Following is a reprint
of the Executive Summary of the report
and recommendations of an NIH committee convened to review and electrify
clinical research at NIH. The committee was headed by Stephen
Straus, NIAID. An implementation plan is now being finalized
and will be published along with the entire "Report of the
NIH Committee on the Recruitment and Career Development of Clinical
Investigators" in the months ahead. The implementation plan
will be published in a future issue of The NIH Catalyst.
Rapid changes in academic
medicine and science are "bedeviling" clinical investigators
nationwide, as Dr. Joseph Goldstein described recently in the first
At the NIH, the morale of clinical investigators has waned in recent
years, and clinical investigators have begun to feel undervalued
and undersupported. Nonetheless, NIH, with its Clinical Center and
large research portfolio, has the ability to transcend these problems
and to remain a bastion of clinical research excellence. Revitalization
of clinical research is now a major priority of the NIH leadership
and the scientific community.
The Committee on the Recruitment and Career
Development of Clinical Investigators was formed to review the current
state of clinical research and to offer specific recommendations
to the deputy director for intramural research and the NIH associate
director for clinical research to improve the recruitment, training,
development, and tenure process for NIH clinical investigators.
A three-month study by more than 40 senior NIH scientists led to
this report's key findings and specific recommendations.
The Committee found that NIH clinical researchers are disheartened
by a perceived decline in numbers of patients, increased obstacles
to studying patients, and diminished respect for patient-oriented research as a rigorous and valuable discipline.
The Committee concluded that these complaints need to be addressed
if NIH is to mount and sustain a broad and vital patient-oriented
research program. Rising national interest in the evolution and
success of clinical research and substantive new commitments at
NIH, such as the construction of a major new Clinical Research Center,
make this a propitious time for the rejuvenation of patient-oriented
The Committee identified four focus areas
and made recommendations for addressing problems in each:
Ongoing NIH clinical research efforts and projections of
The nature and adequacy of training
and professional development for clinical researchers.
The mechanisms by which clinical researchers
are reviewed, tenured, and promoted.
Recruitment of clinical researchers
to NIH and how that process should be improved.
Problem areas identified by the Committee
led to 32 recommendations designed to forge a full career track
for clinical researchers at NIH, to secure stable support for clinical
research activities, and to ensure an optimal environment for conducting
clinical research at NIH. The essence of these recommendations is
Personnel Mechanisms and Funding
Despite the beneficial application of Title
38 at NIH, personnel, salary, and funding mechanisms continue to
generate powerful disincentives to the recruitment and support of
the best clinical investigators.
Under newly clarified authorities, tenure-track clinicians are
covered under Title 42 appointments with a pay cap of $148,400.
Despite this, ICDs have largely been restricting salaries to
a noncompetitive $77,000. ICDs should raise the general salary
cap for Title 42 appointees to $115,700 (Executive Level IV),
with the possibility of exceptions to $148,400 (Executive Level
I) for scarce medical specialties.
Because all clinicians, including those in training, must be protected
under the Federal Tort Claims Act, they must occupy full-time-equivalent
(FTE) positions. With shrinking FTE allocations, there is a
disincentive to sustain clinical training. This disincentive
does not hold for postdoctoral training in basic laboratory
science, where non-FTE personnel mechanisms, such as the Visiting
Fellow and IRTA Programs, are an option. NIH should develop
alternatives to the use of a full FTE for each clinician or
otherwise ensure that all can be readily supplied with malpractice
The current method of funding the Clinical
Center leads to progressively higher per capita management fund
costs as ICDs reduce their clinical efforts. This funding formula
must be changed to eliminate this negative feedback spiral,
either by providing a fixed allocation to the Clinical Center
or taxing all institutes in proportion to the size of their
- Staff clinician appointments are being used to circumvent the
tenure process. More than half of staff clinicians surveyed spend
less than the requisite 50% of their time on clinical service
obligations; many of them control substantial independent budgets.
Staff clinicians' appointments must be distinguished from tenured
investigators', and both appointment mechanisms must be used properly.
Promotion and Tenure
Patient care is a necessary but time-consuming part of clinical
research. In addition, clinical investigators may have training
and clinical service obligations. All of these activities must be
weighed in performance and promotion reviews.
Memberships of the Boards of Scientific Counselors and Institute
Promotion and Tenure Committees must be supplemented by individuals
who actively conduct clinical research to evaluate NIH clinical
investigators fairly. Similarly, clinical researchers must be
included among those whose opinions are solicited regarding
an individual's potential for tenure or promotion. Letters soliciting
this advice must summarize the candidate's clinical and teaching
Because clinical research may take longer than basic research
and may require more collaborative effort, the five-year/eight-year
rule should routinely be relaxed to provide clinical researchers
up to eight years of postdoctoral training prior to competition
for tenure-track positions. Largely patient-oriented researchers
should be permitted up to eight years in a tenure-track position,
especially for outside recruits. The total length of stay in
nonpermanent positions at NIH, however, should not exceed 14
To ensure the fairest tenure review of clinical investigators,
a Committee on Clinical Investigation should be formed to advise
the Central Tenure Committee, analogous to the role played by
the ad hoc Epidemiology Committee and the Computer Science and
Research Support and Training
The best clinical investigation occurs in an atmosphere in which
high-quality medicine is practiced. The NIH associate director for
clinical research must develop and employ measures for supplementing
clinical consultative services where required and for ensuring high
overall quality of clinical services. Clinical directors and chiefs
of clinically oriented laboratories set the standards
for their junior colleagues. Unless senior staff exhibit and demand
the highest standards, their junior colleagues may fail to do so
Bench research requires adequate space and budget and also the
support of technicians and fellows. Clinical research likewise
requires specific resources, not just clinical associates and
nurses who manage inpatients. Many studies would profit
by the availability of research coordinators
and data managers. Some ICDs have appreciated this; many have
not. NIH must develop more uniform support for both inpatient
and outpatient clinical studies. The current transition to greater
reliance on the outpatient clinic has not brought a commensurate
shift in support services for that area.
It takes years of practice and formal training to become adept
at bench research. Clinical research is also complex, and proficiency
in it requires training that is not available in medical schools
and residency programs. NIH has developed a valuable Core Curriculum
for Clinical Research that serves as an excellent introduction
to the field. The NIH should now expand this program for selected
M.D.s and Ph.D.s to provide in-depth training in ethics, trial
design, epidemiology, informatics, etc. These programs could
lead to advanced degrees in clinical investigation.
- Clinical research is not a solitary venture. The advancement of
medical understanding, as well as the advancement of one's career
and reputation, may warrant participation in extramural or multicenter
collaborations. Current regulations that limit such activities
should be abandoned or interpreted as narrowly as possible.
In addition to these 12 major recommendations above, the Committee
made 20 others, both general and specific. The thrust of all these
recommendations is to reinforce the excitement, sense of discovery,
and unbounded opportunity that clinical investigators once enjoyed
at NIH. Restoring a creative clinical environment will require attention
to many more issues than this Committee could consider. It will
take resources, imagination, leadership, and courage: the imagination
to create new ways of translating bench science into practical medicine,
the leadership to recruit, unite and inspire talented people, and
the courage to cast aside bureaucratic
obstacles and old habits that stand in the way.
Therefore, the final recommendation of the
Committee is to establish a Clinical Research Revitalization
Committee - consisting of scientific directors, clinical directors
and other NIH clinical researchers - to provide advice to the deputy
director for intramural research and the associate director for
clinical research in implementing these recommendations and suggesting
innovations to improve clinical research at NIH.
The NIH Shannon Lecture, January 13, 1997, Bethesda, Maryland.
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