INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD 

RELEASE DATE:  February 5, 2004

PA NUMBER:  PAR-04-058  

EXPIRATION DATE:  February 17, 2006, unless reissued. 

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION: 
Fogarty International Center (FIC) 
 (http://www.fic.nih.gov) 
National Institute of Nursing Research (NINR) 
 (http://www.nih.gov/ninr/) 
Office of Dietary Supplements (ODS) 
 (http://dietary-supplements.info.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.989, 93.361, 93.113, 
93.114, 93.115

APPLICATION RECEIPT DATES:  February 18, 2004; February 18, 2005; February 
16, 2006

This Program Announcement (PA) replaces PAR-02-041, which was published in 
the NIH Guide on December 21, 2001.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The Fogarty International Center (FIC), the National Institute of Nursing 
Research (NINR), the NIH Office of Dietary Supplements (ODS), and the National 
Institute of Environmental Health Sciences (NIEHS) solicit proposals for the 
International Research Scientist Development Award (IRSDA).  This program 
supports U.S. postdoctoral biomedical, social, and behavioral scientists in 
the formative stages of their careers to conduct research in, or extend their 
research into, developing countries.  It provides the successful candidate 
with a period of mentored research as part of an established collaboration 
between a U.S. sponsor and a leading developing country scientist at an 
internationally recognized research institution in a developing country.  It 
is expected that this experience will prepare scientists to pursue an 
international research career involving on-going collaboration with developing 
country scientists on global health challenges.

The IRSDA is part of the FIC strategy to encourage research collaborations in 
developing countries in order to build research capacity to address global 
health research priorities.  The role of the IRSDA is to:

o  Attract new research talent to global health research and enhance multi-
disciplinary synergy among the research collaborators at the U.S. and foreign 
site; 

o  Advance the career paths of exceptional junior U.S. scientists with 
mentored training in health issues of developing country populations;

o  Extend the impact and reach of existing research and training support for 
developing country scientists and U.S. scientists committed to international 
research;

o  Provide opportunities for developing country institutions with significant 
potential to advance to higher levels of research excellence; and

o  Stimulate a more effective translation of the results of research on global 
health problems into practical public health actions.

With IRSDA support, the investigator will have the opportunity to work closely 
with both an established foreign scientist in the developing world and a U.S. 
investigator who are involved in collaborative research.  The applicant will 
conduct research and receive training at both the developed and developing 
country institutions.  It is expected that these awards will serve to forge 
collaborative relationships between established, developing country 
researchers and outstanding U.S. junior scientists, who are potential future 
heads of basic, clinical and behavioral/social health research programs in the 
U.S.  Collaborations are expected to lead to advances that will reduce the 
impact of global health problems and narrow the gap in health disparities 
between developed and developing countries.  

RESEARCH OBJECTIVES

The IRSDA provides international research opportunities and cutting-edge 
technical training (in eligible developing countries) for U.S. postdoctoral 
biomedical, epidemiological, clinical and behavioral scientists who are 
committed to careers in international health research.  The award supports the 
recipient to directly collaborate with a U.S. mentor and an established 
developing country mentor on a research project of mutual interest in the 
context of an ongoing or recent research relationship between the U.S. and 
foreign mentors.

The award is specifically designed to facilitate the candidate's productive 
interaction with both the U.S. and foreign institutions, and to enhance 
subsequent pursuit of an independent international research career.  The 
specific research training may be new to the candidate or an extension of the 
candidate's prior research, but should focus on international research areas 
pertinent to global health concerns.  Applicants are encouraged to consult the 
global health research priorities defined by the World Health Organization 
(http://www.who.ch) which include, but are not limited to, infectious 
diseases, nutrition, chronic/degenerative conditions, trauma/injury and mental 
health disorders, all of which can pose an increasing global burden in the 
coming decades.  Basic, behavioral/social and clinical biomedical research 
will be supported in clinical, field or laboratory settings.

The FIC recognizes that there will be significant differences in the U.S. and 
foreign institutional environments, applicants, U.S. and foreign mentor 
backgrounds and approaches to international research collaboration among 
applications.  Therefore, applicants should clearly define specific research 
and training goals, methods to achieve these goals, and specific measurable 
objectives to enable assessment of the proposed project, with reference to the 
overall goals described above.

MECHANISM OF SUPPORT 

This PA will use the NIH career development (K01) award mechanism (general 
K01 guidelines may be found at:  
http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html). 
Please note that this K01 award has some important 
differences from the K01 award described in PA-00-0019. These include:

o The original award period is for three to four years
o A competitive renewal is possible for up to three years
o Both a U.S. and a foreign mentor are required and must have a current or 
past research collaboration with each other
o Requirement of significant time spent in the foreign country
 
NINR is only interested in applications from nursing scientists who are 
pursuing careers related to HIV/AIDS. NINR will support initial applications 
for K01 awards. Renewal applications will be supported by Fogarty 
International Center.

This PA uses just-in-time concepts.  The IRSDA will provide direct costs for 
salary for the Principal Investigator up to $75,000 (based on the actual 
salary scale at his/her institution) plus applicable fringe benefits, plus an 
additional $20,000 for travel and research development support each year for 
up to four years.  The award supports an intensive, mentored research 
experience in a clinical, field or lab setting associated with strong research 
collaboration at a well-recognized research institution in a developing 
country.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.

Current IRSDA grantees who have obtained a tenure-track position at a domestic 
institution (or a developing country institution with prior approval from the 
IRSDA FIC program official) may submit a competitive renewal application at 
the same direct cost level described above in the case of an appointment at 
the assistant professor level, or up to $100,000 per year if the appointment 
is at the associate professor level.  At institutions or in departments where 
tenure-track positions are not available, the institution must demonstrate a 
comparable commitment to the candidate at the assistant professor level or 
above.  In such cases, consultation with the FIC IRSDA program officer is 
required.  The renewal may be for up to a three-year period and should be a 
continuation or extension of the research collaboration begun under the 
original K01.  Although additional training may be justified, the focus in the 
renewal should be on research.  As stipulated in the original K01 application, 
most of the proposed research should take place at the foreign site and the 
grantee is expected to spend as much time there as possible.  A minimum of one 
year of total time is required at the foreign site during the period of the 
grant with at least three months per year at the foreign site.

Responsibility for the planning, direction, and execution of the proposed 
project will be that of the candidate, her/his mentor at the foreign site and 
her/his U.S. mentor on behalf of the applicant institution.  Facilities and 
administrative (F & A) costs of eight percent should be used for IRSDA 
applications.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o Non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Domestic institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

SPECIAL REQUIREMENTS

To be eligible for the award the applicant must:

1.  Be a U.S. citizen, a non-citizen national or a permanent resident and in 
possession of an Alien Registration Receipt Card (I-151 or I-551) or some 
other verification of legal admission as a permanent resident.  Non-citizen 
nationals are usually born in areas that are not states but are under U.S. 
sovereignty, jurisdiction or administration.  Individuals on temporary or 
student visas are not eligible.

2.  Have earned a doctoral, dental or medical degree or the equivalent in a 
health, social or behavioral science field within seven years of the receipt 
date, except as noted below.  Exceptions must be approved by the FIC program 
officer.  

o  Time spent in clinical or other related training that is not research (such 
as policy training), or time spent obtaining another degree (e.g. M.P.H.), 
does not count toward the seven-year limit. 
o  Candidates who are more than seven years beyond the eligible degree, but 
who have interrupted their careers because of illness or family commitments, 
may also apply.  They must clearly demonstrate the potential for productive 
independent research and the need for an additional period of mentored 
research experience in order to accomplish an effective scientific re-entry.

3.  Have demonstrated a commitment and competence in health and health-related 
research, as well as the potential to engage in independent and productive 
biomedical, social, behavioral or epidemiological/clinical research in the 
period following the award.

4.  Have mentors in the United States and in the eligible developing country 
where the proposed research will be performed, who are committed to both the 
research and training requirements of the candidate.  

o  The U.S. mentor  must be at a U.S. institution of higher learning or non-
profit research institution.
o  The developing country mentor must be in an internationally-recognized 
developing country research institution addressing one or more of that 
country's major health problems.  Eligible countries include those in the 
following regions:  Africa, Asia (except Japan, Singapore, South Korea and 
Taiwan), Russia and countries of the Former Soviet Union, Central and Eastern 
Europe, Latin America and the Caribbean, the Middle East (except Israel) and 
the Pacific Ocean Islands (except Australia and New Zealand).  Applications 
for work in institutions in sub-Saharan Africa are especially encouraged.  
Awards may be delayed or denied by any State Department restrictions in effect 
at the time of award.
o  The two mentors for the IRSDA applicant must have a recent or on-going 
collaboration on a relevant research program or project.  An enhancing factor 
for consideration is a funded collaboration between the mentors.  Funding may 
include, but is not limited to, sources such as a National Institutes of 
Health (NIH) R01 grants with a foreign component, Fogarty International 
Research Collaboration Awards, World Health Organization grants, Burroughs-
Wellcome Foundation grants or other U.S. or international agency funding.

5.  Submit a research proposal related to, but not overlapping with, the 
collaborative research project of the U.S. and foreign site mentors;

Applicationsmust be submitted on behalf of the candidate by the U.S. mentor's 
institution, which must be a U.S. research institution.  While in most cases 
the applicant will be at the same U.S. institution as his/her mentor, s/he 
need not hold a position at the U.S. mentor's institution. 

Applicants awarded an initial competitive IRSDA grant agree to spend a minimum 
of 50 percent of the period of the grant at the foreign research site, with at 
least three months per year at the site.  Applicants who already have a 
faculty position need a letter of support from their institution that shows 
they will be released from clinical and teaching duties to conduct research at 
the foreign site for the required minimum time.

Applicants awarded a competitive renewal grant agree to spend a minimum of one 
year of total time at the foreign site and a minimum of three months per year 
at the foreign site.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Rachel A. Nugent, Ph.D.
Division of International Training and Research
Fogarty International Center 
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 496-8733
Fax:  301-402-0779
Email: nugentra@mail.nih.gov

Martha L. Hare, Ph.D., R.N
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD  20892-4870 (Courier: 20817)
Phone: 301-451-3874
Fax: 301-480-8260
Email: harem@mail.nih.gov

Mary Frances Picciano, Ph. D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes Of Health
31 Center Drive, 1B29
Bethesda, MD 20892-2086
Telephone: 301-435-3608
Fax: 301-480-1845
Email: PiccianM@mail.nih.gov

Dr. Carol Shreffler
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-23)
Research Triangle Park, NC  27709-2233
Telephone:  919-541-1445
Fax:  919-541-5064
Email:   shreffl1@niehs.nih.gov 

o Direct your questions about peer review issues to: 

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC 7840, Room 5136
Bethesda, MD  20892-7840 (Courier:  20817)
Telephone:  (301) 435-1021
Fax:  (301) 480-3567
Email: duperes@csr.nih.gov 

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

Bruce Butrum
Office of the Director
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
Fax:  301-594-1211
Email: Butrumb@mail.nih.gov

Teresa Marquette
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
Bethesda, MD  20892-4870
Telephone:  301-594-2154
Fax:  301-402-4502
Email:  MarquetteT@mail.nih.gov 

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 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS

The application must:

o  Establish the candidate's commitment to a career in international 
biomedical, clinical, social or behavioral research addressing a major global 
health problem.
o  Establish the candidate's potential to develop into a successful 
independent investigator.
o  Summarize the candidate's immediate and long-term career objectives, 
explaining how the award will contribute to their attainment.
o  Provide a career development plan.  The plan should incorporate a detailed 
description of Ph.D. and other previous research experiences, as well as an 
explanation of long-term career goals of the applicant and role of this award 
in achieving them, including intentions to establish future foreign 
collaborations.  It should delineate a systematic approach to achieving the 
necessary basic biomedical, social or behavioral science background and 
research experience to launch an independent international research career 
addressing a major global health problem.
o  Provide a research plan using form PHS 398 and the use of a sound research 
approach to a biomedical, social or behavioral problem including the Specific 
Aims, Background and Significance, Progress Report/Preliminary Studies, 
Research Design and Methods sections.  It should include an annual schedule of 
planned research activities at the U.S. and foreign sites during that period.  
The research plan should serve as a justification for conducting research 
abroad and provide a clear description of the relationship between the 
proposed research and current research efforts at U.S. and foreign labs.
o  For renewal applications, the research plan must describe progress made 
under the original K01 and how the research proposed in the renewal continues 
or extends the original research.

U.S. and foreign mentor statements must:

o  Be included in the application and provide information from the U.S. and 
foreign mentors about their research collaboration, their research 
qualifications and previous experience, and their record in supervising 
research training (number of Ph.D. and post-docs mentored and their current 
career status).  Both the U.S. and foreign mentors should submit Biographical 
Sketches, Other Support and Resources Forms.  The application must also 
include a detailed plan for the supervision of the Fellow, by both mentors, at 
each institution, during the proposed award period.

Support Letters

o  For the original K01 application, three sealed letters of recommendation 
from senior research scientists, addressing the candidate's potential for an 
international research career, must be included as part of the application.  
One of the three letters should be from the applicant's thesis advisor, 
research supervisor, chief of staff or department head.  Letters of 
recommendation should not be submitted from either the U.S. or foreign mentor. 
o  For renewal applications, a letter from the applicant's U.S. institution 
must be submitted indicating commitment to provide the candidate with the 
necessary support and time, free from clinical and teaching duties, to 
continue the international work proposed in the application.

Training in Responsible Conduct of Research

o  Candidates must describe evidence of previous training or plans to receive 
instruction in the responsible conduct of research in an international 
context.  The topics, format, frequency and duration of instruction, as well 
as the amount and nature of faculty participation, should be detailed.  No 
award will be made if an application lacks this component.

U.S. and Foreign Institutional Commitments

o  The extent and quality of the research environment, relevant to the 
candidate's research focus, should be described for the U.S. and foreign 
institutions.  The research environment includes faculty and staff capable of 
productive collaboration with the candidate, seminars and opportunities for 
interactions with other research groups and scientists and available research 
facilities and equipment.

o  A detailed description of overall research funding at the foreign 
institution (government, non-government and international sources), specific 
for the proposed research area, should be included to support its status as an 
existing or potential center of research excellence.

Budget

o  Budget requests must be provided according to instructions in form PHS 398 
(rev. 5/2001)

Allowable Costs:

1.  The IRSDA will provide direct costs for salary for the Principal 
Investigator up to $75,000 (based on the actual salary scale at his/her U.S. 
institution) plus applicable fringe benefits, plus an additional $20,000 for 
travel and research development support each year for up to four years.  The 
IRSDA will provide up to $100,000 per year for a renewal candidate who has 
been appointed to a tenure-track position at the associate professor level.  
The institution may supplement the NIH contribution to the candidate's salary 
up to a level that is consistent with the institution's salary scale.  
Institutional supplementation of salary must not require extra duties or 
responsibilities that would interfere with the purpose of the award. 

2.  Research Development Support:  These funds may be used for expenses such 
as:  (a) tuition, fees, and books related to career development; (b) research 
expenses, such as supplies, equipment and technical personnel; (c) language 
training; (d) statistical and computational services (including personnel and 
computer time; (e) in-country travel required for research, research meetings 
or training; round trip economy class airfare (on a U.S. carrier) and 
necessary ground transportation for the candidate to and from the foreign site 
over the duration of the project; roundtrip economy airfare for each dependent 
accompanying the awardee for four months or more abroad.

3.  Ancillary Personnel Support:  Salary for mentors, secretarial and 
administrative assistance, etc., is not allowed.

All expenses must be directly related to the proposed research career 
development program.  Facilities and Administrative (F & A) costs of eight 
percent are applied to allowable direct costs.

Concurrent Applications

A candidate for the K01 award may not have pending nor concurrently apply for 
any other career development award. 

Subsequent Applications for NIH Research Support

Subsequent to receiving the K01 Award, incumbents are encouraged to apply for 
independent research support (e.g., R01, etc.).  K01 recipients who are 
successful in obtaining NIH research grant support may receive salary support 
from the research grant under the policy described in 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html. 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates.  The application must be received by the date listed on the front of 
this program announcement.  The 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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of a substantial 
revision of an unfunded version 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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate national advisory council 
or board. 

REVIEW CRITERIA

Candidate:

o  Commitment to an independent international research career including 
potential to contribute to knowledge that will address a major global health 
problem;
o  Potential to develop (or evidence of the capacity to develop) as an 
independent investigator pursuing international research;
o  Quality and relevance of prior scientific training and experience including 
detailed description of previous research, record of previous research support 
and publications.

Career Development Plan:

o  Likelihood that the research and training in the plan will contribute 
substantially to the scientific development of the candidate, the achievement 
of scientific independence and ongoing involvement in collaborative 
international research;
o  Appropriateness of the plan to the career goals of the candidate;
o  Appropriateness of the plan to increase conceptual and theoretical 
knowledge in the research area proposed;
o  Consistency of the plan with the candidate's prior training, research and 
academic experience and the stated career goals;
o  Clarity of the goals and scope of the plan and the need for the proposed 
research and training experience at the foreign site;
o  Adequacy of the proposed training for responsible conduct of research in an 
international context;
o  Clear description of the roles of the U.S. and foreign mentors in the 
training and research planned.

Research Plan:

o  Usefulness of the research plan as a vehicle for enhancing existing 
research skills as described in the career development plan;
o  Scientific and technical merit of the research question, design and 
methodology judged in the context of the candidate's previous training and 
experience;
o  Relevance of the proposed research to a major global health problem;
o  Relevance of the proposed research to the candidate's career objectives.

U.S. and Foreign Mentors:

o  Appropriateness of U.S. and foreign mentors' collaborative research and 
their other research and training qualifications for the proposed project;
o  The extent of the commitment of each mentor to supervising and guiding the 
candidate throughout the award period;
o  Adequacy of each mentor's previous experience in fostering the development 
of independent researchers highlighting persons involved in international 
research;
o  Adequacy of each mentor's research productivity and grant support related 
to the proposed project.

U.S. and Foreign Institutional Environment:

o  Adequacy of the research facilities at the U.S. and foreign institutions;
o  Adequacy of the training opportunities and quality of the environment for 
scientific and professional development at the U.S. and foreign institutions.

If applying for a renewal K01 award:

Soundness of the rationale for an extended career development award rather 
than a research grant (R01, etc.) award.

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.)  
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm 

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, will be assessed.  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 VERTERBRATE 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

ADDTIIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget in relation to career 
development goals and research aims and plans.

AWARD CRITERIA

Applications submitted in response to this PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:

o  Scientific, technical and educational merit as determined by peer review
o  Availability of funds
o  Likelihood that the proposal will contribute to the achievement of FIC's 
objectives.

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://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm 

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 
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.

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 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.

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). 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 
(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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ 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 Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and 
established within the Office of the Director, National Institutes of Health 
(NIH).  The Dietary Supplement Health and Education Act (DSHEA) [Public Law 
103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act “to 
establish standards with respect to dietary supplements.”  This law 
authorized the establishment of ODS.

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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