PAR-04-143: NINR CAREER TRANSITION AWARD (K22)

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) 435-0714,
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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health
and Human Services

National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892