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. (https://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: jg1w@nih.gov
Jane Fountain, Ph.D.
Program Director (Ovarian and Skin SPOREs)
Email: jf227t@nih.gov
Peter Ujhazy M.D., Ph.D.
Program Director (Leukemia, Lymphoma, Brain, Gastrointestinal, Head and
Neck SPOREs)
Email: pu5s@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
Questions of a general programmatic nature may be submitted to the e-
mail address of the Organ Systems Branch: nciosb-r@mail.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
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: ncidearefof-r@mail.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 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 https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
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.)
(https://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
https://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:
https://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:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a
complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://grants.nih.gov/grants/stem_cells.htm and at
https://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
https://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
https://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.