NICHD CLINICAL INVESTIGATOR DEVELOPMENT AWARD

NIH GUIDE, Volume 22, Number 21, June 11, 1993



PA NUMBER:  PA-93-082



National Institute of Child Health and Human Development



Effective as of October 1, 1993



PURPOSE



The National Institute of Child Health and Human Development (NICHD)

announces the availability of the Clinical Investigator Development

Award (CIDA).  The CIDA includes features of and replaces the

Physician Scientist Award and the Clinical Investigator Award.  It

enables candidates seeking a research career to receive advanced

training and the opportunity to investigate a well-defined problem

under a sponsor competent to provide guidance in the chosen area of

research.  The CIDA is intended to provide greater flexibility in

supporting a career development program suited to the experience and

capabilities of the candidate.  The objectives of the NICHD in

utilizing the CIDA are to:



o  encourage clinically trained individuals to develop the

technological and intellectual investigational skills that will allow

them to pursue an independent research career in the mission areas of

the NICHD;



o  increase the pool of medical scientists prepared to use state-of-

the-art methods to address significant topics in population research,

maternal and pediatric health and disease research, and medical

rehabilitation research.



ELIGIBILITY



The CIDA provides research career development support for clinically

trained individuals with a range of research experience, who are

committed to developing careers as independent investigators.  This

award will allow candidates holding health professional doctoral

degrees, such as the M.D., D.V.M., D.O., or equivalent degree, to

undertake three to five years of advanced study and supervised

research with the goal of developing into independent investigators.

It is expected that candidates will have completed at least two years

of professional experience following the doctoral degree at the time

of award.



Applications may be accepted from those who hold the Ph.D. degree in

addition to the professional degree only if special circumstances can

be shown, such as the Ph.D. degree earned in a field unrelated to

biomedical science, or a substantial intervening period of clinical

or nonresearch activities having occurred since completion of the

Ph.D. degree.  Such applications will be considered on a case-by-case

basis.



MECHANISM OF SUPPORT



PROVISIONS OF THE AWARD



1.  Environment.  Applications will be accepted from domestic

universities, medical schools, or comparable non-Federal institutions

with strong, well-established research and research training

programs, sufficient numbers of accomplished faculty in basic and

clinical sciences, and a commitment and capability to provide

guidance to clinically trained individuals in the development of

research independence.  Evidence of institutional commitment to the

candidate's research and development must be provided in a plan that

identifies personnel and other resources to be devoted to the

candidate's career development program.



2.  Program.  Candidates must be nominated by an institution on the

basis of qualifications, interests, accomplishments, motivation, and

potential for performing quality research.  The candidate's academic

background, previous experience, and career goals should determine

the necessary length and type of plan that is appropriate.  The

candidate and sponsor are jointly responsible for the preparation of

the research development plan.  The amount of course work, seminars,

and other educational experiences will be expected to vary according

to the previous level of experience of the candidate.



All candidates must provide a full description of the research and

career development plan for the period of the award.  The proposed

plan must include hands-on research experience for the entire three

to five year period.  Programs may include studies and research

endeavors leading to a relevant Masters or Ph.D. degree, if the

objective is the development of the candidate into an independent

investigator.



3.  Sponsor.  Each candidate must identify a primary sponsor who is

an accomplished investigator in the research area proposed and has

experience in training new investigators.  The sponsor must provide a

written plan for the development of the candidate into an independent

scientist, and provide guidance during the preparation of the

application.  A secondary sponsor may also be proposed for subsequent

guidance in a special area of expertise, but the primary sponsor must

continue to be involved throughout the award period.  In some cases,

candidates may choose to propose both a basic research sponsor and a

clinical research sponsor.



4.  Advisory Committee.  A committee composed of the sponsor(s) and

two or three other senior faculty members should be identified.  This

advisory committee should meet at least annually with the candidate

to review the research development plan and project, to evaluate his

or her progress, and to provide guidance for future scientific career

development.  A report from this committee should be included in the

annual progress report submitted as part of the noncompeting

continuation application.



5.  Duration and Effort.  The award is made for three, four or five

years, depending on the needs of the candidate and the evaluation by

the initial review group and the National Advisory Child Health and

Human Development Council.  It is nonrenewable and not transferable,

but in extraordinary situations, change of sponsor and/or change of

institution may be allowed with the prior approval of the NICHD.  All

funds must be used on behalf of the original candidate.  A minimum of

75 percent effort must be devoted to the research program, and the

applicant institution must provide assurance that at least 75 percent

time will be available to the candidate for research.  The remainder

may be devoted to other clinical and teaching pursuits that are

directly relevant to the program, i.e., the candidate's scientific

career development or the maintenance of clinical and teaching skills

necessary for an academic medicine career.



The candidate must have a full-time appointment at the applicant

institution.



In general, candidates who have Department of Veterans' Affairs (VA)

appointments may not consider part of the VA effort toward satisfying

the "full-time" requirement at the applicant institution.  Although

exceptional cases may be approved, any such requests must be strongly

justified, and must otherwise meet the intent of the guidelines.

Under no circumstances will the CIDA be used to reimburse part of the

VA Federal salary.  It is permissible for all or part of the research

program to be conducted in a VA laboratory, if, for example, the

sponsor has a VA appointment, but the above conditions must be

satisfied with respect to the CIDA candidate.



6.  Allowable costs.



a.  Salary.  Individual compensation is based on the institution's

salary scale for individuals at an equivalent experience level.

Funding from this award for salary may not exceed $50,000 per year

plus commensurate fringe benefits for a full-time employee with at

least 75 percent effort devoted to the research program.  NIH policy

permits supplementation of salary from non-Federal sources.



b.  Research and Development Support.  A maximum of $10,000 per year

may be requested for research costs such as technical personnel,

supplies, small items of equipment, candidate travel,

telecommunications, publication costs, and tuition for necessary

courses.  All budget items requested must be justified in the

application.



c.  Indirect costs.  Reimbursement of actual indirect costs may be

requested at a rate up to, but not exceeding, eight percent of the

total allowable direct costs of each award, exclusive of tuition,

fees, and equipment purchases.



7.  Concurrent Applications.  CIDA applications may not be submitted

or awarded concurrently with other NIH applications, including any

other career development award, FIRST award, or research project

grant.  This includes support under an institutional physician

scientist award.  Other career development awards may not be applied

for or awarded to a candidate for, or recipient of, the CIDA.

Individuals who have been the principal investigator on an AREA grant

(R15) or a small research grant (R03) may apply for the CIDA.



8.  Subsequent Applications for NIH Research Support.  Individuals

holding the CIDA, during the later years of the award, are encouraged

to apply for independent research support, such as the FIRST Award or

other research project grants.  Care should be exercised that costs

requested on the research grants do not duplicate those on the CIDA.

Consultation with NICHD staff is recommended.



OBJECTIVES



The award is intended to serve the research career development needs

of clinically trained individuals by providing them with research

opportunities appropriate for their academic background, previous

research experience, and other past achievements.  Candidates who

have minimal or no research experience and need guided course work

and supervised laboratory experiences are eligible to apply.

Individuals who do not require additional courses but who need an

intensive research experience under the guidance of an established

scientist are also eligible to apply, as are those who, by the time

of award, will have concluded training support under institutional

training grants or individual fellowships from NIH or other sources.

Women, minorities, and individuals with disabilities are encouraged

to apply.  Current or past Principal Investigators of an NIH grant

(other than an R03 or R15) or the equivalent are not eligible.



All programs should be carefully tailored to meet individual needs

and must include a sponsor who is competent to provide appropriate

research guidance.  In certain cases it may be appropriate to include

a secondary mentor with additional specific expertise.



The CIDA can be integrated with the requirements of clinical

training, and various approaches for doing so may be proposed.

Individuals desiring subspecialty training may wish to complete their

clinical fellowships before starting the CIDA.  An alternative is

interruption of the award to complete clinical training.  For

example, individuals with limited clinical and research training may

propose a plan which includes a one to two year hiatus in the program

to allow for the completion of subspecialty training, followed by

resumption of the research development program.  The period of

interruption would be without award support and would not reduce the

total length of time of support for which the individual is eligible.



At the time of application, candidates must be either citizens or

noncitizen nationals of the United States or have been lawfully

admitted to the United States for permanent residence.  An individual

lawfully admitted for permanent residence must submit with the

application a notarized statement indicating possession of the Alien

Registration Receipt Card (I-151 or I-551).  Individuals on temporary

or student visas are not eligible.



REPORTING REQUIREMENTS



During the period of award, recipients, in conjunction with their

sponsors, are required to submit a detailed annual progress report.

Recipients must also provide a report to the National Institutes of

Health annually for a period of five years subsequent to the

completion of the CIDA, regarding time devoted to research, academic

status attained, publications, and research support (Federal and non-

Federal) obtained.



APPLICATION PROCEDURES



Supplemental instructions for completing and submitting the

application must be obtained from program staff or the NICHD contact

listed below:



Applications are to be submitted on the research grant application

form PHS 398 (rev. 9/91).  This form is available at the applicant

institution's office of sponsored research and may be obtained from

the Office of Grants Inquiries, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD

20892, telephone (301) 435-0714.



Submit a signed original of the application and five signed copies in

one package to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda MD  20892**



REVIEW CONSIDERATIONS



Upon receipt, applications will be screened by NICHD staff for

compliance with the eligibility criteria above.  Applications not

meeting these requirements will be returned to the applicant without

review.



Individuals with significant research experience in the proposed

field of study may not be eligible for this award and should discuss

other methods of research support with appropriate institute staff.



Applications for the CIDA will be evaluated for scientific and

technical merit by an NICHD Review Committee, in accordance with the

usual NIH peer review procedure.  Following the initial review,

applications will undergo a second level review by the National

Advisory Child Health and Human Development Council.



REVIEW CRITERIA



1.  Candidate.  The candidate's overall competence as demonstrated by

academic and clinical performance, potential for a career in

independent research, and commitment to pursuing an academic research

career.



2.  Sponsor(s).  The sponsor's accomplishments in the scientific

research area(s) proposed by the candidate, appropriate experience

and record in training investigators, and degree of commitment for

the duration of a candidate's research development program.



3.  Environment.  The institution's commitment and ability to provide

adequate facilities, resources, and opportunities necessary for the

candidate's training; the institutional commitment to the candidate;

the quality and extent of interaction among the faculty in the basic

and clinical sciences; and the quality of the institution's research

and research training environment.



4.  Career Development Plan.  The adequacy of the research career

development plan, based on the candidate's past experience, training

and career goals. (See Item II, above)



5.  Research Plan.  Scientific merit of a proposed research project,

as described in the Supplemental Instructions, and its

appropriateness as a vehicle for developing the candidate's research

skills.



6.  Advisory Committee.  Appropriateness of the advisory committee to

meet the research career evaluation needs of the candidate's program.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues and requests for the

supplemental instructions to:



Hildegard Topper

Special Assistant to the Deputy Director

National Institute of Child Health and Human Development

Building 31, Room 2A03

Bethesda, MD  20892

Telephone:  (301) 496-0104



Receipt dates of applications by the Division of Research Grants, NIH

are as follows:



Application           NICHD Advisory            Earliest

Receipt Dates         Council Review            Start Date



February 1            October                   December 1

June 1                January                   April 1

October 1             May                       July 1



AUTHORITY AND REGULATIONS



The programs of the NICHD are described in the Catalog of Federal

Domestic Assistance Nos. 93.864, 93.865, and 93.929.  Awards are made

under authorization of the Public Health Service Act, Title IV, Part

A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and

285) and administered under PHS grants policies and Federal

Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not

subject to the intergovernmental review requirements of Executive

Order 12374 or Health Systems Agency review.



.


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