NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32)
RELEASE DATE: March 14, 2003
RFA: HL-03-013 (see continuation RFA-HL-04-027)
National Heart, Lung, and Blood Institute (NHLBI)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
93.233, 93.837, 93.838, 93.839
LETTER OF INTENT RECEIPT DATE: May 22, 2003
APPLICATION RECEIPT DATE: June 23, 2003
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 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 NHLBI 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.
Although the number of underrepresented minority individuals (Blacks,
Hispanics, Native Americans) pursuing advanced degrees in the biomedical and
behavioral sciences increased over the past 20 years, their representation in
these fields remains below their representation in the U.S. population
(National Research Council, Survey of Earned Doctorates, 2000). There are
existing programs at the NIH that are designed to increase the number of
minorities in biomedical and behavioral research. These include the Minority
Biomedical Research Support Program, the Minority Access to Research Careers
Program, and the Research Supplements for Underrepresented Minorities Program.
Even though these programs appear successful in meeting their specific
objectives and career development goals, more needs to be done to attract
minorities to biomedical and behavioral research careers.
The NHLBI Minority Institutional Research Training Program makes research
training grant awards 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).
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Ruth L. Kirschstein
Institutional National Research Service Award (NSRA) mechanism (T32).
Responsibility for the planning, direction, and execution of the proposed
training program will be solely that of the applicant. The total project
period for an application submitted in response to this RFA may not exceed
five years. 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 a second or 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 is April 1, 2004.
The estimated funds (total costs) available for the first year of support for
the entire program is expected to be $250,000 in Fiscal Year 2004 (October 1,
2003-September 30, 2004). The actual amount may vary, depending on the
response to the RFA and availability of funds. Two new awards are
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 for the program may be obtained
through the LRP website at http://www.lrp.nih.gov/.
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 school 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.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS/PROGRAM DIRECTORS
Any individual with the skills, knowledge, and resources necessary to organize
and implement a high quality research training program is invited to work with
their institution as the director of the research training program in order 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.
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.
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
Trainees can fall into one of the following categories:
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.
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
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 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
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
Provisions Of The Award
o 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
o 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.
o 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
Funds may be requested for:
A. Stipends - The current stipend level for graduate and health professional
student trainees at all levels of experience is $18,156 per year. Current
stipend levels for postdoctoral trainees are available at
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:
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
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.
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. The Public Health Service policy on RCR
(http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core
instructional areas that comprise RCR: data acquisition, management, sharing,
and ownership; mentor/trainee responsibilities; publication practices and
responsible authorship; peer review; collaborative science; human subjects;
research involving animals; research misconduct; and conflict of interest and
commitment. Plans for RCR training must describe the proposed subject matter,
format, frequency and duration of instruction. 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.
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
o Direct your questions about review issues to:
Anne Clark, Ph.D.
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:
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
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o A 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
for the review.
The letter of intent is to be sent to Dr. Anne Clark at the address listed
under WHERE TO SEND INQUIRIES by May 22, 2003.
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. Refer to T section. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
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
(NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM) and number (HL-03-
013) 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:
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in one
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
At the time of submission, two additional copies of the application and all
five collated sets of the appendix material must be sent to Dr. Anne Clark at
the address listed under WHERE TO SEND INQUIRIES.
APPLICATION PROCESSING: Applications must be received by June 23, 2003. 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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
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 in 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 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 Heart, Lung, and Blood
The following criteria will be considered in the evaluation of the proposed
NHLBI Minority Institutional Research Training Program:
o Design of the proposed training program;
o Qualifications, dedication, and previous training record of the program
director and all participating faculty, particularly with regard to prior
experience with similar programs;
o Adequacy of facilities, environment, and resources for the proposed research
training, both at the minority institution and the collaborating research
o Adequacy of the cooperative arrangements between the minority institution
and the collaborating research center;
o Recruitment and selection plans for trainees, and the availability of high
o Methods for retaining promising students in the program and methods for
o Commitment of the relevant faculty and the two institutions to the goals of
the training program; and
o 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 section on Federal Citations,
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: Every predoctoral and
postdoctoral NRSA trainee supported by an institutional research training
grant must receive instruction in the responsible conduct of research. (For
more information on this provision, see the NIH Guide for Grants and
Contracts, Volume 21, Number 43, November 27, 1992, see
must include a description of a program to provide formal or informal
instruction in scientific integrity or 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
o 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.
o Plans must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance, and the
frequency of instruction.
o The rationale for the proposed plan of instruction must be provided.
o Program reports on the type of 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 the responsible conduct of research to all graduate students,
postdoctorates, and research staff regardless of their source of support.
NIH initial review groups will assess the applicant's plans on the basis of
the appropriateness of topics, format, amount and nature of faculty
participation, and the frequency and duration of instruction.
The 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, 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 the plan
for instruction in the responsible conduct of research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: May 22, 2003
Application Receipt Date: June 23, 2003
Peer Review Date: October/November 2003
Council Review: February 2004
Earliest Anticipated Start Date: April 1, 2004
Award 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.
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.
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 and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
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 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
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 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
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