applied and clinical research. About four percent of the ASM membership work for a government agency. The ASM is involved with issues of research integrity and has a Committee on Ethics and a Code of Ethics for society members. It also maintains editorial oversight of ethical issues involved in publications and the use of meetings and publications to inform and educate members about research integrity issues. ASM is committed to promoting the highest standards of conduct in science and to ensuring public trust and safety in all areas of research and development.

The ASM recently had the opportunity to meet with NIH officials and several other professional societies regarding the impact of the new rules, particularly as they affect relationships between NIH employees and scientific societies. It has also received a copy of Intramural Research Director Michael Gottesman’s article in the February 22 NIH Catalyst in which he provides guidance on the new requirements and interactions of NIH scientists with scientific societies. It is our understanding that NIH is working to address specific areas of concern, procedures, deadlines and exceptions and we urge NIH and DHHS to be fair in the implementation of the obligations imposed by the regulations to avoid individual hardship or disruption of academic exchange.

The ASM believes it is critical for NIH scientists to continue to participate in the programs and activities of scientific societies that are key to dissemination of scientific knowledge, training and career development. These activities of scientific organizations include publication of articles and books, participation in seminars and conferences, and service on committees and boards that plan and edit scientific publications and plan scientific meetings in the public interest. Such interactions with scientific societies do not conflict with the role of NIH scientists within the NIH. In fact, they supplement and reinforce the invaluable work of NIH in promoting the general health and welfare. NIH should permit its scientists to engage in such activities with scientific societies without being required to suffer personal financial loss or expense through their purely educational and scientific interactions. Therefore, NIH clarification of procedures for the continuation of interactions between NIH employees and scientific societies should be expeditiously issued.

Conflict of interest rules related to prohibited holdings create the difficult task of balancing the avoidance of real and perceived conflicts of interest against the harm of unduly restricting the legitimate personal activities of NIH employees and their spouses. The ASM has reviewed the NIH Assembly of Scientists' Response to the Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services. We understand the Assembly's concerns and its support for more focused limitations on activities. We submit that such concerns should be carefully considered by the NIH and DHHS. Every effort should be made to develop regulations that do not interfere with the right of NIH employees to invest in enterprises that are not affected by the employees' activities at NIH.

The conflict of interest rules are very stringent and can be expected to have unintended consequences for the NIH and biomedical research, academic exchanges and industry collaboration. Therefore, the ASM supports the NIH announcement to review within one year the impact of the new rules, especially as they affect recruitment and retention of top scientists at NIH. The ASM supports the resolution of issues over conflict of interest in a way that will continue the strength and vitality of the NIH intramural research and clinical programs and the retention and recruitment of outstanding personnel.

The ASM believes that there is overwhelming evidence that academic and industry partnerships, both extramurally and intramurally, are essential to research and development in the United States and to the translation of knowledge into products for improved health and economic competitiveness. Carefully crafted rules and management of conflicts are in the public interest, but it would be counterproductive to totally prohibit financial interactions between academia and industry.

The ASM wishes to continue to work with NIH and DHHS on the development of sound policies that both protect the public trust in science and avoid adverse, undue restrictions that could interfere with scientific progress and excellence. Thank you for the opportunity to provide comment.

Sincerely,

James M. Tiedje, Ph.D., President, ASM

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