[Federal Register Volume 59, Number 53 (Friday, March 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6384]


[[Page Unknown]]

[Federal Register: March 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
RIN 0905-ZA17

 

Indian Health Service Research Program; Grants Application 
Announcement

AGENCY: Indian Health Service, HHS.

ACTION: Notice of Competitive Grant and Cooperative Agreement 
Applications for the Indian Health Service (IHS) Research Program.

-----------------------------------------------------------------------

SUMMARY: The IHS announces that competitive applications for fiscal 
year (FY) 1995 are now being accepted for the 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 for FY 
1995. Grants and Cooperative Agreements shall be administered in 
accordance with applicable Office of Management and Budget (OMB) 
circulars and HHS policies. This program is within the Catalog of 
Federal Domestic Assistance Number 93.905. Executive Order 12372 
requiring intergovernmental review is not applicable to this program.
    The Administration's budget request for FY 1995 includes $300,000 
for the Indian Health Service Research Program. It is anticipated that 
$300,000 will be available to support approximately 15 competing awards 
averaging $20,000.
    This program announcement is subject to the appropriation of funds. 
This notice is being published early because awards to IHS components 
are made by special allotments which must be expended by September 30 
of the FY. Research awards must be issued early in each FY to allow 
researchers full use of funds.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of Healthy People 
2000, a PHS-led activity for setting priority areas. This program 
announcement is directly related to many priority areas, including 
nutrition, alcohol and other drugs, unintentional injuries, oral 
health, maternal and infant health, heart disease and stroke, cancer, 
diabetes and chronic disabling conditions, human immunodeficiency virus 
infection, sexually transmitted diseases, clinical preventive services, 
and surveillance and data systems. Potential applicants may obtain a 
copy of Healthy People 2000 (Full Report; Stock No. 017-001-00474-0) or 
Healthy People 2000 (Summary Report; Stock No. 017-001-00473-1) through 
the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325 (Telephone 202-783-3238).

DATES: 

    A. In accordance with OMB Circular A-102, Grants and Cooperative 
Agreements for State and Local Governments, interested parties are 
invited to comment on the proposed funding emphases. This comment 
period is 30 days; written comments received by April 18, 1994, will be 
considered before the final funding emphases are established. No funds 
will be allocated or selections made until a final notice is published 
stating what funding emphases will be applied. Written comments on the 
proposed funding emphases should be addressed to: William L. Freeman, 
M.D., Director, IHS Research Program, 5300 Homestead Road, NE., 
Albuquerque, NM 87110-1293. All comments received will be available for 
public inspection and copying at the above address, weekdays (except 
Federal holidays) between the hours of 7:30 a.m. and 4:30 p.m., 
Mountain Standard Time, beginning approximately 2 weeks after 
publication of this notice.
    B. A pre-application is due on or before April 18, 1994. The pre-
application is required of all applicants, including applicants for a 
competitive renewal. The purposes of the pre-application are: (1) To 
establish communications between the IHS and the applicant; (2) to 
determine the applicant's eligibility; and (3) to determine how well 
the project can compete with other similar pre-applications. The pre-
application will consist of: (1) the Standard Form 424 (cover sheet), 
sections 1., 2., 5., 6., 7., 8., 11., and 15.; (2) a Research Plan (see 
section I); and (3) the Importance and Utility section (see section J). 
In meeting this pre-application deadline, it is the researcher's 
responsibility to assure that Grants Management Branch, Division of 
Acquisition and Grants Operations, IHS, receives the original pre-
application and the appropriate IHS Research and Publication Committees 
(RPCs) simultaneously receive a copy of the pre-application. The RPCs 
will use the same review criteria as the Indian Health Research Study 
Section. The review criteria are discussed under Section M. Review 
Process, of this announcement. An applicant submitting a pre-
application may be declared ineligible to submit an application, based 
on the results of the pre-application review.
    C. An original and 2 copies of the completed final grant 
application must be received by the Grants Management Branch, Division 
of Acquisition and Grants Operations, IHS, suite 100, 12300 Twinbrook 
Parkway, Rockville, MD 20852, on or before June 30, 1994.
    Pre-applications and applications shall be considered as meeting 
the deadline if they are either: (1) Received on or before the deadline 
with hand carried applications received by close of business 5 p.m., or 
(2) postmarked on or before the deadline and received in time to be 
reviewed along with all other timely pre-applications and applications. 
A legibly dated receipt from a commercial carrier or the U.S. Postal 
Service will be accepted in lieu of a postmark. Private metered 
postmarks will not be accepted as proof of timely mailing.
    Pre-applications and applications received after the announced 
closing date(s) will not be considered for funding and will be returned 
to the applicant.

Additional Dates

    D. Pre-application Review Period: On or about April 18-May 18, 
1994.
    E. Comments on pre-application to applicants: On or about June 1, 
1994.
    F. Application Reviews: IHS Study Section: On or about September 
13-15, 1994.
    G. Applicants notified of results (approved, approved unfunded, or 
disapproved): On or about November 16, 1994.
    H. Earliest anticipated starting date: On or about December 1, 
1994.

FOR FURTHER INFORMATION CONTACT:

    A. Programmatic: Tina Dickerson, Assistant Research Program 
Coordinator, Office of Health Program Research and Development, 7900 
South J. Stock Road, Tucson, AZ 85746-9352, (602) 295-2501, or the 
following Area Research Coordinators:

------------------------------------------------------------------------
                                                    Research office:    
Indian health area offices, and states served   contact(s) and telephone
------------------------------------------------------------------------
Aberdeen Area Office, Federal Building,        Thomas Welty, M.D. (Rapid
 1154th Ave., SE., Aberdeen, SD 57401, North    City), (605) 348-1900   
 Dakota, South Dakota, Nebraska, Iowa.          Ext 401, FAX (605) 348- 
                                                8833.                   
Alaska Area Native Health Service, P.O. Box 7- David H. Barrett, M.D.,  
 741, Anchorage, AK 99501, Alaska.              (907) 257-1251 Ext. 263,
                                                FAX (907) 257-1781.     
Albuquerque Area Office, IHS, 505 Marquette    Gary Morigeau, (505) 766-
 NW., Suite 1502, Albuquerque, NM 87102, New    2544, FAX (505) 766-    
 Mexico, Colorado.                              2157.                   
Bemidji Area Office, IHS, 203 Federal          John L. Robinson, D.D.S.,
 Building, Bemidji, MN 56601, Minnesota,        (218) 759-3441, FAX     
 Michigan, Wisconsin.                           (218) 759-3511.         
Billings Area Office, IHS, P.O. Box 2143,      James D. Vesbach, D.D.S.,
 Billings, MT 59103, Montana, Wyoming.          (406) 657-6900, FAX     
                                                (406) 657-6333.         
California Area Office, IHS, 1825 Bell         John Yao, M.D., (916) 978-
 Street, Sacramento, CA 95825, California.      4202, Ext 107, FAX (916)
                                                978-4434.               
Nashville Area Office, IHS, 711 Stewarts       William Betts, Ph.D.,    
 Ferry Pike, Nashville, TN 37217,               (615) 736-2487, FAX     
 Mississippi, North Carolina, Florida, New      (615) 736-2391.         
 York, Maine, Rhode Island, Louisiana,                                  
 Massachusetts, Connecticut, Texas, Alabama.                            
Navajo Area Office, IHS, P.O. Box G, Window    Douglas G. Peter, M.D.,  
 Rock, AZ 86515, Navajo Reservation.            (602) 871-5811, FAX     
                                                (602) 871-5872.         
Oklahoma City Area Office, IHS, 3625 NW 56th   Clark Marquart, M.D.,    
 Street, Five Corporate Plaza, Oklahoma City,   (405) 945-6820, FAX     
 OK 73112, Oklahoma, Kansas, Texas.             (405) 945-6870.         
Phoenix Area Office IHS, 3738 N. 16th Street,  N. Burton Attico, M.D.,  
 Phoenix, AZ 85016, Arizona, Nevada, Utah.      (602) 640-2187, FAX     
                                                (602) 640-2137.         
Phoenix Indian Medical Center, 4212 N. 16th    Roy Teramoto, M.D., (602)
 Street, Phoenix, AZ 85016, Arizona (only       263-1551, FAX (602) 263-
 PIMC).                                         1648.                   
Portland Area Office, IHS, 2201 Sixth Avenue,  Ernest H. Kimball,       
 Room 300, Seattle, WA 98121, Washington,       M.P.H., (206) 615-2791, 
 Oregon, Idaho.                                 FAX (206) 615-2784.     
Office of Health Program, Research and         John Kittredge, M.D.,    
 Development, 7900 South J. Stock Road,         (602) 295-2406, FAX     
 Tucson, AZ 85746-9352, Southern Arizona.       (602) 295-2602.         
------------------------------------------------------------------------

    B. Grants and Business: M. Kay Carpentier, Grants Management 
Branch, Division of Acquisition and Grants Operations, IHS, suite 100, 
12300 Twinbrook Parkway, Rockville, MD 20852, (301) 443-5204. 
(Telephone calls to these numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: This announcement provides information on 
the general program goals, eligibility requirements, research emphases, 
availability of funds application process, and review process for the 
IHS Research Program for FY 1995.

A. 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 
professionals. 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.

B. Eligibility

    The grant application process affords Indian tribes and tribal 
organizations which have contracts with the IHS under the Indian Self-
Determination Act, 25 U.S.C. 450 et seq., an equal opportunity to 
compete with IHS components for research funds. Awards to tribal 
contractors will be made as grants or cooperative agreements. The IHS 
components will receive special allotments of funds to carry out 
approved research activities.

C. Research Emphases

    Grants or special allotments will be made under this announcement 
with special but not exclusive regard to the following IHS research 
emphases for FY 1995.
    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.

D. Fund Availability, Period of Support, and Funding Level

    Subject to the availability of FY 1995 funds, $300,000 will be 
available to support approximately 15 research grants to tribes and 
special allotments to IHS components and up to 5 demonstrative 
cooperative agreements to tribes. (Cooperative agreements are financial 
assistance awards that require the substantial programmatic involvement 
of the Federal Government. Specific programmatic involvement by the IHS 
in a project will be negotiated with an approved applicant before award 
of a cooperative agreement. This involvement will include the statement 
of the study question(s) and objective(s); the adequacy of the research 
literature; the research design and methods proposed; the management, 
quality control, and analysis of the data sources; the development of 
new methods and information; the importance of community involvement; 
the applicability of the research to AI/AN people; the budget 
sufficiency; and the adequacy of the principal investigator and 
research team.)
    The detail required in a research project application and funding 
needs for the project differ widely between experienced and 
inexperienced researchers. Therefore, we anticipate two levels of 
project application and funding. This will allow both the inexperienced 
and experienced researchers to apply for grants and to compete with 
others of similar expertise. The grant application must designate for 
which level the researcher is applying.
    (1) The first level is for a one year pilot research project. This 
level is for less experienced researchers and for less complex and 
detailed applications. A less experienced researcher is defined as an 
investigator who has never received a funded research award in his or 
her own right. The Research Plan and Importance & Utility sections of 
the pilot research project application should be of less detail and 
complexity than expected for the small grant research project 
application; only biographical sketches, not Curriculum Vitae, are 
required. The anticipated maximum funding for a pilot research project 
is $15,000.
    (2) The second level is for a small grant research project. This 
level is for more experienced researchers. A more experienced 
researcher is defined as an investigator who has received at least one 
funded research award in his or her own right. The Research Plan and 
Importance and Utility sections of the small grant research project 
application must be complete and discussed in detail. The small grant 
project application should be more complete, and have more detail and 
complexity, than the pilot research project application. The 
anticipated maximum funding for a small grant research project is 
$50,000 per year. The project may be planned for up to three years with 
a competing continuation application for each succeeding year.
    Research projects are normally funded for a 1 year project period. 
No cost extensions can be requested by the researcher to finish work 
that has encountered unanticipated delays. All applicants must compete 
annually; however, among applications of similar merit, priority will 
be given to applicants for a competing continuation of a previously-
funded research project. No projects may be funded for more than 3 
years.

E. The Complete Application

    The information collection requested in the narrative of the 
application is approved under OMB clearance #0937-0189. An IHS Research 
Grant Application Kit, including required form PHS 5161-1 (rev. 7/92), 
may be obtained from the Grants Management Branch, Division of 
Acquisition and Grants Operations, IHS, Twinbrook Metro Plaza, suite 
100, 12300 Twinbrook Parkway, Rockville, MD 20852, telephone (301) 443-
5204.
    All applications must include the following:

--Completed Standard Forms 424 and 424A.
--A one-page research project abstract. (See section F. Abstract, 
below.)
--A table of contents.
--A detailed budget for the project period. (See section G. Budget, 
below.)
--One-page biographical sketches of all key personnel. (See section H. 
Key Personnel and Research Team, below.)
--A research plan. (See section I. Research Plan, below.)
--A description of the health problems addressed by, and the utility 
of, the research. (See section J. Importance and Utility, below.)
--Documentation of approvals, support, and clearances. (See section K. 
Documentation of Approvals, Support, and Clearances, below.)
--A description of how human subjects, if any, are protected from 
research risks. (See section L. Protection of Human Subjects, below.)
--Appendices, to include:
--Resumes (Curriculum Vitae) of key personnel; and
--A list of all anticipated consultants, collaborators, and contractual 
agreements.

F. Abstract

    The abstract may not exceed one single-spaced typewritten page. It 
should summarize the application, and should answer the basic questions 
``who, what, when, where, how, and costs.'' The abstract should help 
the reviewers understand the application as a coherent whole. The 
abstract should be written last, to ensure that it is an accurate 
summary, even though it is placed in the application packet before the 
sections its summarizes.

G. Budget

    An itemized estimate of costs and justification for the proposed 
research project by line item must be provided on form PHS 5161-1 
(effective date 7/92). A narrative justification must be submitted for 
costs. Indicate needs by listing individual items and quantities 
necessary. The budget should be sufficient, but not exceed what is 
necessary to complete the research project. the budget is not intended 
as a vehicle for the purchase of expensive computer and other 
equipment. These purchases are allowable only with IHS prior approval. 
The budget should include additional resources in the organization(s) 
that will be applied to the research study, e.g., in-kind staff, 
physical resources such as telephones, and consultations. The budget 
should be developed after the Research Plan is written, even though it 
is placed in the application packet before the Research Plan section.

H. Key Personnel and Research Team

    The biographical sketch of each key person may not exceed one 
single-spaced typewritten page. Each sketch should include the person's 
qualifications, training, and experience relevant to the research 
project, and the person's time that will be devoted to the project. 
``Key personnel'' include the principal investigator, co-investigators, 
and significant consultants and contractors. The biographical sketches 
should help the reviewers understand the capabilities of the research 
team to manage, carry out, and complete the project successfully. 
Include in Appendices both the resumes (Curriculum Vitae) of the key 
personnel, and a list of all anticipated consultants, collaborators, 
and contractual agreements.
    The instructions for the preparation of the Research Plan section 
and Importance and Utility section are to be used in lieu of the 
instructions on pages 19-20 of the PHS 5161-1.
    The two sections together may not exceed 25 single-spaced 
typewritten pages in length.

I. Research Plan

    The Research Plan section of the application must include the 
following sub-sections: (1) The specific aims of the research plan, 
with study question(s) and objective(s) stated; (2) the background in 
research literature for the study; (3) a progress report (for competing 
continuation applicants only); (4) the research design and methods to 
be used; (5) data sources, management quality control, and analysis; 
and (6) originality (if applicable). The Plan should be well organized, 
clearly written, and succinct. The plan should address how the 
Scientific Integrity of the project will be maintained. It should 
contain all information necessary for reviewers to understand fully the 
research plan without being familiar with the IHS or tribal health 
programs.
    1. Specific Aims: statement of study question(s) and objective(s).
    State the study question(s) and objective(s) of the research 
clearly and precisely. The rest of the Research Plan should follow 
logically from the study question(s).
    2. Background in Research Literature:
    Give a brief but comprehensive review of existing research and 
knowledge related to the study question(s). Previous related work by 
members of the team, including data from a pilot phase, should be 
included in the review. Describe the conclusions to be drawn from, and 
the applicability of, that review to the research project. References 
should be cited in standard format. (See Index Medicus, or N Eng J Med 
1991; 324:424-428; copies are available from the Area and National 
Research Offices.)
    3. Progress report (for competing continuation studies only).
    Give the progress of the funded research project to date. Indicate 
how the final objective(s) of the research will be achieved.
    4. Research design and methods to be used.
    Briefly define the research design, and why it is appropriate for 
the objective(s) of the research. Describe the research methods in 
detail. The description should include: (a) The population to be 
studied; (b) the inclusion and exclusion criteria for selecting study 
subjects; (c) the sampling techniques; (d) selection of controls (if 
any); (e) the definition of the independent and dependent variables (if 
any) and how to measure them; (f) the validation of interventions (if 
any); and (g) the definition of the expected outcomes or effects (if 
any) and how to measure them. Briefly discuss how to account for 
alternative explanations of expected findings. Provide sample size 
calculations (if needed), and evidence that the research can achieve 
the projected size. Give a project timeline, with completion dates of 
all major tasks.
    5. Data sources, management, quality control, and analysis.
    Describe in detail the data sources, management, quality control 
and analysis. The description should include: (a) The data to be 
collected, by whom, and at which points in the study; (b) the data 
sources, and how access to the sources will be attained; (c) the 
procedures to collect, receive, code, and prepare the data for 
analysis; (d) the contents of interviews (if they are to be done), and 
the connection between the interview question and the variables to be 
studied; (e) how the data will be made secure; (f) how completeness of 
the data will be assured and low response rates dealt with; (g) how 
accuracy of the data will be measured and assured; (h) the plan for 
analysis; (i) the statistical analyses to be done (if any); and (j) the 
non-statistical analyses to be done (if any, e.g., in qualitative 
research). Include a copy of the data collection instruments, if 
available, or the instruments to be modified by the research project 
(if any), in the application's appendices.
    6. Originality.
    If this research will develop new methods or directly lead to new 
information for research in general (not just about AI/AN people), 
briefly discuss that significance.

J. Importance and Utility

    The Importance and Utility section of the application must include 
the following sub-sections: (1) The importance of the health problem(s) 
addressed by the research for the community(ies) involved; (2) the 
importance of the health problems addressed by the research for all AI/
AN people and for the IHS Area; (3) the rationale for the setting of 
the study; (4) the utility of the product of the project and of the 
experience doing the project, to the community(ies) and service unit(s) 
(SUs) involved; and (5) the utility of the product of the project, and 
of the experience doing the project, to the IHS and other AI/AN people. 
The Importance and Utility section should be well organized, clearly 
written, and succinct. It should contain all information necessary for 
reviewers to understand fully both the importance of the health 
problem(s) addressed by the research project and its expected utility, 
without being familiar with the IHS or tribal health programs.
    1. Importance of the health problem(s) for the community(ies) 
involved.
    Using quantitative evidence, briefly document the importance of the 
health problem(s) addressed by the research project among the range of 
health problems of the community(ies) in which the research project 
will be done.
    2. Importance of the health problem(s) for all AI/AN people and for 
the IHS Area.
    Using quantitative evidence, briefly document the importance of the 
health problem(s) addressed by the research project among the range of 
health problems of all or major groups of AI/AN people, and by the AI/
AN people of the IHS Area.
    3. Setting of the study.
    Briefly discuss why the study should be done only, or be done best, 
in an AI/AN population, and why in the proposed community(ies).
    4. Utility of the product and experience to the community(ies) and 
SUs involved.
    Briefly define the 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. Utility of the product and experience to the IHS and other AI/AN 
people.
    Briefly define the 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 and/or other AI/AN people.

K. Documentation of Approvals, Support, and Clearances

    1. Tribal approval.
    The research project must have the full understanding, documented 
approval, and support of the Indian tribe(s) or Alaska village(s) 
involved. Documented approval must be evidenced by a signed and dated 
Tribal Resolution, done no more than 12 months before December 1, 1994. 
If more than one tribe is involved, evidence of support from all tribes 
affected must be submitted with the application. Applications by tribal 
organizations will not require resolution(s) if the current tribal 
resolution(s) under which they operate would encompass the proposed 
grant activities. A statement of proof or a copy of the current 
operational resolution must accompany the application.
    2. Letters of cooperation, collaboration, or assistance.
    If other research programs are to be involved in the research 
project, letters confirming the specific nature and extent of 
cooperation, collaboration, or assistance must be submitted.
    3. Service Unit Director approval.
    All applicants must provide letter(s) of approval from the Director 
of any SUs involved in or affected by the research project.
    4. Area Contracting Officer clearance.
    The IHS components which apply must obtain a letter of clearance 
from the Area Contracting Officer if any purchasing, contracting, or 
consultant hiring actions will be requested in the research project. 
This letter of clearance must be included with the submitted proposal.
    5. Area Director approval.
    The IHS components applying must also obtain a signed Form 424 in 
Section 18.d-e. from the Area RPC as evidence of the IHS Area 
Director's approval. This is in accordance with Part 1--General, 
Chapter 7, research Activities, Sub Part 1-7.4 A. of the IHS Manual 
which establishes the Area RPC as the Area Director's reviewing 
authority for research proposals.

L. Protection of Human Subjects

    The application shall contain assurances that the applicant will 
comply with the following:
    1. Regulations to protect all human subjects of the research.
    If the research project will involve human subjects, the applicant 
must submit for approval the completed protocol to the applicable IHS 
Area Institutional Review Board(s) (IRB). If one or more co-
investigator(s) is (are) from an institution that has a permanent IRB 
(i.e., has a Multiple Project Assurance [MPA]), the applicant must 
submit form HHS 596 to that IRB as well. All IRB approvals must be 
secured prior to funding of the proposal. (See section M. Review 
Process, below.) It is recommended that any applicant who proposes to 
involve human subjects, or who is not sure if the project meets the 
definition of research involving human subjects in 45 CFR part 46, 
contact the appropriate Area Research Coordinator listed in this 
announcement for technical assistance as the application is being 
developed.
    2. Maintenance of data confidentiality, anonymity (if indicated), 
and subject privacy.
    Applicants must describe the process to maintain the 
confidentiality of data collected, the protection of patient records, 
and the privacy of human subjects. If subjects are to be protected by 
anonymity, applicants must describe the process to maintain anonymity.

M. Review 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 MPA. It is suggested but not required that the 
application be sent to the appropriate Area (IRB(s) 2 (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.)                     
    4...................  a. 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?                                      
    10..................  b. 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 applicable)? Do the      
                           conclusions follow from the review?                                                  
    4...................  c. 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?        
    15..................  d. Research design and methods to be used.                                            
                          Does the Research Plan adequately describe the research design? Is the proposed       
                           approach appropriate for the objective(s) 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? Is the application's timeline, with completion dates of all major 
                           tasks, appropriate and feasible?                                                     
    10..................  e. 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 were 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?       
    4...................  f. 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.)            
    10..................  g. 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?                                                             
    9...................  h. 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?                                 
    4...................  i. 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)?                                                             
    10..................  j. Utility of the product and experience to the community(ies) and 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...................  l. 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 project? Does the research team have the      
                           capabilities to carry out and complete the project successfully?                     
                                                                                                                

N. Results of the Review

    The recommendations of the IHRSS will be forwarded to the Associate 
Director, OHPRD, for final review and approval. The Associate Director 
will also consider the recommendations from the appropriate Area 
Research Committee and the Grants Management Office. Applicants will be 
notified of their approval with funds, or approval without funds, on or 
about November 16, 1994. A Notice of Grant Award will be issued 
approximately 10 days prior to the start date. Unsuccessful applicants 
will be notified in writing of disapproval on or about November 16, 
1994. A brief explanation of the reasons why the application was not 
approved will be provided along with the name of the IHS official to 
contact if more information is desired.

    Dated: December 10, 1993.
Michel E. Lincoln,
Acting Director.
[FR Doc. 94-6384 Filed 3-17-94; 8:45 am]
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