ACCESSIBLE HEALTH PROMOTION AND FITNESS FOR PERSONS WITH DISABILITIES:
SBIR/STTR
RELEASE DATE: October 30, 2003
RFA Number: RFA-HD-03-013
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.929
LETTER OF INTENT RECEIPT DATE: March 17, 2004
APPLICATION RECEIPT DATE: April 16, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
NOTICE: This Request for Application (RFA) 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) contains information
about the SBIR and STTR programs, regulations governing the programs, and
instructional information for submission. All of the instructions within the
SBIR/STTR Omnibus Solicitation apply with the following exceptions:
o Special receipt date
PURPOSE OF THIS RFA
The purpose of this initiative is to promote innovative design modifications
of diagnostic medical devices and fitness equipment that will be suitable for
facilities and/or for home in order to increase accessibility for persons with
disabilities, improve their health and wellness, and reduce the occurrence of
secondary conditions. This initiative encourages the use of universal design
principles for 1) diagnostic medical devices in healthcare facilities (but not
modification of the facilities themselves), or 2) fitness and health promoting
equipment in fitness centers or home settings. Applicants should identify a
potential barrier unique to persons with physical disabilities and propose new
designs or substantial modifications of existing devices or equipment. This
initiative primarily focuses on improving access to biomedical and fitness
equipment, but does not extend to architectural modifications, improving
mobility in general (e.g., prosthetics, orthotics or wheelchair design) or
adaptations to equipment and devices that primarily function in a vocational,
educational or outside recreational setting.
RESEARCH OBJECTIVES
Background
An estimated 54 million persons in the United States, or nearly 20 percent of
the population, currently live with disabilities, and this population appears
to be increasing. Medical care expenditures for persons with disabilities are
rising as well. The health promotion and disease prevention needs of people
with disabilities are important regardless of the presence of any disease,
condition or injury that has long-term consequences. People with disabilities
actually have increased health concerns, particularly because they are
susceptible to the identical health concerns as able-bodied individuals and
have increased susceptibility to other conditions because of inactivity due to
their disability. Unfortunately, many people with disabilities are denied
access to preventive and diagnostic healthcare due to barriers related to
medical devices in physician's offices, diagnostic centers, and clinics, or
are limited in their health promotion activities due to lack of appropriate
equipment designed to promote physical health in fitness centers or at home.
The objectives of this initiative are pertinent to the Healthy People 2010
effort (http://www.healthypeople.gov/) to increase the quality and years of a
healthy life and to eliminate disparities among people. It is also very
relevant to the President's New Freedom Initiative
(http://www.hhs.gov/newfreedom/init.html).
Scope of Research
The objective of this initiative is to design and validate alterations to
medical diagnostic devices or exercise equipment that improve access for
persons with physical disabilities in order to improve health and reduce the
occurrence of secondary complications. Insufficient data exist from
adequately powered descriptive studies to provide quantitative and qualitative
standards of desirable fitness levels in persons with disabilities. It is
likely that improvement in medical diagnostic and fitness devices will include
a process to acquire information that could lead to such standards. For
example, the development of standards of age-appropriate resting and training
heart rates in individuals with specific disabilities is well within the scope
of this initiative.
Responsive grant applications will clearly and carefully identify, describe,
and justify in detail the targeted accessibility or barrier, wellness, and
disability issues and considerations of the proposed project. Proposed
projects involving equipment or devices will thoroughly consider the potential
device-user interaction, device design and safety, as well as device
usability, validity, and reliability. All projects should address milestones,
assessment criteria, and outcome measures and include a demonstration of
improved accessibility. The Phase II objectives should include thorough
validation testing and measurement. Proposals that target fitness should
include a goal of demonstrating that the proposed design modifications can
lead to not only better accessibility, but also improved function or reduced
disability. Adequate standard physiological data may not exist for many
populations of people with specific disabilities. It is expected that a
proposal on fitness will address the resting and exercise physiology of the
targeted population in order to demonstrate the effectiveness of the proposed
device or equipment. When human subjects research is proposed, the
application must thoroughly and completely address all of the pertinent issues
described in the application instructions. An adequately focused project will
have an expected scope and completion time that will be compatible with the
NIH SBIR/STTR program.
The following provides examples of modifications that could improve health
outcomes for persons with disabilities. This is not meant to be a
comprehensive or restrictive list of appropriate responses to this RFA, but
merely examples of research needs:
o Development or modification of fitness equipment for individuals with
disabilities (e.g., musculoskeletal abnormalities and reduced strength or
musculoskeletal function, amputations, partial paralysis, stroke, etc.) to
improve or maintain cardiovascular conditioning, pulmonary function, balance,
coordination, muscle tone and strength, and ultimately improve function and
reduce disability;
o Modifications in medical equipment or fitness devices to accommodate
individuals with spasticity, tremors, musculoskeletal deformities or other
physical impairments;
o Specialized devices to dynamically monitor general fitness activity,
cardiovascular function, metabolism, muscle physiology or other aspects of
health status for individuals with disabilities;
o Modifications in the design of examination tables and chairs, and other
large medical equipment, that improve access and proper positioning of
patients with physical disabilities;
o Modifications in the design of imaging equipment (e.g., fMRI, X-ray),
stress-testing devices, electrocardiogram, bone density, mammography or other
diagnostic equipment to accommodate persons with disabilities;
o Specific modifications to improve access for women with disabilities to
gynecological and obstetric exams and procedures, or other specialized medical
needs and health support;
o Specific modifications to improve access for children with disabilities to
standard pediatric and adolescent biomedical devices and exercise equipment.
MECHANISM OF SUPPORT
This RFA 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. The anticipated award date is September 2004. Applications that
are not funded in the competition described in this RFA may be resubmitted as
NEW SBIR/STTR applications using the standard receipt dates for NEW
applications described in the current SBIR/STTR Omnibus Solicitation.
This RFA 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 budget format and
instructions as described in the current SBIR/STTR Omnibus Solicitation. 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.
Except as otherwise stated in this RFA, 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.
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; or the
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus
Solicitation. Phase II applications in response to this RFA 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
RFA. 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.
PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of
funding support and project duration periods for SBIR and STTR Phase I and
Phase II awards. For this RFA, budgets up to $100,000 direct costs per year
and time periods up to three years for Phase I may be requested. Total costs
include direct costs, F&A, and fee/profit.
FUNDS AVAILABLE
The NICHD intends to commit approximately $600,000 in total costs [Direct plus
Facilities and Administrative (F & A) costs plus fee/profit] in FY 2004 to
support four to six Phase I and/or Phase II applications under the SBIR/STTR
set-aside funding mechanism. Although the financial plans of the NICHD
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 this RFA will be
reissued.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.
Only small business concerns are eligible to submit SBIR/STTR applications. A
small business concern is one that, on the date of award for both Phase I and
Phase II agreements, meets ALL of the criteria as described in the current
SBIR/STTR Omnibus Solicitation.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH programs. On an SBIR application, the Principal Investigator
must have his/her primary employment (more than 50 percent) 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 inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Nancy L. Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-2242
FAX: (301) 402-0832
Email: shinowara@nih.gov
o Direct your questions about peer review issues to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: kh246t@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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 NIH staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Nancy L. Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-2242
FAX: (301) 402-0832
Email: shinowara@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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
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 RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for USPS EXPRESS or REGULAR MAIL)
Bethesda, MD 20817 (for EXPRESS/COURIER NON-USPS SERVICE)
To expedite the review process, at the time of submission, send two additional
copies of the application to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NICHD. Incomplete applications will not be reviewed.
If the application is not responsive to the RFA, NIH staff may contact the
applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.
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 Center for Scientific Review in accordance with the review criteria stated
below. As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Child Health and
Human Development Council.
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 evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals within the context of the
SBIR/STTR Program. The scientific review group will address and consider each
of the following criteria in assigning the application’s overall score:
o Significance
o Approach
o Innovation
o Investigator
o Environment
ALL SBIR/STTR APPLICATIONS:
(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 considered 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, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. 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).
ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be
considered by reviewers but will not be included in the determination of
scientific merit.
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, reviewers
will consider:
(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 (formerly
Product Development 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?
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 (formerly
Product Development 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.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 17, 2004
Application Receipt Date: April 16, 2004
Peer Review Date: February/March 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 2004
AWARD CRITERIA
Applications submitted in response to an RFA 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.
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: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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 RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information,"
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes
involving the review, funding, and progress monitoring of grants, cooperative
agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA 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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NIH... Turning Discovery Into Health®
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