SMALL ANIMAL IMAGING RESOURCE PROGRAMS
 
Release Date:  July 31, 2000 (see reissuance RFA-CA-04-011)

RFA:  CA-01-012 
 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 19, 2000
Application Receipt Date:       November 28, 2000

This Request for Applications (RFA) is a reissue of RFA-CA-98-023 "Small 
Animal Imaging Resource Programs" which was released in the NIH Guide on 
August 20, 1998.

PURPOSE
 
The National Cancer Institute (NCI) invites applications from extramural and 
intramural investigators for Small Animal Imaging Resource Programs (SAIRPs).  
These grants will support (a) shared imaging research resources to be used by 
cancer investigators, (b) research related to small animal imaging 
technology, and (c) training of both professional and technical support 
personnel interested in the science and techniques of small animal imaging. 
SAIRPs will enhance capabilities for conducting basic, clinical, and 
translational cancer research relevant to the mission of the NCI. Major goals 
of this initiative are to increase efficiency, synergy, and innovation of 
such research and to foster research interactions that cross disciplines, 
approaches and levels of analysis. Building and strengthening such links 
holds great potential for better understanding cancer, and ultimately, for 
better treatment and prevention.

For this RFA, teams composed of NIH intramural investigators are encouraged 
to submit intramural project applications to become components of the 
network, but they may not request or receive funds from this program 
(Potential intramural applicants please see 
http://cancer.gov/bip/NCI-DIPini.htm).
 
RESEARCH OBJECTIVES
 
Background
 
Small animal models, particularly genetically engineered mice, are 
increasingly recognized as powerful discovery tools in cancer research. The 
potential that could be realized by the use of animal models has not yet 
fully been realized.  One of the limitations is the need to sacrifice the 
animals to perform tissue or molecular analysis.  This prevents researchers 
from observing in vivo the natural or perturbed evolution of the processes 
under study.  Functional, molecular, and morphologic quantitative imaging 
techniques are an important tool for providing data about biochemical, 
genetic or pharmacological processes in vivo, and repetitively in the same 
animal.

Neoplasms have an intrinsic spatially distributed nature.  That is, tumors 
develop in different sites, metastasize to other sites and are internally 
heterogeneous.  To study tumors one must make spatially distributed 
measurements. Imaging is a means of making and displaying spatially coherent 
measurements and is therefore a key resource for studying the development, 
growth and therapeutic response of neoplasms.  One of the important research 
directions for imaging research is to provide quantitative information in the 
setting of cancer diagnosis and therapy.  Quantitation of image data for 
small animals will lead the way to application of quantitative methods in 
human beings.

A major limitation to studying tumors in model systems with current imaging 
techniques is the limited availability of small animal imaging systems. Most 
biomedical imaging devices have been optimized for human studies and have 
suboptimal spatial resolution for small animals and their tumors.  However, 
imaging techniques can be scaled down to yield very high resolution and 
signal sensitivity for in vivo images of mouse-sized organs. Furthermore, 
there are some applications of imaging techniques that could provide valuable 
knowledge from small animal models, but are not feasible for human subjects.  
Therefore, in order to take full advantage of the small animal tumor models 
being developed, it has been recommended that dedicated small animal imaging 
laboratories be developed.

The NCI recognizes the importance, synergy and innovation that often evolve 
from research crossing disciplines, approaches, and levels of analysis. The 
SAIRP award is envisioned as enhancing such multidisciplinary activities by 
supporting coordinated shared research resources for NIH-funded investigators 
performing cancer research.  The use of such shared resources can increase 
efficiency in an area of research by eliminating unnecessary duplication of 
effort and/or the support of research resources (e.g., costly equipment) that 
might be needed in, but not fully utilized by, the activities of any one 
research grant. Shared-resource laboratories can stimulate new research 
directions by providing access to equipment, services, and other resources 
that might not otherwise be available.  Finally, shared research resources 
which are properly coordinated will promote research interactions and 
collaborations that cross disciplines, technical and theoretical approaches, 
and levels of analysis, including interactions across basic and clinical 
cancer research.  Such interactions often have results that exceed the sum of 
the contributing activities.  For this reason, participation of 
scientifically diverse base grants are strongly encouraged and, all else 
being equal, applications for SAIRPs with such scientific diversity will be 
given higher priority for funding consideration.

Objectives and Scope

SAIRPs will offer a unique opportunity for multidisciplinary teams within the 
cancer research community to address critical cancer research questions.

Small Animal Imaging Resource Programs (SAIRP) will provide:

Multiple imaging technologies for small animals, emphasizing, but not limited 
to, those technologies which can provide biochemical, genetic or 
pharmacological information in vivo.

Technology research and development on innovative new imaging technologies 
appropriate for small animals, as well as refinement and development of 
technologies already established.

Capabilities and personnel to assist in the development and/or production of 
necessary probes for the imaging technologies provided.

Capabilities and personnel to aid in small animal anesthesia and care, as 
well as to consult on the optimal use of animals in connection with the 
imaging experiments.

Training for both professional and technical personnel in the techniques and 
methodologies of small animal imaging.

Structure

The structure of the SAIRP must reflect the need to ensure that the small 
animal imaging technologies available for access or under development through 
this mechanism are pushing the state of the art.  In addition, the SAIRP 
should explore the broadest range of cancer research related applications 
appropriate.

The primary purpose of each SAIRP is to support coordinated shared research 
resources and related research to enhance the capabilities of NIH-supported 
investigators to pursue cancer research relevant to the mission of the NCI.  
A SAIRP is characterized as follows:

SAIRPs and SAIRP-related research represent shared research resources and 
activities that can include services (e.g., software development, 
histological processing, bio-statistical support), equipment (e.g., image 
analysis systems, multi-channel recording equipment), and other resources 
(e.g., use of animal handling facilities, access to supercomputing centers, 
time on scanners, other clinical research resources).

SAIRPs must benefit the base grants that they serve and are expected to 
increase efficiency, promote new research directions and foster interactions 
and synergy among investigators.

SAIRPs may also be used by those not in base grants, particularly to the 
extent that they provide opportunities for young investigators, women and 
minorities.  If this is planned, rationale for such usage and for selection 
of such investigators should be provided. 

SAIRPs must address the training of professional and technical individuals 
within the institution as well as from outside in the techniques of small 
animal imaging.

Resource

The SAIRP should use approximately one half to two thirds of its resources 
and time to provide imaging services and collaboration to cancer-related 
research projects.  As part of the initial application, there must be 
commitments from at least three cancer-related research projects [R01, FIRST 
(R29), program project (P01), relevant consortia (U01) and/or MERIT (R37) 
grants],or R01-equivalent cancer-related awards from other agencies, that 
will use the small animal imaging resource at the beginning of year 2. After 
implementation, the applicants would be expected to form similar 
collaborations with at least three additional cancer-related research 
projects by the beginning of the third year of the SAIRP award.  At the time 
of application, applicants must give evidence of potential to form these 
additional collaborations.  Collaboration with at least six other research 
projects using small animals within 2 years after the award is a MINIMUM 
requirement.  Collaboration with more than six research projects is strongly 
encouraged.

Applicants must demonstrate that at the time of application they have 
available at least one state-of-the-art imaging technology optimized for 
small animals.  In addition, they must show evidence of experience with in 
vivo imaging of small animals using the available technology.

Applicants must provide plans for providing at least one additional imaging 
technology for small animals within the first year of the award.  This could 
be acquired commercially or developed in-house.  Funds to acquire or develop 
this additional imaging technology may be included in the budget of year 1 of 
the application.

Imaging Technology Research

The SAIRP should use approximately one third to one half of its resources and 
time for research and development of small animal imaging technology.  This 
could be further development and optimization of existing technologies or 
exploration of novel technologies.  Methods to produce valid quantitative 
results would be particularly encouraged. Funds for small animal imaging 
technology research may be included in the application budget for all years 
of the award.

Training

A plan for training of individuals including basic scientists, clinicians, 
technologists and support personnel interested in learning the techniques and 
science of small animal imaging must be included. Some of the trainees must 
come from institutions other than the awardee institution.  The training 
should include both didactic and hands-on instruction.

Governance

The Director of the SAIRP must have a demonstrated capability to organize, 
administer and direct the shared resource. Applicants must describe their 
plan for governance, and methods to be used to evaluate and select protocols 
to support with the SAIRP.  It is suggested that a scientific advisory board 
of collaborators and other cancer investigators would be established for this 
purpose. The expertise of the scientific advisors and the structure of the 
board should be discussed, but the advisors do not need to named in the 
application.

Two years after the award there will be a review by NCI program staff to 
confirm that: two or more small animal imaging technologies have been 
implemented and are operational; collaboration with a minimum of six cancer-
related research projects requiring imaging data from small animals is in 
progress; developmental research on small animal imaging systems is in 
progress.

If these components do not exist or are insufficient, the award will be 
phased out.

Research Support

The following are examples of ancillary research capabilities for which 
funding could be requested in SAIRP application.  This list of examples is 
not meant to be comprehensive or exclusive of other possibilities.

Contrast agent support: synthesize agents that can be used by investigators 
to differentially label normal or abnormal structures, or make evident 
specific processes in tumor imaging studies.

Supercomputer support: fund access to high performance platforms and 
technical assistance in optimizing algorithms used in analyzing very large 
data sets resulting from high resolution imaging, 3D and 4D imaging, etc.

Informatics support: funds to support the purchase as well as research and 
development of tools and approaches for data storage, retrieval, analysis, 
visualization and manipulation.

Imaging instrument support: purchase equipment, supplies, and service 
contracts needed for small animal imaging.

Research animal support: support of laboratory facilities to provide the 
animal imaging operations.

Biostatistics support: support for statistical consultation in experimental 
design and data analysis for small animal imaging.

Activities Supported

An overall budget for the SAIRP should be provided, as well as budgets for 
each of the proposed imaging instruments, including instrument-related 
research. Direct costs may be requested that are essential for the support of 
the SAIRPs and must be fully documented and justified; salary support for 
administrative costs should be kept at a minimum. 

The SAIRP investigators will organize a public meeting in year 3, open to all 
interested researchers.  Attendance at this meeting should be budgeted for.

SPECIAL REQUIREMENT

A budget item to support travel of two persons to an annual meeting of 
individuals from all the funded SAIRPs should be included. 

MECHANISM OF SUPPORT

Small Animal Imaging Resource Programs will be supported by the resource-
related research projects (R24) mechanism.  This mechanism is used to support 
projects that enhance capabilities of resources to contribute to extramural 
research of the Public Health Service. Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of the 
applicant. Funding for NIH intramural applicants will be derived from 
existing intramural resources.  

This RFA is a one-time solicitation.  Amended or competing continuation 
applications will be accepted only through future RFAs, the publication of 
which will be contingent upon program priorities and availability of funds.

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary.

FUNDS AVAILABLE
 
Approximately $20 million total cost will be available for the 5-year period 
of the award for all the SAIRPs.  Approximately $5.9 million total cost will 
be available for the first year of this RFA, which should fund five resource 
related grants, including funds for adding small animal imaging equipment as 
described below; subsequent year funding would be less, because it would not 
fund equipment acquisition.  Approximately $3.5 million total cost for all 
the SAIRPs will be available each year for years 2 through 5 of the award.  
It is anticipated that five awards will be supported through this RFA.

Purchase or assembling of imaging equipment will be allowed in the first year 
only.  The funds requested should be based on the requirements of the project 
and the requested costs must be fully justified. Each SAIRP will provide 
services, equipment and/or other research resources to the base grants; 
imaging technology research related to the SAIRP, in turn, will enhance the 
capabilities of the SAIRP.  The coordinated use of shared resources increases 
the efficiency of cancer research, facilitates the use of new technologies 
and the pursuit of new lines of research, and promotes interdisciplinary and 
collaborative research. 

Although the financial plans of the NCI provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.  At this 
time, it is not known if competing renewal applications will be accepted 
and/or if this RFA will be reissued.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government. For this RFA, teams composed of NIH intramural 
investigators are encouraged to submit intramural project applications to 
become components of the Consortium, but they may not request or receive 
funds from this program (Potential intramural applicants please see 
http://cancer.gov/bip/NCI-DIPini.htm).  Foreign institutions are not eligible 
for resource-related research project (R24) grants.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
SAIRP Directors and heads of laboratories.  Applicants for SAIRPs may request 
support for a period of up to 5 years. By the beginning of the third year of 
the SAIRP award, each application for a SAIRP must serve a minimum of 6 
cancer-related research projects (R01), FIRST (R29), program projects (P01), 
relevant consortia (U01) and/or MERIT (R37) grants (known as the base 
grants). Training grants (T32) and individual and institutional fellowship 
grants are not eligible for inclusion as base grants.  R01-equivalent cancer- 
related awards from other agencies may be included as base grants.  Only one 
SAIRP will be awarded to any single applicant organization, but base grants 
may be housed in multiple institutions.  In general, each cancer-related 
research project grant should only serve as a base grant for one SAIRP.  If 
well justified, activities and research may be located at sites and 
institutions other than that/those of the base grants and the SAIRP.  For 
example, research related to a program might exist at a transgenic facility, 
supercomputer center, imaging facility, etc., which is neither at nor part of 
the institution applying for the SAIRP, nor at or part of any of the 
institutions housing the base grants. 

One intention of this initiative is to promote regional distribution of small 
animal imaging facilities.

INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:
 
Barbara Y. Croft, Ph.D.
Diagnostic Imaging Program
National Cancer Institute
6130 Executive Boulevard, Room 800
Rockville, MD  20892-7440
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email:  bc129b@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to:
 
Kathleen J. Shino, M.B.A.
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 ext. 248
FAX:  (301) 496-8601
Email: shinok@gab.nci.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit, by October 19, 2000, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, telephone number, and e-mail address of the Principal Investigator, 
the identities of other key personnel and participating institutions, and the 
number and title of the RFA in response to which the application may be 
submitted.  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 IC staff to estimate the potential review workload 
and plan the review.
 
The letter of intent is to be sent to Dr. Barbara Croft by the letter of 
intent receipt date listed.
 
SCHEDULE

Letter of Intent Receipt:         October 19, 2000		
Application Receipt:              November 28, 2000
Peer Review Date:                 March 2001
Review by NCAB Advisory Board:    May 2001
Earliest Anticipated Start Date:  July 1, 2001
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  Applications kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301/435-0714, email: grantsinfo@nih.gov.  For those 
applicants with internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm.
 
The SAIRPs are intended to enhance the capabilities of scientists to pursue 
cancer research relevant to the mission of this Institute.  The manner in 
which the proposed SAIRP will do this must be made clear in the application.  
The following sections should replace the Specific Aims, Background and 
Significance, Preliminary Studies/Progress Report, and the Research Design 
and Methods sections of the traditional Research Plan in form PHS 398 (Rev. 
4/98) (adhering to the 25-page limit):

General Description of the SAIRP:

Describe the SAIRP, existing small animal imaging instrument(s), proposed 
small animal imaging instrument(s), and ancillary capabilities existing and 
proposed.  Describe the provision of imaging services and the small animal 
imaging research and development proposed.  Describe the plans for training 
of professionals and technical support personnel.

General Description of the Base Grants of the SAIRP (Not to exceed 1 page for 
each base grant participating in the SAIRP):

Provide an overview of the research goals and approaches used in each of the 
base grants and the manner in which the SAIRP award will benefit the research 
activities of the base grants.  In addition, describe the specific ways in 
which the SAIRP will increase efficiency, promote new research directions and 
foster research interactions and synergy of cancer-related research.  
Finally, for each of the base grants, the following must be provided: the 
grant number, title, name of the PI, grantee organization, the project period 
end date, and the direct cost budget for the year on which the budget of the 
SAIRP application is based.

Operational Plan:

Describe arrangements required to implement the SAIRP, including the manner 
in which priority for imaging facility access and use is decided, the 
operational and administrative role of the director of the imaging facility, 
etc.  This section is especially important for those applications proposing 
an offsite facility.

Imaging Equipment Descriptions:

Describe the purpose of each component, describe imaging technology-related 
research including the manner in which it is expected to enhance the 
capabilities of the imaging instruments, and clearly indicate the space, 
facilities, resources, services, technical and professional expertise and 
support that the applicant institution will provide.

Describe the specific manner in which each component will relate to the base 
grants.  For each component, describe the level of use by the base grants; 
starting in year 3 of the award, each imaging technology must be used by at 
least three of the base grants.

Ancillary Capabilities

Describe the specific ancillary capabilities requested and how they will 
enhance the SAIRP.

Training Program

Describe a dedicated plan for the training of individuals in the science of 
small animal imaging. A plan for training of individuals such as basic 
scientists, clinicians, technologists, and support personnel interested in 
learning the techniques and science of small animal imaging is required. 
Examples of training for research scientists or clinicians might be in the 
form of, but not limited to, full-time or part-time post-doctoral 
fellowships.  Examples of training for support personnel might be in the form 
of, but not limited to, short-term courses.  Some of the trainees must come 
from institutions other than the awardee institution.  The training should be 
comprehensive and include both didactic and hands-on instruction.

Table of Contents

The table of contents should reflect the actual contents of the application 
and should not copy the categories of PHS 398 Form Page 3.

Budget and Financial Information

Break out the budget contribution for each proposed small animal imaging 
instrument.  The budget and the proposed research and resource provision 
should be aligned.

Appendix:   All instructions in the Form 398 application kit apply.
 
The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

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 must be 
sent to:

Ms. Toby Friedberg
Referral Officer 
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Applications must be received by November 28, 2000.  If an application is 
received after that date, it will be returned to the applicant without 
review.  The Center for Scientific Review (CSR) will not accept any 
application in response to this RFA 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 
substantial revisions of applications already reviewed, but such applications 
must include an introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NCI.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration. 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NCI in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will receive a written 
critique and 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 assigned a priority score, and receive a 
second level review by the National Cancer Advisory Board.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific 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 but is essential to move a field 
forward.

1.  Significance.  Does the application address an important problem?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of this resource program on the concepts 
or methods that drive this field?  What is the likelihood that the proposed 
SAIRP will increase efficiency, promote new research directions, facilitate 
interactions across disciplines and levels of analysis, and/or across 
theoretical and technological approaches?

2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
SAIRP?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  How will the effectiveness of the SAIRP in achieving 
its goals be judged?

3.  Innovation.  Does the imaging research project employ novel concepts, 
approaches or methods? Are the aims original and innovative? Does the imaging 
research project challenge existing paradigms or develop new methodologies or 
technologies?

4.  Investigator.  Is the investigator appropriately trained and well suited 
to manage the SAIRP and carry out the research?  Is the work proposed 
appropriate to the experience level of the principal investigator and other 
researchers (if any)?  Has the principal investigator assembled the 
appropriate team to manage the SAIRP and conduct the proposed research?

5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional 
support?

6.  Relationship to base grants: Will the SAIRP significantly enhance the 
capabilities of the base grants to pursue cancer research relevant to the 
NCI? Is there participation of scientifically diverse base grants?  

7.   Training:  The application will also be reviewed on the merit of a 
plan to provide a comprehensive and balanced didactic and hands-on training 
experience. This should include a plan for the training of individuals from 
the awardee institution as well as from other institutions throughout the 
country in the science of small animal imaging. 

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the provisions for the protection of animal 
subjects; and the safety of the research environment.

AWARD CRITERIA

Applications will compete with other applications received in response to 
this RFA.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of 
funds, and program balance.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, 
Volume 23, Number 11, March 18, 1994, available on the web at the following 
URL address:  http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators may also obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.  

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas. This RFA, Small Animal 
Imaging Resource Programs, is related to priority area of cancer.  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 No. 
93.394. 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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.