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

Attn:  Linda L. Conte

Dear Ms. Conte: 

On behalf of the Council of The American Society for Pharmacology and Experimental Therapeutics (ASPET), I respectfully submit comments on the interim final HHS supplemental ethics rule, Supplemental Standards of Ethical Conduct an Financial Disclosure Requirements for Employees of the Department of Health and Human Services.  ASPET is a 4,400 member scientific society comprised of biomedical researchers in academia, industry, and government.  

ASPET supports strict safeguards that ensure the integrity of the biomedical research enterprise.  These safeguards will protect the safety of patients and promote public trust in the National Institutes of Health.  However, ASPET does have several reservations and concerns about this interim rule, concerns that are detailed below. 

The interim rule designates professional trade associations as a substantially affected organization (SAO).  This broad classification lumps professional trade associations with enterprises such as companies and their subsidiaries involved in research, development, manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, and treatments products. 

ASPET has served the pharmacology community for almost 100 years.  During that time, ASPET member scientists have presented thousands of papers and enjoyed a collegial exchange of scientific information at annual meetings.  Over this time, ASPET has provided funding to minority education, travel awards to graduate students, and other services that aid in the development of young and established scientists.  We fear that the designation as a substantially affected organizations could be unnecessarily punitive, and depending on implementation of the regulations, might potentially affect how ASPET and other professional organizations fulfill these and other important missions.   

ASPET is concerned that the interim rules are too restrictive and unnecessary for professional scientific organizations.  The current rules already provide a firewall from any potential conflict of interest, such as assuming a fiduciary responsibility or engaging in lobbying activities.  We recommend that organizations such as ASPET not be classified as substantially affected organizations and that they be exempt from any prohibitions on outside activities.  Will implementation of the rules be uniform among institutes?  What assurances and mechanisms can be put in place that will allow for a consistent and fair evaluation of activities allowed or prohibited?  Will there be mechanisms for appeal? 

ASPET would like specific clarification on the rules governing compensated outside activity.  If an NIH scientist serves as editor to a journal, is there a limit on how much that individual may be compensated? Are there limits on reimbursement of administrative expenses such as support personnel, telephone, fax, etc?  What mechanisms will NIH put in place to insure that the evaluation of these activities remains consistent from year to year, and from institute to institute? 

As written in the interim rule, the prohibition on the financial interests of employees could severely impact the ability of NIH to attract and retain intramural scientists.  The rule will also unfairly affect NIH employees and their families.  The rule is vague with respect to who might be affected:  “Public and confidential filers by definition are senior officials or other employees [ital. emphasis added] whose duties involve the exercise of significant discretion in certain critical areas of agency operations.”  This must be more explicitly defined in the final regulation.   ASPET recommends that NIH carefully consider the implications of all prohibited financial interests and its impact on recruitment and retention before final regulations are issued.   

ASPET believes industry funded awards given by scientific professional societies to NIH employees should be allowed as long as it is transparent that neither the company providing the funds for the award nor its employees have played a role in nominating or selecting the award winner.   With appropriate safeguards and oversight, ASPET does not believe that NIH scientists should bear the unreasonable restriction on professional recognition because they are not allowed to accept an award.  Fair and uniform implementation of the rules is critical to help ensure that NIH scientists are allowed the professional recognition awarded to them by peers at their scientific professional societies.  Professional societies can play an informational role in advising NIH scientists of their need to inform their respective ethics officer of the pending award.  But there must be a mechanism in place whereby the NIH recognizes prescreened awards.  Only in cases of clear conflict of interest would the award then be disallowed.  

ASPET appreciates the opportunity to offer comments to these interim conflict of interest rules.  We hope that these comments and those submitted by other scientific professional societies are carefully considered before final regulations are made.  ASPET believes that the final regulations can protect the public’s trust of the NIH and not jeopardize interactions between scientists and scientific professional societies.   Scientific professional societies like ASPET can play a helpful role in disseminating information on the final regulations. We hope that NIH will implement necessary changes to protect the integrity of the biomedical research enterprise and not unwittingly discourage critical interaction between NIH employees and professional societies.  ASPET asks that consideration be given to withdrawing the interim final rule until a more thorough consultation that allows for implementation of proper and fair mechanisms for review of potential conflict of interests. 

Sincerely,

 Stephen G. Holtzman, Ph.D.
President