MENTORED CAREER AWARD FOR FACULTY AT MINORITY INSTITUTIONS (K01)

RELEASE DATE:  April 14, 2004

RFA Number:  RFA-HL-04-026 (See continuation, RFA-HL-05-016)

EXPIRATION DATE: June 22, 2006

Department of Health and Human Services (DHHS)
                                                                                          
PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION: 
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, 2004; May 21, 2005; May 20, 2006
APPLICATION RECEIPT DATE:  June 23, 2004; June 22, 2005; June 21, 2006 

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 Eligible 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

This RFA is a continuation of the program formerly named  “NHLBI Minority 
Institution Research Scientist Development Award” (RFA-HL-03-012).

The Mentored Career Award for Faculty at Minority Institutions (K01) is a three to 
five-year non-renewable career development award made to faculty at a minority 
institution.  The faculty member must hold a Ph.D., M.D., D.V.M., D.O., or 
equivalent professional degree and wish to develop research capabilities in 
research areas relevant to the mission of the NHLBI.  The candidate or the awardee 
is in the career stage that will benefit from a mentor who is an accomplished 
investigator, either at the same institution or at a collaborating research 
center.  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 awardee is encouraged to 
mentor at least one and a maximum of two students from disadvantaged backgrounds 
including racial and ethnic minorities.  The student(s) will participate on the 
project as a research assistant(s). 

RESEARCH OBJECTIVES

Important NHLBI program goals are to enhance the institution’s science 
infrastructure, to provide “hands-on” research opportunities for 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.  NHLBI encourages research 
training and career development crossing disciplinary boundaries (examples; 
biophysics, biostatistics, bioinformatics, bioengineering) to develop a new 
interdisciplinary workforce. More than one candidate from each minority 
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 – when offered) or Minority Biomedical Research 
Support Program (MBRS, S06.)

MECHANISM OF SUPPORT

This RFA will use the Mentored Career Award for Faculty at Minority Institutions 
(K01) mechanism of support. As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  An unsuccessful 
application to this RFA for one receipt date may be submitted as an amended 
application on subsequent receipt dates for this RFA.  The anticipated award date 
for the first receipt date is April 1, 2005; for the second is April 1, 2006; and 
for the third is April 1, 2007.  This RFA uses just-in-time concepts.  

FUNDS AVAILABLE

The estimated annual funds (total costs) available for the first year of support 
for the program is expected to be approximately $300,000.  The actual amount may 
vary annually, depending on the response to the RFA and availability of funds.  
The total project period for an application submitted in response to this RFA must 
be at least three but not more than five years.  Three new awards are anticipated 
each year.

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 of 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.  

ELIGIBLE PRINCIPAL INVESTIGATORS  

Candidates for this award are faculty members of a minority school 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 and cultivating 
an interest in research for students from disadvantaged backgrounds at their 
institution by teaching and conducting research.  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 summarizes 
NIH and NHLBI policies for these situations.

SPECIAL REQUIREMENTS

Mentor 

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 career 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.

Research Assistants

The awardee is encouraged to mentor at least one and a maximum of two students.  
Student research assistants are individuals from disadvantaged backgrounds 
including racial and ethnic minorities 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.  

If the candidate mentors students, 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.

Providing research opportunities for individuals from disadvantaged backgrounds, 
including racial and ethnic minorities, and who are underrepresented in biomedical 
and behavioral research, will significantly contribute to a diverse research 
workforce in the future.

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.  
The percent effort devoted to the K01 may not fall below 50 percent and the total 
combined effort on the K01 and competing award must be 100 percent during summer 
and/or off-quarter periods.  The total combined effort during the academic year 
must remain at 25 percent.  Please refer to NIH Guide Notice NOT-OD-04-007 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html  for complete 
details of this policy.

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.

If the candidate mentors students, the salary for a student research assistant(s) 
should be consistent with the institutional salary policies.  Institutional rates 
for student research assistant salaries that exceeds $10 per hour must be 
justified.  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%.

Training in the Responsible Conduct of Research (RCR):  Candidates must describe 
plans to receive instruction in 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.  
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. 
 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.

Concurrent Applications

Applications submitted in response to this RFA 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 this K01 award, 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 receive partial salary 
support, with prior NIH approval, from the research grant for the duration of the 
K01 award provided it is in the last two years of the K01 award and the percent 
effort devoted to the K01 award does not go below 50 percent.  Please refer to the 
NIH Guide Notice NOT-OD-04-007 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html  
for a complete explanation of the salary supplementation policy.  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 should include partial salary in the research grant application for 
the duration of the K01 award, provided the total salary requested on the 
K01 and R01 combined does not exceed the institutional base salary or the 
legislated salary limit for the Principal Investigator.  K01 recipients are 
encouraged to include full 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.

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) 480-1060
Email: mondorot@nhlbi.nih.gov 

o Direct your questions about review issues to:

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

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

Ms. Amy R. McGuire
Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7159, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-1498
FAX:  (301) 480-3310
Email:  mcguirea@nhlbi.nih.gov 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o Descriptive title of the proposed 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 the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document to the Chief of Review at the address listed under WHERE TO SEND 
INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a DUN and Bradstreet 
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier 
when applying for Federal grants or cooperative agreements.  The DUNS number can 
be obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/.  The DUNS number should be entered on line 11 of 
the face page of the PHS 398 form. The PHS 398 document 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 and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked.  The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.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 the Chief of Review at the 
address listed under WHERE TO SEND INQUIRIES.  

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without review.  

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 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. Acceptance of a revised 
application in response to this RFA automatically withdraws the prior version, 
since two versions of the same application cannot be simultaneously pending. 
Before a revised application can be submitted, the principal investigator must 
have received the summary statement from the previous review. There must be 
substantial changes in the content of the application. The application must 
include an Introduction of not more than three pages that summarizes the 
substantial additions, deletions, and changes. The Introduction must also include 
responses to the criticisms and issues raised in the summary statement. The 
changes in the Research Plan must be clearly marked by appropriate bracketing, 
indenting, or changing of typography, unless the changes are so extensive as to 
include most of the text. This exception should be explained in the Introduction. 
Do not underline or shade changes. The Preliminary Studies/Progress Report section 
should incorporate any work done since the prior version was submitted.
 
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 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 written critique 
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 
Mentored Career Award for Faculty at Minority Institutions:

(1) 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.

(2) 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. 

(3) 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.

(4) 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.

(5) Environment and Institutional Commitment -- 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.  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:

Undergraduate Students’ Development Plan and Retention Plan -- 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.  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.

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 sections 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 (RCR):  All trainees supported by 
this award must receive instruction in RCR.  (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 RCR.  

Program reports on the type of RCR 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 RCR to all graduate 
students, postdoctorates, and research staff regardless of their source of 
support.

NIH initial review groups will assess the applicant’s RCR plans on the basis of 
the appropriateness of topics, format, amount and nature of faculty participation, 
and the frequency and duration of instruction.

The RCR 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 as the plan 
for instruction in RCR. 
 
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  May 22, 2004; May 21, 2005; May 20, 2006.
Application Receipt Date:  June 23, 2004; June 22, 2005; June 21, 2006.
Peer Review Date:  October/November 2004; October/November 2005; October/November 
2006.
Council Review:  January 2005; January 2006; January 2007.
Earliest Anticipated Start Date:  April 1, 2005; April 1, 2006; April 1, 2007.

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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN:  NIH Policy for Data and Safety 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. 

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.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  It is the 
responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, the official NIH identifier(s) for 
the hESC line(s) to be used in the proposed research.  Applications that do not 
provide this information will be returned without review.

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and 
progress monitoring of grants, cooperative agreements, and research contracts can 
be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH 
funding must be self-contained within specified page limitations. Unless otherwise 
specified in an NIH solicitation, Internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under no obligation 
to view the Internet sites.   Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas. This 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 the 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.

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)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.