TECHNOLOGY AND AGING: NIA SBIR/STTR PROGRAM INITIATIVE
RELEASE DATE: February 20, 2004
PA NUMBER: PA-04-064 (This PA has been reissued, see PA-06-048 and PA-06-049)
EXPIRATION DATE: November 3, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE: NUMBER: 93.866
APPLICATION RECEIPT DATE(S): Applications submitted in response to this
program announcement will be accepted at the standard application deadlines
[April 1, August 1, December 1]
THIS PA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Project Period and Amount of Award
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations
NOTICE: This program announcement (PA) must be read in conjunction with the
current Omnibus Solicitation of the National Institutes of Health, Centers
for Disease Control and Prevention, and Food and Drug Administration for
Small Business Innovation Research (SBIR) and Small Business Technology
Transfer (STTR) Grant Applications. The solicitation (see
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains
information about the SBIR and STTR programs, regulations governing the
programs, and instructional information for submission. All of the
instructions within the current SBIR/STTR Omnibus Solicitation apply.
PURPOSE OF THE PA
The National Institute on Aging (NIA) seeks small business applications in
specific areas to enhance the coordination and optimization of the SBIR and
STTR grant programs across and within NIA's four programs of research:
Behavioral and Social Research, Biology of Aging, Geriatrics and Clinical
Gerontology, and Neuroscience and Neuropsychology of Aging. All four of
NIA’s programs are participating in this initiative. This program
announcement is NIA's first systematic effort to solicit SBIR and STTR
research proposals within a strategic perspective that emphasizes the
importance and viability of public and private-sector research collaboration
as part of NIA's overall mission to improve the health and well-being of
older Americans through translational research. Specific areas of research
interest are described below.
RESEARCH OBJECTIVES
The topics in this announcement are grouped according to their program area
and reflect the priorities outlined in NIA's five-year strategic research
plan: http://www.nia.nih.gov/AboutNIA/StrategicPlan/. Applications are
encouraged on these and other topics relevant to the health and well-being of
older adults.
Behavioral and Social Research
1. Applications on Technology for Adaptive Aging: NIA recently commissioned
a report from the National Academy of Sciences (NAS), Technology for
Adaptive Aging, to identify opportunities in translational research and
technological development that could be pursued via the SBIR mechanism. The
report is available on the NAS website
(http://books.nap.edu/catalog/10857.html) and contains recommendations and
directions in the areas of: communication, employment, health, learning,
living environments, and transportation. This report identified the
following issues that investigators might consider when designing SBIR
proposals: access, cohorts, control/autonomy/agency/dignity, culture and
language, customization, expectations, legal constraints, privacy, safety,
stereotyping, training, trust, and usability.
2. Products and technologies that translate social and behavioral research on
aging processes. These include interventions and products that take into
account the adaptations that individuals and society need to make to address
population aging, such as visual, cognitive, familial, communication and
other adaptations. Examples of products include technologies that allow older
drivers to better adapt to sensory declines or media programs designed for
older adults to increase compliance with complex healthcare regimens.
3. Research innovations and new products that improve data collection, data
analysis, and data dissemination of gerontological research. Innovative
methods for improving the measurement of well-being in older populations are
particularly encouraged.
4. Data Dissemination: The development of electronic data repositories that
facilitate rapid dissemination and analysis of complex longitudinal and
epidemiological data. Such electronic database resources should be highly
accessible to researchers while ensuring respondent confidentiality; they
should include user-friendly interface modules and utilities, and should
enable cross-platform exchange of data with minimal additional programming
and manipulation.
5. Methodological Innovation: This includes new products and techniques that
facilitate the forecasting of domestic and international demographic trends
in aging segments of these populations and their healthcare needs; the
development of high quality micro- or macro-simulation models that measure
the impact of targeted interventions on health expenditures, well-being, and
other outcomes; the development and evaluation of strategies to improve
healthcare organization and delivery, including attention to assisted living
and new forms of in-home care.
6. Healthcare Interventions: Social, behavioral, environmental, and/or
technical interventions on the individual for health maintenance, improved
well-being, and disease/disability prevention. Such interventions comprehend
the development of strategies and technologies to enhance long-term adherence
to medical regimens for chronic conditions and behavioral-change
interventions for health promotion in older adults. These interventions
might include self-management technologies that enhance compliance.
Interventions of particular interest are those that target less educated
patients with chronic diseases or new programs, products and services to
improve the health, functioning, and well-being of older persons. Potential
settings of these interventions would include home or the community and
potential users would include the patient, the individual, formal and/or
formal caregivers, and even larger social networks.
Biology of Aging Program
7. Vaccine Development: Development of novel vaccine protocols that
enhance innate and adaptive immune responses for use in elderly populations.
These may include development and testing of adjuvants, immunotherapeutic
agents, novel recombinant or subunit vaccine formulations, and optimization
of delivery protocols. Research approaches may include evaluation in
appropriate laboratory animals, including aged rodents or non-human primate
models.
8. Tissue Bioengineering: Development of cells and biomaterials for
augmentation of tissue regeneration, including strategies to achieve
functional repair of tissue defects with integrated graft materials and
cells.
Geriatrics and Clinical Gerontology
9. Exercise Technology: Development of a compact, sturdy treadmill for use by
ambulatory elderly persons for exercise during inclement weather to maintain
their normal walking speed.
10. Sensor technology: Development of new and/or validation of existing but
unproven technologies for detection/surveillance and/or communication of
problems to allow older persons to live independently.
Neuroscience and Neuropsychology of Aging
11. Pre-clinical discovery and development of drugs or natural products to
treat, delay the progression of, or prevent age-related cognitive decline,
Alzheimer's disease, and other dementias of aging.
12. Development of biological or other methods (e.g., neuropsychological) for
early pre-symptomatic diagnosis of age-related cognitive decline, Alzheimer's
disease, and other dementias of aging
13. Development of devices for the amelioration of age-related changes in
human sensory and motor systems.
14. Development of methods for screening, diagnosis, and mechanisms of action
of prions in the transmissible spongiform encephalopathies in the aging
organism.
15. Development of biomaterials and methods for nervous system tissue
regeneration (e.g., growth factors, gene therapy vectors, transplant methods)
in aging and age-related diseases of the nervous system.
16. Development of methods, reagents, biomaterials, etc. to identify and
monitor neural stem cells in brain aging and age-related neurodegenerative
disorders.
MECHANISM OF SUPPORT
This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Future unsolicited, competing- continuation
applications based on this project will compete with all SBIR/STTR
applications and will be reviewed according to the customary peer review
procedures.
This PA uses just-in-time concepts. It also uses the modular budgeting
format. Specifically, if you are submitting an application budget of $100,000
total costs (direct, F&A and fee) or less, use the modular format and
instructions as described in the current SBIR/STTR Omnibus Solicitation.
Otherwise follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Applications may be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; the
SBIR/STTR FAST-TRACK option; or as an SBIR/STTR Phase II competing
continuation as described in the SBIR/STTR Omnibus Solicitation. Phase II
applications in response to this PA will only be accepted as competing
continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase
II application must be a logical extension of the Phase I research but not
necessarily a Phase I project supported in response to this PA. Phase II
competing continuations will ONLY be accepted by NIA’s Neuroscience and
Neuropsychology of Aging (NNA) Program. NNA will accept Phase II competing
continuations SBIR/STTR grant applications from Phase II SBIR/STTR awardees
ONLY for the purpose of continuing the process of developing products that
require approval of a Federal regulatory agency (e.g., FDA). For further
information regarding Phase II competing continuations, contact Dr. Neil
Buckholtz (contact information below).
PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation (see:
http://grants.nih.gov/grants/funding/sbir.htm) indicates the statutory
guidelines of funding support and project duration periods for SBIR and STTR
Phase I and Phase II awards. For Phase II competing continuations, budgets up
to $750,000 total costs per year and time periods up to 2 years may be
requested. Total costs include direct costs, F&A, and fee/profit in
accordance with the current SBIR guidelines.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.
Only small business concerns are eligible to submit applications. A small
business concern is one that, on the date of award for both the Phase I and
Phase II agreements, meets ALL of the criteria as described in the SBIR/STTR
Omnibus Solicitation.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS (PI)
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. On an SBIR application, the PI must
have her/his primary employment (more than 50%) with the small business at
the time of award and for the duration of the project. The PI on an STTR
application may be employed with the small business concern or the
participating non-profit research institution as long as s/he has a formal
appointment with or commitment to the applicant small business concern, which
is characterized by an official relationship between the small business
concern and that individual.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific and financial or grants management issues:
o Direct your questions about scientific/research issues with primary
emphasis on the biology of aging to:
Rebecca Fuldner, Ph.D.
Biology of Aging Program
National Institute on Aging
Gateway Building, Suite 2C231
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
Email: fuldnerr@nia.nih.gov
o Direct your questions about scientific/research issues with primary
emphasis on behavioral and social research on aging to:
Elayne Heisler, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 496-3138
heislere@nia.nih.gov
o Direct your questions about scientific/research issues with primary
emphasis on geriatric and clinical gerontological research to:
Winifred K. Rossi, M.A.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
Gateway Building, Suite 3E327
7201 Wisconsin Avenue
Bethesda MD 20892-9205
Telephone: (301) 496-6761
Email: rossiw@nia.nih.gov
o Direct your questions about scientific/research issues with primary
emphasis on the neuroscience and neuropsychology of aging to:
Neil Buckholtz, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
Email: buckholn@nia.nih.gov
o Direct your questions about financial or grants management matters to:
Cynthia Riddick, M.A.
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Email: riddickc@nia.nih.gov
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all SBIR/STTR Phase
I, Phase II and Fast-Track applications (new and revised.)Effective October
1, 2003, applications must have a DUN and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by
calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line
11 of the face page of the PHS 398 form. The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your
application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS
398. Helpful information for advice and preparation of the application can be
obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The
NIH will return applications that are not submitted on the 5/2001 version of
the PHS 398. For further assistance contact GrantsInfo,
Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov.
The title and number of this PA must be typed on line 2 of the face page of
the application.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: This PA uses the
modular budgeting format. Specifically, if you are submitting an application
budget of $100,000 total (direct, F&A and fee) or less, use the modular
format and instructions as described in the SBIR/STTR Omnibus Solicitation.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five 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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD 20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described on the first page of this program
announcement. 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 unfunded version
of an application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA that are complete will be assigned on the
basis of established PHS referral guidelines. Appropriate scientific review
groups convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate 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:
o Significance
o Approach
o Innovation
o Investigator
o Environment
1. Significance: Does the proposed project have commercial potential to lead
to a marketable product or process? Does this study address an important
problem? What may be the anticipated commercial and societal benefits of the
proposed activity? If the aims of the application are achieved, how will
scientific knowledge be advanced? Does the proposal lead to enabling
technologies (e.g., instrumentation, software) for further discoveries? Will
the technology have a competitive advantage over existing/alternate
technologies that can meet the market needs?
2. Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Is the proposed plan a sound approach for establishing technical and
commercial feasibility? Does the applicant acknowledge potential problem
areas and consider alternative strategies? Are the milestones and evaluation
procedures appropriate?
3. Innovation: Does the project challenge existing paradigms or employ novel
technologies, approaches or methodologies? Are the aims original and
innovative?
4. Investigators: Is the Principal Investigator capable of coordinating and
managing the proposed SBIR/STTR? Is the work proposed appropriate to the
experience level of the Principal Investigator and other researchers,
including consultants and subcontractors (if any)? Are the relationships of
the key personnel to the small business and to other institutions appropriate
for the work proposed?
5. Environment: Is there sufficient access to resources (e.g., equipment,
facilities)? Does the scientific and technological 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be applied to ALL applications in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See additional information and
criteria included in the section on Federal Citations, below).
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: The adequacy of plans to
include subjects from both genders, and all racial and ethnic groups (and
subgroups) as appropriate for the scientific goals of the research. Plans
for the recruitment and retention of subjects will also be evaluated. (See
additional information and Inclusion Criteria in the sections on Federal
Citations, below).
Human Subjects:
1. Protection of Human Subjects from Research Risks - for all studies
involving human subjects. See instructions and "Guidance for Preparing the
Human Subjects Research Section. If an exemption is claimed, is it
appropriate for the work proposed? If no exemption is claimed, are the
applicant's responses to the six required points appropriate? Are human
subjects placed at risk by the proposed study? If so, are the risks
reasonable in relation to the anticipated benefits to the subjects and
others? Are the risks reasonable in relation to the importance of the
knowledge that reasonably may be expected to be gained? Are the plans
proposed for the protection of human subjects adequate?
2. Inclusion of Women Plan - for clinical research only. Does the applicant
propose a plan for the inclusion of both genders that will provide their
appropriate representation? Does the applicant provide appropriate
justification when representation is limited or absent? Does the applicant
propose appropriate and acceptable plans for recruitment/outreach and
retention of study participants?
3. Inclusion of Minorities Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of minorities that will provide
their appropriate representation? Does the applicant provide appropriate
justification when representation is limited or absent? Does the applicant
propose appropriate and acceptable plans for recruitment/outreach and
retention of study participants?
4. Data and Safety Monitoring Plan for clinical trials only. Does the
applicant describe a Data and Safety Monitoring Plan that defines the general
structure of the monitoring entity and mechanisms for reporting Adverse
Events to the NIH and the IRB?
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the required five items described under Vertebrate
Animals (section f of the Research Plan instructions) will be assessed.
BIOHAZARDS: Is the use of materials or procedures that are potentially
hazardous to research personnel and/or the environment proposed? Is the
proposed protection adequate?
ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be
considered by reviewers but will not be included in the determination of
scientific merit.
SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct
costs in any year of the proposed research must include a data sharing plan
in their application. (See
http://grants.nih.gov/grants/policy/data_sharing.) The reasonableness of
the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed
data sharing plan into the determination of scientific merit or priority
score.
BUDGET: The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for
the work proposed? On applications requesting up to $100,000 total costs, is
the overall budget realistic and justified in terms of the aims and methods
proposed? On applications requesting over $100,000 in total costs, is each
budget category realistic and justified in terms of the aims and methods?
PERIOD OF SUPPORT: The appropriateness of the requested period of support in
relation to the proposed research.
PHASE II APPLICATIONS:
In addition to the above review criteria:
1. How well did the applicant demonstrate progress toward meeting the Phase I
objectives, demonstrating feasibility, and providing a solid foundation for
the proposed Phase II activity?
2. Did the applicant submit a concise Commercialization Plan that adequately
addresses the seven areas described in the Research Plan item J?
3. Does the project carry a high degree of commercial potential, as described
in the Commercialization Plan?
AMENDED APPLICATIONS:
In addition to the above criteria, the following criteria will be applied to
revised applications.
1. Are the responses to comments from the previous SRG review adequate?
2. Are the improvements in the revised application appropriate?
TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS:
In addition to the above review criteria, the following items will be applied
to ALL Type 2 Competing Continuation Phase II applications in the
determination of scientific merit and the priority score:
O Does the activity as proposed address issues related to Federal regulatory
approval processes?
o Did the applicant submit a concise Commercialization Plan that adequately
addresses the specific areas described in Item j of the Phase II research
plan?
o Does the project carry a high degree of commercial potential as described
in the Commercialization Plan?
PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA
For Phase I/Phase II Fast Track applications, the following criteria also
will be applied:
1. Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. Did the applicant submit a concise Commercialization Plan that adequately
addresses the seven areas described in the Research Plan, item J?
3. To what extent was the applicant able to obtain letters of interest,
additional funding commitments, and/or resources from the private sector or
non-SBIR/ STTR funding sources that would enhance the likelihood for
commercialization?
4. Does the project carry a high degree of commercial potential, as described
in the Commercialization Plan?
Phase I and Phase II Fast-Track applications that satisfy all of the review
criteria will receive a single rating. Failure to provide clear, measurable
goals may be sufficient reason for the scientific review group to exclude the
Phase II application from Fast-Track review.
AWARD CRITERIA:
Applications submitted in response to this PA will compete for available
funds with all other recommended SBIR and STTR 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
For FAST-TRACK applications, the Phase II portion may not be funded until a
Phase I final report and other documents necessary for continuation have been
received and assessed by program staff that the Phase I milestones have been
successfully achieved.
RECEIPT AND REVIEW SCHEDULE:
See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm
REQUIRED FEDERAL CITATIONS:
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Research components involving Phase I and
II clinical trials must include provisions for assessment of patient
eligibility and status, rigorous data management, quality assurance, and
auditing procedures. In addition, it is NIH policy that all clinical trials
require data and safety monitoring, with the method and degree of monitoring
being commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should seek
guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html );
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s) for the hESC line(s) to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
Federal regulation under the Health Insurance Portability and Accountability
Act (HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This 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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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