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The R01 portion of this funding opportunity has been replaced by PA-07-151,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/archive/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) 435-0714, 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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Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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