NEI CAREER TRANSITION AWARD (K22)

RELEASE DATE:  August 6, 2004

PA NUMBER:  PAR-04-136 January 30, 2009 - See Notice (NOT-OD-09-039) This notice announces the expiration of this PAR.

 May 16, 2008 - See Notice (NOT-OD-08-069) Due to 
the upcoming receipt dates for several FOAs using these mechanisms, 
their expiration dates are being extended.

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

January 25, 2007 - See Notice (NOT-OD-07-043) 
Extension of Several NRSA Training (T), NRSA Fellowship (F), 
and Career Development (K) expiration dates.

(See clarification, NOT-EY-05-006)

EXPIRATION DATE:  New Date January 30, 2009 (per issuance of  NOT-OD-09-039)

(Changed from January 8, 2010 per NOT-OD-08-069)

(Changed to January 8, 2008 per NOT-OD-07-093)

Original Expiration Date: January 3, 2008

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Eye Institute (NEI)
 (http://www.nei.nih.gov)
Office of Dietary Supplements (ODS)
 (http://ods.od.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.867

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR

The purpose of the National Eye Institute (NEI) Career Transition Award is to 
enable outstanding individuals to establish an independent research program 
in vision research and to secure an appointment in an academic institution in 
the United States.  This is accomplished in a two-phase award program.  The 
Scholar Development Phase provides up to three years of mentored career 
development training in an NEI Intramural Research Program (IRP) laboratory.  
The Faculty Transition Phase provides up to two years of research support at 
an extramural institution to which the Scholar has been recruited as an 
independent faculty member.  The NIH Office of Dietary Supplements will 
collaborate with the NEI in supporting Scholars whose research involves 
dietary interventions or risk factors which affect visual system diseases, 
disorders, or development.

RESEARCH OBJECTIVES

Background

The mission of the NEI is to conduct and support the highest quality research 
aimed at increasing our understanding of the eye and visual system in health 
and disease.  This research will promote the visual health of the Nation 
through development of effective means for the prevention, treatment, and 
rehabilitation of visual impairment, and through the timely dissemination of 
research findings and information.

Over the past thirty years the NEI IRP has provided an extraordinary research 
environment for the training of new scientists who have the potential to 
become leaders in the area of vision research.  This Career Transition Award 
mechanism is uniquely designed to facilitate the transition of these newly-
trained individuals to independent research careers in U.S. academic 
institutions.  Applicants for this award may engage in both basic and 
clinical research investigations at the NEI to improve our understanding of 
vision and visual impairment.  Basic research programs include immunology, 
developmental biology, sensorimotor research, molecular biology and genetics.  
The Age-Related Eye Disease Study (AREDS) is an example of a major clinical 
research funded by the NEI to improve our understanding of the predisposing 
factors and clinical course of AMD and cataract. The outcome of this study 
has spurred new treatments and research on vitamins and antioxidants as 
prognostic factors for eye disorders.

Scope

NEI-sponsored investigations broadly cover all aspects of vision research.  
These programs represent a significant fraction of the vision research 
conducted in hundreds of extramural laboratories and clinics throughout the 
world, as well as in the NEI’s own IRP facilities in Bethesda, Maryland.  The 
NEI IRP is organized into eight scientific units:  the Division of 
Epidemiology and Clinical Research; the Laboratories of Immunology, Molecular 
and Developmental Biology, Sensorimotor Research, Retinal Cell and Molecular 
Biology, Mechanisms of Ocular Diseases, and Ophthalmic Genetics and Visual 
Function; and the Section on Molecular Structure and Function.  Detailed 
information regarding specific IRP research projects that are currently being 
pursued and scientists who can potentially serve as mentors is available at 
http://www.nei.nih.gov/intramural/.

Continued advances in vision research will require a diverse, highly trained 
cadre of scientists in adequate numbers to carry out the NEI’s biomedical and 
behavioral research agenda.  The NEI Career Transition Program is designed to 
help ensure that promising applicants fulfill their potential to become 
productive, independent investigators.

MECHANISM OF SUPPORT

This PAR will use the NIH Career Transition Award (K22) mechanism.  The 
applicant and the mentor will be solely responsible for planning, directing, 
and executing the proposed project.

This PAR uses just-in-time concepts.  It also uses the non-modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm

The total period of support for the NEI Scholars Program is up to five years.  
The Scholar Development Phase may be up to three years, and the Faculty 
Transition Phase may be up to two years.  Both phases of the award are 
neither transferable nor renewable.

o  Intramural Scholar Development Phase

The Scholar Development Phase takes place within the NEI IRP for up to three 
years.  During this phase of the award, scholars are expected to spend full 
time on mentored career development activities such as research and didactic 
course work.  Scholars will be fully supported by the NEI intramural unit in 
which the Scholar conducts his/her research.  The level of support will be 
negotiated with the NEI Scientific Director at the time of award.

o  Extramural Faculty Transition Phase

The Faculty Transition Phase will take place at a U.S. extramural institution 
for up to two years.  During this phase of the award the Scholar is expected 
to devote at least 75% effort to the establishment of an independent vision 
research program.

The NEI will provide Scholars with salary support commensurate with the 
applicant institution’s salary structure for persons of equivalent 
qualifications, experience, and rank, up to the legislatively-mandated salary 
limit.  The institution may supplement the Scholar’s salary.  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 
Public Health Service (PHS) funds be used for salary supplementation.  
Institutional supplementation of salary may not require extra duties or 
responsibilities that would interfere with the purpose of this award.  Annual 
direct costs up to $100,000 will be provided for personnel, equipment, 
supplies, tuition and fees, travel, patient care costs, statistical services, 
and other career development- and research-related activities.  The 
extramural institution will be reimbursed indirect costs at eight percent of 
modified total direct costs.

o  Special Considerations

Before submitting an application for the Scholar Development Phase, the 
candidate must identify an individual or individuals within the NEI IRP who 
will serve as the mentor and will be committed to supervise the career 
development research and training activities for the duration of this phase 
of the award.  The mentor must be an active investigator in the area of the 
proposed research and have both the research training experience and the 
resources needed to support the NEI Scholar.

The NEI Career Transition Program is specifically intended to help develop 
scientists who will pursue an independent extramural vision research program.  
Therefore, acceptance into the IRP Scholar Development Phase does not convey 
any intent or commitment of the NEI to consider the NEI scholar for a tenure 
track position within the IRP.  Nevertheless, NEI Scholars are not precluded 
from applying for available intramural tenure track positions at the NIH.  If 
an NEI scholar obtains an NEI tenure track or NIH position, the NEI Scholar’s 
award will be terminated.

Progression to the Faculty Transition Phase is not automatic.  The NEI 
Division of Extramural Research will conduct a formal progress review no 
later than the end of the second year of the Scholar Development Phase to 
determine whether or not the Scholar will be recommended for transition.

Following the Faculty Transition Phase, it is anticipated that Scholars will 
obtain a research project grant (R01) to support the continuation of their 
research.  The Scholar would not be eligible to apply for any NIH mentored 
career development award.

ELIGIBLE INSTITUTIONS

The Scholar Development Phase of this award must be performed in the NEI IRP.  
The Faculty Transition Phase may be pursued at an extramural institution with 
any of the following characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o Domestic institutions/organization
o Foreign institutions are not eligible to apply

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Candidates must be US citizens, non-citizen nationals, or permanent 
residents.  The candidate must have a research or health professional 
doctoral level degree or its equivalent and must have demonstrated the 
potential for a highly productive research career.  Candidates should be 
within seven years of receipt of their degree at the time of application.  
Clinical training does not count against the seven years.  Former Principal 
Investigators on NIH research project grants (R01, R03, R15, R21, R41, R42, 
R43, R44), subprojects of program project grants (P01) or center grants (P30, 
P50), career development awards (K01, K08, K12, K23, K24), or the equivalent 
are not eligible to apply.

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Women, individuals from underrepresented 
racial and ethnic groups, and individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

During the Scholar Development Phase, Scholars must provide annual progress 
reports using form PHS 2590, available at 
http://grants.nih.gov/grants/forms.htm.  The form is due two months prior to 
the end of the budget period.  The reports should detail progress achieved on 
the specific aims of the research plan and on the pursuit of identified 
career goals.  Future goals for the research project and for further career 
development should also be indicated.  The mentor must provide a separate 
narrative of the research and career development of the Scholar.

The Scholars’ progression to the Faculty Transition Phase of the award will 
be based upon the assessment of a Scholar Review Committee (SRC).  The SRC 
will be composed of the extramural program director, NEI Training Officer, 
and other senior NEI extramural staff.  The SRC will meet within 30 days of 
receipt of the second year’s annual progress report (Scholars who wish 
earlier consideration of progression should discuss the timing with their 
extramural program director).  The SRC determination will be based upon the 
cumulative research progress and evidence of increasing scientific 
independence, as documented by both the Scholar and the mentor.  The findings 
of the SRC will be communicated to the Scholar, mentor, and NEI Scientific 
Director.  The successful Scholar will be provided with an “Intent to Fund” 
letter with which he/she may pursue a tenure track appointment.  Activation 
of the Faculty Transition Phase of the award will be made through submission 
of form PHS 2590 from the appropriate extramural institution.

Scholars who do not successfully enter the transition phase of the award will 
be provided with a terminal, third year of Scholar Development Phase support

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 scientific/research issues to:

Chyren Hunter, Ph.D.
Training Officer
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD  20892-9300
Telephone:  (301) 451-2020
FAX:  (301) 402-0528
Email:  clh@nei.nih.gov

The Office of Dietary Supplements, Office of the Director, NIH will support 
meritorious Career Development (K22) applications to this initiative for 
clinical and basic research related to studies involving nutritional 
interventions.  For further information, please contact:

Mary Frances Picciano, Ph.D. (NIH/OD)
Senior Nutrition Scientist
Office of Dietary Supplements 
National Institutes of Health 
Suite 3B01 
6100 Executive Boulevard 
Bethesda, MD 20892-7517 
Phone: 301-435-2920 
FAX: 301-480-1845
Email:  PiccianiM@mail.nih.gov

o Direct your questions about peer review issues to:

Samuel C. Rawlings, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD  20892-9300
Telephone:  (301) 451-2020
FAX:  (301) 402-0528
Email:  rawlings@nei.nih.gov

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

William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD  20892-9300
Telephone:  (301) 451-2020
FAX:  (301) 496-9997
Email:  wwd@nei.nih.gov

SUBMITTING AN APPLICATION

Potential applicants are strongly encouraged to contact the program staff 
listed under INQUIRIES.  Such contact should occur early in the planning 
phase of application preparation and will help ensure that applications are 
responsive to the goals and policies of this announcement.  Early in the 
process, candidates must obtain commitments from the IRP investigator(s) who 
will serve as mentor during the Intramural Scholar Development Phase.  The 
potential Scholar and mentor(s) must work collaboratively to design the 
proposed career development and research experiences.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. PLEASE NOTE THAT THE D&B NUMBERS ARE NOT AVAILABLE FOR THE 
INTRAMURAL PHASE BUT ARE REQUIRED FOR THE EXTRAMURAL FACULTY TRANSITION 
PHASE. The D&B number can be obtained by calling (866) 705-5711 or through 
the web site at http://www.dunandbradstreet.com/. The D&B 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.

Supplemental Application Guidelines

Item 6, Enter the combined dates of support needed to complete both the 
Scholar Development and Faculty Transition Phases.

Items 9, 10, 11, 12, 13, 14, 16:  Leave these items blank.

o  Table of Contents:  Do not use forms in the PHS 398 application.  Prepare 
a page titled “Career Transition Award Table of Contents” which contains the 
following sections:

Section I:  Basic Administrative Data

1.  Face Page

2.  Description, Performance Site(s), and Key Personnel

3.  Budget

Scholar Development Phase:  Do not provide any dollar figures in the 
application.   The final budget will be negotiated with the Scientific 
Director at the time of award.  Use continuation pages as needed to provide a 
detailed justification for the budgetary needs of the proposed research 
program.

Faculty Transition Phase:  Candidates who receive approval for transition to 
faculty support have two years from the approval date in which to activate 
this phase of their award.  Upon activation, a budget will be submitted as 
part of the Form PHS 2590 Non-competing grant Progress Report.  The 
application should provide an updated research plan and documentation of 
institutional commitment to necessary facilities and resources.

4.  Biographical Sketches:  Provide for both the candidate and the mentor(s), 
using the Biographical Sketch Format Page.  Do not exceed four pages.

5.  Resources (Resources Format Page)

Section II:  Specialized Information

1.  Letters of Reference (Attach to Face Page)

Provide three sealed letters of recommendation addressing the candidate’s 
potential for a laboratory or clinical research career.  It is recommended 
that one letter be from the most recent mentor in either a postdoctoral 
research or clinical setting or from the applicant’s thesis advisor.

2.  Candidate (not to exceed one page)

Describe the candidate’s commitment to a career in vision research.  Discuss 
the candidate’s potential to develop into a successful independent 
investigator.

3.  Career Development Plan (not to exceed two pages)

Propose a career development plan for the Scholar Development Phase of the 
award.  The candidate’s education and prior experience should be documented.  
Present a systematic plan to obtain the scientific background and the new 
research training experience necessary to launch an independent research 
career.  Include the need for any formal courses, mentoring format, plans for 
immersion into the laboratory, research techniques or methods, etc.

Describe plans to receive training in the responsible conduct of research.  
Include the proposed subject matter, format, frequency, and during of 
instruction, as well as the amount and nature of senior staff participation.  
No award will be made if an application lacks this component.

4.  Mentor(s)’s Statement (not to exceed one page)

Describe the mentor(s)’s research qualifications and previous research 
training experience.  Describe the nature and extent of the mentor(s)’s 
commitment and supervision.  Document a strong, well-established research 
program related to the candidate’s area of interest.  This should include an 
environment with staff capable of productive collaboration with the 
candidate.  Letters of commitment of space and resources to be provided to 
the Scholar should be provided by the NEI Scientific Director.  Indicate how 
the career development plan will be used to promote the candidate’s 
scientific independence and professional development.

5.  Research Plan (not to exceed ten pages)

Applicants are advised to address the research plan in two parts.

First present the Scholar Development Phase, which should be prepared after 
consultation with the mentor(s).  Include descriptions of the hypothesis and 
specific aims, background, significance and rationale, preliminary studies 
and any results, research design and methods, and literature cited.  As 
appropriate, discuss the use of human and animal subjects.  Relate the 
research plan to the candidate’s career goals and career development plan.

Second, present the Faculty Transition Phase.  This should provide general 
research directions for the independent extramural phase.  Describe the broad 
research goals and potential avenues of research that would be stimulated by 
the specific research project.

6.   Training in the Responsible Conduct of Research

Candidates must describe plans to receive instruction in the responsible 
conduct of research.  These plans must detail the proposed subject matter, 
format, frequency, and duration of instruction.  No award will be made if an 
application lacks this component.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines, 
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 five 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)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 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 eight weeks.

PEER REVIEW PROCESS

Applications submitted for this PAR will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened by the NEI in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for 
scientific and technical merit.

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of 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 Eye Council.

REVIEW CRITERIA

Update: Enhanced review criteria have been issued for the 
evaluation of research applications received for potential FY2010 
funding and thereafter - see 
NOT-OD-09-025)

In the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the 
applicant will assume an independent extramural vision research career.

o Candidate
o Career Development Plan
o Scholar Development Phase
o Faculty Transition Phase
o Mentor(s)
o Environment

   The scientific review group will address and consider each of these criteria 
in assigning the application’s overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.

CANDIDATE:  Does the candidate have the capacity and commitment to pursue an 
independent research career?  Does the candidate have the potential to 
develop into an outstanding independent research scientist who will make 
significant contributions to the field?

CAREER DEVELOPMENT PLAN:  Does the career development propose new training 
appropriate to the candidate’s prior scientific training and experience?  Is 
the plan likely to contribute substantially to the continued scientific 
development and productivity of the candidate?

SCHOLAR DEVELOPMENT PHASE:  Is the research proposed appropriate to the 
candidate’s prior scientific training and experience?  Is the proposed new 
research innovative, significant, and likely to contribute to the scientific 
literature.

FACULTY TRANSITION PHASE:  Are the scholar’s overall goals for the Faculty 
Transition phase in concert with the goals to be achieved during the Scholar 
Development Phase?  Is the scholar’s research program comprehensive, pursuing 
both current and potential avenues for research and research 
collaboration(s).  Has the scholar considered how to best utilize this two-
year phase to enhance his/her research program as a tenure-track 
investigator?

MENTOR(S):  Are the mentor(s)’ research qualifications, scientific stature, 
experience, and track record appropriate to the applicant’s career 
development needs.  Is there evidence of previous experience in fostering the 
development of new investigators.  Is the extent of 

ENVIRONMENT:  For both the Scholar Development Phase and the Faculty 
Transition Phase has the scholar been made aware of and provided appropriate 
resources to carry out his/her research and training goals?  Is there a plan 
for integration of the scholar into the research environment, e.g., through 
attendance at seminars, laboratory meetings, clinical grant rounds, committee 
responsibilities.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

Training in the Responsible Conduct of Research

o Appropriateness and quality of the proposed training in the responsible 
conduct of research.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application.  The reasonableness of the data sharing plan or the rationale 
for not sharing research data will be assessed by the reviewers.  However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PAR will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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).

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
more than $500,000 or more in direct costs in any single year are expected to 
include a plan for data sharing or state why this is not possible 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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 PAR 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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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.  The 
Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and 
established within the Office of the Director, National Institutes of Health 
(NIH).  The Dietary Supplement Health and Education Act (DSHEA) [Public Law 
103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to 
establish standards with respect to dietary supplements." This law authorized 
the establishment of the ODS.  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


H H S Department of Health
and Human Services

 
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