[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