EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARD (EARDA): SPONSORED RESEARCH 
INFRASTRUCTURE PROGRAM (SRIP)

RELEASE DATE:  February 12, 2003

RFA NUMBER:  HD-03-007 

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov)  

LETTER OF INTENT RECEIPT DATE:  March 24, 2003 

APPLICATION RECEIPT DATE:  April 24, 2003  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Program Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The Extramural Associates (EA) Program, National Institute of Child Health and 
Human Development (NICHD), NIH, announces two initiatives directed at 
scientific faculty and academic science administrators of women's colleges and 
of institutions with significant underrepresented minority (i.e., Black, 
Asian/Pacific Islander, Hispanic, or Native American) student populations.  
The two initiatives target two different types of institutions.  The Faculty 
Research Enhancement Support Program (FRESP) is published in a companion 
(RFA HD-03-006).  This RFA describes the Sponsored Research Infrastructure Program 
(SRIP) and is intended for eligible institutions that award the Master's or 
the Ph.D. degree in the biomedical and/or behavioral sciences and/or other 
health-related professional degrees.  In addition, it is expected that these 
institutions already have a modest research base of health-related research.  

The goal of these initiatives is to increase the participation of these 
institutions in biomedical and behavioral research and research training 
through an integrated residency and institutional grant support program.

The objective of the SRIP program, through its five-month residency experience 
at the NIH, is to enhance the research capacity of the awardee institution by 
providing the following resources:  (1) administrative support for the 
development of grant applications and/or contract proposals; (2) updated 
information about the availability of funds to support biomedical and 
behavioral research and research training; (3) grantsmanship seminars for 
faculty; and (4) the resources to develop approaches to encourage faculty and 
students to participate in biomedical and behavioral research.

It is anticipated that the individuals participating in the residency program 
will be responsible for establishing or enhancing an office that provides 
administrative support for research and research training projects receiving 
external funding, and for implementing pilot studies that encourage faculty 
and students to engage in research from a broader perspective.

PROGRAM OBJECTIVES

Background

The EA Program was established in 1978 at the NIH to promote the entry and 
participation of women and underrepresented minority institutions into 
biomedical and behavioral research.  Overall, the program accomplishes this 
mission by providing EAs from women's colleges and underrepresented minority 
institutions with the opportunity to come to the NIH to gain the necessary 
understanding of the processes utilized by the NIH as well as other Federal 
agencies to provide funding to support biomedical and behavioral research and 
research training.  The five-month SRIP winter residency program is for 
institutions with an individual wishing to establish or augment an Office of 
Research Development for the purpose of enriching faculty and student 
participation in biomedical and behavioral research activities. 

Scope

[The terms 'Principal Investigator' and 'Extramural Associate (EA)' are used 
interchangeably in this document.]

Candidates (Principal Investigators) for the Extramural Associates Research 
Development Award (EARDA) must be full-time scientific faculty or academic 
science administrators at the applicant institution.  If approved and invited 
to participate, they will be required to spend five months at the NIH in 
residency training.  The program has the flexibility necessary to allow each 
EA to participate in activities that are consistent with the institution's 
concerns and interests in health-related research.  Upon entering the program, 
EAs are assigned a preceptor and participate in the regular EA Program 
curriculum.  The EA's preceptor, a senior NIH or Public Health Service (PHS) 
official, is available for guidance with respect to working assignments and 
related activities to assure consistency with the Institutional Plan
presented in the EARDA application.  EAs attend an initial series of 
orientation sessions as well as in-depth seminars that prepare them to use 
their time effectively at the NIH.  Working assignments are intended to 
provide in-depth exposure to the administration of NIH and other Federal 
extramural research programs.  EAs have the opportunity to learn about the 
Federal legislative and budgetary processes, to study administrative 
procedures, and to observe staff meetings and scientific review meetings. 

During the course of the residency program, they visit other Federal agencies, 
and a nearby university's office of sponsored research.  Opportunities may 
also be provided to observe NIH site-visits to grantee institutions.  Upon 
completion of the program, the EAs have:  (1) a comprehensive working 
knowledge of the range of Federal support of biomedical and behavioral 
research; (2) skills in preparation of research grant applications; (3) a plan 
to establish or expand the institution's "Office of Research Development;" (4) 
knowledge of the composition of an Advisory Committee with membership capable 
of reviewing, recommending for funding, and monitoring faculty pilot research 
projects; (5) a network of contacts to the NIH and other Federal agencies, so 
they can serve as a liaison for faculty and students to access NIH 
opportunities as well as those of other Federal and private agencies; and (6)  
the embryonic stage of a meaningful partnership with a research intensive 
institution. 

The Residency Program

It is anticipated that awards will be made after the completion of the five-
month NIH residency, which begins the first week of January 2004 and ends the 
latter part of May.  However, successful applicants will be notified following 
the September 2003 meeting of the National Advisory Child Health and Human 
Development Council, so that the identified EA will have time to arrange for 
participation in the residency program during 2004.  

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Extramural 
Associates Research Development Award (G11) mechanism.  The G11 mechanism is 
used to support institutional resources to improve the research infrastructure 
(including part-time professional and administrative staff, equipment, etc.).  
An award made to a successful FRESP applicant or to a successful SRIP 
applicant is termed an EARDA.  As an applicant you will be solely responsible 
for planning, directing, and executing the proposed project. 

FUNDS AVAILABLE

The NICHD intends to commit approximately $190,000 in total costs [direct plus 
Facilities and Administrative (F&A) costs] in FY 2004 to fund three to five 
new grants in response to this RFA.  Facilities and Administrative (F&A) costs 
for these awards are fixed at eight percent of total direct costs.  Applicants 
may request a project period of five years and a budget for direct costs of up 
to $35,000 for the first 12-month budget period.  In Years 02 through 05, 
budgets for direct costs of up to $50,000 may be requested for administration 
of an Office of Research Development.  In addition, up to $35,000 may be 
requested in these four years to support faculty pilot research projects, 
seminars, and student participation in research projects.  Thus, applicants 
may request up to $85,000 in direct costs per year in Years 02 through 05.  
Because the nature and scope of the effort proposed may vary, it is 
anticipated that the size of awards also will vary.  Although the financial 
plans of the NICHD provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 

Transitional Awards

Since a major goal of the program is to establish an Office of Research 
Development, applicants successful in receiving a five-year EARDA are expected 
to compete for a one-time, three-year "Transitional EARDA Award."  The 
Transitional Award of $85,000 per year in direct costs will be based on a 
cost-sharing arrangement.  The purpose of the Transitional Award is to allow 
the institutions sufficient time to assume full financial responsibility for 
the Office of Research Development after eight years of EARDA grant support.  
It is expected that during the first year of the Transitional Award (Year 06, 
overall), NICHD will contribute two-thirds of the total costs, and the 
institution one-third.  During the second year, (07 year) NICHD and the 
institution will each contribute 50 percent, and in the third and final year, 
the institution will contribute two-thirds and NICHD will contribute one-
third.  Thereafter, the institution would assume full financial responsibility 
for maintaining the Office of Research Development.  Applications for the 
Transitional EARDA award will be solicited from eligible institutions at the 
appropriate time.

ELIGIBLE INSTITUTIONS

Applications may be submitted by domestic, private and public women's colleges 
and educational institutions with significant underrepresented minority (i.e., 
Black, Asian/Pacific Islander, Hispanic, or Native American) student 
populations that offer programs in the biomedical or behavioral sciences.  
Preference will be given to those institutions that demonstrate the greatest 
need to establish or strengthen and develop research and research training 
infrastructure.

The SRIP is intended for institutions that offer programs in the biomedical 
and/or behavioral sciences leading to a Master's degree or higher, including 
health-related professional degrees.  These institutions are expected to have 
a modest research base already in place and to be interested in developing or 
enhancing a research infrastructure.  

In selected instances, institutions that award the baccalaureate as the 
highest science or health-related degree may seek to qualify for eligibility 
to apply for the SRIP.  At a minimum, MARC or MBRS, preferably both, must have 
supported such institutions and they must have current or prior support from 
two other Federal agencies other than the Department of Education.  For 
additional information, discuss eligibility with the EA Program Office 
contact, listed under WHERE TO SEND INQUIRIES, below.

Institutions may nominate only one Principal Investigator per cycle for 
participation in the program.  Eligible women's colleges and underrepresented 
minority institutions that have never had a faculty member participate in the 
EA Program are strongly encouraged to apply.  Institutions that have received 
a Research Centers in Minority Institutions (RCMI) award, if successful in 
applying for this award, will have their budget requests reduced if there is 
significant overlap in funding for infrastructure components.

Institutions that received an Extramural Associates Research Development Award 
(EARDA) in years 1994 through 2002 resulting from their response to RFAs
OD-94-002, OD-94-003, OD-95-001, OD-96-001, OD-97-002, OD-98-004, OD-99-001, OD-
00-001, HD-01-003 or HD-02-007 are not eligible to apply under this 
announcement.  Institutions that had EAs enrolled in the five-month NIH 
residency training program prior to 1994 and who have never received an EARDA 
grant are eligible to apply for this program.  However, the proposed Principal 
Investigators from such institutions must agree to repeat the five-month NIH 
residency-training program.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs.   

Full time Science Faculty, i.e., faculty who have earned degrees in the life 
sciences (biomedical and or behavioral sciences) or in the physical sciences, 
mathematics or engineering are eligible to become Principal Investigators of 
the EARDA grant.  Likewise, academic science administrators are also eligible 
as Principal Investigators.  Mid-level and senior level faculty are preferable 
so long as they have the flexibility to participate in the residency training 
and carry out the expectations outlined in the RFA after completing the 
residency training.

SPECIAL REQUIREMENTS

Post-Award Monitoring

To insure that the EA, upon returning to the home institution, is making 
satisfactory progress in achieving the goals and objectives of the EA Program 
and is receiving appropriate institutional support, two EARDA assessments will 
be conducted during the five-year grant period.  The first assessment will 
take place at the institution approximately 18 months after the EARDA is 
awarded.  NIH staff and consultants will be included.  The second one, a 
grantee interview, will take place at the NIH during the latter part of the 
fourth year or early in the fifth year of the grant and will include the EA 
and one or two designated institutional officials.  Applicants should include 
in their budget, funds necessary to participate in the grantee interview at 
NIH.

Institutional Commitment

In nominating the EA candidate, the sponsoring institution is expected to 
commit adequate resources to formulate and implement an Institutional Plan, 
which will build upon the EA's residency training experience.  For the five-
month residency program, this may include a commitment to provide the EA with 
support, in the form of designated authority, to develop or enhance an Office 
of Research Development upon his/her return to the institution.  A sign of 
institutional commitment is a statement in the proposed plan describing how 
the institution plans to continue the developmental research activity once 
EARDA support expires.  A contribution to the EA's residency training costs 
under the Intergovernmental Personnel Act (IPA) is also considered a 
demonstration of the institution's commitment to the goals of the program.  

The EA and the institution must be fully committed to the EA residency 
training.  Specifically, because of the time and effort expended in scheduling 
and conducting the training, only in extreme cases will the EA be excused from 
any part of the training to engage in institutional responsibilities incurred 
prior to or during the residency training.

Allowable Costs

Funding for the program may be used to support the activities of the EA upon 
returning to the home institution.  Such activities include equipping an 
office, support of small pilot research studies, conduct of student/teacher 
seminars and workshops to enhance research interest, and to establish 
consortia research arrangements.  Other purposes for which funds may be used 
include, but are not limited to, the following:  purchase of office supplies 
and equipment, administrative assistance, travel expenses for the EA to gain 
additional experience in carrying out the functions of the office, and 
membership dues in one professional organization whose function is related to 
the goals of the EA Program.  Support for administrative assistance can be 
requested up to, but must not exceed, 50 percent.  Any request for 
administrative assistance greater than 50 percent will be denied.

Salary support for the EA during the five-month residency program will be 
provided through an IPA agreement mechanism described below, not through or 
from the EARDA grant itself.  Therefore, salary should be requested for only 
seven months in the first 12-month budget period of the EARDA.  

The costs for the residency program are entirely separate from the EARDA 
award.  Selected EAs will come to the NIH for the assignment under the IPA.  
The IPA enables temporary appointments to the Federal government by employees 
from academic institutions.  Cost sharing is required.  The IPA provides 
partial support for the EA while he/she is at NIH.  Under the IPA arrangement, 
up to 67 percent of the cost of the EA's salary, while at the NIH, is 
reimbursed.  Similarly, per diem (food and lodging) costs are reimbursed at 75 
percent by NIH and the institution contributes 25 percent.  The cost of 
relocating the EA from the home institution and any other costs incurred that 
are related to the residency program are reimbursed at 100 percent.  Included 
in related costs are expenses to return to the home institution, for a one-
week period, approximately mid-way through the five-month residency to meet 
with institution officials and faculty to discuss plans for implementing the 
institutional plan upon the EA's return.

Although institutions with an existing Office of Research Development or 
similar office, or with funding through programs such as the RCMI may apply, 
adjustments in the final funding level for budgetary overlap will be made 
prior to the award.

Change of Principal Investigator

If a request to change the Principal Investigator of the EARDA is received at 
any time during the five-year grant, the EA Program Director may suspend 
support pending approval of a substitute Principal Investigator by the EA 
Program Director.

Use of Human Subjects or Vertebrate Animals

Should any of the planned pilot studies propose the use of human subjects or 
vertebrate animals, the grantee institution must obtain a Federal Wide 
Assurance (FWA) from the Office of Human Research Protection (OHRP) (for human 
subject) and/or negotiate an animal assurance from the Office of Laboratory 
Animal Welfare (for animals).  In addition, the research protocols must be 
reviewed and approved by an Institutional Review Board (IRB) (for human 
subjects) or an Institutional Animal Care and Use Committee (IACUC) (for 
animals) prior to initiating the studies.  Information about negotiating a FWA 
or establishing an IRB can be found at the OHRP website, 
http://www.hhs.gov/ohrp.  Information about obtaining an animal assurance 
can be found at http://grants.nih.gov/grants/olaw/olaw.htm. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning the RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research/programmatic, peer review, and financial or grants 
management issues.

o  Direct your questions about scientific/research/programmatic issues to:

Matthew A. Kinnard, Ph.D.
Director, Extramural Associates Program
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-2736
Fax:  (301) 480-0393
Email:  kinnardm@mail.nih.gov

o  Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
Fax:  (301) 402-4104
Email:  stretchr@mail.nih.gov

o  Direct your questions about financial or grants management matters to:

Ms. Myrtle Coleman
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-4572
Fax:  (301) 480-4782
Email:  colemama@exchange.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research development activity
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NICHD staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Matthew A. Kinnard, Ph.D.
Director, Extramural Associates Program
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-2736
Fax:  (301) 480-0393
Email:  kinnardm@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact Grants Info, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:  The instructions accompanying Form PHS 398 (rev. 
5/2001) must be followed, with the exceptions noted below:

Special Instructions for Research Plan 

For section I.C.9, Specific Instructions - Research Plan, use Continuation 
Pages to provide information on the three parts described below.  The total 
length for these three parts combined should not exceed 15 pages. 

The Research Plan for a SRIP application consists of three parts.  These parts 
are required and it is imperative that applicants fully address each point 
described in the outline below because they are reflected in the review 
criteria.

Part I:  The Nominee

This part pertains to the nominee's background and potential as an EA.  It 
should be prepared by the nominee and must include:

o  Evidence of rapport with faculty and students, ability to motivate and 
advise others, and commitment to serve the institution.

o  A description of the nominee's commitment to increasing and strengthening 
involvement of women and underrepresented minorities in biomedical and 
behavioral research at the institution.  This description also should address 
his/her interest in and commitment to the objectives of the EA Program, the 
benefits that will accrue to the institution from his/her participation in the 
program, and the nominee's availability to participate in the five-month 
residency program at the NIH.

o  The names, titles, addresses, telephone and fax numbers, and e-mail 
addresses of three colleagues who have consented to submit letters of 
reference to the NIH attesting to the personal qualifications and potential 
effectiveness of the nominee.  The reference letters must be included in the 
appendix.  One of these letters should be from the President of the applicant 
institution.  Reference letters should accompany the two applications sent to 
the NICHD (see SENDING AN APPLLICATION TO THE NIH, below). The reference 
letters must be received in the same package with the EARDA application.  
Otherwise, the application is considered incomplete and will be returned to 
the applicant without further consideration.  In order to comply with this 
requirement, it is recommended that all reference letters be obtained from the 
referring individuals as far in advance of the application deadline as 
possible.

o  A detailed description of the current status of the sponsored programs 
office or similar office at the institution and the nominee's plan to take the 
institution forward with regard to developmental research activities. 

Part II:  The Institution

This part pertains to the institution's mission and goals related to the EA 
Program.  It should be prepared by institutional officials and must include 
the following:

o  Statement of interest in and plans to improve the health-related research 
capabilities of the institution.

o  If applicable, a description of a current Office of Research Development or 
similar institutional unit.

o  If applicable, a description of a current Sponsored Programs Office or 
similar institutional unit.

o  A letter from the head of the Sponsored Programs Office or similar office 
signed and dated should be included in the Appendix.  The letter should state 
explicitly that he or she is committed to working cooperatively with the 
Office of Research Development once established for the benefit of the entire 
institution.

o  Statement of the institution's demonstrated past and potential 
contributions to the advancement of minorities and/or women in biomedical and 
behavioral research and training.

o  Description of the current academic environment.  This should include a 
history/accreditation, profile of the student population including a detailed 
categorization of the enrollment of minorities and women.

o  Description of the research environment.  Include a description of the 
science faculty and the research capability as indicated by:  (1) number of 
faculty members in biomedical and behavioral science disciplines; (2) number 
of faculty engaged in biomedical and behavioral science research; (3) number 
of faculty with external research support; (4) evidence of presentations at 
local, regional, and national meetings; (5) evidence of faculty research 
collaborations with investigators at other institutions; (6) faculty involved 
in peer review activities, as members of standing or ad hoc review committees; 
(7) current student population in the sciences and follow-up data (e.g., 
graduate and post-graduate career profiles); (8) current and planned 
facilities for scientific research and training; and (9) current and planned 
Federal and non-Federal research support.

o  Description of ongoing or planned cooperation and/or collaboration with 
other institutions or Federal or non-Federal organizations.

o  A copy of the institution's course catalogue should be attached to the 
application in the Appendix.

Part III:  Institutional Plan 

The EA selected to participate in the SRIP will submit a preliminary plan that 
describes the establishment or enhancement of the institution's Office of 
Research Development.  This plan should describe an approach for enhancing the 
research capabilities of the institution using the skills to be gained by the 
nominee.  The plan also should include details about steps to be taken for 
identifying, funding, and monitoring progress of scientifically meritorious 
pilot research studies, as well as the development of seminars and workshops, 
and plans to involve students in research activities.  This section should be 
developed by both faculty and administrators and should include:

o  A statement of nominee's role, authority, and institution-wide 
accessibility upon return to the institution as well as a description of 
resources that will be made available to the nominee, including a detailed 
budget. 

o  At least one advisory committee must be described and established.  The 
purpose, function, and expectation of the committee should be described, but 
specific members should not be appointed until after an award is made.  It is 
expected that at least one person external to the applicant institution will 
be on the Advisory Committee.  This committee could serve as advisory to the 
EA in the establishment and maintenance of ongoing research development 
activities.  This committee will also be responsible for the review, 
recommendation for funding, and monitoring of faculty pilot research studies. 
All other planned committees should be included in this section with a 
justification for the particular committee structure and function proposed and 
a description of the proposed membership.  

o  A description of plans to initiate or expand local or regional 
cooperation/collaboration in research activities.  Particular emphasis is 
placed on partnering with foundations and with private companies and 
businesses.

o  A preliminary plan, including the source of budgetary resources, for 
continuation of the program once NIH support expires.

Special Instructions for Appendix

The Appendix to the application should include the following items:

o  Reference letters from colleagues identified.

o  A copy of the institution's course catalogue should be attached to the 
application. 

o  Letter from Director of Sponsored Programs Office.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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 2 of the face page of the application form and 
the YES box must be marked.  The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed photocopies, in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and all 
copies of appendix materials including reference letters must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, Maryland 20892-7510
Rockville, Maryland 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to this RFA by NICHD.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration. 

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will: 

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council.

REVIEW CRITERIA

CRITERIA TO BE USED IN EVALUATION OF THE NOMINEE:

o Strength of personal qualifications as indicated by past training and 
experience.

o Evidence of ability to enhance the institution's effectiveness in involving 
women and underrepresented minorities in health-related research.

o Demonstrated interest and resourcefulness, and evidence that the nominee has 
the requisite experience and access to the science faculty and to the 
administration to accomplish the goals of the program.

o Ability to commit himself or herself to function as the EA, preferably for 
the duration of the EARDA grant but at a minimum, for three full years.

CRITERIA TO BE USED IN EVALUATION OF THE INSTITUTION:

In the context of the institution's history and stage of development:

o Quality of science education and potential for research and/or research 
training in biomedical and behavioral sciences.

o Evidence of commitment to preparing women and/or underrepresented minorities 
for careers in science.

o Evidence of potential for developing research and research training 
infrastructure.

o Strength and quality of faculty and students in health-related science 
departments.

o Potential for conducting collaborative sponsored research and research 
training projects.

CRITERIA TO BE USED IN EVALUATION OF THE INSTITUTIONAL PLAN:

o Evidence of a strong institutional commitment to implementing the plan.

o Evidence, as reflected in institutional statements and the budget, that the 
nominee will be provided sufficient resources to carry out the plan.

o Evidence that the nominee will have sufficient authority to carry out the 
plan.

o Coherence of the plan and evidence that there is adequate coordination among 
key faculty and administrators (i.e., composition and functioning of 
committees) in its development.

o Adequacy of the proposed committee membership to review, fund, and monitor 
pilot research studies.

o The presence, strength, and viability of the proposed evaluation strategy.

o The justification for establishing or expanding an Office of Research 
Development.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following: 

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application. 

o INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below.) 

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed institutional plan.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 24, 2003 
Application Receipt Date:  April 24, 2003
Peer Review Date:  July 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  February 1, 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include: 

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities. 

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research – Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trails that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPATNTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.  All investigators proposing research involving 
human subjects should read the "NIH Policy Guidelines" on the inclusion of 
children as participants in research involving human subjects that is 
available at http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRONIC STEM CELL (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application.  
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.  

URLs IN NIH GRANTS APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site. 

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This  
RFA is related to one or more of the priority areas.  Potential applicants may 
obtain a copy of  "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.864 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization or Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-277, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people. 


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