NHLBI MINORITY INSTITUTION RESEARCH SCIENTIST DEVELOPMENT AWARD (K01)

RELEASE DATE:  March 14, 2003

RFA: HL-03-012

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

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

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Minority Institution Research Scientist Development Award is a five-
year award made to a minority institution on behalf of a candidate with an 
appropriate mentor (at the same institution or at a collaborating research 
center) who is recognized as an accomplished investigator.  It is open to 
candidates having faculty appointments and holding a Ph.D., M.D., D.V.M., 
D.O., or equivalent professional degree who wish to develop research 
capabilities in research areas relevant to the mission of the NHLBI.  A 
"hands-on" research experience is required for the candidate for the duration 
of the award with 100% effort during summer and/or off quarter periods and at 
least 25% effort during the academic year.  The award also requires that at 
least one and a maximum of two students participate on the project as research 
assistants. 

RESEARCH OBJECTIVES

Important NHLBI program goals are to enhance the institution's science 
infrastructure, to provide "hands-on" research opportunities for 
underrepresented minority students at the applicant institutions, and to 
develop the research career and teaching skills of the candidate.  By 
developing these capabilities, the candidate will be better able to prepare 
and direct his/her students to pursue advanced degrees and, ultimately careers 
in biomedical and behavioral research, thereby increasing the pool of well-
trained biomedical and behavioral investigators in cardiovascular, pulmonary, 
hematologic, and sleep disorders research.  Because it is important to sustain 
the candidate's research program following the initial period, recipients may 
reapply for an additional five years of support.  One competing renewal award 
is allowed. More than one candidate from each institution may apply.  At the 
end of the period of K01 support, it is anticipated that the awardee will be 
prepared to apply for other types of NIH support such as the Research Project 
Grant (R01), Academic Research Enhancement Award (AREA, R15), 
Exploratory/Development Grant (R21) or Minority Biomedical Research Support 
Program (MBRS, S06.)

MECHANISM OF SUPPORT

This RFA will use the NHLBI Minority Institution Research Scientist 
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 and the applicant may reapply for an additional five years of 
support.  The anticipated award date is April 1, 2004.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of support for 
the entire program is expected to be approximately $400,000 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.  Three new 
awards are anticipated.

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 

The Institution must be a domestic college or university with student 
enrollment drawn substantially from minority ethnic groups (including African 
Americans/Blacks, Hispanics, American Indians, Alaska Natives, and non-Asian 
Pacific Islanders).  It must have the ongoing staff and facilities required 
for the proposed program.

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS  

Candidates for this award are minority school faculty members who: 1) are 
citizens of the United States, non-citizen nationals or permanent residents by 
the time of the award; 2) have a doctoral degree, such as the Ph.D., M.D., 
D.O., D.V.M., or an equivalent, in a biomedical or behavioral science; 3) wish 
to receive specialized training in cardiovascular, pulmonary, hematologic, or 
sleep disorders research; 4) have the background and potential to benefit from 
the training; and 5) are committed to providing research opportunities for 
underrepresented minority students at their institution.  The candidate is 
responsible for tracking and reporting on the progress of the students for up 
to five years after they complete their undergraduate education.

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 
http://www.nhlbi.nih.gov/funding/training/redbook/sl_guide.htm
which summaries NIH and NHLBI policies for these situations.

SPECIAL REQUIREMENTS

Mentor at Same or Collaborating Research Center

Each candidate must also identify and complete arrangements with a mentor (at 
the same institution or at a collaborating research center) who is recognized 
as an accomplished investigator in the proposed research area and who will 
provide guidance for the candidate's development and research plan.  
Arrangements with mentors at institutions at a distance from the applicant 
institution will be considered, but approaches for ensuring close and active 
involvement of a distant mentor must be clearly outlined in the application.  
Plans for intensive training of the candidate and his/her student(s) during 
the summer period (2 - 3 months) and during the academic year should be 
developed with the mentor.  The establishment of a viable mentoring plan is 
essential to the success of the candidate and the student. 

The commitment of the mentor and the mentor's department chair to both the 
summer and academic year training periods must be documented in the 
application.  A mentoring plan that describes the candidate=s interaction with 
the mentor and his/her staff, how it will enhance the candidate=s research 
capabilities and teaching skills, and steps to assist the candidate and 
student(s) advance their career goals must be delineated in the application.  
The mentor must provide an annual evaluation of the candidate=s career 
development.  This evaluation is to be included as part of the annual progress 
report if an award is made.

Student Research Assistants

Student research assistants are underrepresented minority students enrolled at 
the applicant institution who: 1) are citizens of the United States, 
noncitizen nationals, or permanent residents (i.e. in possession of a 
currently valid Alien Registration Receipt Card I-551, or some other legal 
verification of such status) at the time of application; 2) have declared a 
major or concentration in a biomedical, mathematical, computer, or behavioral 
science; 3) have an overall B grade average; 4) have the potential and desire 
to pursue an advanced degree in the biomedical, mathematical, computer, or 
behavioral sciences; and 5) wish to receive research training in areas 
relevant to cardiovascular, pulmonary, hematologic, or sleep disorders 
research.  At least one and a maximum of two students may participate on the 
project simultaneously as research assistants.  Students are expected to 
participate in the program for a minimum of two years.  

The candidate should identify and list in the application the student(s) 
proposed for the first two-year period; provide a brief summary of their 
interest in biomedical, mathematical, computer or behavioral science; and 
describe any previous research or laboratory experience of the students.  The 
candidate should describe a mentoring plan stating how (s)he and the mentor 
will foster student interest in graduate school in behavioral or biomedical 
research and a career in scientific research in areas related to heart, lung, 
blood, or sleep disorders.

For the purpose of this announcement, underrepresented minority students are 
defined as individuals belonging to a particular ethnic or racial group that 
has been determined by the applicant institution to be underrepresented in 
biomedical or behavioral research.  Nationally, NHLBI considers African 
American/Black, Hispanic, American Indian, Alaska Native, and non-Asian 
Pacific Islander students to be underrepresented.

Provisions Of The Award

Salary

The awardee (candidate at the minority institution) will receive salary 
support up to a maximum of $75,000 per year plus fringe benefits for five 
years.  These funds must be used to support the awardee.  The level of support 
will be based upon the awardee's actual salary and must be consistent with the 
established salary structure of the minority institution for persons of 
equivalent qualifications, experience, and rank.  The actual salary level will 
be determined by the amount of effort devoted to this program.  Awardees must 
commit 100% effort during summer and/or off-quarter periods and at least 25% 
of effort during the academic year.  Supplementation of the awardee's salary 
from non-Federal sources is permissible.  Supplementation of the awardee's 
salary from other Federal funds is not allowed unless explicitly authorized by 
both the program from which funds are derived and the NHLBI.  In no case may 
other NIH funds be used to supplement the salary of the awardee.

In addition to salary support for the awardee, support for up to 5% of the 
mentor's salary plus fringe benefits during the summer experience may also be 
requested.  If funds are to be transferred to the mentor's institution for the 
mentor's salary, arrangements for the transfer of funds and the conduct of 
activities should be formalized in a subcontract agreement with the mentor's 
institution.  The mentor=s salary should not be included in the research and 
development costs.

A maximum of $8.50 per hour plus fringe benefits may be requested for the 
student research assistant(s).  Level of support and hours worked during the 
academic year should reflect the institution's policy for student work-study 
programs.  Students must commit 100% effort during the summer and off-quarter 
periods and at least 25% effort during the academic year. 

Research and Development Costs

Up to $36,000 per year beyond that requested for the awardee's, mentor's, and 
student(s)' salaries will be provided for research support.  Details regarding 
the apportionment of these funds between the minority institution and the 
mentor's institution must be worked out with the mentor, agreed to by 
representatives of both institutions, and included as part of the agreement 
submitted as part of the application. 

These research support funds may be used for:

o Personnel:  support for technical personnel.

o Equipment:  limited to specialized research equipment essential to the 
proposed program.  In accordance with PHS policy, title to such equipment will 
vest with the grantee institution.

o Supplies:  consumable supplies essential to the proposed program.

o Travel:  essential to the proposed program.

o Other:  publication costs, computer costs, or other costs necessary for the 
research program.
 
Facilities and Administrative (F & A) Costs

F & A costs will be provided at a rate of 8% of the total direct costs of each 
award, exclusive of equipment.  The F & A cost rate on an agreement with the 
mentor's institution may not exceed 8%.

Concurrent Applications

NHLBI Minority Institution Research Scientist Development Award applications 
may not be submitted or awarded concurrently with other NIH Career Development 
Award 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 Minority Institution Research Scientist 
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 
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:

Traci Heath Mondoro, Ph.D.
Division of Blood Diseases and Resources (responding for all NHLBI 
programmatic Divisions)
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7950
Bethesda, Maryland  20892-7950
Telephone: (301) 435-0052
FAX: (301) 480-0868
Email: [email protected] 

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
National Institutes of Health
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
Email: [email protected]

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
Email: [email protected] 

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) 710-0267, Email:  [email protected].

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 MINORITY INSTITUTION RESEARCH SCIENTIST DEVELOPMENT AWARD) and number 
(HL-03-012) 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: 
http://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)

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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 

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 
Advisory Council.

REVIEW CRITERIA

The following criteria will be considered in the evaluation of the proposed 
NHLBI Minority Institution Research Scientist Development Award program:

o Candidate -- The candidate's overall qualification as demonstrated by 
academic record and research performance, potential for a career as an 
independent researcher, potential to mentor undergraduate and graduate 
students, commitment toward pursuit of an academic research career and toward 
the enhancement of the scientific program at the minority institution, and 
commitment to the career development of minority students.

o Candidate's 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 relevance of the proposed 
didactic training, structure of interaction with mentor, attendance at 
scientific meetings, and participation in journal clubs and research seminars. 

o Student's Development Plan B The quality of the student career development 
plan as demonstrated by such things as exposure to research opportunities to 
attend/present at scientific meetings, interaction with mentor, 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 and 
student(s)' research skills.

o Keeping Students in Research Careers -- The candidate=s record and an 
outline of future plans for involving students in research and guiding them to 
science graduate programs and careers in academic, biomedical and behavioral 
research, and plans for tracking students.

o Mentor(s) -- The mentor's accomplishments in the scientific research area(s) 
proposed, plans for mentoring the candidate and students, experience and 
record in training investigators, and commitment for the duration of the 
project.  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.

o Environment -- The applicant institution's ability to provide adequate 
facilities, resources, and opportunities necessary for the candidate's and 
student(s)' training, and the institutional commitment to the candidate and 
student(s).  If the mentor(s)' institution is different from the applicant, 
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 at 
the mentor's institution will be considered.

o Institutional commitment -- The institution's commitment to the development 
of the candidate and student(s).

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, if your 
research involves human subjects 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, 
below).

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 
activities.

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 
http://grants.nih.gov/grants/guide/notice-files/not92-236.html.  Applications 
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 
without review.

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 NHLBI Advisory Council provides a second level 
of 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

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: 
http://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 "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at http://grants.nih.gov/grants/funding/women_min/
guidelines_amended_10_2001.htm.  The amended policy incorporates: the use
of an NIH definition of clinical research; updated racial and ethnic
categories in compliance with the new OMB standards; clarification of
language governing NIH-defined Phase III clinical trials consistent with
the new PHS Form 398; and updated roles and responsibilities of NIH staff
and the extramural community.  The policy continues to require for all
NIH-defined Phase III clinical trials that: a) all applications or proposals
and/or protocols must provide a description of plans to conduct analyses,
as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by
sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances.  Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA.  It is important for applicants to understand the basic scope
of this amendment.  NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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 
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 
American people.

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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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