This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED


NINR CAREER TRANSITION AWARD (K22)

RELEASE DATE:  August 13, 2004 

PAR NUMBER:  PAR-04-143  April 15, 2008 (Reissued as PAR-08-148)

September 21, 2007 - Expiration Date adjusted to 
accommodate recent changes to standing  submission deadlines, per NOT-OD-07-093.

(See Notice NOT-OD-07-043 Extension of 
Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) expiration dates. 

EXPIRATION DATE:  January 3, 2008  (now January 8, 2008 per NOT-OD-07-093)


Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism of Support 
o Allowable Costs
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR

The National Institute of Nursing Research (NINR) invites applications for 
the career transition program from recently graduated doctorally prepared 
nurse scientists. The overall goals of this program are to support 
outstanding individuals to obtain a research training experience at the NIH 
in the intramural research laboratories and to facilitate their successful 
transition to an extramural environment as independent researchers.  
 
RESEARCH OBJECTIVES

Background

Intramural scientists and facilities at the NIH provide an infrastructure for 
the research training and career development of promising new scientists who 
will subsequently enter the extramural biomedical and health care research 
community and have the potential to become leaders in their fields of 
investigation.  The goal of the NINR Career Transition Award program is to 
provide highly qualified developing, doctorally prepared nurses with an 
opportunity to receive postdoctoral research training in an NIH intramural 
research laboratory or clinical research department.  Transition funding will 
be provided upon completion of the fellowship for the continuation of their 
program of research in an extramural institution.

The NINR Career Transition Award consists of an Intramural Support Phase and 
an Extramural Support Phase.  The total period of combined intramural and 
extramural support will be up to five years.  Initially, up to three years of 
the research training program will be provided in the Intramural Support 
Phase in which the salary of the awardee will be commensurate with his/her 
level of experience.  The final two years of the program, the Extramural 
Support Phase, will provide salary and funds for supplies, equipment and 
technical support thorough the NIH Career Transition Award.  

Intramural Research at the NIH

The NINR intramural research program is located on the Bethesda campus. 
Research opportunities exist within the NINR Intramural Research 
Laboratories. In addition, NIH intramural research opportunities are 
available with other NIH institutes.  Examples include, but are not limited 
to: National Institute on Aging, where research opportunities are possible in 
conjunction with the Baltimore Longitudinal Study of Aging or with other on-
going studies; National Cancer Institute, where opportunities are available 
with the Division of Cancer Epidemiology and Genetics; and the National Human 
Genome Research Institute, where there are both laboratory and clinical 
opportunities.

To assist the applicant in finding a sponsor for this research training and 
career development experience, a listing of NIH intramural research 
opportunities can be accessed through the following website - 
http://www1.od.nih.gov/oir/sourcebook/sci-prgms/sci-prgms-toc.htm

The website identifies individual Institutes and Centers, describes 
intramural laboratories and clinical research services, and the topic areas 
of interest within the institutes and centers.  Names and phone numbers of 
scientists are listed on the websites, and prospective applicants are 
encouraged to contact the scientists directly and dialogue with them about 
the potential for a laboratory and/or clinical postdoctoral research training 
experience.  It is strongly recommended that potential candidates receive 
guidance regarding research and mentoring opportunities with NINR and with 
other NIH intramural research programs by contacting staff identified in the 
Inquiries section below.  

MECHANISM OF SUPPORT
 
This PAR will use the National Institutes of Health (NIH) Career Transition 
K22 award mechanism.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.   The total period 
of combined support is up to five years (up to three years intramural, up to 
two years extramural).   There is no grant award associated with the 
intramural phase.  Awards are not renewable.  Total cost of the intramural 
phase is based on the candidate's experience and research expenses, not to 
exceed $125,000 per year.  The final two years of the scholar's research 
program will be supported at the extramural institution to which the scholar 
is recruited and will be funded through an extramural, non-competing, K22 
award.  Direct costs for the extramural phase cannot exceed $125,000 plus 
fringe benefits. 

Transition from the intramural phase of support to the extramural phase is 
not automatic.  Approval of the transition will be based on the success of 
the awardee’s research program as determined by an NINR progress review, 
which will take place no later than the end of the second year of the 
Intramural Support Phase, and the evaluation of a research plan to be carried 
out at the extramural institution.  The extramural institution must 
demonstrate a commitment to the candidate by providing protected research 
time, space needed to perform the proposed research and a plan for career 
development. Awardees approved to proceed with the second phase of support 
will receive notification of approval in writing from the NINR.  An 
application from the extramural institution on behalf of the candidate will 
be required for the NINR to process the second phase of the K22.

Acceptance into the NINR Career Transition Award program does not imply any 
commitment or intent of the NINR to consider the awardee for Federal 
employment within the NINR.  The NINR Career Transition Award is specifically 
intended to give a postdoctoral research training experience to candidates 
who will pursue their career in the extramural scientific research community.  
However, the NINR Career Transition awardee is not explicitly precluded from 
applying for available positions at the NIH.  If an awardee obtains an NIH 
position, the NINR Career Transition Award will be terminated.

ALLOWABLE COSTS

Intramural Support Phase:

The budget for the Intramural Support Phase includes the candidate's salary 
and research expenses determined by the NINR Division of Intramural Research.  
There is no grant award associated with the intramural phase. Total costs for 
the intramural phase are based on the candidate's experience and research 
expenses, and are not to exceed $125,000 per year.  The salary must be 
commensurate with the level of training and experience specified by the 
intramural salary structure and will be negotiated with NINR at the time of 
an award. 

Extramural Support Phase:

1.  Salary:  The NIH will provide salary for the award recipient up to 
$50,000, plus fringe benefits for a minimum of 75 percent effort.  Although a 
greater effort may be proposed, the maximum allowable salary is $50,000.  The 
total salary requested must be based on a full-time, 12-month faculty or 
staff appointment.  It must be consistent with the established salary 
structure at the institution and with salaries actually provided by the 
institution from its own funds to other faculty or staff members of 
equivalent qualifications, rank, and responsibilities in the department 
concerned.  There should be no less than 75 percent effort devoted by 
the candidate specifically to the proposed program of research.  The 
institution may supplement the NIH contribution up to a level that is 
consistent with the institution's salary scale; however, supplementation may 
not be from Federal funds unless specifically authorized by the Federal 
program from which such funds are derived.  

In no case may PHS funds be used for salary supplementation.  Institutional 
supplementation of salary must not require extra duties or responsibilities 
that would interfere with the purpose of the Career Transition Award.  Under 
expanded authorities, institutions may re-budget funds within the total costs 
awarded, but may not re-budget funds involving the salary component of the 
budget.  

2.  Research Support: The NINR will provide up to $75,000 per year for (a) 
research expenses, such as supplies, equipment, consultants, patient care 
costs, and technical personnel; (b) travel to research meetings or training; 
and (c) statistical service, including personnel and computer time. 

3.  Ancillary Personnel Support: Salary for secretarial and administrative 
assistance, etc., is not allowed.

4.  Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed 
at eight percent of modified total direct costs.

FUNDS AVAILABLE
 
NINR anticipates funding up to three awards in each year.  The number of 
applications funded will be dependent upon the number of meritorious 
applications received, funds available, and the particular resource needs for 
the proposed project.

ELIGIBLE INSTITUTIONS

Intramural Support Phase:

Intramural phase applications may be submitted for research within any 
intramural program at the NIH.

Extramural Support Phase:

Applications for transition to the extramural phase require that the 
extramural institution falls within one or more of the following categories:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, and 
hospitals
o Units of state and local governments
o Eligible agencies of the Federal government
o Domestic organizations 

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS

Doctorally prepared nurse scientists who are recent recipients of a doctoral 
degree and who have demonstrated the potential for a highly productive 
research career are eligible to apply.  The doctoral degree must be awarded 
before the Career Transition Award can be activated.  In general, individuals 
who have had more than five years of postdoctoral research training at the 
time of application are not eligible to apply.  During the NIH intramural 
phase of the award, the candidate is expected to devote 100 percent effort on 
research training for up to three years.  During the extramural phase, the 
candidate must spend a minimum of 75 percent effort conducting research and 
engaging in research career development activities for the two years of the 
award.

Candidates must be U.S. citizens or non-citizen nationals, or must have been 
lawfully admitted for permanent residence and possess an Alien Registration 
Card (I-151 or I-552) or some other verification of legal admission as a 
permanent U.S. resident by the time of the initiation of the intramural phase 
of the award Non-citizen nationals, although not U.S. citizens, owe permanent 
allegiance to the U.S.  They are usually born in lands that are not states, 
but are under U.S. sovereignty, jurisdiction, or administration.  Individuals 
on temporary or student visas are not eligible.

Because the purpose of this initiative is to ease the transition of persons 
with newly awarded doctoral degrees into postdoctoral education, current  or 
former principal investigators on PHS research grants  (R01), FIRST Awards 
(R29), SBIR/STTR awards, sub-projects of program projects (P01) or center 
grants (P20, P30), NIH career development(K)awards or the equivalent are not 
eligible. Former principal investigators of an NIH Small Grant (R03) or 
Exploratory Development Grant (R21) remain eligible.  A candidate for the 
NINR Career Transition Award may not concurrently apply for any other PHS 
award that duplicates the provisions of this award nor have another 
application pending award.

Applicants are encouraged to contact the NINR program staff listed under 
INQUIRIES regarding their eligibility for this award prior to the preparation 
of an application.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAR and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about the intramural support phase to:

Melinda M. Tinkle, PhD, RN 
Intramural Program Director for Research and Training
National Institute of Nursing Research
Building 31, Room 5B-13
Bethesda, MD 20892-2078
TELEPHONE: (301) 402-7889
FAX: (301) 480-2479
Email: tinklem@mail.nih.gov

o  Direct your questions about the extramural support phase to:

Martha L. Hare PhD, RN
Program Director
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
TELEPHONE:  (301)  451 3874
FAX:  (301) 480-8260
Email: harem@mail.nih.gov

o Direct your questions about peer review issues to:

Jeffrey Chernak, PhD
Scientific Review Administrator
Office of Review
Division of Extramural Activities
National Institute of Nursing Research
6701 Democracy Blvd, Room 707, MSC 4870
Bethesda, MD  20892-4870
ATTN:  NINR Career Development Award
Telephone:  (301)  402 6959
FAX:  (301 480 8260
Email:   chernakj@mail.nih.gov

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

Teresa Marquette
Office of Grants and Contracts Management
Division of Extramural Activities
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2177
FAX:  (301) 451-5649
Email Marguettet@mail.nih.gov

SUBMITTING AN APPLICATION

Potential candidates are strongly encouraged to contact the program staff 
person listed under INQUIRIES.  Such contact should occur early in the 
planning phase of application preparation.  Such contact will help ensure 
that applications are responsive to the goals and policies of this 
announcement.

The candidate must obtain a commitment from the intramural scientist before 
completing the K22 application.  The candidate and proposed mentor must 
collaborate closely in completing the application. Potential applicants are 
encouraged to contact Dr. Melinda Tinkle, at the address listed under WHERE 
TO SEND INQUIRIES, prior to application submission.  Questions regarding the 
extramural phase may be addressed to Dr. Martha Hare.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001) for the initial competing application 
(intramural phase), and for the noncompeting transition to the extramural 
phase. Applications must have a Dun and Bradstreet (Duns) number when 
applying for Federal grants or cooperative agreements.  The Duns number can 
be obtained by called (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 is available at 
http://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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

The initial application for the NINR Career Transition Award program will NOT 
be processed through your current institution; therefore, follow the 
supplemental guidelines below for the face page.

The applicant must provide her/his signature in item 14; signature is not 
required for item 15.

Leave items 9-13 and 15 on the face page blank.

Enter in item 6 (Dates of Proposed Period of Support) the combined 4 to 5 
years of support needed to complete the intramural and the extramural support 
phases of the NINR Career Transition Award Program.

Utilize the "Research Career Award" Table of Contents page, but re-label the 
page, "Career Transition Award."  This page is included in the Form 398 
packet and will facilitate organizing the research and career development 
components of the application.  Add a "Career 
Development Plan" under "Section II: Specialized Information."

Budget 

o  Do NOT provide any dollar figures in the application.  The final budget 
will be negotiated when a selected applicant accepts a position and will be 
within the allowable costs specified above.
o  For candidates who receive approval for transition to extramural support, 
a budget will be submitted as part of the form PHS 2590 Non-Competing Grant 
Progress Report as discussed below in Extramural Support Phase.

The application must address the following issues:

Candidate

o  Establish the candidate's commitment to a career in biomedical or 
behavioral research.
o  Establish the candidate's potential to develop and pursue a successful 
program of research as an independent investigator.
o  Establish the candidate's ability to work with other scientists in an 
interactive research environment.
o  Summarize the candidate's immediate and long-term career objectives, 
explaining how the award will contribute to their attainment.
o  Letters of recommendation.  Three sealed letters of recommendation 
addressing the candidate's potential for a research career must be included 
as part of the application.  One should be from a dissertation advisor or 
mentor, if the candidate is in a doctoral or postdoctoral 
research setting.  These letters should address the candidate qualifications 
as already outlined.

Career Development Plan

o Applicant should describe the research training and career development 
plan, incorporating consideration of the candidate's goals and prior 
experience.  The applicant should describe a systematic plan to obtain the 
necessary scientific background and research training experience to launch an 
independent research career (including the need for any courses, mentoring 
format, plans for immersion into the laboratory, research techniques or 
methods, etc.).

Intramural Research Training Plan

o The application must describe: 1) how the specific laboratory postdoctoral 
intramural experience will enhance the candidate's projected research career; 
and, 2) identify specific research training objectives.  Research training 
objectives should include how the intramural research experience will assist 
the candidate in developing a unique program of research at an extramural 
institution.

Research Plan 

o Describe the research plan, including the scientific objectives and 
specific aims, and the use of a basic or clinical approach to a scientific 
research problem sufficient to justify five years of support. The candidate 
must indicate what is proposed for the intramural phase and what is to be 
carried out in the extramural phase. It is understood that some refinement of 
the extramural research plan will occur based on the outcomes of the 
intramural phase. 

Sponsor's/Mentor’s Statement (Intramural Phase)

o The application must include a statement from the intramural sponsor/mentor 
describing the elements of research training planned for the candidate, 
including any formal course-work, and specify how the candidate's scientific 
independence and professional development will be promoted.  The sponsor 
should also include information on his/her research qualifications, previous 
experience as a research supervisor, research activities and support related 
to the candidate's research plan, and nature of the supervision that will 
occur during the proposed award period.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines 
for  New Career Awards , which are available at 
http://grants.nih.gov/grants/dates.htm .  Application deadlines are also 
indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

John E. Richters, PhD
Chief, Office of Review
Division of Extramural Activities
National Institute of Nursing Research
6701 Democracy Blvd, Room 707, MSC 4870
Bethesda, MD  20892-4870
ATTN:  NINR Career Development Award
Telephone:  (301) 594-5971
FAX:  (301) 451-5645
 
APPLICATION PROCESSING: Applications must be received by, or mailed on or 
before, the published receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The Center for 
Scientific Review (CSR) will not accept any application in response to this 
PA 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 a substantial revision of an 
unfounded version of an application already reviewed, but such application 
must include an Introduction addressing the previous critique. 

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.
 
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NINR.  Incomplete applications and non-responsive 
applications will be returned to the applicant without review.  

Applications that are complete and responsive to the PAR will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NINR 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 Advisory Council for Nursing 
Research
 
REVIEW CRITERIA

The peer review criteria for applications submitted in response to this PAR 
are:

Candidate

o  Capacity and commitment to pursue an independent research career;
o  Potential to develop into an outstanding independent research scientist 
who will make significant contributions to the field;
o  Quality and breadth of prior scientific training and experience including, 
where appropriate, the record of previous research support and publications;
o  Ability to plan, develop, and organize a program of research that will 
make full use of the support offered under this award.

Career Development Plan

o  Appropriateness of the career development plan, considering the 
candidate's goals and prior experience;
o  The consistency of the career development plan with the candidate's 
research plan and potential for contributing to the scientific literature.

Intramural Training Plan

o  Appropriateness of the intramural training plan, considering the 
candidate's goals and prior experience;
o  The logical sequence and scientific rigor of the intramural training plan 
with the candidates research plan;
o  Potential of the scholar to contribute to the scientific literature.

Sponsor

o  Appropriateness of the sponsor's research interests and qualifications to 
the career development needs of the candidate;
o  Adequacy of the nature and extent of supervision that will occur during 
the proposed award period;
o  Adequacy of the proposed mentoring plan.

Research Plan 

o  A sound research plan that is consistent with the candidate's level of 
research development must be provided;
o  Usefulness of the intramural research plan as a vehicle for enhancing or 
expanding existing research skills as described in the career development 
plan; 
o  Appropriateness of the proposed specific aims for the intramural phase of 
the research and evidence of long-term viability of the proposed research for 
the extramural phase.
o  Scientific and technical merit of the research question, design and 
methodology, judged in the context of the candidate's previous training and 
experience;
o  Adequacy of plans to include both genders, children, and minorities and 
their subgroups as appropriate for the scientific goals of the research.

Plans for the recruitment and retention of subjects will also be evaluated, 
where appropriate.

SELECTION and AWARD PROCEDURES

Following peer review, the written evaluations and priority score assigned to 
the application by the initial review group will be sent to the candidate.

Intramural Support Phase

Successful candidates will be selected based on priority score ranking, 
programmatic needs, and available resources.  Each awardee will be evaluated 
for progress on an annual basis by the mentor and the appropriate member of 
the NINR Division of Intramural Research.

Extramural Support Phase

Transition to the extramural support phase is not automatic.  The NINR will 
conduct a formal scientific progress review no later than the end of the 
second year of the Intramural Support Phase to determine whether or not the 
awardee will be recommended for the extramural phase of support. This review 
will be conducted by an NINR Progress Review Committee composed of members of 
the NINR intramural and extramural staff and other reviewers as needed. The 
NINR Progress Review Committee will consider whether the awardee is 
adequately positioned to make the transition to the extramural phase of 
support and undertake the research proposed. Attention will also be paid to 
the adequacy of human subjects protection; gender, minority and children 
inclusion plans; animal protection; and data sharing plans for the extramural 
phase of support. The results of the review will constitute a final 
evaluation of the Intramural Support Phase and be presented in writing to the 
awardee.  Approval will result in eligibility for the extramural phase of 
funding of the Career Transition Award, and up to a third additional year of 
intramural support to facilitate the transition to an extramural laboratory.

In order to proceed to the scientific progress review, the candidate must 
have a formal tenure-track (or equivalent) offer of a faculty position from 
an extramural institution.  Other specific requirements for the scientific 
progress review include:

o Annual progress report from the awardee
o Rrevised research plan for extramural support phase
o Letter of commitment to the candidate from the Dean of the extramural 
institution agreeing to provide: protected research time, infrastructure, 
space needed to perform the proposed research and funds from the institution 
for equipment and supplies, and any necessary salary).

Upon approval, the applicant will submit an application through the 
extramural institution for the extramural phase of support, using the form 
PHS 398. The PHS 398 should be submitted no later than two months prior to 
the start of the extramural phase and should specifically include:
 
o Face page
o Abstract and personnel page
o Budget (12 month and multi-year)
o Budget justification
o Current investigator-initiated research grant support (in Other Support 
format)
o All applications submitted for investigator-initiated support
o Updated career progress
o Publications in press or submitted
o Revised research plan for extramural phase
o Checklist

At the end of the first year of extramural support, the awardee will submit a 
PHS 2590 for the final year of support.  Upon completion of the final year, 
the awardee will submit a final progress report.

Evaluation of Scientific Progress

Intramural Support Phase

Each awardee's research progress will be evaluated on an annual basis.  For 
this purpose, the awardee will prepare an annual progress report that will be 
evaluated by the mentor and the NINR Division of Intramural Research.  
Additionally, the NINR will conduct a formal scientific progress review no 
later than the end of the second year (See section on Selection Procedures, 
Extramural Support Phase).

Extramural Support Phase

The awardee will be required to submit a form PHS 2590 Non-Competing Grant 
Progress Report for the final year of extramural support.  After the 
completion of this award, the awardee will be required to submit a final 
progress report.  Additionally, periodic updates on various aspects of 
employment history, publications, support from research grants or contracts, 
honors and awards, professional activities, and other information helpful in 
evaluating the impact of the program may be solicited from the awardee.
 
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: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.    (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 PA 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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.



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