Journal of Gerontology 1976, Vol. 31, No. 6,696-704

Report from the National Institute on Aging: The Research Grant Support Mechanism1 Donald G. Murphy, PhDJ

HE National Institute on Aging T (NIA) is mandated by enactment law (PL 93-296) ". . .to conduct and support biomedical, social, and behavioral research and training related to the aging process and the diseases and other special problems and needs of the aged." The research grant is the primary means of NIA research support. Grant awards for health research have been a fundamental aspect of Federal policy since the late 1940s, and now account for 54% of the total National Institutes of Health (NIH) budget. The NIA is one of 11 Institutes of the NIH, and with these Institutes shares law, policy, and organizational units in the processing and awarding of grants. The following discussion of grant mechanism is exclusive of the professional training and development awards also available through the NIA. The annual reports of the NIH institutes first mentioned gerontology as a specific grant-supported category in 1952. This was by the National Heart Institute with identification of five gerontology project grants totaling $67,442 (not to be confused with 5 center grants awarded by NIH later in that decade). This represented \°/o of the National Heart Institute grant commitments. Gerontology grant activity grew during the following decade, involving, but not limited to, support from the Division of 'I am grateful to Mrs. Helen Walter and her staff, Statistical and Analysis Section, N1CHD, for data compilation and presentation. 'National Institute on Aging, NIH, Bethesda, MD 20014.

General Medical Sciences (now National Institute of General Medical Sciences), the National Institute of Mental Health, and continued National Heart Institute support. The program on aging became more visible by incorporation into the National Institute of Child Health and Human Development (NICHD) at its establishment in 1963, being organized as the Adult Development and Aging Branch (ADAB). ADAB staff and program were transferred to the NIA on July 1, 1975. The support of aging research per se (in contrast, to support for the training of investigators), has been by way of the project grant and program project grant mechanisms. A third research support mechanism introduced by the NIA this year is the special research award program. The project grant is the award mechanism most used by NIH grantees. The application usually reflects the focus of the principal investigator on a single problem implemented through a single discipline. The program project application, in contrast, represents a concerted effort by perhaps three or more investigators combining diverse disciplinary backgrounds to consider a set of problems or experimental systems. The special research awards program is designed to encourage and assist newly trained investigators to remain active in research during the formative stages of their careers. The special research awards program is commonly known as the small grants program. 696

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Most NIH support of research on aging has been in the area of the biomedical sciences, followed by behavioral and social sciences. Research project and program project grants are the primary mechanisms available to the NIA for support of research on aging. The grant process for aging research begins with preparation and review at the applicant institution. The process of review at NIH proceeds from referral to an initial review group for peer review and NIA for possible funding, NIA staff review, the National Advisory Council on Aging review, and concludes with NIA funding action. The primary mode of applicant appeal of a negative decision by NIA on an application is reapplication.

NIA RESEARCH GRANT SUPPORT

vance to program objectives. Although details of grant review award processes have changed through time within NIH and, further, differ between the Institutes, there remains a consistent adherance to these principles. Described here are the processes of grant application, review, and award specifically as they apply to the NIA. Grant support of aging research prior to the establishment of the NIA is discussed, as are other considerations which affect existing and future NIA grant funding policy. THE RESEARCH GRANT PROCESS

The process of grant application, review and award is outlined in Table 1. The preparation of the application is the responsibility of the principal investigator, although it is often carried out with co-investigators in the case of the project grant application and necessarily so in the case of the program project application. Standard forms (NIH 398) and presentation of material are required of the applicant by NIH. Application kits and copies of the Public Health Service Grants Policy Statement are routinely supplied most grantee institutions; they are otherwise available by writing or phoning the Grants Inquiries Office, Division of Re-

Table 1. National Institute on Aging, NIH, The Research Grant Process.

I II

APPLICATION PREPARATION PARENT INSTITUTION REVIEW

1. concept development, 2. communication with NIA staff (optional), 3. selection of grant mechanism, 4. drafting and review of application. J ~ 1 . time and resources commitment, 2. academic review, 3. business office review, ~|_4. official offici endorsement.

III

FORMAL SUBMISSION TO NIH

1. formal copies in self-addressed envelope to DRG, 2. informal copy to NIA staff (optional).

IV

REFERRAL

1. DRG referral office: assignment to a) review cycle by Advisory Council meeting date, b) initial review group, c) NIA (or other funding agency), 2. NIA rejection if inappropriate to mission.

V

EVALUATION BY INITIAL REVIEW GROUP

1. project grant application reviewed by DRG Study Section, program project grant applications reviewed by the NIA Aging Research Committee, 2. executive secretary of review group assigns primary reviewers, 3. site visit conducted if indicated, 4. merit recommendations given or action deferred, 5. summary statement prepared for NIA.

VI

REVIEW BY NIA

VII VIII

AWARD STATUS COMMUNICATION TO APPLICANT POST REVIEW ACTION

[

1. program review of applications and IRG action, 2. management review for fiscal conformance, 3. staff recommendation to Advisory Council, 4. Advisory policy confc on program relevance and funding status. Council action acti 1. statement of a) award, b) uncertain funding, c) not fundable, d) deferred, e) disapproval; 2. critique statement to applicant if requested.

J~1. possible budget modification, 2. recycling to IV, V, or VI if deferred, 3. appeal (_of Advisory Council action: submission of revised application.

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Within the NIA, these awards will provide support for meritorious research projects in the behavioral, biomedical, and social sciences related to aging. Applications are reviewed by the same process as project grant applications. Awards are made for a nonrenewable period of up to 3 years, but must be submitted within 6 years of award of doctoral degree (renewals will be considered as competing continuations in the regular research grant category). Direct costs, i.e., costs exclusive of institutional overhead allowance, may not exceed $12,000 per year. The award is limited to cost of equipment, supplies, travel to one related-research meeting per year, and up to 50% salary support for technical personnel. The principles implicit in the policies of NIH research grant programs are: (1) ideas and competencies for health research are to be found among the practicing researchers in the scientific community at large; (2) the public investment in health-oriented research is well-served through short-term grant awards in response to requests from these scientists; and, (3) a key to selection of scientists to receive grant support is competitive peer evaluation of the relative merit of applications; a second major factor is rele-

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proposals (not "wordy") are preferred by reviewers. All aspects of the proposed study should be presented in as concise a manner as possible. Human and animal subjects of experiments are protected from undue risk by local institution policy, NIH guidelines, and Federal law. These matters should be thoroughly understood and met as applicable at early stages of experiment design. Safeguarding the rights and welfare of human subjects involved in activities supported by NIH grants is the responsibility of the grantee institution (for guidelines see: DHEW Publication No. (NIH) 72-102, Institutional Guide to DHEW Policy on Protection of Human Subjects). The responsibility for determining the adequacy of proposed procedures is shared by NIH staff and advisory committees. Human fetal research proposals undergo an additional advisory board review at NIH. A similar situation pertains for warmblooded animals used in research. Compliance with applicable portions of the Animal Welfare Act (PL 89-544 as amended) and DHEW Publication No. (NIH) 73-23, Guide for the Care and Use of Laboratory Animals, is required. The protection of human and animal subjects of research is a rapidly evolving subject, requiring timely information from an investigator. Written and/or phone inquiries for pertinent documents (including those identified above), consultation and clarification of issues are encouraged. Address these matters to NIA program staff or the Office for Protection from Research Risks, Office of the Director, NIH. Similarly, local authorities should be consulted, as the ethical review at grantee institutions is rapidly emerging as a major component of experiment review. Since grant awards are usually made to institutions, with the principal investigator (P.I.) having specific responsibilities to the parent institution and the NIH, local institutional policies and regulations should be considered prior to writing an application. As NIH review cycles are coordinated with deadlines for receipt of applications, applicants should anticipate the time required for formal clearance at the parent institution. An informal, critical review of the draft application solicited from peers, by the applicant, may strengthen the final proposal. Such consultation should not include initial re-

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search Grants, NIH. It may prove useful to the applicant to know the membership of the initial review group likely to receive the application and the mission and program emphasis of the institute anticipated to be responsible for the application. The composition and charge of initial review groups, as is true of all NIH public advisory groups, are published biannually in NIH Public Advisory Groups (available at local institutional libraries or from the Division of Public Information, Office of the Director, NIH). Institute policy and program emphasis are available directly from the NIA and other NIH Institutes. Changes in NIH or NIA policy and announcements of program activities are published routinely in the NIH Guide for Grants and Contracts. Institutional offices and/or individuals may be put on the mailing list for the NIH Guide by phoning or writing the Grants and Contract Guide Distribution Center, Division of Research Grants, NIH. The grant application kit provides detailed instructions and a checklist to facilitate compliance with requirements. In the body of the application, under a description of the research plan, the applicant provides an introduction (objective, background, rationale and progress report for renewal and supplemental applications), specific aims, methods of procedure, significance, a facilities statement and collaborative arrangements, if any. A succinct presentation of theoretical framework for the proposed research is useful. Experimental procedures should be detailed, the sequence of proposed research clear, expectations of what will be achieved in the requested period realistic, the ability of the applicant to conduct the studies evident, and the supporting facilities and resources adequate. The statement of significance of proposed research should be written with attention to the health mandate of NIH. The budget should not anticipate Federal funding postures or possible reductions, but rather be an accurate and well-justified reflection of projected costs for the proposed research. Inadequate budget representation can defeat a proposal as readily as an inflated budget. Up to 5 years of support may be requested. Three-year awards are common for project grants, 5-year awards for program project grants. There is no prescribed length for an application; however, it is apparent that thorough and detailed

NIA RESEARCH GRANT SUPPORT

staff for assignment to NIA if not perceived in conflict with referral guidelines. This staff request to the Division of Research Grants that the NIA is awaiting receipt of an application is a formal procedure which must be accomplished prior to receipt of the application at NIH. For this reason an applicant for support in aging research should consider contacting NIA staff at least a month in advance of submission. The referral officer determines the grant mechanism appropriate to an application and thus has final authority on designation as program project or project grant. Usually, this is consistent with NIA and applicant expectations, but reversals of grant type have been made. The NIA has an opportunity to decline an application if the staff determines the referral was in error and the application not consistent with NIA mandate. The application is first reviewed by an initial review group composed of the applicant's scientific peers. In the case of the project grant and special research award applications, the review will be by one of 54 established study sections within the Division of Research Grants. Program project applications are reviewed by the Aging Research Committee of NIA. The peer membership of the initial review group reflects appointment recommendations made by the staff of the respective institute or division, that is, the Division of Research Grants for the study sections and NIA for the Aging Research Committee. These recommendations are subject to the approval of the Director, NIH. Candidates for these appointments are selected to achieve the required breadth of expertise for the charge to each review group and to maintain a high standard of scientific excellence. Appointments are for 4 years and staggered within each group to enhance continuity. Expanded competence of the initial review group to accommodate special review needs indicated by an application are generally accomplished by use of ad hoc reviewers. This is almost always necessary for reviews of program projects conducted by the Aging Research Committee. An initial review group is administered by an executive secretary, an NIH professional staff member. The executive secretary assigns primary, often secondary, and alternate reviewers to a given application. All applications are mailed to all initial review group members for study prior to their meeting. The executive sec-

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view group and National Advisory Council on Aging members to preclude subsequent conflict of interest at review meetings. NIA staff can be contacted for advice on procedures, policy, and matters such as availability of special resources (cultured-cell banks, rodent and primate colonies, etc.). Although staff consultation may assist an applicant in application development, it is not necessary for project or small grant applicants, nor can rapport, per se, place an applicant in a favored position for funding. On the other hand, although unsolicited program projects are accepted for review, applicants are urged to undertake in-depth discussions with NIA staff at the earliest possible time if a program project application is under consideration. Consultation with NIA staff will enable the project grant applicant to determine the acceptability of the intended proposal prior to submission, and if the concept appears acceptable, enables the staff to request of the Division of Research Grants that the proposal be assigned to the NIA. The application, upon completion, is submitted by the applicant's institution and sent with six copies to the Division of Research Grants using a pre-addressed label contained in the application kit. Applications from foreign institutions follow the same procedure as described for domestic applications; however, foreign awards are made on an exceptional basis justified by level of excellence and relevance to mandate. Under exceptional circumstances an award can be made to an individual. If such a situation is anticipated, early negotiations to that end should be opened by the applicant with NIA. Grant applications are logged in at the Division of Research Grants and acted upon by the referral officer and deputies. There are currently three full-time referral officers; these officers are assisted by nine executive secretaries of NIH study sections and four officers from non-NIH agencies serviced by the Division of Research Grants referral and/or review. The Referral Branch of this Division has three key functions: (1) screening of all applications for conformity to NIH policy and mandate, (2) grant assignment to an initial review group to assess the scientific merit of the proposal, and (3) assignment to an institute, e.g., NIA, for funding consideration and Advisory Council action. The referral officers will meet requests of NIA

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visit and are often joined by three or more ad hoc site visitors. Following a site visit, a report is prepared for consideration by the parent group. The action by the initial review group is a recommendation to the NIA and the National Advisory Council on Aging. A summary statement of the review deliberations and actions is communicated to NIA staff for presentation to the Advisory Council. The summary statement, because of color-coded paper, is widely referred to as the "pink sheet." It is a key document used by the Advisory Council as a basis for its recommendation and the NIA staff for funding action. It also provides the basis for staff communication of the application critique to the applicant. The recommendation and the application are reviewed for conformance to policy and NIA program as well as for conformance to fiscal criteria of the NIH. The NIA staff prepares a recommendation regarding the application and the initial review for use by the Advisory Council. This recommendation usually is in concurrence with the initial review; however, the NIA staff may recommend to raise or lower an application in the funding sequence because of higher or lower program relevance. The Advisory Council may independently advise a change in funding sequence on the basis of program relevance. A disapproved proposal can be returned to the Division of Research Grants for reconsideration, perhaps by a different study section in the event staff or the Advisory Council wishes reconsideration of an initial review group action. Initial review group recommendations are usually not reversed by an Advisory Council, rather under these circumstances they are returned with comment for reconsideration. The National Advisory Council on Aging is a body established by law to, among other duties, take action enabling grant awards (PL 93-296). For an NIA grant award to be made, it must have Advisory Council approval. The Advisory Council can act on applications to (1) approve for funding and recommend relative funding status, (2) disapprove, or (3) defer for additional information on which to base a decision. The funding of approved applications is dependent upon availability of NIA grant monies and relevance of individual proposals to NIA programs. Although some new awards are often made after each Advisory Council meeting,

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retary may solicit additional opinions by mail at the request of a group member. The number and complexity of applications is such that a significant commitment of total annual productivity is required of the participating scientist for grant review. At the initial review group meeting, the primary and secondary reviewers submit written notes or verbally report on the application. These statements usually contribute to the official summary statement representing the deliberations of the group, but, written notes are not maintained as part of the official documentation. At the group meeting, an application is presented and critiqued by the primary and secondary reviewers, then discussed by the full membership. If mail reviews have been solicited, they are read; if ad hoc consultants are present they are heard. NIA staff are available to discuss Institute policy. The initial review group votes to approve, disapprove, or defer the application. For an approved application, each member of the initial review group, in private, assigns a priority rating to the application. These assigned ratings are averaged by the executive secretary, with an optimum score represented by 100 and a minimal score represented by 499 (a score of 500 is equivalent to disapproval). The average of all the scores is applied to the application. For study section actions, the individual priority scores are statistically adjusted to achieve a statistical normalization of distribution of scores for each study section. Thus a study section predominantly scoring applications in the low (i.e., excellent) range would have those scores redistributed to accommodate the full possible range of 100-499. The initial review group recommendation on an approved application may include budget modification and/or modification from total award period requested. Such adjustments in time and amount of an award are usually, but not always, downward. Inadequately justified personnel slots and major equipment items are usually recommended for deletion. Deferral is recommended when more information is required, a situation which may call for a site visit to the applicant. With Aging Research Committee reviews of program projects, a site visit is almost always necessary to the review and is conducted prior to the formal committee meeting. Normally two or three members of the Aging Research Committee participate on a site

NIA RESEARCH GRANT SUPPORT

Table 2. NIH Grant Application Review Schedule. Advisory Council actions are announced 1 or 2 weeks after the meetings. Application Receipt Deadline

Feb \y

Mar 1-2/

Initial Review Group Meeting

June

National Advisory Council Meeting

Earliest Possible Funding

Sep (weeks 3-4)

Dec 1

Oct (weeks 1-2) Jun 1-1^ Jul 1-2/

Jan (week 4)

Nov (weeks 1-3)

Feb (week 1)

Feb (week 4)

May (weeks 3-4)

Apr 1

Jul 1

Mar (weeks 1-3)

'Receipt deadline for competing renewals of all grant types, new and supplemental program project and center grant applications. 'Receipt deadline for new and supplemental research project grant and small grant applications.

many approved applicants are advised of an uncertain funding status. When an approved application will clearly not be funded, the applicant is advised that the NIA has inactivated the application. NIH policy is to inactivate all approved, but not funded applications early in the fiscal year following that in which the applicant requested a starting date. The grant review deliberations of initial review groups and advisory councils are recognized as privileged (Title 5, U.S. Code 552(b) and Sec. 10(d) of PL 92-463) and therefore closed to the public. The portions of these meetings open to the public are announced in the Federal Register. Advisory Council meetings accommodating the Federal fiscal year of 1 October through 30 September are planned for September-October, January-February, and May (Table 2). The initial review group meeting is held 3 or 4 mo. in advance of a given Advisory Council meeting. Project and small grant applications received by the deadlines of the first of November, March, or July will have results announced by the following June, October, or February, respectively. Deadlines for receipt of program project applications and competing renewals of project grants are the first of October, February, and June. The Referral Office, Division of Research Grants, has the only authority to consider requests for waiver of an application deadline. If a deadline waiver is sought, the applicant is to submit a

letter with the application (in the same package) requesting the receipt date be waived. This letter should explain (a) why the application is late, and (b) what hardships will be imposed if the review is delayed until the next cycle. The earliest possible funding date for an application is approximately 2 mo. following council action. Shortly after an Advisory Council meeting, the applicant receives a status letter announcing the Advisory Council action. A critique letter reporting the combined actions of the initial review group and the Advisory Council is sent to the applicant on request. This is a routine procedure, welcomed by program staff, and usually of value to the applicant. Unfunded applicants who reapply for support will usually benefit from a consideration of the NIA critique of earlier proposals. A letter or phone call to the NIA or program staff from the applicant enables release of the critique. Awarded applications may be subjected to budget modification. Administrative increases can be made to accommodate unusual circumstances of the applicant. In other situations, negotiated or formula-based decreases accommodate fiscal constraints of the NIA. Grants approved for funding for more than 1 year are usually funded on a yearly basis. NIA recognizes a commitment to fund the applicant for an entire award period, although the annual funding is dependent upon the annual appropriations of Congress. A deferred application may be returned to the Division of Research Grants, if appropriateness of initial review group is in question, or if initial review is at variance with Advisory Council opinion. Program projects may be returned to the Aging Research Committee for additional review, or to the NIA staff if some special action is considered necessary. Occasionally a site visit by the Advisory Council is appropriate to achieve a sound basis for decision. The appeal procedure for the applicant who takes issue with the Advisory Council's action is to submit a revised application for a subsequent review cycle. Investigators with an active grant award may seek additional support for the existing project through a supplementary application, support for a separate project with a new application, and support to continue the existing grant beyond scheduled termination through a competing renewal. The scheduling of a competing

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Oct 1 - ^ Nov 1 ^ /

Oct (week 4)

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2,000 | -

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Constant Dollars



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FISCAL YEAR

Fig. 1. Grant and contract funds obligated by NIH, NICHD, and ADAB, FY 1967-1975. Note that these figures are also presented in constant dollars to facilitate distinction between actual growth and dollar inflation. The deflation factor for constant dollar presentation was obtained from "NIH Biomedical Research Deflator Series." 5 iProgram Projects

A.

A PERSPECTIVE OF AGING RESEARCH GRANT SUPPORT

The relationship of NIH to the health research community is a dynamic one reflecting internal NIH policy and procedure modifications, DHEW actions, and Congressional actions through laws of budget appropriation and the establishment or modification of funding institutes. Since the establishment of the first categorical Institute (the National Cancer Institute) in 1938, there has been dramatic growth of study sections and Institutes. The progressive establishment of Institutes at NIH reflects a commitment on the part of Congress for an increased emphasis on research on problems identified with each agency. To be successful, this commitment must be expressed through the grant funding capacity of the Institute. The increase in study sections, necessary to cover the required disciplines represented in grant applications and to accommodate an expanding workload, also has a bearing on the accessibility to funds within a discipline. This latter concept can be appreciated if each study sec-

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Report from the National Institute on Aging: the research grant support mechanism.

Journal of Gerontology 1976, Vol. 31, No. 6,696-704 Report from the National Institute on Aging: The Research Grant Support Mechanism1 Donald G. Murp...
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