NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD (K01)

RELEASE DATE:  March 6, 2002

RFA:  HL-02-022

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/) 

LETTER OF INTENT RECEIPT DATE:  May 20, 2002

APPLICATION RECEIPT DATE:  June 19, 2002

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 
independent investigators.

RESEARCH OBJECTIVES

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.  

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 
positions). 

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, 2003.

For this RFA, no detailed budget is required.  However, total direct costs for 
all years must be provided in addition to the name, role on project, percent 
effort and narrative justification for all key project personnel.  Other 
Support information for the applicant is not required as part of the initial 
application.  Other Support information is required, however, for the mentor. 
 If there is a possibility for an award, necessary budget, and Other Support 
information will be requested by NHLBI staff following the initial review.  
The "Submitting an Application" section of this RFA provides specific details 
of modifications to standard PHS 398 application instructions.

FUNDS AVAILABLE

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 2003 (October 
1, 2002-September 30, 2003).  The actual amount may vary, depending on the 
response to the RFA and availability of funds.  Ten to twelve new awards are 
anticipated.

ELIGIBLE INSTITUTIONS

Eligible institutions include:

o For-profit and non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions, foreign institutions are not eligible 
 
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 Black, 
Hispanic, American Indian, Alaska Native and 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.  

SPECIAL REQUIREMENTS

Applicant Institution

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.
 
Minority Candidate
 
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) 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.  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.

Mentor

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 
independent investigator.

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.

Advisory Committee

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.

Allowable Costs

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 
development costs.

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 
for equipment.

Concurrent Applications

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:  Candidates must describe 
plans to receive instruction in the responsible conduct of research (RCR).  
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 
programmatic Divisions)
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7934
Bethesda, MD  20892-7934
Telephone:  (301) 435-0709
FAX:  (301) 480-1667
Email:  silsbeeL@nhlbi.nih.gov

o Direct your questions about review issues to:

Anne Clark, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7178
6701 Rockledge Drive, MSC 7924
Bethesda, MD  20892-7924
Bethesda, MD 20817 (for express mail)
Telephone:  (301) 435-0270
FAX:  (301) 480-0730
Email:  clarka@nhlbi.nih.gov

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

Kevin Keating
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7136, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0185
FAX:  (301) 480-0422
Email:  KeatingK@nhlbi.nih.gov 

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 20, 2002.

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.

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-02-022) 
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:  
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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)

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 19, 2002.  If 
an application is received after that date, it will be returned to the 
applicant without review.  

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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

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 
Advisory Council.

REVIEW CRITERIA

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 
skills.

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.

Training in the Responsible Conduct of Research

o Quality of the proposed training in responsible conduct of research.

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

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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 included in the 
section on Federal Citations, below)

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

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research and career development 
activities.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  May 20, 2002
Application Receipt Date: June 19, 2002
Peer Review Date:  October/November 2002
Council Review:  February 2003
Earliest Anticipated Start Date:  April 1, 2003

AWARD CRITERIA

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

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: 
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 
available at 
https://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.

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 
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 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 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 
https://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 
American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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