SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs) IN HUMAN CANCER FOR THE 
YEAR 2004

RELEASE DATE:  August 4, 2003

PA NUMBER: PAR-03-158 (This PA has been reissued, see PAR-05-042)
                      (see addendum NOT-CA-04-031, NOT-CA-04-023 and NOT-CA-05-001)

EXPIRATION DATE:  February 02, 2005. 

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.397, 93.121 

LETTER OF INTENT RECEIPT DATE:  

Myeloma and Genitourinary Cancer SPOREs:  April 1, 2004
Breast Cancer SPOREs:   August 1, 2004 
Gynecological Cancer SPOREs:   December 1, 2004 (per NOT-CA-04-023)

APPLICATION RECEIPT DATE:  

Myeloma and Genitourinary Cancer SPOREs: June 1, 2004
Breast Cancer SPOREs:  October 1, 2004
Gynecological Cancer SPOREs:  February 1, 2005 (per NOT-CA-04-023)

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 Letter of Intent 
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations

PURPOSE OF THIS PAR  

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 (PAR) addresses only SPORE applications for organ 
sites specified to be received in the year 2004.  See announcement PAR-02-126 
which was released in the NIH Guide on July 10, 2002, 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-126.html) for the receipt 
dates for SPORE applications associated with specific organ sites to be 
received in the year 2003.

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 uses knowledge of human biology to develop and test 
the feasibility of cancer-relevant interventions in humans and/or determines 
the biological basis for observations made in individuals with cancer or in 
populations at risk for cancer. 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.  
As an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  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.  

(Updated language in paragraph below per NOT-CA-04-031)

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 up to $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.

This PAR uses just-in-time concepts.  It also uses the non-modular budgeting 
formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Follow the instructions for non-modular research grant applications.  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

ELIGIBLE INSTITUTIONS 

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 

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.  

SPECIAL REQUIREMENTS 

GUIDELINES OF THE SPORE PROGRAM: The general components and procedures for 
preparing a SPORE application are outlined in this program announcement under 
Eligible Institutions, Application Processing, and Peer Review Process. 
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/guidelines/guidelines.html
 
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:

Jorge Gomez, M.D., Ph.D.
Chief, Organ Systems Branch 
Email:  jg1w@nih.gov 

Jane Fountain, Ph.D. 
Program Director (Gynecological SPOREs)
Email: jf227t@nih.gov 

Peter Ujhazy M.D., Ph.D. 
Program Director (Myeloma SPOREs)
Email: pu5s@nih.gov

Andrew Hruszkewycz, Andrew M.D., Ph.D. 
Program Director (Genitourinary SPOREs)
Email: hruszkea@mail.nih.gov

Rashmi Gopal-Srivastava, Ph.D. 
Program Director (Breast  SPOREs)
Email: gopalr@mail.nih.gov

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

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:  ncirefof@dea.nci.nih.gov

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:  kelli.oster@nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PAR 

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 the Program Director 
for the organ site (listed under Where to Send Inquiries) at the following 
address:

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, updated 6/28/2002).  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 "SPORE in (specific organ site) Cancer" and number of the PAR 
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 dates listed on the first page 
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
Bethesda, MD  20817 (for express/courier service)

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
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: Applications must be received on or before the 
receipt date(s) for the respective organ sites listed on the first page of 
this program announcement.  The CSR will not accept any application in 
response to this PAR 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/guidelines/guidelines.html).

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 
for responsiveness to the guidelines of this PAR by the NCI program staff.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.

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 Division of Extramural Activities of the NCI in accordance 
with the review criteria stated below.  

As part of the initial merit review, all applications:

o Will receive a written critique
o May undergo a selection process in which only those applications deemed to 
have the highest scientific merit will be discussed and assigned a priority 
score
o That receive a priority score will receive a second level of review by the 
National Cancer Advisory Board  

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.  

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

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.

INNOVATION.  Originality and novelty of the experimental design as it relates 
to translational research.

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.

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)

1. Tumor Bank/Tissue Resources

o 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;

o adequacy of the proposed plan and/or track record to prioritize the 
distribution of tissues within and outside the SPORE;

o 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;

o adequacy of proposed plan and/or track record to obtain informed written 
consent for all prospectively collected tissues;

2. Other Resources

o 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;

o demonstration that the resource is essential to the success of the SPORE;

o adequacy of qualifications and performance (if applicable) of resource 
directors;

c.  Developmental Research Program

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

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.

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;

d.  Career Development Program

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

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

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;

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

e.  Overall Program Organization and Capability

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;

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;

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

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;

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

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.);

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);

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;

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;

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

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;

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:

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).
 
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 CONSIDERATIONS 

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, shared resources, 
developmental research program and career development program.

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 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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  
Myeloma and Genitourinary Cancer SPOREs:        April 1, 2004
Breast Cancer SPOREs:                           August 1, 2004 
Gynecological Cancer SPOREs:                    December 1, 2004 


Application Receipt Date:
Myeloma and Genitourinary Cancer SPOREs:        June 1, 2004
Breast Cancer SPOREs:                           October 1, 2004
Gynecological Cancer SPOREs:                    February 1, 2005 

Peer Review Date:  October/November 2004 and February/March 2005
Council Review:  February 2005 and June 2005
Earliest Anticipated Start Date:  April 2005 and July 2005

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 "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 is 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://stemcells.nih.gov/index.asp 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, 
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 
PAR 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


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Research (OER)
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and Human Services (HHS)
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