INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD
RELEASE DATE: February 5, 2004
PA NUMBER: PAR-04-058 (Reissued as PAR-07-014)
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.ninr.nih.gov/)
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) 710-0267, 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://www.hhs.gov/ohrp/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://www.hhs.gov/ohrp/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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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