RFA-HL-04-027: MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32)

MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32)

RELEASE DATE: April 13, 2004

RFA Number: RFA-HL-04-027 (Reissued as RFA-HL-08-017)

( See Notice NOT-OD-07-043 Extension of
Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) expiration dates.

(Dates changed, see NOT-HL-05-111)

EXPIRATION DATE: January 3, 2008

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.233, 93.837, 93.838, 93.839

LETTER OF INTENT RECEIPT DATE((Dates changed, see NOT-HL-05-111): May 22, 2004; May 21, 2005; May 20, 2006
APPLICATION RECEIPT DATE: June 23, 2004; June 22, 2005; June 21, 2006

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Eligible 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

This RFA is a continuation of the program formerly named “NHLBI Minority Institutional
Research Training Program” (RFA-HL-03-013).

The NHLBI’s Minority Institutional Research Training Program is a Ruth L. Kirschstein
National Research Service Award Program intended to support training of graduate and
health professional students and individuals in postdoctoral training at minority
schools having the potential to develop meritorious training programs in
cardiovascular, pulmonary, hematologic, and sleep disorders. Graduate and health
professional students and individuals in postdoctoral training in minority schools need
further opportunities to develop biomedical and behavioral research skills. The NHLBI
Minority Institutional Research Training Program is designed to attract students in
their developmental stages; to increase their awareness of cardiovascular, pulmonary,
hematologic, and sleep disorders research; and to encourage them to pursue research
career opportunities in these areas.

RESEARCH OBJECTIVES

Through the Minority Institutional Research Training Program, research training grant
awards are made in cardiovascular, pulmonary, hematologic, and sleep disorders research
to minority schools to enable qualified graduate and health professional students and
individuals in postdoctoral training to participate in research programs. It is
expected to attract students in their developmental stages, increase their awareness of
these diseases, and to encourage them to pursue career opportunities in research
related to the mission of the National Heart, Lung, and Blood Institute (NHLBI).

Trainee appointments will be determined by the institution and carried out in a manner
that will include the recruitment of women, and individuals from disadvantaged
backgrounds (including racial and ethnic minorities) into heart, lung, blood, and sleep
disorders scientific research areas.

NHLBI encourages research training and career development crossing disciplinary
boundaries (examples; biophysics, biostatistics, bioinformatics, bioengineering) to
develop a new interdisciplinary workforce.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Ruth L. Kirschstein
Institutional National Research Service Award (NSRA) mechanism (T32). As an applicant
you will be solely responsible for planning, directing, and executing the proposed
project. See the SUPPLEMENTARY INSTRUCTIONS section for additional information. An
unsuccessful application to this RFA for one receipt date may be submitted as an
amended application on subsequent receipt dates for this RFA. Funds will be provided
on an annual basis to develop and maintain a stable research training experience for
qualified students. Successful applicants may compete for subsequent awards of up to
five years' duration upon completion of the initial grant period.

Funding beyond the first year of the grant is contingent upon satisfactory progress
during the preceding year and availability of funds. The anticipated award date for
the first receipt date is April 1, 2005; for the second is April 1, 2006; and for the
third is April 1, 2007.

FUNDS AVAILABLE

The estimated annual funds (total costs) available for the first year of support for
the program is expected to be $250,000. The actual amount may vary annually, depending
on the response to the RFA and availability of funds. The total project period for an
application submitted in response to this RFA may not exceed five years. Two new
awards are anticipated each year.

Facilities and Administrative Costs will be awarded based on 8% of total direct costs
exclusive of tuition, and fees.

Loan Repayment Program (LRP): Awardees under this program may be eligible to apply for
the NIH Extramural Loan Repayment Program. Information regarding the eligibility
requirements and benefits of the program may be obtained through the LRP website at
http://www.lrp.nih.gov/

ELIGIBLE INSTITUTIONS

The Institution must be a domestic college or university with student enrollment drawn
substantially from minority ethnic groups (including African Americans/Blacks,
Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders). It must
have the ongoing staff and facilities required for the proposed program. The program
director at the minority institution will be responsible for the selection and
appointment of students and the overall direction of the program. Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to apply as
program directors. Foreign institutions are not eligible to apply.

ELIGIBLE PRINCIPAL INVESTIGATORS/PROGRAM DIRECTORS

Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research training program 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. The research training program director at the institution will be
responsible for the selection and appointment of trainees to the NRSA research training
grant and for the overall direction, management, and administration of the program.

SPECIAL REQUIREMENTS

Research Center

The minority institution must identify and collaborate with a research center (medical
school or comparable institution) that has strong, well-established cardiovascular,
pulmonary, hematologic, or sleep disorders research and research training programs.
Cooperation and collaboration between institutions is needed to provide each trainee
with a mentor who is recognized as an accomplished investigator in cardiovascular,
pulmonary, hematologic or sleep disorders research and who will assist the advisor at
the minority institution with the trainee's development and research plan. Plans for
summer training as well as academic year training should be developed by the student
and advisor at the trainee's home institution in collaboration with the mentor at the
research center. It is expected that both advisor and mentor will guide the trainee
through the initial training period and continue this interaction throughout the award.
The development of strong mentoring relationships is essential to the success of the
trainees and the program.

The minority institution will identify and complete arrangements with an established
cardiovascular, pulmonary, hematologic, or sleep disorders research center(s) before
submitting an application. Arrangements between the participating institutions for the
recruitment of trainees and joint selection of trainers for the provision of training,
and for ongoing cooperation and collaboration between the institutions in the
implementation of the program, should be clearly outlined in the application.

A written commitment to the training plan signed by the intended faculty mentors at the
research center, the department(s) involved and countersigned by both institutional
officials, must be part of the application. The trainee and his or her faculty advisor
at the minority institution will jointly select a faculty mentor at the research
center.

Trainees

Trainees appointed to the training program must have the opportunity to carry out
supervised biomedical or behavioral research with the primary objective of developing
or extending their research skills and knowledge in preparation for a research career.

A trainee must be a citizen or non-citizen national of the United States or must have
been lawfully admitted for permanent residence (i.e., in possession of a currently
valid Alien Registration Receipt Card I-551, or some other legal verification of such
status). Non-citizen nationals are generally persons born in outlying possessions of
the United States (e.g., American Samoa and Swains Island). Individuals on temporary
or student visas are not eligible.

Trainees must be in one of the following categories:

(A) Predoctoral Trainees. Predoctoral trainees must have received a baccalaureate
degree by the beginning date of their NRSA appointment, and must be training at the
postbaccalaureate level and enrolled in a program leading to a Ph.D. in science or in
an equivalent research doctoral degree program. Health-professional students, graduate
students in the quantitative sciences, or individuals in postgraduate clinical training
who wish to interrupt their studies for a year or more to engage in full-time research
training before completing their formal training programs are also eligible.

(B) Postdoctoral Trainees. Postdoctoral trainees must have received, as of the
beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral
degree from an accredited domestic or foreign institution. Eligible doctoral degrees
include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D.,
D.P.M., Sc.D., Eng. D., Dr. P. H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy),
D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting
institution certifying all degree requirements have been met prior to the beginning
date of training is acceptable.

(C) Short-Term Health Professional Trainees. To be eligible for short-term predoctoral
research training positions, students must be enrolled and in good standing and must
have completed at least one quarter in a program leading to a clinical doctorate or a
masters or doctorate in a quantitative science such as physics, mathematics, or
engineering prior to participating in the program. Individuals already matriculated in
a formal research degree program in the health sciences, or those holding a research
doctorate or master’s degree or a combined health-professional/research doctorate
normally are not eligible for short-term training positions. Within schools of
pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for
short-term positions.

Positions on NRSA institutional grants may not be used for study leading to the M.D.,
D.D.S., or other clinical, health-professional training except when those studies are a
part of a formal combined research degree program, such as the M.D./Ph.D. Similarly,
trainees may not accept NRSA support for clinical training that is a part of residency
training leading to clinical certification in a medical or dental specialty or
subspecialty. It is permissible and encouraged, however, for clinicians to engage in
NRSA supported full-time, postdoctoral research training even when that experience is
creditable toward certification by a clinical specialty or subspecialty board.

Trainees are required to pursue their research training on a full-time basis, devoting
at least 40 hours per week to the program. Within the 40 hours per week training
period, research trainees who are also training as clinicians must devote their time to
the proposed research training and must confine clinical duties to those that are an
integral part of the research training experience.

Providing research opportunities for individuals from disadvantaged backgrounds,
including racial and ethnic minorities, and who are underrepresented in biomedical and
behavioral research, will significantly contribute to a diverse research workforce in
the future.

The trainees may be appointed for 9 - 12 months at any time during the course of the
budget period. Students must be enrolled on a full-time basis. A strong interest in a
cardiovascular, pulmonary, hematologic, or sleep disorder research career must be
evident. Short-term training positions for health professional students are allowed
under this program. Predoctoral trainees appointed to the grant may receive support
for up to five years. Postdoctoral trainees appointed to the grant may receive support
for up to three years.

Provisions Of The Award

Program Evaluation Plan

Procedures for annual evaluation of the program should include plans to measure the
impact of the program on the individual students and plans to measure the trainees=
progress. The evaluation procedures should also describe plans to monitor the future
career course of individual trainees, to evaluate the effectiveness of the overall
program, and assess the impact of the training program on the institution. It should
also include plans for assessing the effectiveness of the mentoring relationship and
the training plan.

Training in the Responsible Conduct of Research (RCR)

The application must include a description of plans to provide instruction in the
responsible conduct of research. Applications without plans for instruction in the
responsible conduct of research will be considered incomplete and will be returned to
the applicant without review. Although the NIH does not establish specific curricula
or formal requirements, all programs are encouraged to consider instruction in the
following areas: conflict of interest, responsible authorship, policies for handling
misconduct, data management, data sharing, and policies regarding the use of human and
animal subjects. Within the context of training in scientific integrity, it is also
beneficial to discuss the relationship and the specific responsibilities of the
institution and the graduate students or postdoctorates appointed to the program.
Plans for RCR training must describe the proposed subject matter, format, frequency and
duration of instruction. The rationale for the proposed plan of instruction must be
provided. No award will be made if an application lacks this component. See the NIH
website http://www.nih.gov/sigs/bioethics for resources and information on this topic.

Budget

Funds may be requested for:

(A) Stipends - The current stipend level for graduate and health professional student
trainees at all levels of experience is $20,772. Current stipend levels for
postdoctoral trainees are available at http://grants.nih.gov/training/nrsa.htm.

(B) Tuition, Fees, and Health Insurance - The combined cost of tuition, fees, and
health insurance (either self-only or family as appropriate) will be offset at the
following rate: 100% of all costs up to $3,000 and 60% of costs above $3,000 per
trainee. Costs associated with tuition and fees are allowable only if they are
required for specific courses in support of the research training experience supported
by the training grant. A full description of the tuition policy is contained within
the NRSA Policy Guidelines on the NIH website at:
http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812072.

(C) Trainee Travel Costs - The institution may request funds to cover the costs of
trainees’ travel, including attendance at scientific meetings, that are necessary to
the individual's training. The maximum allowable per student per year is $1,400.

(D) Training-Related Expenses - Institutional costs of $2,200 a year per predoctoral
trainee and $3,850 a year per postdoctoral trainee may be requested to defray the costs
of other research training related expenses, such as staff salaries, consultant costs,
equipment, research supplies, and staff travel.

(E) Facilities and Administrative Costs - The Notice of Grant Award will provide
facilities and administrative costs based on 8% of total direct costs, exclusive of
tuition and fees.

(F) Short-Term Training - Applicants who wish to include a request for short-term
research training positions should identify short-term positions separately within the
"stipends" and "training related expenses" categories on the budget page. Under
"stipends," short-term positions should be listed in the "other" category. Tuition,
fees, health insurance, and trainee travel, and other expenses are to be included in
"training related expenses." Within each section of the program plan, a separate
description of the short-term training should be included. The applicant should address
the relationship of the proposed short-term training to the regular research training
and provide assurance that the short-term program will not detract from the regular
program. Applicants must observe the 25-page limit on the narrative section.

Payback Agreement - As specified in the NIH Revitalization Act of 1993, NRSA recipients
incur a service payback obligation only during their first 12 months of postdoctoral
support. Additionally, the NIH Revitalization Act of 1993 specifies that the second
and subsequent years of postdoctoral NRSA training will serve to pay back a
postdoctoral service payback obligation. Accordingly, the following guidelines apply:

o Predoctoral trainees are not required to sign the payback agreement and do not incur
a service payback obligation.

o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign
the payback agreement form (PHS form 6031) before initiating an appointment.
Postdoctoral trainees in their first 12 months of support will incur a period of
service payback obligation equal to the period of support.

o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support
are not required to sign the payback agreement form and will not incur a service
payback obligation.

o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable
payback service for prior postdoctoral support. For example, postdoctoral trainees who
continue under that award for 2 years have fulfilled the obligation incurred during the
first 12 months of support by the end of the second year. Simple guidelines for
completing the payback requirement are available at
http://www.nhlbi.nih.gov/funding/policies/t32/payback.htm . Service payback
obligations can also be paid back by conducting health-related research or teaching
averaging more than 20 hours per week of a full work year after terminating NRSA
support.

o Recipients with service obligations must begin to provide service on a continuous
basis within two years of termination of NRSA support. The period for undertaking
payback service may be delayed for such reasons as temporary disability, completion of
residency requirements, or completion of the requirements for a graduate degree.
Requests for an extension must be made in writing to the NIH specifying the need for
additional time and the length of the required extension.

o Recipients of NRSA support are responsible for informing the NIH of changes in status
or address.

o For individuals who fail to fulfill their obligation through service, the United
States is entitled to recover the total amount of NRSA funds paid to the individual for
the obligated period plus interest at a rate determined by the Secretary of the
Treasury. Financial payback must be completed within three years beginning on the date
the United States becomes entitled to recover such amount.

o Under certain conditions, the Secretary, U.S. Department of Health and Human Services
(or those delegated this authority) may extend the period for starting service or
repayment, permit breaks in service, or in rare cases in which service or financial
repayment would constitute an extreme hardship, may waive or suspend the payback
obligation of an individual.

o Officials at the awardee institution have the responsibility of explaining the terms
of the payback requirements to all prospective training candidates before appointment
to the training grant. Additionally, all trainees recruited into the training program
must be provided with information related to the career options that might be available
when they complete the program. The relationship of the positions available and the
training provided must also be discussed along with the applicability of these
positions to any outstanding service payback obligation.

A Statement of Appointment form (PHS 2271, rev. 5/01) must be submitted at the start of
each trainee appointment and reappointment. This form is available at the following
URL address: http://grants.nih.gov/training/phs2271.pdf. Postdoctoral individuals
supported under this program are required to sign an NRSA Payback Agreement and all
appointed trainees are required to submit an NRSA Termination Notice.

WHERE TO SEND INQUIRIES

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

o Direct your questions about programmatic issues to:

Sandra Colombini Hatch, M.D.
Division of Lung Diseases (responding for all NHLBI programmatic Divisions)
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7952
Bethesda, Maryland 20892-7952
Telephone (301) 435-0222
FAX: (301) 480-3557
Email: HatchS@nhlbi.nih.gov

o Direct your questions about review issues to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: (301) 480-0730

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

Beckie Chamberlin
Grants Management Specialist
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7144, MSC 7926
Bethesda, Maryland 20892-7926
Telephone: (301) 435-0174
FAX: (301) 480-1948
Email: chamberr@nhlbi.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
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 NHLBI
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
to the Chief of Review at the address listed under WHERE TO SEND INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application instructions
and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data
Universal Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS
number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398
document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. Refer to section V. Institutional National Research Service Award.
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:
GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS

NHLBI’s Minority Institutional Research Training Program (T32) applicants may use the
“Suggested Tabular Formats for Required Data for the Ruth L. Kirschstein Institutional
National Research Service Award (T32) located at URL:
http://www.nhlbi.nih.gov/funding/policies/t32/index.htm. For Competing Continuation
applications in addition to Tables VIII, IX, and X, provide a table giving a brief
summary of the research conducted by each trainee supported during the period covered.

While not required, these specific formats will facilitate peer review and may also be
useful framework for the narrative sections. These tables should be included in the
main application (will not be counted toward the page limitation) rather than in the
Appendix.

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/labels.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)

All grant applications submitted to the Center for Scientific Review (CSR) must come
via United States Postal Service or a recognized delivery/courier service. Individuals
may not personally deliver packages to the building on Rockledge Drive. For further
information please see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

At the time of submission, two additional copies of the application and all five
collated sets of the appendix material must be sent to the Chief of Review at the
address listed under WHERE TO SEND INQUIRIES.

APPLICATION PROCESSING: Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8 weeks.

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. Acceptance of a revised application
in response to this RFA automatically withdraws the prior version, since two versions
of the same application cannot be simultaneously pending. Before a revised application
can be submitted, the principal investigator must have received the summary statement
from the previous review. There must be substantial changes in the content of the
application. The application must include an Introduction of not more than three pages
that summarizes the substantial additions, deletions, and changes. The Introduction
must also include responses to the criticisms and issues raised in the summary
statement. The changes in the Research Plan must be clearly marked by appropriate
bracketing, indenting, or changing of typography, unless the changes are so extensive
as to include most of the text. This exception should be explained in the Introduction.
Do not underline or shade changes. The Preliminary Studies/Progress Report section
should incorporate any work done since the prior version was submitted.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. 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 a Special Emphasis Panel convened by the Division of
Extramural Affairs, NHLBI, in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:

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 written critique
o Receive a second level review by the National Heart, Lung, and Blood Advisory
Council.

REVIEW CRITERIA

The following criteria will be considered in the evaluation of the proposed NHLBI
Minority Institutional Research Training Program:

(1) Program Design: Design of the proposed training program;

(2) Program Director and Faculty of Minority School: Qualifications, dedication,
commitment, and previous training record of the program director and all participating
faculty, particularly with regard to prior experience with similar programs;

(3) Research Center: Adequacy of the cooperative arrangements between the minority
institution and the collaborating research center; commitment of the relevant faculty
at the collaborating Research Center to the training program;

(4) Recruitment and Retention Plans for Trainees: Recruitment and selection plans for
trainees, and the availability of high quality candidates; methods for retaining
promising students in the program and methods for tracking students;

(5) Environment: Adequacy of facilities, environment, and resources for the proposed
research training, both at the minority institution and the collaborating research
center;

(6) Program Evaluation: Procedures for evaluation of the effectiveness of the program
and impact of the program on the trainees involved.

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and
protections from research risk relating to their participation in the proposed research
will be assessed. (See criteria included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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
in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used
in the project, the five items described under Section f of the PHS 398 research grant
application instructions (rev. 5/2001) will be assessed.

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

Training in the Responsible Conduct of Research (RCR): Every predoctoral and
postdoctoral NRSA trainee supported by an institutional research training grant must
receive instruction in RCR. (For more information on this provision, see the NIH Guide
for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see
http://grants.nih.gov/grants/guide/notice-files/not92-236.html.) Applications must
include a description of a program to provide formal or informal instruction in
scientific integrity or RCR.

Program reports on the type of RCR instruction provided, topics covered, and other
relevant information, such as attendance by trainees and faculty participation, must be
included in future competing continuation and noncompeting applications. The NIH
encourages institutions to provide instruction in RCR to all graduate students,
postdoctorates, and research staff regardless of their source of support.

NIH initial review groups will assess the applicant’s RCR plans on the basis of the
appropriateness of topics, format, amount and nature of faculty participation, and the
frequency and duration of instruction.

The RCR plan will be discussed after the overall determination of merit, so that the
review panel’s evaluation of the plan will not be a factor in the determination of the
priority score. Plans will be judged as acceptable or unacceptable. The acceptability
of the plan will be described in an administrative note on the summary statement.
Regardless of the priority score, applications with unacceptable plans will not be
funded until the applicant provides a revised, acceptable plan. Staff within the NIH
awarding component will judge the acceptability of the revised plan.

Following initial review, the NHLBI Advisory Council provides a second level of review.
The Council will consider the assessment of the scientific and educational merit of the
research training grant application as well as the plan for instruction in RCR.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: May 22, 2004; May 21, 2005; May 20, 2006
Application Receipt Date: June 23, 2004; June 22, 2005; June 21, 2006
Peer Review Date: October/November 2004; October/November 2005; October/November 2006
Council Review: January 2005; January 2006; January 2007
Earliest Anticipated Start Date: April 1, 2005; April 1, 2006; April 1, 2007

AWARD CRITERIA

Criteria that will be used to make award decisions include:

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

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and
proposals involving human subjects must be evaluated with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained or to
be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: NIH Policy for Data and Safety 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 "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 are 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 trials 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 PARTICIPANTS 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.

All investigators proposing research involving human subjects should read the "NIH
Policy and 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 EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application
as appropriate, 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department
of Health and Human Services (DHHS) issued final modification to the “Standards for
Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection of
individually identifiable health information, and is administered and enforced by the
DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the
researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr) provides
information on the Privacy Rule, including a complete Regulation Text and a set of
decision tools on “Am I a covered entity?” Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress monitoring of
grants, cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT 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. 93.233, 93.837, 93.838, and 93.839 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems Agency
review. Awards are made under the authorization of Section 487 of the Public Health
Service Act as amended (42 USC 288) and administered under NIH grants policies
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 66.

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 103-227, 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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NIH Funding Opportunities and Notices

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