The American Physiological Society (APS) respectfully submits the following comments on the Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services. The APS is a professional society with more than 11,000 members who are active participants in the research community. It counts among its members many at the National Institutes of Health (NIH). As a member of the Federation of American Societies for Experimental Biology (FASEB), the APS endorses FASEB’s comments, submitted separately, on the Interim Final Rule.
The APS understands the need for an organization such as the NIH to have ethics rules that serve to protect the integrity of this important research institution. Rules concerning conflict of interest must protect the public, NIH employees and the integrity of the science they produce. At the same time, the rules should not be so onerous as to deter government service or to restrict participation of government employees in research-related activities sponsored by universities and scientific societies.
Of particular concern are the aspects of the new rule restricting the financial holdings of employees who are not involved with decision-making or grant-making. The far-reaching requirement for divestiture of certain stocks has precipitated an enormous crisis of morale on the NIH campus. The APS is concerned that this will interfere with the ability of the NIH to retain qualified personnel ranging from scientists for the intramural research program to doctors and nurses at the clinical center and all the employees needed to provide essential services at every level.
Implementation and evaluation of the conflict of interest rules
The success of the conflict of interest rules is dependent on implementation. The rules are intended to delineate a bright line that will prevent even the appearance of conflict of interest. To accommodate communication between NIH employees and the greater scientific community, the rules require a number of exceptions. In order for the rules to be successful in preventing conflicts without limiting critical interactions between scientists, the practical process for granting exceptions must be efficient and easily navigated. If the process for approval is sufficiently arduous, it is reasonable to think that NIH employees will avoid those interactions altogether rather than devote time and energy to a tedious approval process. Such an outcome would impair important communication offered by NIH employees who may bring unique expertise to the broader scientific community.
In monitoring the success of the rules, the APS recommends that the NIH consider the following factors:
Approval of Activities
The time required for obtaining approval of activities, both those approved as outside activities or as part of employees’ official duties, should be monitored. The time required for approval of awards should also be included in this analysis. It is important to keep track of how long it takes to process exceptions to ensure that requests are processed in a timely manner. Following the approval process, NIH employees should be asked for feedback regarding the ease of the process so that it can be improved and streamlined over time.
The consistency of the rules as applied across institutes and centers should also be considered in evaluating the approval process. With decisions being made independently at each individual institute and center, there is a risk that the rules will not be applied evenly and fairly. While the APS understands that decision making at the level of institutes and centers allows more flexibility for discipline-specific decisions, it is important that those decisions be made with some degree of consistency. There should be evaluation of requests for exceptions with the commensurate outcome of either approval or denial.
The effects of the rules on the careers of NIH employees
The effect of the policy on recruitment at all levels of NIH should be considered in the evaluation of the rules. This should include collecting data on the quality of interested candidates, and feedback from candidates who choose other institutions. The effect of the policy on retention at all levels of NIH must also be considered, but most importantly among senior scientists. While the conflict of interest rules apply to all NIH employees, the restrictions imposed will most significantly affect those employees that are more senior. This should also include an evaluation of emeritus faculty leaving for retirement when they might have otherwise chosen to remain. The effect of the rules on recruitment and retention is highlighted by the reports of low morale on the NIH campus in response to the new regulations.
While difficult to measure, the effect of the policy on the career development of NIH scientists should also be monitored. Any limitations on the outside activities of NIH scientists have the potential to negatively influence career development.
Other items of concern to the APS include:
Definition of NIH employee
The APS joins FASEB in calling for flexibility in the rules to accommodate the variety of employees that serve the NIH, and we submit that not all NIH regular employees are subject to the same risk of developing conflicts of interest. We suggest that NIH employees should be classified based on job description, which would allow different classes of employees to have more freedom in their dealings with outside organizations. This could be an extension of the distinction drawn between senior and non-senior employees with regard to financial holdings. Of particular concern is the fact that the conflict of interest rules as originally drafted applied to all NIH employees including clinical and post-doctoral fellows, with the exception of Special Government Employees. While fellows are full-time employees of the NIH, their positions are temporary and typically do not extend beyond a period of three years. Further, fellows are in training positions and thus have limited authority over decisions made at the NIH. The APS commends the NIH for exempting fellows from conflict of interest rules regarding financial holdings. Requiring incoming fellows to divest their financial holdings when taking a limited term training position would pose a significant risk of negatively influencing recruitment.
The rules requiring that NIH employees divest financial holdings that were previously allowed has generated criticism because many feel that it unfairly penalizes those employees. Many employees may own stock that was allowed under the previous rules, and may now be forced to divest at a loss under the new regulations. The APS encourages the NIH to consider ways to protect the previously held financial holdings of employees, for example implementing a grandfather clause.
Interactions with scientific societies
The APS joins FASEB in urging the NIH to exempt professional societies from the restrictions imposed on interactions with outside organizations. Under the new conflict of interest rules, NIH employees are prohibited from compensated or uncompensated teaching, speaking, editing and writing for an outside organization. Outside organizations include pharmaceutical and biotechnology companies, health care providers and insurers, educational institutions that receive NIH funds and trade and professional organizations. The NIH has indicated that scientists will be allowed to maintain interactions with their societies if they obtain exceptions on a case-by-case basis. Given the number of exceptions that will have to be handled, it is critical that the process for obtaining approval be made as clear and simple as possible for both the scientist and the professional society. For example, while the responsibility of obtaining proper permission falls on the NIH scientist, a professional society issuing a speaking invitation would be helped by knowing what information to include in the invitation, and the time required to complete the process. Participation in professional societies constitutes an important opportunity for career development in the scientific community. Limiting interactions between intramural scientists and their professional societies has significant potential to harm the career advancement of NIH scientists.
Procedures for award approval
As a professional society, the APS regularly offers several awards to outstanding scientists in the field of physiology. Some of these are also associated with cash prizes and/or reimbursement for travel to meetings. In the past, awardees have included NIH scientists. Awards such as those offered by the APS and other professional societies provide important recognition of outstanding scientists by their peers. While the NIH has assured us that exceptions will be granted, the APS requests that the NIH take steps to ensure that applications for award exceptions are processed in a timely manner and that the process be facilitated with a clear set of instructions for both the award granting society and the award recipient. Those instructions should include a detailed description of any restrictions on the source of award funds.
The conflict of interest rules also specify that for a period of one year following award acceptance, the NIH employee may not be involved in matters relating to the donor of the award. It is not clear whether this would preclude an employee of the NIH who accepts an award from a professional society from participating in activities with that organization over the next year. The APS requests clarification on that point.
In summary, the APS welcomes the opportunity to work with the NIH to develop a set of rules that protects the nation’s investment of science without unfairly limiting the activities of intramural scientists.