NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD (K01)
RELEASE DATE: March 14, 2003
RFA: HL-03-011 (See continuation, RFA-HL-05-015 and see Notice of Additional Receipt Date, NOT-HL-04-015)
National Heart, Lung, and Blood Institute (NHLBI)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
93.233, 93.837, 93.838, 93.839
LETTER OF INTENT RECEIPT DATE: May 22, 2003
APPLICATION RECEIPT DATE: June 23, 2003 (see NOT-HL-04-015)
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The NHLBI Mentored Minority Faculty Development Award is a three to five-year
award made to underrepresented minority faculty members, with varying levels
of research experience, who are committed to developing into independent
biomedical investigators in research areas relevant to the mission of the
NHLBI. The award will enable suitable faculty members holding doctoral
degrees, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent, to undertake
special study and supervised research under a mentor who is an accomplished
investigator in the research area proposed and has experience in developing
The proportion of biomedical investigators who are members of underrepresented
minority groups is strikingly lower than the percentage of minority U.S.
citizens. There has been a dramatic increase in the number of
underrepresented minorities in the basic biomedical workforce going from 1,076
in 1975 to 3,943 in 1997. In spite of this increase, minorities remain a
small percentage of the overall biomedical workforce. In 1997, 4.2 percent of
biomedical scientists were underrepresented minorities, compared to 2.6
percent in 1975.
("Addressing the Nation's Changing Needs for Biomedical Scientists, National
Research Council, 2000"). One method of increasing the number of minority
faculty members is to offer them additional research training and career
development opportunities with experienced mentors. In so doing, the pool of
minority biomedical and biobehavioral investigators in cardiovascular,
pulmonary, and hematologic research, and sleep disorders can be increased.
Furthermore, these minority individuals may serve as role models for minority
undergraduate and graduate students, and stimulate these students to become
more cognizant of research opportunities in cardiovascular, pulmonary,
hematologic, and sleep disorders.
The objective of this one-time award is to develop highly trained minority
investigators whose basic or clinical research interests are grounded in the
advanced methods and experimental approaches needed to solve problems related
to cardiovascular, pulmonary, hematologic, and sleep disorders. This program
provides research development opportunities for underrepresented minority
faculty members with varying levels of research experience. The research
development program of the candidate should be based on their scholastic
background, previous research experience, past achievements, and potential to
develop into an independent research investigator. Minority scientists and
physicians with limited research experience needing guided course work and
supervised laboratory experiences, as well as minority faculty needing only an
intensive research experience under the guidance of an established scientist,
are eligible to apply.
MECHANISM OF SUPPORT
This RFA will use the NHLBI Mentored Minority Faculty Development Award (K01)
mechanism of support. Responsibility for the planning, direction, and
execution of the proposed training project will be solely that of the
applicant. The total project period for an application submitted in response
to this RFA must be at least three but not more than five years. The
anticipated award date is April 1, 2004.
The estimated funds (total costs) available for the first year of support for
the entire program is expected to be $1.2 million in Fiscal Year 2004 (October
1, 2003-September 30, 2004). The actual amount may vary, depending on the
response to the RFA and availability of funds. Ten to twelve new awards are
Loan Repayment Program (LRP): Awardees under this program may be eligible to
apply for the NIH Extramural Loan Repayment Program. Information regarding
the eligibility requirements and benefits for the program may be obtained
through the LRP website at http://www.lrp.nih.gov/.
Eligible institutions include:
o For-profit and non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions
Foreign institutions are not eligible to apply.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
For the purpose of this program, underrepresented minority faculty members are
defined as individuals belonging to a particular ethnic or racial group that
has been determined by the grantee institution to be underrepresented in
biomedical or behavioral research. Nationally, the NHLBI considers African
American/Black, Hispanic, American Indian, Alaska Native and non-Asian Pacific
Islanders to be underrepresented.
At the time of award, it is required that at least two years have elapsed
since the receipt of the doctoral degree and that the candidate have at least
one year of documented research experience. Current or past Principal
Investigators of an NIH grant or its equivalent, including the Clinical
Investigator Award, Physician Scientist Award, Clinical Investigator
Development Award, Mentored Clinical Scientist Development Award, or Mentored
Patient-Oriented Research Career Development Award are not eligible for the
NHLBI Mentored Minority Faculty Development Award. Similarly, individuals
serving as responsible investigators or project leaders on large grants, such
as a Program Project Grant, are not eligible for award. An individual who has
previously received support from the Minority Access to Research Careers
(MARC), Minority Biomedical Research Support (MBRS) Program, Academic Research
Enhancement Award (AREA), or a minority supplement is eligible to apply.
It is envisioned that most candidates for this award will hold non-tenured
faculty appointments (such as instructor or assistant professor), although in
some instances other individuals may be eligible to apply (such as individuals
due to be appointed to a faculty position or individuals with tenured faculty
Guidelines for Special Leave: K01 Award recipients may take leave to train at
another institution, take a leave of absence during the award period, or train
at a lower level of effort for a longer period of time. K01 Award recipients
should review a document describing the Special Leave Guidelines for
Recipients of Mentored Career Awards at
which summaries NIH and NHLBI policies for these situations.
Applications will be accepted from domestic colleges or universities, medical
schools, or comparable institutions. The application must include a plan that
identifies personnel and other resources to be devoted to the candidate. In
addition, evidence of institutional commitment to the candidate's research
development and level of effort should be included in a statement from the
institution. The statement should also address the institution's plans for
the candidate during and following the tenure of the award. The statement
should be signed by an institutional official (e.g., a dean) and the
candidate's department chair.
To receive an award under this program, individuals must have been awarded a
doctoral degree, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent
degree at least two years prior to the award and have a full-time faculty
appointment at an accredited college or university at the time of award.
Candidates for this award must be either citizens or noncitizen nationals of
the United States or have been admitted lawfully to the United States for
permanent residence (i.e., in possession of the Alien Registration Receipt
Card I-551, or some other legal verification of such status) by the time of
the award. Noncitizen nationals are generally persons born in outlying
possessions of the United States (i.e., American Samoa and Swains Island).
An individual admitted lawfully for permanent residence must submit with
the application a notarized statement indicating possession of the Alien
Registration Receipt Card I-551. Individuals on temporary or student visas
are not eligible.
The candidate's academic background, previous experience, and career goals
should determine both the necessary length and the kind of program that is
appropriate. The applicant institution should provide a statement in the
application that the candidate is a member of an underrepresented minority
group and describe the evidence that this group is underrepresented. Three
sealed letters addressing the candidate's potential for a research career must
be submitted. The Mentor's Statement (see below) must not be included as one
of these letters.
Each candidate must identify a mentor(s) who is an accomplished investigator
in the proposed research area and has experience in developing independent
investigators. The mentor is not required to be affiliated with the applicant
institution. If the mentor is affiliated with another institution,
appropriate documentation must be provided concerning the relationship of the
applicant institution and the mentor's institution, as well as a clear
delineation of the arrangements proposed for the research development program
at a location distinct from the applicant institution. The mentor must submit
a written plan for the development of the candidate and provide guidance
during the preparation of the research project. A secondary mentor may also
be proposed, but the primary mentor must continue to be involved throughout
the award period. In some cases candidates may choose to have both a basic
research mentor or a research mentor and a career development mentor. The
mentor must submit a report each year on the candidate's progress, which
should be included in the annual progress report.
Research Development Program
All research development programs should be carefully tailored to meet the
candidate's needs and must include a mentor(s) who is competent to provide
appropriate research guidance. All candidates must provide a full description
of the research and career development plan for the period of the award. The
proposed plan must include hands-on research experience, with either a
clinical or a basic science focus, for the entire three to five year period.
Awardees, in conjunction with their mentor(s), are required to submit a
detailed annual progress report.
For minority candidates with minimal research experience, the development
program may be designed to start with a creative and detailed scientific
learning experience and progress to an intensive research activity under the
guidance of an appropriate mentor(s). The first year or two of the program
may incorporate any needed course work, and seminars and other educational
experiences necessary to prepare the candidate for the subsequent research
program, but must include a hands-on research experience. This initial phase
of the program may resemble a traditional postdoctoral research training
program. The remainder of the development plan could include an intensive,
fully-described research program and research projects that can be reasonably
completed within the planned period. During this latter phase, the program
should provide for progressive development of the individual into an
If the minority candidate has already acquired some research experience, as
might be obtained through a research fellowship, but needs further development
under the guidance of an appropriate mentor(s), the candidate may propose a
three to five year program encompassing an advanced research experience
focusing on a specific research project. Such a candidate may take additional
courses or engage in special instruction in research techniques in other
laboratories for a reasonable period of time if needed. During the latter
phases of the award, the relationship of the mentor and candidate may more
closely resemble that of collaborators.
Individuals with significant research experience in the proposed field of
study should not apply for this award but rather should consider applying for
independent research grant support.
Because the research training environment provides a powerful context in which
to promote responsible research practices, all competing applications must
include a description of formal or informal activities or instruction related
to the responsible conduct of research that will be incorporated into the
proposed research training program.
A committee composed of the candidate's mentor(s) and two or three other
senior faculty members should be identified. This advisory committee should
meet with the candidate to review the research development plan and research
project, to evaluate the awardee's progress, and to provide guidance for
scientific career development. The roles and scheduled meeting frequency of
the Advisory Committee should be described in the application.
Duration and Effort
The award is granted for three to five years depending on the needs of the
candidate and the evaluation of the initial review group and the National
Heart, Lung, and Blood Advisory Council. It is not renewable and all funds
must be used on behalf of the original candidate. Substitution of another
mentor and/or a change of institution may be permitted with the prior approval
of the NHLBI. A minimum of 75% effort must be devoted to the research
program. The remainder may be devoted to other clinical and teaching pursuits
that are consistent with the program goals; i.e., the candidate's development
into an independent biomedical scientist or the maintenance of the teaching
and/or clinical skills needed for an academic research career.
The candidate must have a "full-time" appointment at the applicant
institution. In general, candidates who have Veteran's Administration (VA)
appointments may not consider part of the VA effort toward satisfying the
"full-time" requirement at the applicant institution. However, it is
permissible for part or all of the research program to be conducted in a VA
laboratory, for example if the mentor has a VA appointment, so long as the
above conditions are satisfied as they apply to the NHLBI Mentored Minority
Faculty Development Award.
Salary - Individual compensation is based on the institution's salary scale
for individuals at an equivalent experience level. The maximum salary for
recipients of NHLBI K01 Career Awards is $75,000 per year plus commensurate
fringe benefits for full-time professional effort (i.e., 75% to 100%). The
salary must be consistent with both the established salary structure at the
institution and with salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. The NHLBI Research Career
Development Award Programs require the recipients to devote a minimum of 75%
effort to the research plan being supported by the career development award;
the remaining 25% effort should be devoted to research and research-related
activities such as teaching, patient care, or other research-related
activities. If 100% effort is to be devoted to the research program during the
"summer months," the percent effort for the remainder of the year may be
reduced provided that the effort over the course of the year is at least 75%.
NIH policy permits supplementation of salary from non-Federal sources.
Supplementation from other Federal funds is not allowed unless explicitly
authorized by the program from which the funds are derived and the NHLBI.
Under certain circumstances and with prior NHLBI approval, other NIH funds may
be used for supplementary salary support if derived from a grant for which the
awardee applied after receipt of the K01 award.
Mentor's Salary - Salary support may be requested for the primary mentor up to
a level commensurate with 5% effort. If the mentor is at a different
institution than the applicant institution, arrangements for the transfer of
funds for the mentor's salary and, if necessary, for research expenses should
be formalized in a contract or written agreement with the mentor's institution
and included as part of the application. The mentor's salary support is
considered as separate and distinct from funds requested for the candidate's
salary or research and development support. The percent effort may exceed 5%
for selected periods of time, provided the total effort for the budget period
(12 months) does not exceed 5%. If the mentor's salary is requested as a
consortium cost, the subcontracting grantee is only allowed to request
Facilities and Administrative Costs based on 8% of total allowable direct
costs. The mentor=s salary should not be included in the research and
Research and Development Costs - A maximum of $30,000 per year may be
requested for research project requirements and related support, (e.g.,
technical personnel costs, supplies, equipment, candidate travel, telephone
charges, publication costs, and tuition for necessary courses).
Facilities and Administrative Costs - Funds will be provided for the
reimbursement of facilities and administrative costs at a rate of 8% of the
total direct costs of each award, exclusive of tuition, fees, and expenditures
NHLBI Mentored Minority Faculty Development Award applications may not be
submitted or awarded concurrently with other NIH applications, such as the
Independent Scientist Award, Mentored Clinical Scientist Development Award,
Academic Award, Research Project Grant, or Mentored Patient-Oriented Research
Career Development Award.
Subsequent Applications for NIH Research Support
During the later years of the NHLBI Mentored Minority Faculty Development
Award (K01), incumbents are encouraged to apply for independent research
support (e.g., R01, etc.). K01 recipients who are successful in obtaining
subsequent NIH research grant support may not receive salary support from the
research grant for the duration of the K01 award except under certain
circumstances and with prior NHLBI approval. After the conclusion or
termination of the K01 award, salary support should transfer to the research
grant. K01 recipients who apply for subsequent research grant support are
encouraged to include salary and all other research needs in the research
grant application for the period following completion of the K01.
Alternatively, recipients of research grant awards may terminate the K01 prior
to the start of the research grant.
Training in the Responsible Conduct of Research (RCR): Candidates must
describe plans to receive instruction in the responsible conduct of research.
The Public Health Service policy on RCR
(http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core
instructional areas that comprise RCR: data acquisition, management, sharing,
and ownership; mentor/trainee responsibilities; publication practices and
responsible authorship; peer review; collaborative science; human subjects;
research involving animals; research misconduct; and conflict of interest and
commitment. Plans for RCR training must describe the proposed subject matter,
format, frequency and duration of instruction. This description should be
about one paragraph long and include an explicit statement that the candidate
has taken or will take the course, and when. No award will be made if an
application lacks this component. See the NIH website
http://www.nih.gov/sigs/bioethics for resources and information on this topic.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: programmatic, review and financial or grants management issues:
o Direct your questions about programmatic issues to:
Lorraine M. Silsbee, M.H.S.
Division of Epidemiology and Clinical Applications (responding for all NHLBI
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7934
Bethesda, MD 20892-7934
Telephone: (301) 435-0709
FAX: (301) 480-1667
o Direct your questions about review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: (301) 480-0730
o Direct your questions about financial or grants management matters to:
Ms. Marsha D. Mathis
Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7158, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0170
FAX: (301) 480-3310
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o A descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NHLBI staff to estimate the potential review workload and plan
for the review.
The letter of intent is to be sent to Dr. Anne Clark at the address listed
under WHERE TO SEND INQUIRIES by May 22, 2003.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Refer to K section. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
(NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD) and number (HL-03-011)
must be typed on line 2 of the face page of the application form and the YES
box must be marked. The RFA label is also available at:
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application 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)
All grant applications submitted to the Center For Scientific Review (CSR)
must come via United States Postal Service or a recognized delivery/courier
service. Individuals may not personally deliver packages to the building on
Rockledge Drive. For further information please see
At the time of submission, two additional copies of the application and all
five collated sets of the appendix material must be sent to Dr. Anne Clark at
the address listed under WHERE TO SEND INQUIRIES.
APPLICATION PROCESSING: Applications must be received by June 23, 2003. If
an application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by a Special Emphasis Panel in the Division of
Extramural Affairs, NHLBI, in accordance with the review criteria stated
below. As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Heart, Lung, and Blood
The following criteria will be considered when assessing the merits of the
proposed NHLBI Mentored Minority Faculty Development Award Program:
o Candidate -- The candidate's overall competence as demonstrated by previous
training and research performance, potential for a career as an independent
researcher, and commitment toward pursuit of an academic research career.
o Career Development Plan -- The quality of the research career development
plan, based on the candidate's past research experience, training, and career
goals as demonstrated by such things as research experience, attendance at
scientific meetings, and participation in journal clubs and research seminars.
o Research Project -- Scientific merit of the proposed research project and
its appropriateness as a vehicle for developing the candidate's research
o Mentor(s) -- The mentor's accomplishments in the scientific research area(s)
proposed, experience and record in training investigators, and commitment for
the duration of a candidate's research development. A curriculum vitae with
relevant publications and a list of current and pending research support must
be included for all mentors. Mentors should also include a list of current
and past research trainees (not more than the last 10 years) with information
on their current positions. This information should be provided for the co-
mentor, if relevant and for the members of the Advisory Committee.
o Environment -- The applicant institution's ability to provide adequate
facilities, resources, and opportunities necessary for the candidate's
training, and the institutional commitment to the candidate. If the mentor=s
institution is different from the applicant institution, the quality and
extent of interaction of the faculty in the basic and clinical sciences, and
the quality of the research and research training programs.
o Institutional Commitment -- The institution=s commitment to the development
of the candidate.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section
on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the section on Federal Citations,
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research and career development
Training in the Responsible Conduct of Research: Every predoctoral and
postdoctoral NRSA trainee supported by an institutional research training
grant must receive instruction in the responsible conduct of research. (For
more information on this provision, see the NIH Guide for Grants and
Contracts, Volume 21, Number 43, November 27, 1992, see
must include a description of a program to provide formal or informal
instruction in scientific integrity or the responsible conduct of research.
Applications without plans for instruction in the responsible conduct of
research will be considered incomplete and will be returned to the applicant
o Although the NIH does not establish specific curricula or formal
requirements, all programs are encouraged to consider instruction in the
following areas: conflict of interest, responsible authorship, policies for
handling misconduct, data management, data sharing, and policies regarding the
use of human and animal subjects. Within the context of training in
scientific integrity, it is also beneficial to discuss the relationship and
the specific responsibilities of the institution and the graduate students or
postdoctorates appointed to the program.
o Plans must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance, and the
frequency of instruction.
o The rationale for the proposed plan of instruction must be provided.
o Program reports on the type of instruction provided, topics covered, and
other relevant information, such as attendance by trainees and faculty
participation, must be included in future competing continuation and
noncompeting applications. The NIH encourages institutions to provide
instruction in the responsible conduct of research to all graduate students,
postdoctorates, and research staff regardless of their source of support.
NIH initial review groups will assess the applicant's plans on the basis of
the appropriateness of topics, format, amount and nature of faculty
participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, so that
the review panel's evaluation of the plan will not be a factor in the
determination of the priority score. Plans will be judged as acceptable or
unacceptable. The acceptability of the plan will be described in an
administrative note on the summary statement. Regardless of the priority
score, applications with unacceptable plans will not be funded until the
applicant provides a revised, acceptable plan. Staff within the NIH awarding
component will judge the acceptability of the revised plan.
Following initial review, the NHLB Advisory Council provides a second level
review. The Council will consider the assessment of the scientific and
educational merit of the research training grant application as well the plan
for instruction in the responsible conduct of research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: May 22, 2003
Application Receipt Date: June 23, 2003
Peer Review Date: October/November 2003
Council Review: February 2004
Earliest Anticipated Start Date: April 1, 2004
Award criteria that will be used to make award decisions include:
o Scientific and career development merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
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
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
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
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not
be used to provide information necessary to the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance No. 93.233, 93.837, 93.838, and 93.839 and is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under authorization of 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
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
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
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Department of Health
and Human Services
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892