NINR CAREER TRANSITION AWARD (K22)
 
RELEASE DATE:  July 29, 2003
 
RFA Number:  RFA-NR-04-004

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361
 
LETTER OF INTENT RECEIPT DATE: October 17, 2003

APPLICATION RECEIPT DATE: November 14, 2003 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
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 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 National Institute of Nursing Research (NINR) invites applications 
for the career transition program from recently graduated doctorally 
prepared nurse scientists or doctorally prepared nurse scientists 
venturing into novel areas of research. 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 registered 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.  Transition from the intramural phase of 
support to the extramural phase will be based upon the success of the 
recipient's postdoctoral research training program as determined by a 
formal internal NINR scientific progress review. 

Intramural Research at the NIH

The NINR intramural research program is located on the Bethesda campus.  
In addition, NIH intramural research opportunities are available with 
other NIH institutes, such as the National Institute on Aging, the 
National Cancer Institute, the National Institute of Environmental 
Health Sciences, and the National Human Genome Research Institute.  For 
example, at the National Institute on Aging, research opportunities are 
possible in conjunction with the Baltimore Longitudinal Study of Aging 
or with other on-going studies.  At the National Cancer Institute 
opportunities are available with the Division of Cancer Epidemiology 
and Genetics.  At the National Human Genome Research Institute 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 institute 
intramural research programs by contacting staff identified in the 
Inquiries section below.

MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Career 
Transition (K22) award mechanism.  Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of 
the applicant.  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 by the extramural institution to which the scholar is 
recruited and will be funded through an extramural, non-competing, K22 
award.  Costs for the extramural phase cannot exceed $125,000 plus 
fringe benefits per year in direct costs.

Acceptance into the NINR Career Transition Award program does not 
convey 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 tenure 
track positions at the NIH.  If an awardee obtains a 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 in the Federal pay schedule and will 
be negotiated with NINR at the time of an award.  

Extramural Support Phase:

1.  Salary:  The NIH will provide up to $50,000 in salary plus fringe 
benefits to the NINR Career Transition Award recipient.  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
 
It is anticipated that applications for the NINR Career Transition 
Award will be solicited annually through the re-issuance of this RFA.  
NINR anticipates funding up to three awards in FY 2004 and has set 
aside up to $375,000 total costs annually for salary and research 
expenses.  The funding level 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-for-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

Registered Nurses (RN) who are recent recipients of a doctoral degree 
or its equivalent 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; however, clinical training does not count against 
the five-year rule.  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 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 
newly awarded doctoral candidates into postdoctoral education, current 
principal investigators on PHS research grants are not eligible.

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:  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
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:

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
Email: john.richters@nih.gov

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

Cindy McDermott
Chief, 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) 594-6869
FAX:  (301) 451-5648
Email:  cindy_mcdermott@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 NINR 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.  The letter of intent should 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
Email: john.richters@nih.gov

SUBMITTING AN APPLICATION

The candidate must obtain a commitment from the intramural scientist 
before completing the K22 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).  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) 435-0714, Email: GrantsInfo@nih.gov.

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.

Sponsor's Statement (Intramural Phase)

o The application must include a statement from the sponsor 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 
support related to the candidate's research plan, and nature of the 
supervision that will occur during the proposed award period.

Extramural 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 two years of support 
in the extramural phase, i.e., what are the research goals and 
potential avenues of research that will be undertaken based upon the 
intramural research training?  The candidate must describe the research 
plan as outlined in form PHS 398 (rev. 5/01) including sections on the 
Specific Aims, Background and Significance, Progress Report/Preliminary 
Studies, Research Design and Methods.

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/label-bk.pdf.
 
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 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.  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 NINR.  Incomplete applications and non-
responsive applications will be returned to the applicant without 
review.  

Applications that are complete and responsive to the RFA 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 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 Advisory Council for 
Nursing Research
 
REVIEW CRITERIA

The peer review criteria for applications submitted in response to this 
RFA 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.

Extramural 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  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 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.  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 revised 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 if necessary, 
salary).

This review will be conducted by an NINR Progress Review Committee 
composed of members of the NINR Selection Committee, and other 
intramural and extramural staff and other reviewers as needed.  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.

Upon approval, the extramural institution will submit an application on 
behalf of the candidate for the extramural phase of support, using the 
form PHS 2590, the Non-Competing Grant Progress Report. The PHS 2590 
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.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: October 17, 2003
Application Receipt Date: November 14, 2003
Peer Review Date: February 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 2004

AWARD CRITERIA

Applications will compete for available positions/funds with all other 
scored applications submitted in response to this RFA.  The following 
will be considered in making award decision: qualifications and 
potential of the applicant and quality of the proposed research project 
as determined by peer review; quality and appropriateness of the 
training environment to the applicant's career goals; availability of 
intramural NIH resources; programmatic priorities; and availability of 
funds. 

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 

MONITORING PLAN AND DATA AND SAFETY 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 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. 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.

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). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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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