Full Text HS-94-004

FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION AWARD

NIH GUIDE, Volume 22, Number 40, November 5, 1993

RFA:  HS-94-004

P.T. 34

Keywords: 
  Health Services Delivery 


Agency for Health Care Policy and Research

Application Receipt Date:  March 11, 1994

PURPOSE

The Agency for Health Care Policy and Research (AHCPR) announces the
availability of the First Independent Research Support and Transition
(FIRST) Award (R29) in health services research.  The purpose of the
FIRST Award is to provide a sufficient period of research support for
newly independent health services researchers to initiate their own
research and demonstrate independent investigative efforts; to
provide a reasonable opportunity to demonstrate creativity,
productivity, and further promise; and to help in the transition to
traditional types of AHCPR research project grants.  The award is not
intended for established investigators who may be in transition to
another endeavor.  A FIRST Award is for a distinct research endeavor
and may not be used merely to supplement or broaden an ongoing
project at the applicant institution.  FIRST Awards are intended to
provide funds for newly independent investigators for five years
during which time they can establish their own research program and
make significant and innovative contributions to health services
research.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  The AHCPR
urges applicants to submit grant applications with relevance to the
specific objectives of this initiative.  Potential applicants may
obtain a copy of Healthy People 2000 (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone: 202/783-3238).

ELIGIBILITY

To be eligible for a FIRST Award, the proposed Principal Investigator
(PI) must be genuinely independent of a mentor yet at the same time
must be at the beginning stages of his or her research career with,
in most instances, no more than five years research experience since
completing postdoctoral research training or its equivalent.  If the
applicant is in the final stages of such training, it is permissible
to apply, but no FIRST Award will be made to persons in training
status.  In addition, the proposed PI must otherwise be eligible to
serve in the same capacity on a traditional research project grant
(R01) awarded to the applicant institution.  Only non-profit domestic
institutions and organizations are eligible to receive FIRST Awards.

The applicant investigator must never have been designated previously
as PI on any PHS-supported research project OTHER THAN a PHS small
grant (R03), an Academic Research Enhancement Award (R15), or certain
career development awards (K series) directed principally to
physicians, dentists, or other clinicians with little research
experience.  (Current or past Research Career Development Awardees
are not eligible.)  Subproject leaders on multicomponent PHS awards
such as Program Project grants (P01), Center grants (P50), or
Minority Biomedical Research Support grants (S06) may also be
eligible, depending on their stage of career development; however,
potential applicants in these categories are urged to contact AHCPR
prior to filing an application.

MECHANISM OF SUPPORT

This Request for Applications (RFA) represents the initial use of the
First Independent Research Support and Transition (FIRST) Award (R29)
by AHCPR.  See SPECIAL REQUIREMENTS, below, for details of this
mechanism.

FUNDS AVAILABLE

The AHCPR expects to fund approximately three FIRST Awards in Fiscal
Year (FY) 1994.  The actual number awarded in FY 94 will depend on
availability of funds as will the number in future years.

RESEARCH OBJECTIVES

The AHCPR conducts and supports research on the quality,
appropriateness, efficiency, and effectiveness of health care
services and the systems for delivery of these services.  Research
areas of interest for FIRST applications are as follows:

o  Health care reform issues;
o  Health care costs and financing;
o  Relationship between primary care and health care costs, access,
and quality;
o  Rural health including access to services, supply of health
professionals, delivery systems issues, primary health care, health
promotion and disease prevention, technology diffusion, and special
populations;
o  Health care quality improvement and quality assurance including
methods and measures;
o  Information technologies and factors affecting their use;
o  Costs and quality of alternative delivery systems and managed
care;
o  Health care technologies, facilities, and equipment;
o  Medical effectiveness and patient outcomes research;
o  Medical liability and malpractice;
o  Access, medical effectiveness, and patient outcomes research in
low-income, minority, elderly, and other underserved populations;
o  Dissemination of health and clinical information and research
findings to practitioners, consumers, and patients for use in
improved health care decisionmaking;
o  Services for persons with human immunodeficiency virus (HIV) and
acquired immunodeficiency syndrome (AIDS); and
o  Evaluation of outcomes associated with the use of clinical
practice guidelines.

The following announcements, which were published in the NIH Guide
for Grants and Contracts, provide more detailed information on
selected areas of interest:  "Health Services for Persons with HIV
Infection" (PA-93-110), Vol. 22, No. 33, September 17, 1993; "Health
Care Quality Improvement and Quality Assurance Research" (PA-93-084),
Vol. 22, No. 19, May 21, 1993; "Primary Care and Health Care Reform"
(PA-93-063), Vol. 22, No. 10, March 12, 1993; "Cost and Financing
Issues in Health Care Reform" (PA-93-45), Vol. 22, No. 4, Jan. 29,
1993; "Health Services Research on Rural Health" (PA-92-71), Vol. 21,
No. 16, May 1, 1992; and "Effective Dissemination of Health and
Clinical Information and Research Findings" (PA-92-51), Vol 21, No.
10, March 13, 1992.

STUDY POPULATIONS

SPECIAL INSTRUCTION TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND
MINORITIES IN RESEARCH STUDY POPULATIONS

The AHCPR requires all applicants for research grants to include
minorities and women in study populations so that research findings
can be of benefit to all persons at risk of the disease, disorder, or
condition under study.  Special emphasis must be placed on the need
to include minorities and women in studies of diseases, disorders,
and conditions that disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in research, a
clear and compelling rationale should be provided.  AHCPR will not
award grants for applications which do not comply.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing the research
design and sample size appropriate for the scientific objectives of
the study. This information should be included in the form PHS 398 in
sections 1 to 4 of the Research Plan and summarized in section 5,
Human Subjects (or in the Program Narrative section of form PHS 5161
for State and local governments).

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
AHCPR recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of U.S.
racial/ethnic minority populations (i.e., Native Americans,
Asian/Pacific Islanders, African Americans, and Hispanics).  Where
appropriate, the applicant must provide the rationale for studies on
single minority population groups.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed and the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

This policy applies to all AHCPR research grants.  The AHCPR will not
award grants for applications that do not comply.  If the application
does not contain the required information, it will be returned
without review.

SPECIAL REQUIREMENTS

An individual may submit only one FIRST Award application to the
Public Health Service (PHS) for the receipt date and may not submit
any other type of research grant application (including research
career applications), to the PHS during the applicable review cycle.
However, applications for an R03 and an R15 may be submitted to the
PHS simultaneously with a FIRST application provided they are on
separate topics.  Applications for other projects may be submitted
during the FIRST Award period, if the time and effort on the FIRST
Award are less than 100 percent.

FIRST Award applications must request five years of research support.
Applications submitted to AHCPR in which the request is for fewer
than five years of support will be designated R01s and so reviewed
unless the applicant withdraws the application.

The Principal Investigator must make a commitment of no less than 50
percent effort to the proposed project.  Up to 100 percent effort may
be requested if a greater commitment of the principal investigator is
required to do the research.  The request for effort of the applicant
investigator will be reviewed and modifications may be recommended.

The total direct cost award for the five-year period may not exceed
$350,000.  The direct cost award in any yearly budget period should
not exceed $100,000.  Indirect costs will be paid to the grantee
institution in accord with applicable policy of the Department of
Health and Human Services (DHHS).  FIRST Awards are not renewable.

Replacement of the PI on a FIRST Award will not be approved.
Transfer of the FIRST Award with the Principal Investigator to
another institution for the remaining performance period may be
requested.

APPLICATION PROCEDURES

The application receipt date is March 11, 1994.  The research grant
application form PHS 398 (rev. 9/91) is to be used, and the
applicants must provide relevant information on eligibility.  These
forms are available at most institutional offices of sponsored
research and the Office of Grants Information, Division of Research
Grants, National Institutes of Health, Westwood Building, Room 449,
Bethesda, MD 20892, telephone 301/710-0267.

Application page limitations apply to the Research Plan section of
the PHS 398 application form.  Sections 1-4 of the Research Plan, as
described on page 20 of the instructions for the PHS 398 (rev. 9/91),
are limited to a total of 25 pages, including tables and figures.
Applications exceeding the 25-page limitation will be returned.  If
appendix material is submitted, five collated sets must be included
with the application package.  Identify each of the five sets with
the name of the principal investigator and the project title.  This
material will not be routinely duplicated and will be used in a
limited way by members of the initial review group.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page of the application.  Failure
to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box in
2a must be marked.

Special care should be taken to thoroughly understand and carefully
address the matters of human subject certifications and assurances,
including issues related to gender and minority representation, as
described in the application form PHS 398 (especially pages 11-13,
21-23, and 25-26).  In the instructions for the PHS 398, "human
subject" is defined by regulations as "a living individual about whom
an investigator (whether professional or student) conducting research
obtains (1) data through intervention or interaction with the
individual or (2) identifiable private information."  The human
subject regulations encompass graphic, written, or recorded
information derived from individually identifiable human subjects.

The following is to be addressed in a letter or memorandum from a
suitable department head or dean and submitted with the application:
(1) eligibility of the proposed Principal Investigator to
independently lead a research project at the applicant institution,
is this person otherwise qualified to be the PI on a traditional
research project grant (R01)?; and (2) details of the intended
commitment of the institution to the project for the five-year
period.

In addition, three letters of reference for the proposed PI are
needed.  Reference letters must be submitted with the application.
Such letters are critically important and should reflect the
investigator's research originality and potential for independent
investigation.  When the application is from the institution where
the proposed PI received postdoctoral research training, it must be
made absolutely clear that the FIRST Award would be to support a
research endeavor independent of that conducted in the former
training environment.

FIRST applicants are to request the letters of reference well in
advance of the application submission, advising the referees to
return the reference letters to the applicant in sealed envelopes as
soon as possible.  To protect the utility and confidentiality of
reference letters, applicants should not open envelopes.  The sealed
envelopes must be attached to the front of the original applications.
Applications received without the three reference letters will be
returned to the applicant.  A list of individuals providing letters
of reference must be included in Section 10 of the Research Plan.
Provide the name, title, and institutional affiliation for each
person.

The completed, signed, original application and five legible copies
of form PHS 398; the letter or memorandum from the department head or
dean; and the three letters of reference must be sent or delivered
to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

Completed applications must be received by the Division of Research
Grants by March 11, 1994.  If an application is received after that
date, it will be returned to the applicant.

The following is the review schedule for FIRST applications:

Application Receipt Date:      March 11, 1994
Initial Review Date:           May/June 1994
Council Review Date:           September 1994
Earliest Possible Start Date:  September 30, 1994

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the Division of
Research Grants, NIH, for completeness and by AHCPR staff for
responsiveness to the RFA.  Incomplete and nonresponsive applications
will be returned to the applicant without further consideration.

Applications may be subject to triage to determine their scientific
merit relative to other applications received in response to this
RFA.  The AHCPR will withdraw from further competition those
applications judged by triage to be noncompetitive for award and
notify the Principal Investigator and institutional official.  Those
applications judged to be competitive will undergo further scientific
merit review.  Review results and funding decisions will be announced
approximately six months after the submission date.  Review criteria
are described below.

Review Criteria

Applications will be evaluated by an appropriate peer review group
convened by AHCPR in accordance with the criteria for scientific and
technical merit stated below, taking into consideration the
investigator's stage of development, merit of the proposed research,
the resources and environment, and the appropriateness of the
proposed budget.  Applications may be reviewed by the National
Advisory Council for Health Care Policy, Research, and Evaluation for
policy relevance and research value.

For a FIRST application, it is recognized that an investigator with
limited experience is less likely to be able to submit an application
with the breadth and depth of that submitted by an experienced
investigator.  Reviewers are expected to recognize that, in general,
less detail will be expected with regard to work planned for the
later years of the project, but the Principal Investigator should
outline the general plans for these years.

A FIRST application must provide clear evidence of the investigator's
ability to develop a plan for the research project.  The following
criteria will be used in evaluating the application for scientific
and technical merit:

Principal Investigator

o  Potential to carry out independent research;
o  Quality and extent of education, scientific training, and research
experience;
o  Evidence of research productivity, appropriate to the level of
experience;
o  Quality of any research publications; and
o  Commitment to a research career.

Research Design

o  Originality and significance of the research goals;
o  Appropriateness and significance of the research hypotheses;
o  Feasibility and adequacy of design and methodology; and
o  Availability of data and appropriateness of plans for organizing
the project and carrying out the data collection and analysis.

Resources and Environment

o  Availability of essential facilities and equipment, subject
populations, computer time, or other resources, as appropriate; and
o  Evidence of institutional commitment to the project.

Budget Appropriateness

o  Appropriateness of budget estimates in relation to aims and
methods; and
o  Appropriateness of period of support for carrying out the research
and for demonstrating the investigator's scientific abilities.

AWARD CRITERIA

The decision to fund an application will depend on the overall
scientific and technical merit of the proposal as determined by peer
review, program balance and relevance, and availability of funds.  In
very unusual circumstances, FIRST awards may be recommended by the
initial review group or the awarding component for periods of fewer
than five years.

INQUIRIES

Inquiries regarding programmatic issues may be directed to the
appropriate office listed below:

For applied dissemination research:

Center for Research Dissemination and Liaison
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 501
Rockville, MD  20852
Telephone:  (301) 594-1362

For medical effectiveness and outcomes research:

Center for Medical Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852
Telephone:  (301) 594-1485

For other AHCPR health services research:

Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852
Telephone:  (301) 594-1349, Ext. 104

Direct inquiries regarding fiscal/administrative matters to:

Ralph Sloat, Grants Management Officer
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 594-1447

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.180 and 93.226.  Awards are authorized under the
Public Health Service Act, Title IX, as amended by Public Laws
101-239 and 102-410, (42 U.S.C. 299-299c-6) and Section 1142 of the
Social Security Act (42 U.S.C. 1320b-12).  Awards are administered
under the PHS Grants Policy Statement and Federal Regulations 42 CFR
Part 67, Subpart A and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order
12372.

.

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