RELEASE DATE:  April 29, 2003

PA NUMBER:  PAR-03-114 (See Notice NOT-GM-08-124 Change in Review Contact)

APPLICATION RECEIPT DATES:  April 5 and December 5

EXPIRATION DATE:  December 6, 2006, unless reissued

National Institute of General Medical Sciences (NIGMS) 

This Program Announcement (PA) replaces PAR-99-142, which was published in the 
NIH Guide, August 16, 1999. 

93.233,  93.272,, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 
93.846-93.849, 93.853-93.856, 93.859, 93.862-93.867, 93.880, 93.894, and 93.929. 


o  Purpose of the PA
o  Training Objectives
o  Mechanism of Support
o  Individuals Eligible to Apply
o  Specific Instructions to Applicants
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Additional Review Criteria
o  Award Criteria
o  Required Federal Citations


In 2002, the National Research Service Award Program was renamed the Ruth L. 
Kirschstein National Research Service Award program as a tribute to Dr. 
Kirschstein's years of exceptional service to the country.  Additional details 
related to this legislative change are available at
training/news.htm.  Under this congressional authority, the Minority 
Access to Research Careers (MARC) Program of NIGMS awards individual 
predoctoral fellowships (F31) to eligible applicants. 

The intent of the MARC Predoctoral Fellowship Program is to encourage students 
from minority groups underrepresented in the biomedical and behavioral sciences 
to seek graduate degrees, thus furthering the goal of the NIGMS MARC Branch of 
increasing the number of underrepresented minority scientists who are 
competitively trained to pursue careers in biomedical or behavioral research.  
It is expected that training will be conducted in graduate degree programs of 
the highest quality.

MARC Predoctoral Fellowships will provide up to five years of support for 
research training leading to the Ph.D., M.D./Ph.D. or other combined 
professional degree/Ph.D. in the biomedical or behavioral sciences, including 
mathematics.  These Fellowships are for selected students who are graduates of 
MARC undergraduate research training programs.  Support is not available for 
individuals enrolled in medical or other professional degree schools unless 
they are enrolled in a combined professional degree/Ph.D. program in the 
biomedical or behavioral sciences.  Support is also not available for study 
toward only the Master's degree.

This NIGMS MARC Predoctoral Fellowship Program should not be confused with the 
Ruth L. Kirschstein Minority Predoctoral Fellowship Program, a trans-NIH 
supported program, which has different eligibility and program requirements, 
and different application receipt dates.


The goals of the MARC Branch are to increase the number of underrepresented 
minorities engaged in biomedical research and their potential for quality 
research, and to strengthen science course curricula and research training 
environments at minority/minority serving institutions.  As part of its ongoing 
commitment to the development of research training capabilities at these 
institutions the MARC Branch will provide funds to eligible underrepresented 
minority students who, as undergraduates, were MARC trainees, and who have been 
accepted or enrolled in a program leading to a Ph.D. degree or equivalent in 
the biomedical/behavioral sciences.


This PA will use the individual Predoctoral Fellowship (F31) award mechanism.  
It is issued under the auspices of the Ruth L. Kirschstein National Research 
Service Award Program (see AUTHORITY AND REGULATIONS).  The proposed training 
under the F31 award must be within the fields related to biomedical or 
behavioral research and must be directed to obtain a research doctoral degree.  
Applicants are required to pursue their research training on a full-time basis, 
devoting at least 40 hours per week to the training program.  Awards are not 
made for study leading to any of the professional degrees (M.D., D.O., D.D.S.,

The period of fellowship support requested in response to this PA may not 
exceed five years.  (Note: the total period of predoctoral training support is 
limited to five years by statute, 42USC 288, except in unusual circumstances.)  
The recipient of MARC predoctoral fellowship support must submit a written 
request to waive this limit on the duration of support from the NIGMS.  
Continuation of the fellowship for each subsequent year beyond the first award 
period is based upon evidence of satisfactory progress in a graduate program.

Fellowship awards are administered as described in the NIH Grants Policy 
Statement found at and the NRSA 
Guidelines for Individual Awards and Institutional Grants, available on the 
NIH Website at  


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

MARC STATUS:  Applicants must be graduates of either the MARC HURT or the 
MARC U*STAR Programs.  In addition, applicants must be currently enrolled in 
a Ph.D. or equivalent research degree program, a combined M.D./Ph.D. program 
or other combined professional degree/Ph.D. program in the biomedical or 
behavioral sciences, including mathematics, and must have a thesis mentor and 
thesis project acceptable to the institution's Ph.D. dissertation committee(s).


ALLOWABLE COSTS: The MARC Predoctoral Fellowship Award provides an annual 
stipend to help meet the fellow's living expenses and an annual institutional 

STIPEND: A MARC Predoctoral Fellowship provides an annual stipend of $19,968.  
The actual amount of stipend will be prorated by the length of the award if the 
award is less than 12 months.  The stipend is not provided as a condition of 
employment with either the Federal Government or the institution.  

TUITION, FEES, AND HEALTH INSURANCE:  The NIH will offset the combined cost of 
tuition, fees and health insurance (either self-only or family as appropriate) 
at the following rate: 100% of all costs up to $3,000 and 60% of all costs 
above $3,000.  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 fellowship.  A full description of the tuition 
policy is contained within the NRSA Policy Guidelines on the NIH website at 

INSTITUTIONAL ALLOWANCE:  NIH will provide an institutional allowance of $2,750 
per 12-month period to nonfederal, nonprofit, or foreign sponsoring 
institutions to be used for expenses directly related to the applicant's 
research training.  Examples of such training related expenses might be 
research supplies, small equipment, and travel to scientific meetings.  The 
allowance is not available until the fellow officially activates the award. 

OTHER TRAINING COSTS:  Additional funds may be requested by the institution 
when the training of a fellow involves extraordinary costs for travel to field 
sites remote from the sponsoring institution or accommodations for fellows who 
are disabled, as defined by the Americans with Disabilities Act.  The funds 
requested for extraordinary costs must be reasonable in relationship to the 
total dollars awarded under the fellowship and must be directly related to the 
approved research training experience.  Such additional funds shall be provided 
only in exceptional circumstances that are fully justified and explained by the 

FACILITIES AND ADMINISTRATIVE COSTS:  F&A (indirect) costs are not allowed on 
individual fellowship awards.  

permitted to provide funds to a fellow in addition to the stipend paid by the 
NIH.  Such additional amounts may be in the form of augmented stipends 
(supplementation) or compensation for services.

SUPPLEMENTATION:  Supplementation or additional support to offset the cost of 
living may be provided by the sponsoring institution, but must not require any 
additional effort from the fellow.  Federal funds may not be used for 
supplementation unless specifically authorized under the terms of both the 
program from which such supplemental funds are to be received and the program 
whose funds are to be supplemented.  Under no circumstances may PHS grant funds 
be used for supplementation.

COMPENSATION:  An institution may provide additional funds to a fellow in the 
form of compensation (as salary and/or tuition remission) for services, such as 
teaching or research.  Compensation for services is not considered stipend 
supplementation.  A fellow may receive compensation for services as a research 
assistant or in some other capacity on a Federal research grant, including a 
PHS research grant.  However, compensated services must occur on a limited, 
part-time basis apart from the normal training activities, which require a 
minimum of 40 hours per week.  In addition, compensation may not be paid from 
a research grant supporting research that is part of the F31 research training 

Under no circumstances may the conditions of stipend supplementation or the
services provided for compensation interfere with, detract from, or prolong the 
fellow's approved NRSA training program.  Additionally, compensation must be in 
accordance with institutional policies applied consistently to both Federally 
and non-Federally supported activities and supported by acceptable accounting 
records determined by the employer-employee relationship agreement.

EDUCATIONAL LOANS OR THE GI BILL:  An individual may make use of Federal 
educational loan funds and assistance under the Veteran's Readjustment Benefits 
Act (GI Bill).  Such funds are not considered supplementation or compensation.

CONCURRENT AWARDS:  An F31 may not be held concurrently with another federally 
sponsored fellowship or similar Federal award that provides a stipend or 
otherwise duplicates provisions of the NRSA.

TAX LIABILITY:  The Internal Revenue Code, Section 117, applies to the tax 
treatment of all scholarships and fellowships.  Under that section, non-degree 
candidates are required to report gross income, all stipends and any monies 
paid on their behalf for course tuition and fees required for attendance.  

The taxability of stipends, however, in no way alters the relationship between 
NRSA fellows and institutions.  NRSA stipends are not considered salaries.  
NRSA fellows are not considered to be in an employee-employer relationship 
with the NIH or with the institution at which they are receiving their training. 

The interpretation and implementation of the tax laws is the domain of the 
Internal Revenue Service (IRS) and the courts.  The NIH takes no position on 
the status of a particular taxpayer, and it does not have the authority to 
dispense tax advice.  Individuals should consult their local IRS office about 
the applicability of the law to their situation and for information on the 
proper steps to be taken regarding their tax obligations.

LEAVE:  Fellows may continue to receive stipends during periods of vacation and 
holidays available to individuals in comparable training positions at the 
training institution.  Also, fellows may continue to receive stipends for up to 
15 calendar days of sick leave per year.  Sick leave may be used for the 
medical conditions related to pregnancy and childbirth.  Fellows may continue 
to receive stipends for up to 30 calendar days of parental leave per year for 
the adoption or the birth of a child when those in comparable training 
positions at the grantee or sponsoring institution have access to paid leave 
for this purpose and the use of parental leave is approved by the sponsor.  
A period of terminal leave is not permitted and payment may not be made from 
grant funds for leave not taken.  Individuals requiring extended periods of 
time away from their research training experience must seek approval from 
NIGMS for an unpaid leave of absence.


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

o  Direct your questions about programmatic issues to:

Adolphus P. Toliver, Ph.D.
Chief, Minority Access to Research Careers Branch 
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.37, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-3900
FAX:  (301) 480-2753

o  Direct your questions about peer review issues to:

Richard I. Martinez, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2781

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

Ms. Antoinette Holland
Grants Management Officer
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:  (301) 480-2554


Applications for a Ruth L. Kirschstein Individual National Research Service 
Award must be prepared using PHS 416-1 (6/02 rev.).  The PHS 416-1 is available 
at in an interactive format.  For 
further assistance, contact Grantsinfo, telephone (301) 710-0267, Email:  

Prospective student applicants are strongly advised to seek the assistance of 
their MARC Program Director, graduate program director, and/or research advisor 
in preparing his/her application.

SUPPLEMENTAL INSTRUCTIONS:  The applicant must follow all general instructions 
in the application kit (PHS Form 416-1, Revised 6/02) except for those which 
are modified by the supplemental instructions below.

A.  Information about the Student Applicant-Section 1/Part 1  

Applicants are responsible for completing the following sections of the 
Fellowship Application Kit:

Face Page: Items 1-8, 15 
Form Page 2: Items 16-18; 22 (if appropriate) 
Form Page 3: Table of Contents  
Form Page 4: All 
Form Page 5: All 
Form Page 6: All 
Personal Data Page: All 
Form Page 9 (checklist): Section I only

Clarifying Instructions for Selected Items

1.  Face Page

Item 2 (Face Page, Level of Fellowship):  Type in the space provided "MARC 
Predoctoral Fellowship".
Item 3 (Program Announcement/Request for Applications):  Type "PAR-03-114".  
Item 6 (Prior and/or Current NRSA Support):  Check "yes" and complete Item 24, 
Form Page 5.
(Items 9 - 14 should be completed by the sponsor or research advisor.)

2.  Form Page 2 

Item 17 (Form Page 2, Employment):  Your employment history during college 
should also be included if it involved a significant time commitment.
Items 19, 20, and 21 should be completed by your sponsor or research advisor.
Item 22 (Research Proposal Description):  Complete this section following the 
instructions in the kit (instruction page 9).

3.  Form Page 4 

Item 23 (Form Page 4, Scholastic Performance):  Be sure to include your scores 
from the GRE or MCAT at the bottom of the page.

4.  Form Page 5

Item 24 (Form Page 5, Prior and/or Current NRSA Support):  List the institution 
where you were a MARC trainee and give the dates.  If you have received any 
other support from a National Research Service Award grant, such as a 
predoctoral training grant, list the grant number, institution, and dates.  If 
you are not sure, check with the director of your graduate program.  Generally, 
only students already enrolled in a graduate program will have had such support.
Item 25b (Title of Thesis/Dissertation):  If you have a Master's Degree, give 
the title of your thesis and indicate that it is your MS thesis; otherwise 
leave blank.
Item 26 (Name of Thesis Advisor):  Give the name, title, department, and 
institution of your thesis advisor.

5.  Form Page 6

Item 28 (Form Page 6, Research Experience):  Provide a thorough description of 
your relevant work and research experiences, including time, place, research 
director, the research projects, and your role in the research.

Include a list of publications, abstracts, and poster presentations, if 
available.  If you have them, submit three collated sets of copies of 
publications and abstracts as part of Section 3 (Appendix).

Do not complete Item 28b.

Item 29 (Revised Application) need not be completed unless THIS application is 
a revision of one submitted earlier.

Item 30 (Research Training Plan)
o  Item 30a (Approximate Percentage…):  Fill out the Table.
o  Item 30b and 30c (Research Proposal and Respective Contributions)
o  Complete these items according to the instructions in the application kit 
(instruction pages 11-21).  You should work closely with your research advisor 
to complete this section.
o  Item 30d (Selection of a Sponsor and Institution):  You should explain your 
reasons for selecting the degree program and school in which you have enrolled.
o  Provide a rationale for choosing that particular individual as your mentor.
o  Item 30e  Give a description of the plan to provide formal and informal 
instruction on scientific integrity and ethical principles in research.

B.  Information about the Faculty Sponsor and Graduate Program-Section 2/Part II

Your thesis research advisor should complete these items.

Clarifying Instructions for Selected Items

All of Section 2/Part II (Form Page 7) should be completed by the faculty 

1.  Item 32 and Item 33 (Form Page 8) should be completed by the applicant's 
thesis research advisor.

2.  Item 34 (Training Plan, Environment, Research Facilities, Form Page 8):  In 
addition to the information requested in the application kit (instruction page 
27), provide a full description of the graduate or combined degree program in 
which the applicant is/is to be enrolled.  This description should also outline 
the normal course of study (both didactic and laboratory) for students enrolled 
in the program.

For example, the description of a degree program would commonly sketch the 
program's administrative organization and responsibilities.  The following 
questions include the kind of information that the review group finds useful 
in assessing a graduate program.  (The specific features described should be 
tailored to the local program being presented and need not necessarily include 
all, or be limited to, the suggested questions.)

o  How does a student become aware of the laboratories/mentors available for 
thesis research?
o  Who advises a student concerning course and research mentor selection?
o  What are the qualifications required of a faculty member if he/she is to be 
eligible to serve as a Ph.D. mentor?
o  Who is responsible for monitoring a student's overall progress?
o  Describe any special program features (courses, seminars, retreats, teaching 
requirements, etc.).
o  What is the current student enrollment of the program?  How many students 
have entered and how many have completed the program in each of the last five 
o  What have these graduates done since graduation?
o  What proportion of the program's entering students complete their Ph.D. or 
M.D./Ph.D. degree studies?
o  What has the program's experience been in recruiting and training 
underrepresented minorities?
o  In the case of M.D./Ph.D. programs, how are the medical and graduate 
portions of a student's program integrated, and how is the transition between 
the two assisted?

Describe the applicant's course of study up to the time of submission of the 
application and plans for further study.

C.  Reference Reports/Letters-Section 3 

At least three faculty reference reports must be submitted with your 
application.  You should complete the top part of the reference form (Name of 
Applicant, Proposed Sponsoring Institution) and give one form to each person 
writing a reference letter for you.

o  One reference report must be from the MARC program director or a MARC 
faculty member who knows you well.
o  We strongly advise that at least one letter be from an individual who was 
your supervisor/advisor for one of your major research experiences, preferably 
a research experience outside of your home institution.

WILL BE RETURNED WITHOUT REVIEW.  The reference letters must be in sealed 
envelopes and attached with a clip to the original copy of your applications.

In addition to the three reference letters cited above, the following MUST be 
included with the application at the time of submission: 

o  A copy of the results of either the Graduate Record Examination (GRE) or the 
Medical College Admission Tests (MCAT) for M.D./Ph.D. applicants must be 
included at the end of the application.
o  A clear and legible copy of the applicant's transcript(s) from all 
undergraduate and graduate institutions in which the applicant is/has been 
enrolled must be included at the end of the application.
o  A description of the graduate or combined degree program in which the 
applicant is either enrolled or has been admitted and agreed to enroll must be 
included as Item 33 of the application.


Fellowships must be administered in accordance with the current NRSA Policy 
Guidelines for Individual Awards and Institutional Grants (see the NIH Website, the current 
NIH Grants Policy Statement (see the NIH Website at
grants/policy/policy.htm), and any terms and conditions specified on the 
Notice of Research Fellowship Award. 

ACTIVATION:  No funds may be disbursed until the fellow has started training 
under the award and an Activation Notice (PHS 416-5) has been submitted to the 

An awardee has up to six months from the issue date on the Notice of Research 
Fellowship Award to activate the award.  Under unusual circumstances, NIGMS 
may grant an extension of the activation period upon receipt of a specific 
request from the fellow.

CERTIFICATION AND REPORTING PROCEDURES:  No application will be accepted 
without the applicant signing the certification block.  Individuals admitted to 
the United States as Permanent Residents must submit notarized evidence of 
legal admission prior to the award.  At completion of the training, the fellow 
must submit a Termination Notice (PHS 416-7) to the NIH.  These forms may also 
be found on the NIH Website at

INVENTIONS AND DATA COLLECTION:  Fellowships made primarily for educational 
purposes are exempted from the NIH invention requirements.  F31 awards will not 
contain any provision giving PHS rights to inventions made by the award 

DATA SHARING:  NIH policy is to make available to the public the results and 
accomplishments of the activities that it funds.  Therefore, fellows are 
encouraged to publish the results and accomplishments of their F31 activities 
in the journals of their choice.  Awarding unit support must be acknowledged 
in the publications.  There are no restrictions on the publication of results 
in a timely manner.

COPYRIGHTS:  Except as otherwise provided in the terms and conditions of the 
award, when publications, data, or other copyrightable works are developed in 
the course of work under a NIH grant-supported project or activity the 
recipient is free to arrange for copyright without awarding unit approval. Any 
such copyrighted or copyrightable works shall be subject to a royalty-free, 
nonexclusive, and irrevocable license to the Government to reproduce them, 
translate them, publish them, or otherwise use them, and to authorize others 
to do so for Federal Government purposes.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at only two of the standard application deadlines, 
i.e., April 5 and December 5.  Standard application deadlines are available at  Application deadlines are also 
indicated in the PHS 416-1 application kit.

SENDING AN APPLICATION TO NIH:  Submit a signed, typewritten (single-sided) 
original of the application (including the checklist, Personal Data form, at 
least three sealed reference letters, and all other required materials), and 
one signed photocopy 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 same time, one additional copy should be sent under separate cover to:

Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12, MSC 6200
Bethesda, MD  20892-6200

APPLICATION PROCESSING:  Applications must be received by the receipt dates 
listed on the first page of this announcement.  The Center for Scientific 
Review (CSR) will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous critique.

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


Applications for this PA will be assigned to NIGMS.  Applications will be 
evaluated for the merit of the overall research training by the MARC Review 
Committee, composed primarily of non-government scientists selected for their 
competence in research and research training, which is convened in accordance 
with the standard NIH peer review procedures. 

As part of the initial merit review, all applications will:

o  Receive a written critique
o  Receive a second level review by the NIGMS Fellowship Oversight Group (FOG), 
comprised of NIGMS professional staff.


The MARC Review Committee will address and consider each of the criteria listed 
below in assigning the application's overall score, weighting them as 
appropriate for each application.  The application need not be strong in all 
categories to be judged likely to have an important training impact and thus 
to deserve a high priority score.  

In the written comments, the reviewers will be asked to discuss the criteria 
listed below in order to judge the likelihood of successful completion of the 
proposed research training leading to a research doctoral (Ph.D. or equivalent) 
degree by the applicant and achievement of the goals of this PA.  The review 
criteria focus on four main components: 

o  Candidate
o  Sponsor and Training Environment
o  Research Proposal
o  Research Training Potential
(1)  CANDIDATE:  An assessment of the applicant's qualifications and potential 
for a career as a researcher and teacher, based on past accomplishments, such 
as scholastic record and scholastic honors, career goals, scientific 
publications and/or presentations (if any), professional honors, and awards
and letters of recommendation.

(2)  SPONSOR AND TRAINING ENVIRONMENT:  An assessment of the qualifications of 
the sponsor as a mentor for the proposed research training program and of the 
quality of the training environment.

(3)  RESEARCH PROPOSAL:  The quality and appropriateness of the proposed 
training, including the merit of the scientific proposal and its relationship 
to the candidate's career plans. 

(4)  RESEARCH TRAINING POTENTIAL:  An assessment of the value of the proposed 
research training in preparing the candidate for quality research and/or 

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

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).

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 will be assessed.  Plans for the recruitment and retention of subjects 
will also be evaluated.  (See Inclusion Criteria included in the section on 
Federal Citations, below.)


DATA SHARING:  The adequacy of the proposed plan to share data.

the candidate's plans for obtaining instruction in the responsible conduct of 
research, including the rationale, subject matter, appropriateness, format, 
duration and frequency of instruction. No award will be made if an application 
lacks this component.


Applications submitted in response to this PA will compete for available funds 
with all other recommended applications for Ruth L. Kirschstein NRSA MARC 
Predoctoral Fellowship Awards.  The following will be considered in making 
funding decisions:

o  Scientific and technical merit of the application as determined by peer 
o  Availability of funds.
o  Relevance to program priorities. 


the policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification are 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 research involving human subjects 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 (
notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines 
is available at
_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: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and 
report analyses, as appropriate, by sex/gender and/or racial/ethnic group 

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

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  

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see  
It is the responsibility of the applicant to provide the official NIH 
identifier for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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:

Applicants may wish to place data collected under this PA 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.

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). Those who must comply with the Privacy Rule (classified under 
the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
( 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

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 a 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 PA is related to 
one or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at 

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  NRSA awards are made under the authority of Section 
487 of the Public Health Service Act as amended (42 USC 288) and Title 42 of 
the Code of Federal Regulations, Part 66.   Fellowships must be administered 
in accordance with the current NRSA Guidelines for Individual Awards and 
Institutional Grants, the current NIH Grants Policy Statement, and any terms 
and conditions specified on the Notice of Research Fellowship Award.  

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.