CLINICAL RESEARCH
ACTION PLAN

This implementation plan, under consideration by the ICD directors, includes components derived from recommendations of a working group of ICD personnel officers, senior staff of the Office of Human Resource Management, the Office of Intramural Research, the Board of Scientific Directors, and the Office of the Associate Director for Clinical Research.

The NIH leadership is pleased to respond in detail to the recommendations of the NIH Committee on the Recruitment and Career Development of Clinical Investigators. All the recommendations have been carefully considered, and each is judged to be meritorious. The following implementation plan addresses the more specific ones.^*

PERSONNEL MECHANISMS AND FUNDING

We concur that the existing personnel salary and funding mechanisms in some cases do not support the special needs of clinical researchers and in other cases are disincentives to the recruitment and retention of clinical researchers. Therefore, we support the recommendations of the committee as follows.

1. The authority to pay tenure-track clinicians (investigators) under Title 42 up to a maximum of $115,700 (or the equivalent Executive Level IV salary) is hereby delegated to the ICD directors. They may redelegate this authority to scientific directors, who must exercise it in consultation with the clinical directors. All redelegations must be in writing. For salaries between $115,700 (or the equivalent Executive Level IV salary) and $133,700 (or the equivalent Executive Level II salary), review by the Medical Executive Committee will be required, with concurrence by the associate director for clinical research and approval by the DDIR. For salaries between $133,700 and $148,400 (or the equivalent Executive Level I salary), or increases in excess of $20,000, review by both the Medical Executive Committee, with approval by the associate director for clinical research, and review by the Title 38 Policy Board, with approval by the deputy director for intramural research (DDIR) and the NIH director, will be required. The Office of Human Resource Management is charged with the development of a specific review and approval process, publicizing the new pay caps, keeping track of comparable private-sector pay scales, and evaluating the role of pay in affecting recruitment and retention of clinical researchers at NIH.

2. There is no guarantee that nonfederal employees are covered under the federal Tort Claims Act. Therefore, NIH has decided that each clinical researcher in training, while caring for patients, should occupy an FTE. However, during training in laboratory investigation, there is no need for Tort Claims Act coverage, and, in fact, a stipend to support this aspect of training could be provided under NIH training authority (or equivalent for NCI). In addition to their status as postdoctoral fellows supported under NIH training authority, such individuals could also be appointed intermittently as clinical fellows under Title 42. Total pay (IRTA stipend plus salary) should not exceed established salaries for full-time clinical fellows.

3. The NIH director has established an advisory group, led by a subcommittee of the Clinical Center Board of Governors, to make recommendations on stabilizing the budget of the Clinical Center so that there is no financial incentive to decrease clinical research activities. A mechanism to provide incentives to ICDs to recruit new tenure-track clinical investigators is also being pursued. These recommendations will be reviewed by the ICD directors and acted upon by the NIH director.

Staff Clinicians

4. The staff clinician appointment has been used at NIH to fulfill a variety of clinical research needs: primary patient care, oversight of research protocols, and, as noted in the report, some staff clinicians have controlled independent research resources and managed their own clinical protocols. It is the intent of NIH to preserve as much as possible the flexibility of this appointment mechanism, which has supported clinical research at NIH so well for many years, while at the same time assuring proper oversight of resources and providing the possibility of career development for our staff clinicians. With these goals in mind, the following steps will be taken.

a. Staff clinicians whose primary responsibility is patient care:

Appointments will stay as they are. Some of these staff clinicians may exercise considerable judgment regarding the design and execution of projects decided upon within their ICDs and branches, including serving as principal investigators on clinical protocols. However, a scientist within the ICD should supervise the staff clinician in this work and report on it to the Board of Scientific Counselors (BSC). Occasionally, a staff clinician with primary clinical responsibilities conducts independent research as well. All such clinical research must be reviewed by a BSC.

b. Staff clinicians whose primary responsibility is clinical research:

At the discretion of the ICD, such staff clinicians may be offered the opportunity to enter the tenure track, without loss of general schedule (GS) position and salary. The "grandfathering" process will be modeled after that established in 1994 for bench scientists. No one hired after June 1, 1997, will be considered for "grandfathering" into tenure track. The candidate must receive a positive scientific review by the BSC, must be nominated by the clinical director and scientific director, must already have been engaged in significant and meritorious independent clinical research prior to June 1, 1997, and must receive the approval of the DDIR before Dec. 31, 1997. If such a tenure-track investigator fails to achieve tenure after eight years, that person must give up independent resources and return to the position of staff clinician. In exceptional cases, a staff clinician who has a substantial record of achievement in independent clinical research may be considered for tenure at NIH following discussion with the DDIR, scientific review by the BSC, a letter of nomination from the scientific director, and review and recommendation for approval by the Board of Scientific Directors, with final approval by the DDIR.

c. New hires of staff clinicians after June 1, 1997:

The rules that govern staff clinicians, as specified in 4a above, will apply here; a staff clinician is responsible primarily for care of patients and will not be allocated independent resources by the scientific or clinical director. Any such resources must be provided under direct supervision by a supervisor who is reviewed by a BSC.

PROMOTION AND TENURE

NIH recognizes the additional responsibilities of clinical investigators compared with laboratory-based researchers and concurs that they should be weighed into promotion and tenure decisions. The following recommendations deal with how this can be accomplished.

1. The Clinical Research Revitalization Committee* should review existing standards for promotion of staff scientists and senior investigators. Recommendations to augment these standards to account for the additional training and clinical service roles of clinical investigators and staff clinicians should be developed for review by the Medical Executive Committee and the Board of Scientific Directors and approved by the associate director for clinical research and the DDIR.

2. Each BSC of an ICD that conducts clinical research should include at least one recognized clinical researcher who conducts patient-oriented research and has been approved for inclusion by the DDIR and the NIH director. When NIH clinical investigators are reviewed by the BSC or by site visitors, there should be at least two reviewers present who are expert in patient-oriented research. Those members of the BSC who are clinical investigators should be asked to provide names of potential ad hoc reviewers of NIH clinical researchers. Either the scientific or the clinical director, or both, must ensure that each institute's promotion and tenure committee includes clinical researchers.

3. The five-to-eight-year rule should be utilized to encourage career development of potential clinical researchers. After five postdoctoral years, those candidates judged likely to succeed as independent clinical investigators can be offered an appointment as a clinical fellow for another three years. A memorandum to the fellow explaining the reason for this extension - to allow career development as a clinical researcher-should be sent, with a copy to the Office of Intramural Research.

The tenure track for a clinical investigator shall last up to 8 years, especially for outside recruits, with the usual requirement for a midterm review and a pre-tenure review by the BSC. As recommended by the committee, the total length of stay for a clinical researcher in a nontenured position at NIH should not exceed 14 years.

4. The tenure-review process for clinical investigators will be the same as that for laboratory-based investigators. The DDIR, in consultation with the associate director for clinical research, will ensure that the NIH Central Tenure Committee has members who are active in patient-oriented research. In addition, a Committee on Clinical Investigation has been appointed by the DDIR in consultation with the associate director for clinical research to review the application packages of candidates for tenure who are clinical researchers and make recommendations to the Central Tenure Committee. This is currently standard practice for the review of epidemiologists, computer scientists, and engineers.

RESEARCH SUPPORT AND TRAINING

NIH acknowledges that the quality of clinical research and training at NIH is dependent on the environment and resources that are brought to bear in these areas. The following recommendations are aimed at improving the overall support for clinical research activities at NIH.

1. A subcommittee of the NIH Medical Executive Committee is developing a new policy statement on consultative services. This policy will provide a mechanism for evaluating the consultation services and assure that appropriate authority is vested with the Clinical Center director, who is ultimately responsible for the quality of consultative services.

2. The Clinical Research Revitalization Committee,^* with the assistance of appropriate Clinical Center staff, is charged with working with individual clinical directors, scientific directors, and ICD directors to review support resources for clinical research provided within each ICD, especially resources for outpatient care. The committee will direct its recommendations to individual ICDs. Data and recommendations about Clinical Center­supported activities will be given to the Clinical Center director for presentation to the Clinical Center Board of Governors.

3. The associate director for clinical research is pursuing bringing advanced-degree programs (Ph.D. and Masters degrees) to NIH through partnerships with
existing universities. In addition, NIH is considering the development of a degree-granting program in translational research.

4. The Clinical Research Revitalization Committee^* is charged with recommending ways to facilitate involvement of clinical researchers at NIH in extramural research activities, including examinations of current rules that limit such activities and stringent restrictions on extramural involvement imposed at the ICD level.

In addition, a Committee on Extramural/Intramural Investigations in the Clinical Research Center has been established, chaired by Ed Liu, scientific director, Division of Clinical Sciences, NCI. This committee is exploring ways for extramural investigators to work in the Clinical Center.

Status of Clinical Directors

During discussions related to the preparation and implementation of this report, it was recognized that an enhanced role for clinical directors is a prerequisite to establishing an environment for outstanding clinical research, including the recruitment of the highest-quality clinical researchers. The institute director is charged with determining how to enhance clinical director status. Possible measures include having clinical directors, along with scientific directors, report directly to institute directors and assigning to clinical directors specific resources for clinical-research portfolios and support. Because such changes in the status of the clinical director involve a substantial change in job description, the ICDs may need to initiate national searches to identify the best-qualified candidates for these positions.

*Those recommendations more general in nature and requiring more detailed analysis have been forwarded to a newly established committee - the Clinical Research Revitalization Committee, consisting of scientific directors, clinical directors, and other NIH clinical researchers.