SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs) IN HUMAN CANCER FOR THE 
YEAR 2003

Release Date:  July 10, 2002

PA NUMBER:  PAR-02-126

EXPIRATION DATE:  October 2, 2003, unless reissued. 

National Cancer Institute (NCI)
 (www.nci.nih.gov)

Letter of Intent Receipt Dates:
Skin and Ovarian Cancer SPOREs:                          December 1, 2002
Lymphoma, Leukemia and Gastrointestinal Cancer SPOREs:   April 1, 2003
Brain, Head and Neck Cancer SPOREs:                      August 1, 2003

Application Receipt Dates:
Skin and Ovarian Cancer SPOREs:                          February 1, 2003
Lymphoma, Leukemia and Gastrointestinal Cancer SPOREs:   June 1, 2003
Brain, Head and Neck Cancer SPOREs:                      October 1, 2003

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
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 Award Criteria
o Required Federal Citations

PURPOSE

The Organ Systems Branch of the Office of the Deputy Director for 
Extramural Science at the National Cancer Institute (NCI) invites grant 
applications (P50) for Specialized Programs of Research Excellence 
(SPORE) in organ-specific cancers.  Applicant institutions must be able 
to conduct the highest quality, balanced, translational research on the 
prevention, etiology, screening, diagnosis, and treatment of a specific 
organ-site cancer.  SPORE applicants are judged on their current and 
potential ability to move basic research findings into a clinical or 
population setting or, conversely, to take a finding from the 
clinic/population and expand upon it in the laboratory.  A SPORE must 
develop and maintain human cancer tissue resources for the particular 
organ-site that will benefit translational research, foster extended 
collaborations in critical areas of research need with laboratory and 
clinical scientists within the institution, as well as in other 
institutions, and participate with other SPOREs on a regular basis in 
sharing positive and negative findings, assessing scientific progress 
in the field, identifying new research opportunities, and promoting 
Inter-SPORE collaborations.  Each SPORE and the "network" of SPOREs are 
expected to conduct research that will have the most immediate impact 
possible on reducing incidence and mortality of human cancer.  A SPORE 
should support a mix of basic and clinical researchers whose formal 
interactive and collaborative research efforts will result in new 
approaches for early detection, diagnosis, therapy, prevention and 
control of human cancer.  The SPORE mechanism is not intended to 
support basic research to the exclusion of clinical research or vice 
versa.

This Program announcement (PA) addresses only SPORE applications for 
organ sites specified to be received in the year 2003.  See 
announcement PAR-01-110 which was released in the NIH Guide on June 20, 
2001.  (http://grants.nih.gov/grants/guide/pa-files/PAR-00-087.html) 
for the receipt dates for SPORE applications associated with specific 
organ sites to be received in the year 2002.

RESEARCH OBJECTIVES

A SPORE must provide focal points for sustaining and maintaining state-
of-the-art research that will contribute to improved detection, 
diagnosis, treatment and prevention of an organ-specific cancer (or 
related group of cancers).  SPOREs are expected not only to conduct a 
wide spectrum of research activities, but should also contribute 
significantly to the development of specialized research resources (or 
cores), improved research model systems, and collaborative research 
projects with other institutions. The research supported through this 
program must be translational in nature.  Translational research is 
defined as the movement of a laboratory discovery into a patient or 
population setting or the movement of an observation in a patient or 
population setting into a laboratory research environment.  Inherently, 
this process involves an interdependence between basic and applied 
investigators.  It should be noted that clinical/ epidemiological 
research that does not include a laboratory component or capitalize 
upon a biological discovery relevant to human cancer is not considered 
translational for the purposes of this program. 

MECHANISM OF SUPPORT

A SPORE is supported through the specialized center (P50) grant 
mechanism.  This mechanism provides funding for a broad range of 
research and developmental activities, from basic to human intervention 
studies.  These grants are intended to promote multidisciplinary 
research focused upon a specific cancer (or related cancer) site(s).  
SPORE grants differ from traditional Program Project (P01) grants in 
that they also provide support for pilot research projects and a career 
development program, as well as enable investigators more flexibility 
to modify their research activities when new opportunities arise.  
Applicants are responsible for the planning, direction, and execution 
of their proposed SPORE.  

NCI policy for SPORE grants establishes the following limits to the 
requested budgets: new or competing renewal P50 SPORE applications may 
request a maximum annual direct cost of $1.75 million and maximum 
annual total cost of $2.75 million.  The facilities and administrative 
costs related to subcontracts to other institutions or organizations 
are included in the total cost cap of $2.75 million, but not the direct 
cost cap of $1.75 million.  Applications can exceed these caps in 
subsequent years as a result of standard cost-of-living increases or 
special supplements approved by NCI.  A SPORE grant application may be 
submitted for up to five years of funding.

ELIGIBILITY REQUIREMENTS

You may submit (an) application(s) if your institution has 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 Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

Eligible institutions may include foreign components as full research 
projects, or shared resources, or as part of a research project.  
SPOREs may also use developmental funds to establish collaborative 
research efforts with foreign entities.  Consortia agreements with 
foreign institutions must include provisions that ensure adequate 
representation of women, minorities, and children in all research 
components that involve clinical trials or any other type of human 
intervention and must be in compliance with NIH policies.  

To be considered, applications must have: (1) a statement of 
institutional commitment that addresses how the SPORE will be given 
high priority within the institution, (2) a minimum of four independent 
principal investigators who are successful in obtaining peer-reviewed 
research support (e.g., R01, P01, U01, U10, U19, ACS, DOD, or 
equivalent) directly related to the cancer being investigated, and who, 
as a group, have expertise in both laboratory and clinical research, 
(3) a minimum of four research projects, representing a balance and 
diversity of translational approaches. At least one research project 
must focus on early detection, screening, prevention, and/or population 
science.  All proposed research projects must be led by co-
investigators in basic and applied sciences who commit adequate percent 
efforts to the translational research endeavors, (4) a qualified 
principal investigator who is a scientific leader in the field, (5) a 
patient care facility that serves a substantial cancer patient 
population and, if the facility is not part of the parent institution, 
a consortium agreement with an associated institution that assures 
adequate access to cancer patients for clinical research, the statement 
must be signed by the responsible officials of the applicant 
institution and the consortia care facility, (6) a developmental 
research program, (7) a career development program, (8) a tissue 
resource, as well as (9) other shared resources designed to support the 
proposed translational objectives of the SPORE.  Although an 
application can only be submitted by a single institution, 
subcontracted collaborative arrangements with scientists from other 
institutions may be included if these arrangements are clearly 
delineated and officially confirmed by signed statements from the 
responsible official at each institution.  This circumstance, however, 
does not preclude the need for a full institutional commitment from the 
applicant organization. 

Support will not be provided for applications containing research 
projects focused exclusively on basic research, epidemiological 
research, or clinical interventions.  Funding for the performance of a 
Phase I or II clinical trial can be requested in a SPORE application.  

NCI program staff listed under INQUIRIES should be consulted if there 
are questions regarding eligibility or the required components of a 
SPORE.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the 
opportunity 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:

Jorge Gomez, M.D., Ph.D.
Chief, Organ Systems Branch 
Email:  [email protected] 

Jane Fountain, Ph.D. 
Program Director (Ovarian and Skin SPOREs)
Email: [email protected] 

Peter Ujhazy M.D., Ph.D. 
Program Director (Leukemia, Lymphoma, Brain, Gastrointestinal, Head and 
Neck SPOREs)
Email: [email protected]

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD  20892-7008 (for U.S. Postal Service)
Telephone:  (301) 496-8528
Fax:  (301) 402-5319

Questions of a general programmatic nature may be submitted to the e-
mail address of the Organ Systems Branch:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Kelli Oster
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard MSC 7150
Rockville, MD  20852-7150 (for express/courier service)
Bethesda, MD  20892-7150
Telephone:  (301) 496-8627
Email:  [email protected]

Direct inquiries regarding review issues to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Email:  [email protected]

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 PA 

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 NCI 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:

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Rockville, MD  20852 (for express/courier service)
Bethesda, MD 20892-7008 (for U.S. Postal Service)

SUBMITTING AN APPLICATION

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) 710-0267, Email: [email protected].

The title "SPORE in (specific organ site) Cancer" and number of the PA 
should be typed on line 2 of the face page of the application form and 
the YES box marked.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted by the receipt date listed at the 
beginning of this program announcement.  

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
(20817 for express service)

At the time of submission, two additional copies of the application and 
five copies of the appendices must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

It is important to send these copies at the same time that the original 
and three copies are sent to the Center for Scientific Review (CSR), 
otherwise, the NCI cannot guarantee that the applications will be 
reviewed in competition with other applications received by the receipt 
date. 

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This change in practice is effective immediately.  This policy is 
similar to and consistent with the policy for applications addressed to 
Centers for Scientific Review as published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Complete applications must be received by the 
specified receipt dates for the respective organ sites listed on the 
first page of this PA.  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.  Applications must meet all eligibility 
requirements summarized above and must address all programmatic 
requirements further described in the SPORE GUIDELINES 
(http://spores.nci.nih.gov/).

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and for adherence to the guidelines of this PA by the NCI program 
staff.  Applications not adhering to the guidelines of this PA, and 
those applications that are incomplete as determined by CSR or by NCI 
program staff, will be returned to the applicant without review.

Applications that are complete and adhere to the guidelines of this PA 
will be evaluated for scientific and technical merit by an appropriate 
peer review group convened by the Division of Extramural Activities of 
the NCI 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  Those that receive a priority score will undergo a second level 
review by the National Cancer Advisory Board.

GUIDELINES OF THE SPORE PROGRAM

The general components and procedures for preparing a SPORE application 
are outlined in this PA under Eligibility Requirements, Application 
Procedures, and Review Considerations. SPECIAL GUIDELINES that address 
programmatic, review and award concerns in more detail, however, must 
be followed when preparing a SPORE application.  SPORE GUIDELINES CAN 
NOT BE SUPERSEDED BY THIS OR ANY OTHER ANNOUNCEMENT.  Prospective 
applicants should request a copy of the SPORE GUIDELINES from the 
program staff listed under INQUIRIES above or can view a copy at 
http://spores.nci.nih.gov/.

REVIEW CRITERIA

a.  Research Projects

Within the SPORE concept of translational research, reviewers will 
evaluate each research project using the five criteria listed below.  
Each of these criteria will be addressed and considered by the 
reviewers in assigning a merit score to the project.  Note that the 
project does not need to be strong in all categories to be judged 
likely to have a major translational impact and, thus, deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative (e.g., correlative 
or hypothesis generating studies) but is essential to assess the 
relevance of a research finding in a clinical/population setting.  

a.1.  Significance.  The importance of the translational research 
objective to human cancer and its likelihood of completion within the 
project period.

a.2.  Approach.  The adequacy of the experimental design and methods to 
achieve the research objectives, clear evidence of co-leadership by a 
basic and more applied scientist in the conception, design and proposed 
implementation of the project.

a.3.  Innovation.  Originality and novelty of the experimental design 
as it relates to translational research.

a.4.  Investigators.  The qualifications of the basic and more applied 
co-investigators to conduct the proposed research and the 
appropriateness of the time commitments of each co-investigator to the 
conduct of the project.

a.5.  Environment. The scientific environment in which the 
translational research work will be done, and the unique features, if 
any, of the environment to support the proposed work.

b.  Shared Resources (Cores)

b.1. Tumor Bank/Tissue Resources

b.1.a.  adequacy of the proposed plan and/or track record to develop 
and maintain a human cancer site-specific tissue resource, store the 
tissue and distribute the tissue with appropriate pathological and 
clinical data,

b.1.b.  adequacy of the proposed plan and/or track record to prioritize 
the distribution of tissues within and outside the SPORE,

b.1.c.  evidence of experienced and available personnel dedicated to 
the activities of tissue collection, quality control of tissue 
specimens, tissue storage, tissue distribution, collection of initial 
and follow-up clinical information, data entry, and maintenance of 
database and computer networks,

b.1.d.  adequacy of proposed plan and/or track record to obtain 
informed written consent for all prospectively collected tissues,

b.1.e.  appropriateness of the budget to conduct and integrate tissue 
banking activities.

 b.2. Other Resources

 b.2.a.  degree to which plans and/or track record indicate that shared 
resources (will) effectively and efficiently support the research of 
the SPORE in a manner that can not be supported through available 
resources,

b.2.b.  demonstration that the resource is essential to the success of 
the SPORE,

b.2.c.  adequacy of qualifications and performance (if applicable) of 
resource directors,

b.2.d.  appropriateness of the requested budgets to conduct each 
resource operation.

c.  Developmental Research Program

c.1.  adequacy of the process and/or track record for attracting new 
ideas for pilot studies within and outside of the SPORE institution.

c.2.  adequacy of the proposed process and/or track record for 
continuously reviewing and funding a spectrum of pilot projects (e.g., 
research, technology development, resources) based on their potential 
relevance to translational research and impact on human cancer.

c.3.  general quality of the pilot projects provided by the SPORE to 
demonstrate the effectiveness of the process and/or track record of 
funding pilot projects,

c.4.  appropriateness of the budget relative to the needs and 
demonstrated capabilities of the SPORE.

d.  Career Development Program

d.1.  adequacy of the plan, in general, to sustain significant activity 
for career development of translational research scientists,

d.2.  adequacy of the process and/or track record for selecting 
candidates for independent careers in translational research,

d.3.  adequacy of the process and/or track record to seek out and 
include qualified minorities, women, and persons with disabilities in 
the career development program,

d.4.  current status and research activities of individuals who have 
been supported by the career development program, if applicable,

 d.5.  appropriateness of the budget relative to the proposed plans for 
sustaining a significant effort in career development.

e.  Overall Program Organization and Capability

e.1.  scientific qualifications and involvement of the SPORE principal 
investigator, as well as his/her demonstrated scientific and 
administrative leadership capabilities, adequacy of the time commitment 
of the principal investigator,

e.2.  adequacy of the planning and evaluation process to include: 
determining translational research productivity of existing projects 
and resources, discontinuing activities of low productivity, initiating 
new activities in response to important translational research 
opportunities, establishing collaborations, and utilizing the advice of 
external advisors,

e.3.  adequacy of access to patients and populations for conducting 
current and projected therapeutic, prevention, detection and control 
research,

e.4.  a balance and diversity of research activities with a minimum of 
four scored projects of which at least one is devoted to early 
detection, screening, prevention, and/or population science,

e.5.  effectiveness of and/or plans for promoting interdisciplinary 
scientific interaction,

e.6.  effectiveness of and/or plans for integrating SPORE research and  
resources with existing Cancer Center programs (e.g., use of clinical 
data and safety management systems, biostatistical cores, etc.),

e.7.  adequacy of tangible institutional commitments that will enable 
and facilitate the research objectives of the SPORE (e.g., special 
facilities, recruitments, discretionary resources such as dollars and 
space),

e.8. degree to which the organization and leadership of the SPORE 
promote and facilitate scientific interactions between projects, pilot 
projects, etc., and effective use of the SPORE infrastructure (e.g., 
tissue bank, other shared resources) in the conduct of research,

e.9. written assurance that SPORE interactions with commercial entities 
will uphold the principles of academic freedom, including the ability 
of SPORE investigators to collaborate freely, and to send and receive 
biomedical research materials without restriction to other scientific 
researchers,

e.10. facilitation of technology transfer, management of the 
intellectual property rights of the SPORE under the requirements of the 
Bayh-Dole Act and NIH funding agreements.

f.  Interactions with Other SPOREs

f.1.  adequacy of plans (new application) or progress (competing 
renewal applications) to promote and maintain communication and 
integration of scientific projects of mutual interest with other 
SPOREs,

f.2.  willingness to interact with other SPOREs and with the NCI in 
sharing information and in participating in committees to assess 
current scientific issues, research activities, and priorities.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

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

DATA SHARING:  The adequacy of the proposed plan to share data. 

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

OVERALL EVALUATION AND SCORING OF APPLICATIONS

Each component of the SPORE will be given a score.  A single numerical 
priority score will then be assigned to the SPORE application as a 
whole. Although this score will be based primarily on scientific merit 
and progress where applicable (competing renewal applications), 
significant consideration will also be given to interdisciplinary 
interactions, potential for impacting on the disease, inter-SPORE 
collaborations and institutional commitment.  The overall score will be 
weighted as follows:

o  60%   scientific merit of the translational research
o  15%   evidence of multidisciplinary/team approaches in the conduct 
of the research 
o  15%   potential of the research to impact on the disease
o  10%   institutional commitment 

If a required component(s) of an otherwise meritorious SPORE 
application is of such low merit that it is not recommended for further 
consideration (NRFC) by the peer review committee, the entire 
application will also receive a NRFC.  See Section I.E. of SPORE 
GUIDELINES (http://spores.nci.nih.gov/) for a more detailed description 
of each of the required components of a SPORE.

AWARD CRITERIA

Applications submitted in response to a PA 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 

MONITORING PLAN AND DATA SAFETY AND 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 Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB).  
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional review Board (IRB).  For 
details about the Policy for the NCI for Data and Safety Monitoring of 
Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I 
and II clinical trials, investigators must submit a general description 
of the data and safety monitoring plan as part of the research 
application.  See NIH Guide Notice on "Further Guidance on a Data and 
Safety Monitoring for Phase I and II Trials" for additional 
information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

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 AMENDMENT 
"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.  
A continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Guidance for investigators and institutional review boards regarding 
research involving human embryonic stem cells, germ cells, and stem 
cell-derived test articles can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.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 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.

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.health.gov/healthypeople/

AUTHORITY AND REGULATIONS
  
This program is described in the Catalog of Federal Domestic Assistance 
Nos. 93.397 and 93.121.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not 
subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-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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