Special Article

National Institute of Mental Health Clinical Research Career Opportunities

David Shore, M.D., Leonard Lash, Ph.D. SU7aOoe Hadley, Ph.D., Althea Wagmao, Ph.D.

S. Charles Schulz, M.D.

Mental health professionals interestea in clinical research careers need accurate, current information about research support mechanisms of the National Institute of Mental Health (NIMH). NIMH has recently expanded the research opportunities it ofters in response to increased interest by the public and by Congress in schizophrenia, AIDS, and mental disorders of the elderly and children. This article describes the various types of NIMH programs available and their goals, criteria, and time and budget limitations. It also summarizes the grant review process and the role of NIMH program staft. Descrip­tions of new and revised grant mechanisms, including small grants, FIRST awards, Sci­entist Development Awards, and Academic Awards, and requirements for NIMH extramural and intramural fellowships and investigator-initiated training fellowships are also outlined.

Major mental disorders affect a signifi­cant percentage of the V.S. population

(1) and have been estimated to cost the V.S. over $70 billion a year in treatment costs and lost income. Psychiatrists and other mental health professionals are wen aware of the severe disability caused by these disorders and the limits of currently available treat­ments. Thus, many new mental health pro­fessionals may consider pursuing a clinical research career to develop more effective treatments and insights about the etiology and course of these disorders.

In the past few years the support struc­ture for mental health research has im­proved steadily and an academic research career is now a particu1arly exciting option (2-4). The many recent advances in the be­havioral neurosciences have contributed greatly to this improvement. Those of us on the staff of the National Institute of Mental Health (NIMH) and most contemporary re-

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searchers are very enthusiastic about these new opportunities. Noninvasive technol0-gies, such as computerized tomography, magnetic resonance imaging, cerebral blood flow, single photon emission computer to­mography, and positron emission tomogra­phy, allow the structure and function of the brains of living patients to be examined under a variety of conditions.

Drs. Shore, Lash, Hadley, and Wagman are affili­ated with the National Institute oE Mental Health (NIMH) in Bethesda, Maryland. Dr. Shore is assistant chief of the Schizophrenia Research Branch in the Divi­sion of Clinica1 Research; Dr. Lash is associate director for research training and research resources in the Divi­sion of Clinica1 Research; Dr. Hadley is acting director of the NIH Office of Scientific Integrity; and Dr. Wag­man is chief of the Clinica1 Neuroimaging and Electro­physiology Program in the Schizophrenia Research Branch. Dr. Schulz is chair of the psychiatry department at Case Western Reserve University in Oeveland, Ohio. Address reprint requests to Dr. Shore, NIMH, Parklawn Building. Room lOC-06, 5600 Fishers Lane, Rockville, MD 20857.

In addition, new theories of biological etiology and pathophysiology have gained credibility and have stimulated studies on neuromodulators and their receptors, be­havioral and psychophysiological vulnera­bility markers, and genetic linkage. Research on treatment of the refractory patient, psy­chotherapy, and rehabilitation continue to be major foci of NIMH-funded studies.

Psychiatrists, psychiatric residents, psy­chologists, nurses, sodal workers, and neu­roscientists should be aware that research on major mental disorders is the leading prior­ity of NIMH. Looking to the future, NIMH is especially concerned about research man­power needs for the next generation (5) and has implemented several initiatives to en­courage and fadlitate the development of scientists.

Of course, research is not for everyone; unless a person has been involved in re­search there is no sure way to determine whether he or she would be happy in such a role. Those interested in research should seek out opportunities for such experience with active, successful investigators. Many academic departments have a variety of in­teresting, ongoing research projects; NIMH can provide lists of research grants funded in various research areas at academic insti­tutions an around the country. If a conve­niently located university or hospital does not have an active clinical research program in one' s area of interest, one should consider a fellowship to study with amentor at an­other institution. Research experience of this sort not only helps potential research train­ees decide about the desirability of this ca­reer option but places them in a more competitive position for future research or research training opportunities.

RESEARCH SUPPORT MECHANISMS

NIMH offers three mechanisms for clinical research project support, three for research scientist development, two for research training support of developing investiga-

tors, and several programs (mainly pre­doctoral) for minority students as weIl as an "in-house" fellowship program at the NIMH Intramural Research Program. Be­cause of this wide variety of opportunities, it is often unclear to potential applicants which one is best suited to their needs. AB a first step, a potential applicant should un­derstand the different mechanisms and some of the details of their administrative requirements.

Research Project Support Mechanisms

Research project support mechanisms consist of small grants, First Independent Research Support and Transition (FIRSTI awards, and regular research grants. All three mechanisms provide funding for re­search costs, which may cover the costs of salaries, equipment, travel, patient care, and subject compensation, for instance. Small grant and FIRST awards were created in recognition of the importance of pilot data and the need to encourage a new generation of researchers.

Small grants. The newly revised small grants mechanism was developed to pro­vide funds for pilot work or start-up funds, primarily for new investigators. A maxi­mum of $50,000 per year is nowavailable for aperiod of one or !wo years, and extensions without additional funds are routinely avail­able.

The recent doubling of maximum time and funding may expand the utility of this mechanism for clinical studies. This mecha­nism is best suited for tightly focused studies that can be completed within two years. It has been used successfully in the past by promising investigators with relatively few publications.

FIRST. This mechanism was designed to provide salary and research support to newly independent investigators in the V.S. who have never before been the prindpal

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investigator (PI) on a federally funded grant (except for a small grant, fellowship, or Re­search Scientist Development Award [RSDA]). This mechanism was designed for those within five years of completing train­ing and provides up to $100,000 per year for up to five years, with a total funding limit (direct costs) of $350,000. Research plans for fewer than five years must prorate the direct costs to the equivalent of $70,000 a year. Applicants must submit a well-thought-out program of research on which they must spend at least 50% of their time. These grants ~ not renewable or assignable to another PI. They are designed to act as a bridge to raise the beginning investigator to a compet­itive position to apply for a regular research grant.

Regular research grant. The investigator-ini­tiated research project grant is the "bread­and-butter" research funding mechanism of NIMH. It provides research funds for appli­cants at qualified institutions in the V.S. or foreign countries. Vp to five years of funding can be requested, and there are no limits on the amount requested. This mechanism is best suited for relatively complex studies that require multiple years of support and may be part of a long-range program of re­search. The grant can be transferred to an­other PI or to another institution under special circumstances. Regular research grants have been used in the past by begin­ning investigators who have a well-devel­oped research plan and pilot data that demonstrate feasibility and support the re­search strategy.

Research Scientist Development Awards

The mentored RSDAs are designed pri­marily to provide sa1ary support and career development opportunities, along with some funding for research support. Award­ees must be V.S. citizens or noncitizen per­manent residents of the V.S. These awards

are not renewable and cannot be transferred to another investigator. RSDAs consist of three types: Academic Awards, Scientist Oe­velopment Awards for Clinicians, and Sci­entist Development Awards. The latter two have recently replaced the Physician Scien­tist Award, the Clinical Investigator Award, and the RSDA Level 1 mechanism.

Academic Awards. Academic Awards in schizophrenia, disorders of children and ad­olescents, and the aging are designed to fa­cilitate the development of psychiatrists and psychiatric nurses with high potential for academic careers. These three-year awards require commitments by the applicant, sponsor, and institution to prepare the awardee to function as a researcher, a re­source to help develop other researchers, and a teacher of research findings in these areas. Ouring the tenure of the award, the awardee is provided the opportunity to de­velop substantive expertise through individ­ualized learning opportunities in preparation for a faculty leadership role. The applicant must have or be eligible for a full­time faculty appointment at the time of ap­plication, a guarantee of employment upon award of the grant, and at least two years of successful teaching experience.

The institution must also document the need for a specially prepared faculty mem­ber to implement a research and education program in schizophrenia, disorders of chil­dren and adolescents, or the aging.

Scientist Development Award tor Clinicians. This award is designed to support clinically' trained individuals, including psychiatrists, psychologists, and social workers, while they develop excellent research skills. Most applicants will have achieved junior-level faculty status. The five-year award provides an opportunity for supervised research ex­perience for those who show special promise for a research career. The eligibility criteria for this award take into account that the applicant has been trained primarily as a

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clinician and may possess only minimal re­search experience or skills. The application must describe the career development plan, the preceptor's role, and details of the re­search proposal to be facilitated by the plan.

Current sa1ary support is a maximum of $75,000 per year. As these amounts are ad­justed from time to time, it would be wise to consult NIMH staff about salary levels in the future. Up to $35,000 may be requested for research and/or career development ex­penses. Applicants may not concurrently apply for any other grant from the Public Health Service (PHS). After an award is granted, the awardee is expected to establish regular PHS research grant support. These awards cannot be transferred to another in­stitution without the concurrence of the ap­propriate NIMH scientific review committee during the first four years; NIMH staff ap­proval is sufficient in the fifth year.

Scientist Development Award. This award is designed to support highly promising, de­veloping scientists while they acquire fur­ther, new, or more specialized research skills. Most applicants will have achieved faculty status. The award is also available for established investigators who wish to de­velop research skills in a new field or to enter mental health research. The requirements and support level for this award are similar to those listed for Scientist Development Awards for Clinicians.

RESEARCH FELLOWSI-llPS

The primary goal of research fellowships is to provide salary stipends during a research training interval. The fellowships fall into four categories: National Research Service Award (NRSA) individual fellowships, Pub­lic Hea1th Service epidemiology fellowships, medica1 staff (clinical associate) fellowships through the NIMH Intramural Research Programs (IRP), and NRSA postdoctoral in­stitutional research training grants. The NRSA individual fellowships and the epide-

miology fellowships involve a maximum of three years of postdoctoral training. All NRSAs incur a payback obligation.

NRSA postdoctoral fellowship. Prior to mak­ing a formal application for an NRSA, the applicantmust arrange fora sponsor to su­pervise the research training experience in a facility that has an appropriate environment to provide the proposed research training. The arrangements, the qualifications of the applicant, the commitment and qualifica­tions of the sponsor, and the training goals must be explicitly documented in the appli­cation.

Postdoctoral stipends range from $17,000 to $31,500 per year depending on the applicant' s number of years of experience. In addition, $3,000 may be requested for insti­tutional allowances, but funding for re­search costs are not provided. Historically these fellowships have been most helpful to individuals with a doctoral degree in the basic sciences who are not ready yet to as­sume a faculty position and to young psychi­atrie investigators at the completion of their residencies.

PHS epidemiology fellowship. This award is somewhat different from the other awards described above in that the first year of sup­port covers training leading to a master' s degree in public health while the second and third years of support finance research expe­rience in epidemiology at NIMH. Recipients of these awards receive NIMH appoint­ments equivalent to recipients of the IRP medical staff fellowships. Sa1ary support be­gins at $37,000 for the first year and increases by $2,000 increments for each year of sup­port. The purpose of this program is to in­crease the number of medica1 professionals in mental health epidemiology.

NIMH Intramural Research Programs' medical staff (clinical associate) fellowships. Medica1 staff fellowships at NIMH in Bethesda or at the NIMH Neuroscience Center at St. Eliza-

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beths in Washington, D.C., are available for those who are completing or have com­pleted residency training. Unlike the extra­mural grant programs described above, the IRP conducts research on its own campuses, rather than providing grants to other institu­tions. There are active programs in schizo­phrenia, affective and anxiety disorders, basic neurosciences, and neuroimaging, etc. Medical staff fellowships last two years, with a starting salary of approximately $37,000. Additional information concerning these fellowships may be obtained from David Rubinow.1

NRSA postdoctoral institutional research train­ing grants. These grants are awarded to an institution for the support of a number of research trainees selected by the training program director, the faculty member who prepares the grant application and provides leadership for the program. Each of these programs is unique, offering research train­ing focused on the ability and expertise of the participating faculty and the resources of the home institution. Although most of these grants provide training for all postdoctoral trainees, a few are restricted to individuals with either a Ph.D. or an M.D. Stipends are identical to those provided under the NRSA individual fellowship support mechanism. Applications for support under one of these grants should be submitted directly to the training program director. An annotated list of current research training programs sup­ported by NIMH and the Alcohol, Drug Abuse, and Mental Health Administration can be obtained from Leonard Lash.2

THE GRANT REVIEW PROCESS

All applications for grant support proceed through a competitive, dual-review process. Scientific peer review is conducted by initial

review groups (IRGs) composed primarily of nonfederal scientists. Final review is con­ducted by the National Advisory Mental Health Counci1, a group of distinguished experts in science, education, and public af­fairs with special interests in the NIMH mis­sion. The Council is appointed by the Secretary, Department of Health and Human Services (DHHS), and is an advisory body to the Secretary, the administrator of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), and the direc­torofNIMH.

Each IRG is supported by a staff consist­ing of an executive secretary and one or more grants technical assistants. Members of the IRG are nominated by the executive secre­tary and appointed by the ADAMHA ad­ministrator based on the recommendations of the NlMH director. Scientific expertise is the essential criterion for the selection of IRG members. The executive secretary is primar­ily responsible for the supervision and con­duct of the scientific reviews and for the preparation of summary statements, known as pink sheets. The grants technical assistant is responsible for distribution of all materials to the proper IRG members, NIMH program staff, and the NIMH Grants Management Branch.

Each grant application is sent to all members of the IRG. Two or three members whose expertise is most relevant to the pro­posal are assigned to provide an intensive reading and critical review of the proposal. One of these panel members is designated as the primary reviewer. Written outside opin­ions from experts in a particular field are sometimes obtained when none of the panel's members have enough expertise in the subject area. A project site visit may be arranged to collect information that can only be gained during extended discussions be­tween the investigator and project staff and

I David Rubinow,M.D., Clinical Director, Intramural Research Programs, National Institute o{ Mental Health, Building 10, Room 3N-238, Bethesda, MD 20892.

2Leonard lßsh, Ph.D., Division of Clinical Research, National Institute of Mental Health, ParkJawn Building, Room 10-99, 5600 Fishers Lane, Rockville, MD 20857.

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the site visit panel. The executive secretary acts as a moderator for these visits. A listing of all NIMH review groups, their topic areas, and membership can be obtained from the Division of Extramural Activities.3

At the meeting of the IRG, the reviewers provide an evaluation of the scientific merit of each application using the following gen­eral criteria: scientific and technical merit, significance and originality of the proposed research, appropriateness and adequacy of the experimental approach and method to be used, qualifications and relevant research experience of the principal investigator and staff, reasonable availability of resources, and appropriateness of the proposed budget and duration. Additional criteria may apply to the evaluation of applications submitted in response to a specialized program announcement. Applications involving human or animal subjects or the environ­ment will also be evaluated for the adequacy of the proposed means for protecting against or minimizing risk.

An IRG can make three types of recom­mendations: approval as requested or with modifications in the duration or budget, dis­approval, or deferral for additional informa­tion. Additional information may be obtained from a detailed letter or from a site visit, depending upon the IRG recommen­dation. Approved proposals are then ranked according to priority scores (from 1.0 to 5.0) assigned privately by each reviewer. The scores are averaged and multiplied by 100 to producea three-digitscore, with l00indicat­ing the most meritorious proposal and 500 the least. Currently, for informational pur­poses only, the priority score is also repre­sented as a percentile based upon the scores obtained from the last three meetings of the particular IRG.

After the meeting of the IRG, the execu­tive secretary prepares a pink sheet, which serves as the official summary of the discus­sion. This document, also known as the

Summary Statement, is sent automatically to each applicant as soon as is feasible. Pink sheets indude a critique of the research pro­posal and the recommendations of the IRG, and they are forwarded to the National Ad­visory Mental Health Council (small grant and individual fellowship applications do not go to the Council). The Council reviews the recommendations of the IRGs; their de­liberations provide a second formal review of the applications previously evaluated by theIRGs.

The Council can conrur with the IRG recommendations or propose that addi­tional review take place or that an applica­tion receive special funding attention. The Council cannot change priority scores. By law, the Council's recommendation of ap­proval is required before the Institute may award research project grants or institu­tional research training grants. In those cases where recommendations of the Council dif­fer from those of the IRG, the applicant is notified.

Peer review by IRGs is used to provide advice solelyon the scientific quality of grant applications, in order that the Institute may have a dear assessment on this most basic criterion for award of public funds. National Advisory Mental Health Council recommendations may be based on policy considerations in addition to considerations of scientific or technica1 merit. NIMH pro­gram staff are responsible for determining whether to make an award for those appli­cations recommended for approval by Council. Program staff may take into ac­count other factors (e.g., availability of funds, program priorities, and administra­tive policy requirements); however, Council and IRG recommendations are used, in the main, as the primary basis for funding deci­sions.

The review of NRSA individual fellow­ships and small grants follows the same pro­cedures except that the IRG review is

3Division 01 Extramural Activities, Par/clawn Building, Room 9-105, 5600 Fisher's Lane, Rockville, MD 20857.

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final-the applications do not go to the Council for a second review. NIMH IRP fel­lowship applications are reviewed and awarded by the intramural units. Fellowship applications at universities with NRSA insti­tutional research training grants are re­viewed by the training program director at the grantee institution, who offers positions to research trainees.

In order to use the peer review system as effectively as possible and to maintain its independence from considerations of pro­gram priorities, it is necessary to separate management of the review process and man­agement of grant programs. For this reason, under the NIMH review system the initial review process is separate from and inde­pendent of program management. Review staff have responsibility for an application from the time of its receipt and assignment through Council review.

SCIENTIFIC PROGRAMS

It is the responsibility of the Institute director and the NIMH program staff to define and implement scientific priorities. The profes­sional staff of the programs are individuals knowledgeable in the specialty areas repre­sented by the science mission of the particu­lar division and branch of NIMH. A primary function of this staff is to provide consulta­tion to the field on scientific issues. This function can vary from outlining priority research areas to providing individualized critique of applications prior to submission. Although program staff are not direetly in­volved in the review process, they often act as a first line of communication between potential applicants and NIMH. New inves­tigators are frequently unaware of this ser­vice.

In order to make the best use of this scientific resource, a potential applicant should make contact with the appropriate branch and program staff person early in the planning of an application. Program staff consultation cannot operate during the ac-

tual review process. Since the staff has exten­sive expertise in the application process, early communication can save the investiga­tor from making false starts and may im­prove the chances of eventual approval and funding of the application.

NIMH staff also must gather and syn­thesize information from a nu mb er of sources in order to devise policy recommen­dations that facilitate the science mission. Information is gathered from scientific meet­ings, where program representatives often describe new initiatives and consult infor­mally with investigators. It is the program staff s responsibility to identify underserved research areas and prepare documents out­lining research needs. Investigators can con­tact the program staff to discuss ideas concerning NIMH initiatives, need for new programs, or ongoing scientific plans and developments. NIMH sponsors workshops or working groups where staff and investi­gators delineate issues and prepare guide­lines for research solutions. The Institute also responds to the needs of the field and sponsors workshops designed to stimulate or clarify important scientific areas or issues.

In addition, program staff write, edit, and disseminate research information through public information booklets and regular publications such as Psychopharma­cology Bulletin and Schizophrenia Bulletin. Program representatives frequently partici­pate in professional symposia and lay-spon­sored conferences providing information about recent scientific developments.

Cooperation and communication be­tween review and program staff facilitate the review process and guarantee the scientific excellence of each review. Program staff at­tend IRG meetings in order to obtain infor­mation to facilitate presentation of the proposal to the Council and inform the fund­ing process. Program staff are also responsi­ble for monitoring the progress of each research award. Yearly progress reports pre­pared by the investigators are reviewed by staff, who then authorize continuance of suc-

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cessful efforts. Program staff identify diffi­culties in the research and work with the principal investigator to alleviate them. In exceptional cases, program staff may re­quest supplemental funds for a particularly deserving project.

Applicants, both new and more senior, are urged to take a greater part in the grant process. Potential applicants should contact program staff prior to initiating an applica­tion and use them or others to provide a presubmission review. Concise, logical, and to-the-point applications fare most favor­ably. Successful applications fill a gap in scientific knowledge and should reflect the creativity and ingenuity of the investigators. An applicant should learn the composition of potential review committees and deter­mine which committee might most appro­priately review the application. If an

References

1. Regier DA, Boyd JH, Burke }D, et al: One month prevalence of mental disorders in the United States. Arch Gen Psychiatry 1988; 45:977-987

2. Pincus HA, Shore D, Sirovatka P: lncentives and disincentives for schizophrenia research careers. Schizophr Bull1986; 12:183-290

3. Shore D, Schulz SC, Lash L: Schizophrenia research career incentives. Jefferson Journal of Psychiatry

application requires Special attention by the Division of Research Grants (DRG) that as­signs applications to IRGs and programs, the applicant should submit a letter requesting such attention. If necessary, the applicant may wish to suggest names of approprlate reviewers and alternate committees.

Prior to submission of a revised applica­tion, program staff should be contacted for assistance.1t is very important to respond to all items of the pink sheet critique, although agreement with each and every criticism is not necessary if an alternative explanation can be well documented. Most important, applicants should realize that most initial submissions do not receive fundable priority scores. Those that can be revised based on the critique may be greatly strengthened. Reapplication almost always improves the chances that an application will be funded.

1987;5:87-91 4. Burke}D, Pincus HA, Pardes H: The clinician-re­

searcher in psychiatry. Am J Psychiatry 1986; 143:968-974

5. Healy B: lnnovators for the 21st century: will we face a crisis in biomedical-research brainpower? N Engl J Med 1988; 319:1058-1064

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