and Human Services (HHS)
EXPIRED
DEVELOPMENT OF NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR)
Release Date: May 29, 2001
PA NUMBER: PAR-01-102
National Cancer Institute
National Institute of Environmental Health Sciences
Letter of Intent Receipt Dates: June 11, 2001, February 11, 2002 and
June 11, 2002.
Application Receipt Dates: July 16, 2001, March 18, 2002, and July 16, 2002.
This PAR is a reissue of PAR-00-090, which was published in the NIH Guide on
April 27, 2000.
PURPOSE
The National Cancer Institute (NCI) and the National Institute of
Environmental Health Sciences (NIEHS) invite applications for the
development of novel image acquisition or enhancement methods, and
which may incorporate limited pilot or clinical feasibility evaluations
using either pre-clinical models or clinical studies. This initiative
is intended to facilitate the proof of feasibility and development of
novel imaging technologies for early detection, screening, diagnosis or
image guided treatment of cancer (NCI) and environmentally induced
diseases (NIEHS), and to facilitate clinical evaluation studies of the
development that are specifically limited to proof of concept. The
National Institute of Biomedical Imaging and Bioengineering (NIBIB) may
accept assignments of grant applications that address development of
novel imaging technologies that are not organ or disease specific.
Specific emphasis of this PAR is directed at (a) the development of
highly innovative image acquisition and enhancement methods, including
high risk/high gain research on technologies that exploit our knowledge
of the molecular basis of cancer and environmentally induced diseases,
and (b) the development of other novel imaging methods and the
integration of these technologies with emerging molecular imaging
methods, where appropriate, for more effective health care delivery.
The motivation for this Program Announcement (PA) is that current
technologies for the molecular analysis of disease are largely
restricted to in vitro methods and need to be extended to the in vivo
situation. Furthermore, developments of molecular probes or tracers for
imaging molecular events in pre-clinical and clinical investigations
are essential for detection of molecular changes in vivo. Developments
of innovative, high-resolution imaging methods at the cellular or
molecular scales are needed, with particular emphasis on identification
and characterization of processes in the early formation of disease or
early molecular changes during intervention or therapy. Integrations of
these emerging molecular imaging methods with advances in traditional
imaging methods are also required for more effective in vivo
investigations of environmentally induced disease and cancer.
This PA (Development of Novel Technologies for in vivo Imaging
(SBIR/STTR)) will utilize the Small Business Innovation Research (SBIR)
and Small Business Technology Transfer (STTR) mechanisms that are
designed to encourage technology development by eligible small
businesses. This PA must be read in conjunction with the current
Omnibus Solicitation of the National Institutes of Health, Small
Business Innovation Research (SBIR) and Small Business Technology
Transfer (STTR) Grant Applications
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). An SBIR
and STTR application responding to this PA may be submitted as a Phase
I, Phase II or Fast Track pair of Phase I and Phase II applications.
The Fast Track applications will benefit from expedited evaluation of
progress following the Phase I feasibility study for transition to
Phase II funding for expanded developmental work. Applications will
undergo expedited review, and will be subject to cost and duration
guidelines that are expanded over those stated in the Omnibus
Solicitation of the National Institutes of Health, Small Business
Innovation Research (SBIR) and Small Business Technology Transfer
(STTR) Grant Applications (PHS 2001-2). All of the instructions in the
current PHS Omnibus Solicitation for SBIR/STTR Grant Applications
apply, except for the following:
o Special receipt dates (see above),
o Review by an NCI special study section,
o Up to 2 years of Phase I feasibility study support, up to 3 years of
Phase II developmental study support, but a 4 year limit of support for
both Phase I and II, whether submitted separately or together as a Fast
Track,
o Additional review criteria..
There is a parallel NCI program announcement of identical technical and
scientific scope that utilizes a new Phased Innovation Award mechanism
(R21/R33) that is intended primarily for applicants other than small
businesses, originally issued as PAR-00-089 (see
http://grants.nih.gov/grants/guide/pa-files/PAR-00-089.html), and which
is being reissued concurrently with this PA as PAR-01-101 (see
http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html).
BACKGROUND
Significant advances in medical imaging technologies have been made
over the past 25 years in such areas as magnetic resonance imaging
(MRI), computed tomography (CT), nuclear medicine and ultrasound.
However, these advances largely focused on structural or anatomical
imaging at the organ or tissue level. Now there is a clear need and
opportunity to stimulate the development and integration of novel
imaging technologies that exploit our current knowledge of the genetic
and molecular bases of environmentally induced disease and cancer.
Molecular biological discoveries have great implications for
prevention, detection, and targeted therapy. Imaging technologies that
can provide similar kinds of cellular and molecular information in vivo
that are currently available only from techniques in vitro would be
very useful. This is commonly known as in vivo molecular imaging.
The need for NCI to encourage and support bioengineering and technology
development by academic and industrial researchers was stressed by
participants at several NIH- and NCI-supported forums over the past few
years [Imaging Sciences Working Group (ISWG) July 1997, Lung Imaging
Workshop: Technology Transfer, Jan 1997, Computer Aided Diagnosis and
3D Image Analysis, Oct 1998, Quantitative In Vivo Functional Imaging in
Oncology, Jan 1999, Focus Group on Magnetic Resonance Spectroscopy
(MRS) in Clinical Oncology, April 1999, and NIH BECON Symposium, June
1999]. The needs are to (a) promote the development of novel, high
risk, high gain technologies, including continued support for their
maturation and full exploitation, (b) promote system integration of
technologies for targeted applications, including the development of a
system prototype and small number of copies, as required, for research
and clinical feasibility studies, and (c) improve technology transfer
by promoting partnerships between academia and industry. The NIEHS has
reached similar conclusions, which motivated their joining in this PA.
Developments of novel imaging technologies usually will require
multidisciplinary approaches to provide teams with broad expertise in a
variety of research areas. Such varied expertise might include imaging
physics, engineering, chemistry, molecular and cellular biology,
informatics and biostatistics. The coordination and collaboration of
investigators with the necessary variety of disciplines to demonstrate
the utility and applicability of new imaging methods is encouraged.
RESEARCH OBJECTIVES
This initiative is primarily intended to facilitate the development of
novel imaging technologies for early detection, screening, diagnosis or
image guided treatment of cancer and environmentally induced disease,
and to facilitate clinical evaluation studies of the development that
are specifically limited to proof of concept. Specific emphasis of this
PAR is directed at (a) developments of highly innovative image
acquisition and enhancement methods, including high risk/high gain
research on technologies that exploit our knowledge of the molecular
basis of cancer and environmentally induced disease, and (b)
developments of other novel imaging methods and their integration with
emerging molecular imaging methods, where appropriate, for more
effective health care delivery. In particular, developments of
innovative, high-resolution imaging methods at the cellular or
molecular scales are needed for both pre-clinical models and clinical
studies, with emphasis on identification and characterization of either
the early formation of disease or early molecular changes during
intervention or therapy. Methods that establish ground truth are
required at appropriate levels of resolution to validate these emerging
imaging methods. They may include the imaging of excised tissue using
protocols similar to those used for imaging in vivo. Developments of
probes or tracers are considered essential for detection of molecular
changes in vivo to take better advantage of many technologies with
potential for molecular imaging.
The following objectives would make appropriate topics for proposed
projects. This list is not meant to be all-inclusive.
o Imaging to detect early changes. Developments of innovative high-
resolution imaging methods at the cellular or molecular scales are
encouraged, with a particular intent to identify and characterize pre-
malignant abnormalities or early changes preceding the development of
other diseases. Novel solutions for in vivo microscopic imaging
systems, or microscopic implanted devices with high spatial, contrast
and temporal resolution are encouraged. Similarly, developments of
contrast enhancement methods and imaging probes are also encouraged.
Proposed imaging methodologies that emphasize analysis of molecular
events on the path to disease are encouraged.
o Large scale screening applications for cancer and environmentally
induced disease. Development and optimization of efficient, low-cost
imaging systems for rapid and automated large-scale screening with the
intent of achieving significantly higher sensitivity and specificity
for disease detection are encouraged. Applications could address
significant innovative improvements to current imaging methods or new
emerging imaging systems. Research topics of interest include, but are
not limited to, technologies for molecular imaging, means to
significantly reduce imaging time or motion effects, use of novel
contrast agents or imaging probes, and use of technologies that do not
involve ionizing radiation. System integration could include a variety
of image processing techniques including temporal analysis of serial
studies, close to real-time image processing, novel image display
methods, and related imaging informatics and information reduction
methods for more cost-effective solutions for screening.
o Imaging for diagnosis, staging, or monitoring the effects of
therapy. This initiative encourages the development of novel imaging
methods such as functional or molecular imaging or spectroscopy methods
that would significantly improve the specificity of diagnosis of cancer
and environmentally induced disease, allow deterministic methods or
patient-specific staging, or measure early effects of therapy.
Examples of system integration would include image fusion or
registration from the different modalities employed, development of
software methods that would estimate the probability of malignancy or
other specific disease identification, quantitative information for
monitoring the effects of therapy, and close to real-time image
analysis.
o Image guided biopsy (IGB), therapy (IGT), and interventional
procedures. Novel approaches using imaging technologies are needed to
significantly improve specificity, to identify lesion extent and
microscopic involvement, and to minimize the tissue damage accompanying
biopsy and therapy. Of particular interest are innovative approaches to
IGB, IGT or interventional methods that include novel imaging systems
that provide information at the cellular or molecular level. Examples
of system integration that are of interest include, but are not limited
to, navigational systems, registration methods for several imaging
modalities, real-time feedback mechanisms for controlling therapy or
the use of methods that are adaptive or allow patient-specific
optimization of treatment and computer-assisted surgery
MECHANISMS OF SUPPORT
The following are points to note about the mechanism of support and its
implementation:
o Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.
o Awards will be administered under NIH grants policy as stated in the
NIH Grants Policy Statement, March 2001, available at
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Hard copies
are not available. Support for this program will be through the
National Institutes of Health (NIH) SBIR/STTR grant program described
in the Omnibus Solicitation of the National Institutes of Health for
Small Business Innovation Research (SBIR) and Small Business Technology
Transfer (STTR) Grant Applications
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)
o The total project period for an application submitted in response
to this PA may not exceed the following durations: Phase I SBIR R43 or
STTR R41, 2 years, Phase II SBIR R44 or STTR R42, 3 years, Fast Track
R41/R42 or R43/R44 application, 4 years. In any case, the total
project period may not exceed 4 years, whether submitted as a Fast
Track or as separate Phase I and Phase II applications.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by eligible, domestic, for-profit small
business organizations, as described for SBIR and STTR grant
applications in the Omnibus SBIR/STTR Solicitation. The parallel
program announcement, PAR-01-101 (see
http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html), has a
wider range of eligibility that encompasses foreign and domestic, for-
profit and non-profit organizations, public and private, such as
universities, colleges, hospitals, laboratories, companies, units of
State and local governments, and eligible agencies of the Federal
government.)
Potential applicants are encouraged to access the PHS SBIR and STTR
Omnibus Solicitation for information on eligibility requirements at the
following website: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
Partnerships with medical device manufacturers to facilitate the
integration of system components are encouraged, as they enable the
useful pooling of resources necessary for successful execution of a
project. Partnering options available to small business organizations
may include subcontracts. In addition, joint ventures are eligible
provided that the entity created qualifies as a small business concern
as defined in the NIH SBIR/STTR Omnibus Solicitation
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).
INQUIRIES
Inquiries are encouraged. Opportunities to clarify issues and
questions from potential applicants are welcome.
Direct inquiries regarding programmatic issues to the following:
For the NCI
Houston Baker, Ph.D.
Biomedical Imaging Program
National Cancer Institute
6130 Executive Plaza, Suite 6000
Bethesda, MD 20892-7412
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 9531
FAX: (301) 480 3507
Email: bakerhou@mail.nih.gov
For the NIEHS
Jerrold (Jerry) J. Heindel, Ph.D.
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
FedEx: 79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Telephone: (919) 541 0781
FAX: (919) 541 5064
mailto: heindelj@niehs.nih.gov
Direct inquiries regarding fiscal matters to:
For the NCI
Kathleen J. Shino, M.B.A.
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS 243
Bethesda, MD 20892-7150
Rockville, MD 20852-7150 (for express/courier service)
Telephone: (301) 846 1016
FAX: (301) 846 5720
Email: ks48e@nih.gov
For the NIEHS
Carolyn B. Winters
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
FedEx: 79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Telephone: (919) 541 7823
FAX: (919) 541 2860
mailto: winters@niehs.nih.gov
Direct inquiries regarding review matters to:
Ms. Toby Friedberg.
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda, MD 20892-8236
Rockville, MD 20852 (for overnight/courier service)
Telephone: (301) 496 3428
FAX: (301) 402 0275
Email: tf12W@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a Letter of Intent by the
date listed at the beginning of this PA and in the SCHEDULE, below. It
should provide the number and title of this program announcement, a
descriptive title of the proposed research, the name, address,
telephone number, and e-mail address of the Principal Investigator and
identify other key personnel and participating institutions. 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.
Address the letter of intent to Dr. Houston Baker at the address listed
under INQUIRIES, above.
SCHEDULE
Letter of Intent Receipt: June 11, 2001, February 11,
2002, June 11, 2002
Application Receipt Date: July 16, 2001, March 18,
2002, July 16, 2002
Peer Review Date: Oct-Nov, 2001, June-July,
2002, Oct-Nov, 2002
Review by National Cancer Advisory Board, or
National Environmental Sciences Advisory Council: February, 2002, September,
2002, February, 2003
Earliest Anticipated Start Date: March 2002, October, 2002,
March 2003
APPLICATION PROCEDURES
SBIR and STTR application information is available at the following
website: http://grants.nih.gov/grants/funding/sbir.htm, where
instructions and application forms in pdf files are hyperlinked as
Appendices A through E, subtopics under the SBIR/STTR Phase I
Solicitation link.
Application forms, requirements and procedures are the same as listed
in the Omnibus Solicitation for Phase I SBIR/STTR Grant applications
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), with the
following exceptions:
o Type the title and number of this PA on line 2 on the face page of
the application.
o The Omnibus Solicitation states levels for Phase I and Phase II
budgets that are guidelines, not ceilings. Under this PA, the NCI and
NIEHS will consider larger budgets for longer periods of time that are
well-justified and necessary to complete the proposed research and
development. Phase I budgets are limited to project periods up to a
two year ceiling, and up to a guideline of $100,000 per year, excluding
subcontractor facilities and administrative costs. Include a second
budget page, and expand the narrative budget justification page(s) to
provide second year justification if there are significant line item
differences. If second year changes reflect only cost of living
factor(s), include a statement to that effect, the factor(s) used, and
omit repetition of detail already provided for first year line items.
o There are no dollar limitations under this PA for Phase II budgets,
but requested amounts are subject to peer review recommendations,
availability of funds, and Program priority.
o A flexible SBIR/STTR Phase I budget period of one or two years
(versus the Omnibus Solicitation guideline of 6 months for the SBIR and
1 year for the STTR).
o A flexible SBIR/STTR Phase II budget period of one to three years
(versus the Omnibus Solicitation guideline of up to two years).
o A four year limit to funding for either a Fast Track, or a Phase I
and renewal Phase II application.
Specific Aims: The application must present specific aims that the
applicant considers technically or scientifically appropriate for the
relevant phases of the project. Since the goal of this PA is the
development of innovative imaging technologies, hypothesis testing per
se may not be the driving force in developing such a proposal, and
therefore, may not be applicable. For the R41 or R43 phase of
feasibility studies, preliminary data are not required, but should be
included if they are available.
Project Period and Amount of Award. Because the length of time and
cost of research involving advanced technology projects may exceed that
normally awarded for SBIR/STTR grants, NCI and NIEHS will entertain
well-justified Phase I applications with a project period up to two
years and a budget guideline that may not exceed $100,000 per year
direct and indirect costs (maximum of $200,000 direct and indirect
costs for up to 2 years, excluding subcontractor facilities and
administrative costs).
Phase II Applications. Phase II applications in response to this PA
will only be accepted as competing continuations of previously funded
NIH Phase I SBIR or STTR awards. The Phase II application must be for
developmental work that is a logical extension of the Phase I
feasibility research. Phase II budgets normally may not exceed
guidelines of $500,000 total costs per year for the STTR R42 and
$750,000 total costs per year for the SBIR R44. Budgets that exceed
these guidelines require justification.
Applications for Phase II awards should be prepared following the
instructions for NIH Phase II SBIR or STTR applications. The Phase II
SBIR instructions and application may be found on the Internet at:
http://grants.nih.gov/grants/funding/phs398/phs398.html.
The Phase II STTR instructions and application may be found on the
Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
Fast Track Applications. Applications may be submitted for the Fast
Track review option. Information on the Fast Track option may be found
at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
Project Period and Amount of Award. Because the length of time and
cost of research may exceed that normally awarded for SBIR grants, NCI
and NIEHS will entertain well-justified Phase II applications for this
SBIR/STTR award with project periods up to three years with budget
levels appropriate for the work proposed (subject to the four year
funding limit for Phase I and Phase II grants).
Clinical Trials: All clinical trials supported by any NIH Institute or
Center require some form of safety monitoring plan. The method and
degree of monitoring to be included in the plan should be commensurate
with the degree of risk involved 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 to a
Data and Safety Monitoring Board (DSMB). These monitoring activities
are distinct from and in addition to the requirement for human subject
study review and approval by an Institutional Review Board (IRB). For
details about the Policy of the NCI for Data Safety Monitoring of
Clinical Trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For additional information, see
http://grants.nih.gov/grants/guide/notice-files/not98-084.html and
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
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 overnight express or courier service)
At the time of submission, two additional copies of the application
must be sent to:
Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda, MD 20892-8236
Rockville, MD 20852 (for overnight express or courier service)
Telephone: (301) 496 3428
FAX: (301) 402 0275
The Center for Scientific Review (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 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 the 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 PA 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 Advisory Council or Board.
REVIEW CRITERIA:
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments reviewers will be asked to discuss the
following aspects of the application 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 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 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 this study address an important problem? If the
aims of the application are achieved, how will in vivo imaging
technology or scientific knowledge be advanced? What will be the
effect of these studies on the concepts or methods that drive this
field? To what degree does the technology support the needs of
oncology, environmental health science, or imaging that is not disease
or organ specific? Does this project have commercial potential? What
may be the anticipated commercial and societal benefits of the proposed
activity?
2. Approach. Are the conceptual framework, design, and methods
adequately developed, well integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas
and consider alternative tactics? What is the time frame for developing
the proposed technologies, and suitability of this time frame for
meeting the community"s needs? How easy will it be to use the proposed
technology? Are the plans adequate for the proposed technology, its
integration as an effective solution for implementation, and
dissemination? If industrial partnerships are proposed, how will they
facilitate the development and integration of system components?
3. Milestones (for Phase I R41 or R43 or Fast Track applications) and
Proof of Principle (for Phase II applications). For the Phase I
application, how appropriate are the proposed Milestones against which
to evaluate the demonstration of feasibility for transition to the R42
or R44 Phase II development work? Do they provide an objective target
against which to evaluate results? For Phase II applications, how well
has feasibility or proof of principle been demonstrated?
4. Innovation. Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies? What is the throughput and cost effectiveness of the
proposed technology? What additional uses can be projected for the
proposed technology?
5. Investigator. Is the principal investigator appropriately
trained, experienced, and well suited to direct or carry out this work?
Is the work proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?
6. Environment. Does the technical and scientific environment in
which the work will be performed contribute to the probability of
success? Does the proposed work take advantage of unique features of
the technical and scientific environment or employ useful collaborative
arrangements?
Additional Considerations:
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also
be evaluated.
o The reasonableness of the proposed budget and duration in relation
to the proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications recommended by the National Cancer Advisory Board for NCI
or the National Environmental Sciences Advisory Council for NIEHS will
be considered for award on the basis of (a) quality of the proposed
project as determined by peer review, (b) availability of funds, and
(c) program priority.
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 sub- populations 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
to indicate 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 updated "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a
complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
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 clear and compelling 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 which is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of these policies from program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should
read the NIH policy on education in the protection of human research
participants now required for all investigators, which is published in
the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August
25, 2000), available at the following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program on the protection of human participants in
research is now available online at http://cme.nci.nih.gov/.
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 a 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 PA,
Development of Novel Technologies for In Vivo Imaging (SBIR/STTR), is
related to the priority areas of cancer and environmental health.
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, Cancer Detection and Diagnosis Research (NCI), and 93.113.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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NIH... Turning Discovery Into Health® |
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