[Federal Register Volume 59, Number 116 (Friday, June 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14857]
[[Page Unknown]]
[Federal Register: June 17, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Research Program Grants Application
Announcement
AGENCY: Indian Health Service, HHS.
ACTION: Notice of final funding emphases for competitive grant
applications for the Indian Health Service (IHS) Research Program.
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SUMMARY: The IHS announces the final funding emphases for fiscal year
(FY) 1995 IHS Research Program authorized by Section 208 of the Indian
Health Care Improvement Act, as amended, 25 U.S.C. 1621g. There will be
only one funding cycle during FY 1995. Grants shall be administered in
accordance with applicable Office of Management and Budget (OMB)
Circulars and HHS polices.
This program is described at 93.905 in the Catalog of Federal
Domestic Assistance. Executive Order 12372 requiring intergovernmental
review is not applicable to this program.
General Program Goals
1. To support practice and community-based research projects likely
to improve the health of American Indians and Alaska Natives (AI/AN)
served by the IHS. Projects that are basic science or laboratory
research are not considered as conforming to the program goals, and
will be returned to the applicant.
2. To develop research skills among IHS and tribal health
professional. The applicant, as the direct and primary recipient of PHS
funds, must perform a substantive role in carrying out project
activities and not merely serve as a conduit for an award to another
party, or to provide funds to another party.
3. These grants will be awarded and administered in accordance with
the published program announcement in the Federal Register of March 18,
1994 (59 FR 12964) and the Indian Health Care Improvement Act, as
amended, 25 U.S.C. 1621g.
Research Funding Emphases
Proposed funding emphases were published in the Federal Register of
March 18, 1994 (59 FR 12964) for public comment. No comments were
received during the 30-day comment period. Therefore, as proposed, the
following funding emphases will be retained as listed below.
1. Studies of documented high importance to the community in which
the research is to be done.
2. Studies with high relevance for the AI/AN populations. (The
series ``The Research Agenda for Indian Health'' in the IHS Primary
Care Provider, lists many relevant research subjects. Reprints are
available from the IHS Research Program and the Area Research Offices.)
3. For studies that involve problems that are both social and
medical (e.g, dysfunctional families), research on factors that enable
the community or individuals to overcome the problems.
4. Competing continuations of previously-funded research projects.
Review Process
Applications meeting eligibility requirements that are complete and
conform to the published program announcement in the Federal Register
of March 18, 1994 (59 FR 12964) will be reviewed in accordance with the
following process.
1. Review by authorized Institutional Review Boards (IRB). All
applications involving human subjects will be reviewed by the
authorized Area or National IRBs in the IHS for compliance with
requirements to protect human subjects contained in 45 CFR 46, and as
specified in the IHS Multiple Project Assurance (MPA). It is suggested
but not required that the application be sent to the appropriate Area
IRB(s) two months before the deadline, for the IRB review of the
proposal to permit making the changes before the final submission. The
IRB will review only IRB issues, not purely technical methods. Any
applications involving investigators from institutions with IRBs with
MPAs and involving human subjects must also be reviewed by the IRBs of
the respective institution(s). The researcher should contact non-IHS
IRBs for their deadline requirements. No research project can be funded
by IHS unless it has been approved by, and has met the conditions of,
all applicable IRBs.
2. Review by the Indian Health Research Study Section (IHRSS).
Applications meeting eligibility requirements that are complete,
responsive, and conform to this program announcement will be reviewed
for merit by the IHRSS appointed by the IHS to review these
applications. The IHRSS review will be conducted in accordance with the
IHS objective review procedures. The technical review process ensures
selection of quality research projects in a national competition for
limited funding. The IHRSS will include at least 60 percent non-IHS,
Federal or non-Federal, individuals, all experts in research. For each
application, the IHRSS will decide to disapprove, or to defer pending
more information, or to approve the project. If the IHRSS decides to
approve the project, it will review the application against established
criteria, and will assign a numerical score to the application. The
members of the IHRSS will use the following criteria and weights to
make the score.
Weights
(Criteria ``a'' through ``f'' refer to section I. Research Plan.)
4a. Specific Aims: Statement of study question(s) and objective(s).
Are the study questions stated clearly and precisely? Does the rest
of the Research Plan follow logically from the study questions?
10b. Background in Research Literature. Does the background in
research literature include the important existing research and
knowledge relevant to the study question(s), and pilot data (if
applicable)? Do the conclusions follow from the review?
4c. Progress Report (for competing continuation studies, only).
What is the progress to date? Is the report timely? Does the progress
report demonstrate that investigators will achieve the objective(s) of
the research?
15d. Research design and methods to be used. Does the Research Plan
adequately describe the research design? Is the proposed approach
appropriate for the objective9s) of the research? Does the Plan
adequately describe: the population to be studied; the inclusion and
exclusion criteria, and how the investigators will determine inclusion
and exclusion; the sampling techniques; selection of controls (if any);
the definition of the independent and dependent variables (if any) and
how to measure them; the interventions (if any) and how to assure that
they are done in fact; and the definition of the expected outcomes or
effects (if any) and how to measure them? Are these methods appropriate
to achieve the objective(s) of the research? Are sample size
calculations included, if needed? Is the projected sample size
achievable, and sufficient to achieve the objective(s) of the research?
Does the Plan adequately account for alternative explanations of
expected findings? If the application's timeline, with completion dates
of all major tasks, appropriate and feasible?
10e. Data sources, management, quality control, and analysis. Does
the Research Plan adequately describe: the data to be collected, by
whom, and at what time; the data sources, and how access to the sources
will be attained; the procedures to collect, receive, code, and prepare
for analysis of the data; the contents of interviews (if they are to be
done), and the connection between the interview question and the
variables to be studied; how the data will be made secure; how
completeness of the data will be assured and low response rates dealt
with; how accuracy of the data will be measured and assured; the plan
for analysis; the statistical analyses to be done (if any); and the
non-statistical analyses to be done (if any)? Are these plans
appropriate and adequate for the research questions?
4f. Originality. Will this research likely develop new methods, or
directly lead to new information, useful for research in general?
(Criteria ``g'' through ``k'' refer to section J. Importance and
Utility.)
10g. Importance of the health problem(s) for the community(ies)
involved. Are the health problems addressed by the research project of
high importance in the community(ies) involved?
9h. Importance of the health problem(s) for all AI/AN people and
the IHS Area. Are the health problems addressed by the research project
of high importance in all or major segments of AI/AN people, and in the
IHS Area?
4i. Setting of the study. Should the research be done only, or be
done best, in an AI/AN population, and in the proposed community(ies)?
10J. Utility of the product and experience to the community(ies)
and Service Units (SUs) involved.
Does the research project have a high expected utility of the product
(e.g., new information) or of the experience (e.g., new research
skills, capabilities, resources, or liaisons to do practice-based or
community-based research) to the community(ies) and/or SUs involved?
5 k. Utility of the product and experience to the IHS and other AI/
AN people. Does the research project have a high expected utility of
the product (e.g., new information) or of the experience (e.g., new
research skills, capabilities, resources, or liaisons to do practice-
based or community-based research) to the IHS, to the IHS Area, and/or
to other AI/AN people?
5 1. Budget. (This criterion refers to section G. Budget.) Is the
proposed budget sufficient to do the project? Is the proposed budget
excessive? Is the proposed budget being used for the purchase of
computers or other expensive equipment? If the research project is a
competing continuation, are the additional years necessary? Is the cost
justified by the expected benefit?
10 m. Key Personnel and Research Team. (This criterion refers to
section H. Key Personnel and Research Team.) Does the principal
investigator have the training, experience, and time necessary to do
and to manage the proposed research projects? Does the research team
have the capabilities to carry out and complete the project
successfully?
FOR FURTHER INFORMATION CONTACT: William L. Freeman, M.D., Director,
IHS Research Program or Donna Pexa, Research Program Coordinator,
Office of Health Program Research and Development, 7900 South J. Stock
Road, Tucson, AZ 85746-9352, (602) 295-2503.
This program is described at 93.905 in the Catalog of Federal
Domestic Assistance. Executive Order 12372 requiring intergovernmental
review is not applicable to this program.
Dated: June 13, 1994.
Michel E. Lincoln,
Acting Director.
[FR Doc. 94-14857 Filed 6-16-94; 8:45 am]
BILLING CODE 4160-16-M
