TRANSITION TO INDEPENDENT POSITIONS (TIP)
RELEASE DATE: February 24, 2003
RFA: ES-03-006
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113 and 93.115
LETTER OF INTENT RECEIPT DATE: June 13, 2003
APPLICATION RECEIPT DATE: July 14, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplemental Instructions
o Allowable Costs
o Peer Review Process
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
Human health and human disease result from three interactive elements: (1)
environmental exposures, (2) individual susceptibility, and (3) time. The
mission of the National Institute of Environmental Health Sciences (NIEHS) is
to reduce the burden of human illness and dysfunction from environmental
exposures by understanding each of these elements and how they interrelate.
The NIEHS achieves its mission through multidisciplinary biomedical research
programs, prevention and intervention efforts, and communication strategies
that encompass training, education, technology transfer, and community
outreach.
An important element of the NIEHS mission is to develop the next generation of
exceptionally talented young scientists who are committed to understanding the
impact of environmental exposures on human health. The NIEHS TIP Program is a
Research Scholar Development Award (K22) program targeted to talented
postdoctoral scientists. It provides a unique mechanism for attracting and
supporting the transition to independent faculty positions of exceptionally
talented new investigators who can impact our understanding of the problems
and mechanisms associated with exposure to environmental agents in order to
better protect the public health.
RESEARCH OBJECTIVES
Background
The Congress of the United States enacted the Ruth L. Kirschstein National
Research Service Act (NRSA) Program in 1974 to help ensure that highly trained
scientists would be available in adequate numbers and in appropriate research
areas to carry out the Nation's biomedical and behavioral research agenda.
Under this congressional authority, the NIEHS awards the NRSA individual
postdoctoral fellowship (F32) and Intramural Research Training Award (IRTA) to
the most promising applicants to support full-time research training related
to the mission of the NIEHS. The goal of these and other postdoctoral
training programs is to develop the next generation of exceptionally talented
young scientists who are committed to understanding the impact of
environmental exposures on human health. The NIEHS has determined that there
is a need for a mechanism to assist exceptionally talented investigators in
making the career transition from postdoctoral training to independent
academic research positions. To meet this need, the NIEHS has initiated the
TIP Program to facilitate the transition of the most talented postdoctoral
investigators into career positions relevant to the research priorities of the
NIEHS.
Goals and Scope
The NIEHS TIP Program is designed for exceptionally talented new environmental
health scientists in basic, clinical or population-based (epidemiology)
research who have demonstrated outstanding scientific abilities during their
training. The objective of the program is to provide a commitment of support
for the most promising new investigators early in their career while they
establish their independent research program in a research-intensive
environment relevant to environmental health sciences. The TIP investigators
are expected to design and pursue their research projects independently in
their areas of interest. It is anticipated that the successful applicant will
use the award to establish an independent research program and obtain
preliminary data that will be the basis for a future research application.
Specifically, the TIP investigator is expected to use the preliminary data in
the environmental health sciences as a basis for an investigator initiated
research grant (R01) or equivalent to the National Institutes of Health (NIH)
in an area of a science directly relevant to the mission of the NIEHS within
the first 24 months after initiation of the award.
The NIEHS has identified priority areas of research that can significantly
contribute to our understanding of the impact of environmental exposure on
human health. Research proposals that address one of these areas will receive
a priority for funding. The current areas of special emphasis are:
o Molecular Epidemiology
o Basic Molecular Mechanisms of Environmental Insult
o Genetic Susceptibility and Predispostion (Environmental Genome Project)
o Human Health Effects of Complex Mixtures
o Reproductive Health
o Neurodegenerative/Neurobehavioral Diseases or Disorders
o Translational Research
o Impact of Environmental Exposures on Special Populations (Women, Children
and Minorities)
o Immune System Modulation
Additional information about these research topics is available on the NIEHS
website at: http://www.niehs.nih.gov/dert/programs/special/special.htm.
This site is updated each year.
MECHANISM OF SUPPORT
This RFA will use the NIH Research Scholar Development Award (K22) mechanism.
As an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. Awards will be made prior
to September 2005.
This RFA uses just-in-time concepts. A detailed budget will be required at
the time of activation of the award. This program does not require cost
sharing as defined by the current NIH Grants Policy Statement at:
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm
FUNDS AVAILABLE
The NIEHS intends to commit approximately $500,000 in FY04 to fund five new
awards in response to this RFA. An applicant may request a project period of
up to three years and a budget for direct costs of up to $100,000 per year.
Although the financial plans of the NIEHS provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. Scholar
Development grants (K22) are not renewable but may be extended at no
additional costs at the discretion of the sponsoring institution where the TIP
award has been made. At this time, it is not known if this RFA will be
reissued.
ELIGIBLE INSTITUTIONS
Awards will be made at the institution where the postdoctoral applicant
accepts a suitable position. Institutions eligible to receive awards include
public or private domestic institutions, such as universities, colleges,
hospitals, and laboratories. Please see the Award Process and Initiation
section below for details.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
To be eligible to apply for a TIP Award the following criteria will apply:
1. The applicant must be either:
A. A current or former NIEHS Individual National Research Service Fellow
(NRSA, F32); or
B. A current or former NIH Individual NRSA (F32) Fellow who is training in an
area specific to the mission of the NIEHS, but whose support is from another
Institute, Center or Division (IC) of the NIH and whose proposed research
project directly addresses the effect of an environmental exposure on human
illness or dysfunction; or
C. A current NIEHS Intramural Research Training Awardee (IRTA), equivalent
staff fellow, or intramural clinical fellow who has competed successfully in
the NIEHS Intramural eligibility process. NIEHS clinical fellows with the
M.D., M.D.- Ph.D., D.O., D.D.S., Pharm.D - MS, Pharm.D - Ph.D., RN - Ph.D. or
comparable clinical or combined clinical/research degrees are eligible to
apply. In most cases, clinical fellow applicants will have finished their
clinical training and may have had some research experience in either a
laboratory or clinical setting prior to an appointment in the NIEHS Intramural
Program. Clinical candidates should possess aptitudes for independent research
in clinically relevant, patient-oriented or population- based research (e.g.,
epidemiology, behavior, or disease prevention) areas. The Intramural contact
person for this program is Dr. William T. Schrader, 919-541-3433,
schrader@niehs.nih.gov.
Individuals with a research or health professional doctoral level degree or
equivalent with at least 18 months but not more than six years (72 months) of
postdoctoral research training at the time of application, and with
demonstrated outstanding abilities in basic, clinical or population-based
(e.g., epidemiologic) research, are eligible to apply. This includes
individuals with postdoctoral research experience in any environment (e.g.,
academic, industry, and government). Individuals who have had more than six
years (72 months) of postdoctoral research experience are NOT eligible to
apply. However, years of clinical training will not count against the six
years of relevant research experience. Individuals who have held research or
other professorship or equivalent positions in academe or elsewhere or have
been a Principal Investigator on either PHS research grants (e.g., R29, R01,
P01, or its subprojects) or non-PHS peer-reviewed research grants are NOT
eligible to apply for this award.
The NIEHS will return applications not considered relevant either to the
mission or to the research priorities of the NIEHS as part of the initial
review described in the section, REVIEW CRITERIA of this Request for
Applications. This decision is final. Fellows are STRONGLY ENCOURAGED to
contact the program administrator listed under WHERE TO SEND INQUIRIES to
determine the priority and relevance of his/her research topic to the NIEHS
prior to submitting an application. Applicants should identify an NIEHS area
of special emphasis that is relevant to his/her research interests. This
information is available on the NIEHS web site at
http://www.niehs.nih.gov/dert/programs/special/special.htm.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.
Candidates must be U.S. citizens or non-citizen nationals, or must have been
lawfully admitted for permanent residence and possess an Alien Registration
Card (I-151 or I-152) or some other verification of legal admission as a
permanent U.S. resident, at the time of submission. Non-citizen nationals,
although not U.S. citizens, owe permanent allegiance to the U.S. They are
usually born in lands that are not states, but are under U.S. sovereignty,
jurisdictions, or administration. Individuals on temporary or student visas
are NOT eligible to apply. The TIP K22 is a domestic U.S. award and may not
be awarded to non-U.S. grantee institutions.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Carol Shreffler, Ph.D.
Scientific Program Administrator
Organs and Systems Toxicology Branch (EC-23)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1445
FAX: (919) 541-5064
Email: shreffl1@niehs.nih.gov
o Direct your questions about peer review to:
Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Susan Ricci
Grants Management Specialist
Grants Management Branch (EC-22)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 316-4666
FAX: (919) 541-2860
Email: ricci@niehs.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed project
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIEHS staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent to by the date listed at the beginning of
this document. The letter of intent should be sent to:
Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive
79 T.W. Alexander Drive, 3rd Floor (for express/courier service)
Research Triangle Park, NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://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.
SUPPLEMENTAL INSTRUCTIONS
Only one grant application may be submitted by a Principal Investigator for
the specified receipt date. The applicant institution information requested
on the face page should be that for the institution from which the application
is being submitted, i.e., the institution where the trainee is located at the
time of submission. The Description, Performance Sites, and Key Personnel
should appear as page two.
The Detailed Budget for the Initial Budget Period (Form Page 4) and Budget for
Entire Proposed Period of Support (Form Page 5) are NOT required for the
initial application and should be omitted. A detailed budget is subsequently
required only for the activation of the award at the academic institution of
employment. See specific instructions below for allowable costs
The maximum amount awarded to each grantee on this RFA will be $300,000 direct
costs for a three-year project period. The amount awarded for any given year
(budget period) will not exceed $100,000 direct costs.
The maximum salary allowed from this award is $50,000 per year.
A two section narrative presentation (two-page maximum) should be inserted in
the application just prior to the research plan titled "Future Goals and
Objectives" and "Biography", respectively. In the Future Goals and Objectives
section (one-half page maximum), the applicant should briefly describe his/her
career track vision and describe the types of positions to be pursued. In the
Biography section (one and one-half page maximum), the applicant should
describe their scientific development from graduate school through
postdoctoral experience(s). For each training experience, the applicant
should describe his/her role in the laboratory/project and cite relevant
publications that resulted from the experience. The applicant should also
include in this section a short narrative on how the proposed research project
will lead to a successful R01 application.
The Research Plan itself (Specific Aims, Background and Significance,
Preliminary Studies, Research Design and Methods sections) is not to exceed 15
pages. Tables and figures but not the reference bibliography are included in
the 15-page limitation. Applications that exceed the page limitations stated
in this RFA announcement or the PHS 398 requirements for font size (height or
letters), type density (characters per inch), and margins (see PHS 398
directions) will be returned to the investigator.
The Research Plan is expected to follow the typical NIH grant application
organization and structure, and should include, but is not limited to the
following:
o a one-page description (or less) of the long term research goals and how
his/her research program would impact on an environmental health problem, and
o a specific testable hypothesis, and
o a set of specific aims to address the hypothesis, and
o methods to obtain data to satisfy the specific aims.
Although the research proposal is expected to be independently designed and
carried out by the candidate, sponsor and other senior faculty input into the
review and editing of the research proposal is encouraged as a part of the
career development experience.
If the application is a revision of a previously considered application, there
should be a clear indication of changes marked as indicated in the
instructions for the PHS 398 application. It is expected that a TIP award
would provide an investigator the opportunity to obtain the scientific data
needed for a subsequent investigator-initiated research grant (R01) or
equivalent to the NIH within the mission of the NIEHS.
The applicant MUST include three letters of recommendation that address the
applicant=s potential to become an important contributor to basic or clinical
biomedical or behavioral research or population-based (e.g., epidemiological)
research relevant to the mission of NIEHS. One of the letters of
recommendation MUST be from the current postdoctoral mentor and one MUST be
from the applicant=s pre-doctoral program, preferably the mentor.
Applications without letters of recommendation will be considered incomplete
and will not be accepted. Late receipt of letters of recommendation (e.g.
letters not submitted concomitantly with the application) will not be allowed.
Letters should be mailed directly to Dr. Janice Allen at the address given in
the WHERE TO SEND INQUIRIES section of this RFA.
Note: The letter from the current postdoctoral mentor should address the
following points.
1. The applicant=s role and intellectual contribution to the research
activities of the laboratory.
2. The current postdoctoral mentor=s role in the development of the proposed
project.
3. The applicant=s potential for independent research.
Color/glossy photos may be submitted as an appendix, however, the appendix may
not be used to circumvent the page limitation. Letters of recommendation are
not considered appendices, and do not count towards the 15-page limit.
The applicant must provide one to three publications from his/her Ph.D. work
and one publication from his/her postdoctoral work.
A PHS 398 form biographical sketch of the postdoctoral mentor should be
included in the application.
SPECIFIC INSTRUCTIONS FOR ALLOWABLE COSTS
The detailed budget for the TIP award will be $100,000 direct cost per year
for three years. The total direct costs for this award are $300,000 over a
period of three years. Facilities and Administration (F&A) costs will be
reimbursed at eight percent of modified total direct costs or at the actual
facilities and administration (indirect) cost rate, whichever is less.
The awardee and sponsoring institution will have considerable latitude in
deciding how these funds will be expended, with the exception of salary
(described below). This is to allow sufficient flexibility and benefit to the
awardee=s research and academic career.
Salary: The awardee may request up to $50,000 per year (plus fringe benefits)
from this award for salary. The award does not require that salary support be
derived from the award; use of the entire direct costs for research related
expenses is allowed. The total salary requested must be based on a full-time,
12-month staff appointment. It must be consistent both with the established
salary structure at the institution and with salaries actually provided by the
institution to other staff members of equivalent qualifications, rank, and
responsibilities in the department.
Research-Related Expenses: The entire direct costs of this award, or the
balance remaining after subtracting the amount devoted to salary, may be used
for supplies, equipment, technical personnel, travel and other research
related expenses.
Applicants must budget travel costs associated with a professional meeting
(one per year) in their applications.
Equipment is limited to $100,000 direct costs for the three-year project
period.
Ancillary Personnel Support: Salary for secretarial or administrative
assistance is not allowed.
USING THE RFA LABEL
The RFA label available in the PHS 398 (rev. 5/2001) application form must be
affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked. The RFA label available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf
SENDING AN APPLICATION TO THE NIH
Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive
79 T. W. Alexander Drive, 3rd Floor (for express/courier service)
Research Triangle Park, NC 27709
APPLICATION PROCESSING
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it will
be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIEHS. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIEHS in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique.
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score.
o Receive a second level review by the National Advisory Environmental Health
Sciences Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
your application.
Candidate
o the applicant=s potential to become an important contributor to basic,
clinical or population-based (e.g., epidemiological) research or behavioral
science within the mission of NIEHS;
o the qualifications and research experience of the Principal Investigator and
staff, particularly, but not exclusively, in the area of the proposed
research.
Research Plan
o the originality, innovation and scientific or medical significance of the
project as to new concepts and ideas;
o the appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research; the appropriateness of the
work proposed to the experience level of the principal investigator; the
acknowledgment of potential problem areas and consideration of alternative
tactics;
o the adequacy of plans to include both genders, minorities, and their
subgroups as appropriate for the scientific goals of any clinical research
activities. Plans for the recruitment and retention of subjects will also be
evaluated.
o the adequacy of the proposed protection for humans, animals, or the
environment to the extent they may be adversely affected by the activities
proposed in the application.
Budget
Although a budget is not required, the appropriateness of the scope of work
for the funds that are available through this grant will be considered. The
applicant should assume that general laboratory equipment items such as
spectrophotometer, centrifuges, etc., will be available at the institution.
However, highly sophisticated or limited use equipment required for the
studies should be identified and funds for the use of such equipment should be
considered by the applicant in developing the research plan. For example,
magnetic resonance imaging equipment and fluorescence cell sorters are
available for a fee at many institutions, and the cost for their use should be
considered by the applicant.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 14, 2003
Application Receipt Date: July 14, 2003
Peer-Review Date: October-November, 2003
Council Date: February 2004
Earliest Award Date: July 2004
AWARD CRITERIA
The anticipated date of notification of a Letter to Commit Funds is March-
April, 2004. The following will be considered in making funding decisions:
(a) potential of the applicant to make a significant contribution to the NIEHS
mission; (b) quality of the proposed projects scientific merit as determined
by peer review; (c) availability of funds; and (d) program balance among
research areas of the announcement.
AWARD PROCESS AND INITIATION
At the time a decision is made to make an award, the applicant will be
provided a Letter to Commit Funds that states intent to commit funds, which
will be signed by the NIEHS Grants Management Officer. This letter states the
conditional intent of the NIEHS to make a grant award and may be used by the
candidate when entering into negotiations for a position with a suitable
institution to document potential grant support for the candidate=s research
project. The date of this letter will determine the expiration date of the
NIEHS offer to commit funds to a grant award. Please note that this is
different from the usual NIH process since this commitment is not made
initially to a specific institution.
After a TIP investigator has identified a permanent position, preferably
tenure-track or equivalent, at a research intensive domestic institution
(sponsoring grantee institution), the sponsoring institution will request that
an award be issued by submitting the appropriately prepared form PHS 398
(competing grant application) that includes a detailed budget. The
application must also include letters from the institutional official signing
the application describing the position and confirming that the TIP
investigator has been offered and has accepted a permanent, preferably tenure-
track or equivalent, position. In addition, a statement from the Department
Chair or equivalent official must be included which describes the resources
that will be available for the TIP investigator. Finally, if the research
involves animals/human subjects, the certification that the protocols were
approved by the appropriate institutional committee of the designated grantee
institution must be provided. These and other relevant materials are to be
submitted to the NIEHS Grants Management Office at the address listed on the
Letter of Commitment.
These materials will be used by NIEHS staff to carefully assess the
appropriateness and soundness of the proposed arrangement. The institution
will be examined for its ability to make a significant commitment of
resources, time and other factors conducive to the research project and career
establishment of the TIP investigator. In addition, the TIP investigator must
be appointed to a permanent position in a research-intensive environment
relevant to environmental health sciences. It is the intent of the NIEHS that
the applicant relocate to another, different research intensive institution,
and not remain at the current postdoctoral institution. Arrangements in which
a candidate moves from a postdoctoral position to that of an assistant
professor at the same institution are specifically discouraged, and if
proposed by the TIP investigator, must document an especially strong,
compelling case for such a position=s eligibility for consideration.
Please note that an award can ONLY be made after the TIP investigator has
accepted a position at a sponsoring institution; this acceptance of a position
must be confirmed by the institutional official. Finally, it is important to
note that no funds can be obligated or used until the award has been made to a
grantee sponsoring institution.
NIEHS recognizes that each TIP investigator will have unique circumstances
that will affect the timing for the initiation of the award. Thus, the NIEHS
will allow the TIP investigator up to 18 months between the date of the Letter
to Commit Funds notifying the applicant of funding availability for an
application and the start of a permanent position at a research-intensive
institution. The grantee institution application submitted on behalf of the
TIP applicant to activate the award must be received no later than 5:00 p.m.
(EST) of the last business day of the first week in August of the year in
which the 18-month period concludes. Please note that this timing is
determined by the Federal fiscal year, not subject to change, and funds
identified in the NIEHS Letter to Commit Funds will not be available after the
close of the final NIEHS fiscal year for the 18-month period specified
therein.
REQUIRED FEDERAL CITATIONS
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 involving human subjects 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 read the AMENDMENT "NIH
Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research B Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001,
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC)
Criteria for Federal funding of research on hESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov/). It is the responsibility of the applicant to provide
the official NIH identifier(s) for the hESC line(s) to be used in the proposed
research. Applications that do not provide this information will be returned
without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applications to understand the basic scope of this
amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when the directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA is related to one or more of
the priority areas. Potential applicants may obtain a copy of "Healthy People
2010" http://www.health.gov/healthypeople.
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 authorization of Sections 301 and 405 of the Public Health
Service Act, as amended (42 USC 241 and 284) and administered under NIH
grants policies described at https://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Part 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
https://grants.nih.gov/grants/policy/policy.htm.
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.