ORAL HEALTH OF SPECIAL NEEDS AND OLDER POPULATIONS
RELEASE DATE: December 8, 2003
PA NUMBER: PA-04-031
The R01 portion of this funding opportunity has been replaced by PA-07-151,
which now uses the electronic SF424 (R&R) application for February 5, 2007
submission dates and beyond.
EXPIRATION DATE: November 1, 2006 (unless reissued)
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 Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
93.121, Oral Diseases and Disorders
93.866, Aging Research
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement is to encourage investigator-initiated clinical
research focused on the oral health of special needs populations, including
those with developmental or acquired physical or mental disabilities, people
with mental retardation (MR), people living with HIV/AIDS, and frail or
functionally dependent elders. The types of clinical research welcomed are
epidemiologic, behavioral/social sciences, health care, patient-oriented and
community-based studies aimed at understanding and improving the oral, dental
and craniofacial health status, quality of life and health outcomes among
elders and other special needs populations. Given the complexity of factors
that may contribute to oral health disparities of these populations the use
of multiple approaches and interdisciplinary teams is anticipated. Studies
that nest oral health projects into ongoing, funded research are encouraged.
The research interests of the National Institute of Dental and Craniofacial
Research are described in the NIDCR Strategic Plan
(http://www.nidcr.nih.gov/about/strat-plan/) and in A Plan to Eliminate Oral
Health Disparities (http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf).
RESEARCH OBJECTIVES
Oral Health in America: A Report of the U.S. Surgeon General indicates that
oral, dental and craniofacial diseases and disorders are among the most
common health problems affecting the general population. The U.S. Surgeon
General’s Report and the NIDCR’s Plan to Eliminate Oral Health Disparities
note that certain segments of our society have significant disparities in
oral health. This program announcement encourages the submission of clinical
research applications that focus on improving the oral health status and
quality of life of a specific segment of the population those with special
needs. Special needs populations, for the purposes of this program
announcement, include people with developmental or acquired physical or
mental disabilities, people with mental retardation (MR), people living with
HIV/AIDS, and frail and functionally dependent elders.
As a group, Americans are aging and by 2030 one-fifth of the population or
approximately 70 million people will be 65 years and older. An estimated 30
percent of elders have limited mobility, are homebound, live in nursing homes
or are functionally dependent on others in their daily life. The impact of
oral, dental and craniofacial diseases and conditions on the health and
quality of life of frail and functionally dependent elders may be
considerable. National surveys indicate that serious oral health problems
exist even among many older adults who are non-institutionalized or non-
homebound. These oral health problems may have an impact on general health,
social well-being, and quality of life.
Studies conducted in a variety of settings indicate that older people with
impaired dentitions have trouble sleeping because of dental problems, avoid
social contact and conversation, and may be too embarrassed to laugh or
smile. The psychosocial impacts of oral diseases and conditions are of
concern given the growing evidence that social support is related to general
health. Many older adults suffer from severe periodontal disease and there
is evidence that periodontal disease or tooth loss may be associated with
poor diabetic control, respiratory disease, cardiovascular disease, and
stroke.
Nationally representative surveys indicate that the loss of teeth is
associated with lower intakes of nutrient rich foods and dietary fiber and
lower levels of important biochemical analytes. The U.S. Surgeon General’s
Report states that people who are missing teeth would have difficulty
complying with the healthful diet recommendation of the 5-A-Day campaign for
intake of fiber-rich fruits and vegetables. Prosthetic replacement of lost
teeth using current approaches does not appear to significantly improve
nutritional outcomes. Few studies have explored innovative approaches to oral
care aimed at improving quality of life, nutritional status and health
outcomes.
Great strides have been made in the prevention and treatment of oral diseases
and conditions in segments of the general population, but these achievements
may not be applicable to people with developmental and acquired disabilities.
Despite the fact that as many as one in five persons in the United States has
some level of disability, that is developmental (e.g. mental retardation,
cerebral palsy, syndromic disorders) or acquired (such as head or spinal cord
injuries, HIV/AIDS, degenerative neurological disorders, psychiatric
disorders) little clinical research related to their oral health has been
conducted. For example, data on the prevalence, incidence and determinants of
oral health is almost non-existent for people with disabilities. Information
regarding the types and severity of oral diseases and conditions; the
biological, behavioral and environmental factors related to oral health;
documentation of inequalities of oral health and oral health care within
various populations with disabilities; and impact of oral health on social
well being, quality of life and general health is needed to guide the
development of effective and appropriate prevention and treatment of oral
disease for people with developmental and acquired disabilities. Factors of
particular importance to special needs populations may include dietary and
special feeding practices; use of medications for chronic conditions; ability
to perform self-care procedures; access to health information; health
literacy of patients or their care givers; professional care approaches; and
interactions between environmental, behavioral and biological factors that
increase vulnerability.
Small-scale studies, such as screening examinations conducted by the Special
Olympics Special Smiles Program, give clues to the burden of disease and
suffering experienced by people with MR or other disabilities. Using a very
conservative protocol, dental examiners found that nearly 40% of Special
Olympics participants showed signs of gingival infection, a fourth had
untreated decay, and nearly 13% reported some form of oral pain. These data
are even more significant when it is considered that The U.S. Surgeon
General’s Report: Oral Health in America noted that those participating in
Special Olympics tend to be from higher-income families. Another Surgeon
General’s Report, The Surgeon General’s Conference on Health Disparities and
Mental Retardation acknowledged that challenges of people with MR from
minority and low-income communities may be magnified. This may well be the
case for oral health given the documented disproportionate burden for oral
disease that exists for racial and ethnic minorities, the poor, and those
with less education in the general population. The disparities in oral
health and its impact on the quality of life of these populations and their
caregivers may be substantial.
Frail and functionally dependent elders may be at particular risk for oral
diseases, conditions and discomfort due to side effects of medications and
complications from medical or surgical care. Many prescription and over-the-
counter drugs are associated with oral side effects including xerostomia,
gingival enlargement and altered taste perception. Some medications contain
sucrose that when coupled with xerostomia and poor oral hygiene may increase
risk for dental caries. Medical and surgical treatment for conditions such as
head and neck cancer can result in painful and debilitating oral pathosis.
Some people with special needs have problems swallowing or mastication and
require special diets or feeding that may increase risk for dental caries.
Strategies to overcome these and other challenges requires additional
research.
Innovative strategies using state-of-the art technology may be helpful in
overcoming barriers to care and access to information that confronts people
with special needs and their caregivers. The application of technology such
as telehealth and telemedicine in oral health care has the potential for
increasing health literacy and information transfer, implementing tailored
interventions, assessing health and monitoring compliance with
recommendations for with oral health care. Development of novel approaches
and adaptation of existing technology for the oral health care of people with
special needs are needed. The development of assistive devices for the oral
health care of special needs populations with disabilities has received
little attention. The use of interdisciplinary health care provider and
caregiver teams warrants exploration.
Listed below are examples of studies that would be responsive to this program
announcement. These are only illustrative examples and are not listed in
priority order. Applicants are encouraged to propose other topics consistent
with the goals of this program announcement to address the oral, dental and
craniofacial health of elders and other special needs populations. Applicants
are encouraged to consider nesting oral health projects in ongoing, funded
observational studies of community-dwelling and institutionalized
populations.
o Documentation of the prevalence, incidence and determinants of oral, dental
and craniofacial diseases and conditions in special populations where
insufficient information is available.
o Documentation of the impact of oral, dental and craniofacial health on the
quality of life across multiple domains such as comfort and well-being,
function (eating, chewing, food selection), social and personal interaction
(talking, smiling, communicating), and self-image.
o Documentation of the impact of oral health-related quality of life on
general health.
o Development and testing of strategies to improve oral health-related quality
of life and its impact on general health.
o Identification and testing of innovative strategies to improve oral health
that are self- or caregiver provided across the spectrum of physical and
cognitive conditions of people with special needs.
o Exploration of innovative approaches to improve or maintain oral health and
quality of life of people with needs by increasing the ability and
willingness of health care professionals and other caregivers to provide oral
care.
o Exploration of innovative health promotion approaches (social, educational,
legal, fiscal) to address environmental, behavioral and biological
determinants of oral health and oral health-related quality of life.
o Identification of strategies to improve dissemination and implementation of
research findings to people with special needs, their caregivers, and health
care professionals.
o Exploration of innovative and appropriate technology to diagnose and prevent
disease and improve or maintain oral health and quality of life of people
with special needs.
o Exploration of physical and psychosocial factors that influence perceptions
of oral health and care needs of people with special needs and their
caregivers.
o Development and testing assistive devices for use by people with
disabilities or their caregivers.
o Development and testing novel approaches to prevent or mitigate the effects
of medications, treatments or feeding practices on oral health including
dental caries, xerostomia, mucositis, and periodontal disease.
o Identification and testing of novel use of technology to improve
dissemination of oral health information, compliance with recommendations for
oral health care, oral health literacy, and oral health.
o Assessment of the degree to which oral health practices or decision making
practices regarding oral health are similar to other health practices or
economic decisions in older individuals, and/or the degree to which practices
and decisions are related to such changing cognitive functions in old age as
memory, executive function (ability to plan and carry out behavior), or
emotion.
Investigators are encouraged to form multidisciplinary research teams to
address the prevention and treatment of oral, dental and craniofacial
diseases and conditions and to address the improvement in quality of life for
people with special needs. People with special needs or their advocates
should be included in all phases of the research whenever possible. Social
science, behavioral, and other patient-oriented research with outcome
assessments may be conducted within the scope of this PA. Investigators
interested in conducting developmental research in preparation for R01 level
research are referred to Request for Applications number DE-04-009 NIDCR
Exploratory and Developmental Grants in Clinical Research at
http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-04-009.html.
Applications for clinical trials will NOT be accepted under this Program
Announcement. If an investigator wishes to propose a clinical trial in oral
health of special needs and older populations, she/he must follow the NIDCR’s
guidelines for submitting a clinical trial that are found at
http://www.nidr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp.
MECHANISM(S) OF SUPPORT
This PA will use the NIH R01 award mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project. This PA uses just-in-time concepts. It also uses the modular
budgeting as well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular budget format. 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity 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 oral health disparities research related to
elders and other special needs populations to:
Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS-43J
Bethesda, MD 20892-6401
Telephone: (301) 594-5394
FAX: (301) 480-8322
Email: Ruth.Nowjack-Raymer@nih.gov
o Direct your questions about behavioral, social science, or health services
research issues to:
Pat Bryant, PhD
Director, Behavioral Research Program
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS-43A
Bethesda, MD 20892-6401
Telephone: (301) 594-2095
FAX: (301) 480-8319
Email: Patricia.Bryant@nih.gov
o Direct your questions about epidemiology research issues to:
Maria Teresa Canto DDS, MPH
Director, Population Sciences Research Program
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS-43B
Bethesda, MD 20892-6401
Telephone: (301)594-2095
FAX: (301)480-8322
Email: Maria.Canto@nih.gov
o For questions related to cognitive changes and aging, or decision making
and dental health planning in older individuals contact:
Jeffrey Elias, PhD
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Email: eliasj@nia.nih.gov
o Direct your questions about financial or grants management matters to:
Mary Daley
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44B
Bethesda, Maryland 20892-6402
Telephone: (301) 594-4808
FAX: (301) 594-3562
Email: daleym@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting $500,000 or more in direct costs for any year must
carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 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 an 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 evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
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?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
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 criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting $500,000 or more in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. 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 and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
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
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.
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.
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: 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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
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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