EPIDEMIOLOGICAL AND BEHAVIORAL RESEARCH IN ORAL HEALTH

RELEASE DATE:  November 14, 2003

PA NUMBER:  PA-04-022

The R01 portion of this funding opportunity has been replaced by PA-07-169,
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/)
 
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 (Oral Diseases and 
Disorders)

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 Special Requirements
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 PA seeks to stimulate epidemiological and behavioral research to improve 
oral health or increase the understanding of the determinants of oral health.  
This initiative addresses specific research opportunities identified in the 
NIDCR Strategic Plan (http://www.nidcr.nih.gov/about/strat-plan/) issued in 
2003 and in NIDCR’s Plan to Eliminate Oral Health Disparities 
(http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf. Such research 
projects will contribute to the Institute’s clinical research programs by 
providing a clearer understanding of behavioral and environmental factors 
influencing oral health, oral health care, and the prevention, diagnosis, and 
treatment of specific oral diseases/conditions. 

RESEARCH OBJECTIVES

Background: 

Oral, dental, and craniofacial diseases are among the most common health 
problems affecting individuals in the US (Oral Health in American: A Report 
of the Surgeon General, 2001). The prevalence of most oral diseases is 
influenced by biological, behavioral, and environmental factors.  Such 
factors include, for example, diet, personal self care behavior, tobacco and 
alcohol use, environmental influences such as the availability of fluoridated 
community water, access and motivation to seek preventive and therapeutic 
professional oral health care, health care providers’ decisions and practice 
behaviors, genetic influences, bacterial exposures, and immunological status. 
A better understanding of risk factors for oral diseases, and of the 
behavioral and environmental influences on oral health and dental treatment 
outcomes is needed. 

Over the past three decades, oral health in the US overall has improved. 
Among most age groups, the average number of teeth per person affected by 
dental caries has decreased and more US adults are keeping their natural 
teeth. Nevertheless, as noted in Oral Health In America: A Report of the 
Surgeon General and in the recent NIDCR Strategic Plan, profound differences 
in the prevalence of oral diseases persist.   

Dental caries and the periodontal diseases are very prevalent in the US. Both 
are caused by bacteria in dental plaque (biofilm) and are influenced by 
environmental, genetic and behavioral factors. While the prevalence of dental 
caries has declined in the past three decades, it remains the most common 
chronic childhood disease in the U.S. By age 17, more than 80 percent of U.S. 
adolescents are affected by this disease. The poor and uninsured, the very 
young and the elderly, and those with compromising medical conditions or 
disabilities are at increased risk for dental caries. The periodontal 
diseases range from mild forms of gingivitis to severe forms of periodontitis 
that results in tooth loss.  Almost half of US adults age 35 to 44 have 
gingivitis, a reversible inflammation of the gingiva. Approximately one-
fourth has periodontitis with clinical attachment loss of at least 4 
millimeters.  Severe periodontal disease (6 millimeters or more of clinical 
attachment loss) affects 14 percent of adults ages 45 to 54, and 23 percent 
of 65- to 74-years old. Tobacco use is a major risk factor for the 
development and progression of periodontal diseases.  Diabetes, particularly 
if poorly controlled, increases the risk for periodontal disease.  

Sjögren’s syndrome is an autoimmune condition involving the salivary glands. 
It affects between 1 and 4 million Americans, mostly middle age women. 
Individuals with cystic fibrosis are also at high risk for salivary gland 
dysfunction, as are the estimated 40,000 people per year who lose salivary 
gland function as a result of radiation treatment for head and neck cancer.  
Individuals lacking adequate saliva commonly experience rampant tooth decay, 
mucosal infections such as candidiasis, loss of taste, and oral discomfort. 

Acute or chronic dental or craniofacial pain afflicts approximately ten per 
cent of the adult population. Sources of orofacial pain include caries, 
periodontal diseases, and neuropathic and musculoskeletal conditions.  
Orofacial pain is a major symptom of temporomandibular muscle and joint 
disorders (TMJD), currently estimated to affect at least ten million people 
in the United States.    

Craniofacial anomalies are among the most common of all birth defects. Cleft 
lip and cleft palate occur in about 1 to 2 out of 1,000 births in the United 
States.  Many other rarer disorders, such as the ectodermal dysplasias, 
Treacher Collins syndrome, Apert’s syndrome, and Waardenburg syndrome include 
oral and craniofacial manifestations and share with cleft lip/palate the 
potential for producing significant functional, esthetic and social 
consequences across the entire life span. In addition, oral facial injuries 
can lead to serious disfigurement or problems with speech or chewing. Oral 
and craniofacial injuries occur throughout life and can result from a variety 
of causes such as athletic activities, failure to use appropriate protective 
equipment, interpersonal violence, falls, and vehicular accidents. To date, 
only limited research has addressed the epidemiology, prevention, and 
behavioral concomitants of craniofacial injuries.

Numerous studies indicate that poorer individuals in the US are significantly 
more likely to have fewer diagnostic and preventive dental visits compared 
with persons with more economic resources. Minorities, the elderly, and 
children on Medicaid and other low-income children have fewer preventive 
dental visits. A lack of preventive care is correlated with poorer oral 
health. For example, more than a third (36.8 percent) of poor children aged 2 
to 10 were found to have untreated decayed teeth compared to 17.3 per cent of 
nonpoor US children. Rural residents are less likely to receive preventive 
dental care than their urban counterparts. Predisposing and enabling factors 
(e.g., attitudes, health literacy, access to insurance) are strongly 
predictive of use of dental services. For many medical conditions, 
individuals who are sick are more likely to seek and receive medical care 
than are those who are healthy. In contrast, people who have the most dental 
needs often are the same people who seek or receive the least dental care.  
Studies are needed to identify determinants of seeking dental care and 
elucidate processes through which appropriate preventive oral health care can 
be encouraged among all people.  

NIDCR’s Strategic Plan

The NIDCR’s Strategic Plan supports studies that expand and enhance the 
integration of population-based, genetic, social, and behavioral research.
  
Specific research activities highlighted in the Strategic Plan and relevant 
to this PA include but are not limited to:

o Further the understanding of how genetic, behavioral and environmental 
factors interact to contribute to disease susceptibility or resistance;

o Assess and bridge gaps in the knowledge, opinions, and practices of the 
public, educators, and health care professionals about oral diseases and 
their prevention;   

o Identify risk factors and markers for the progression of disease to oral, 
dental and craniofacial diseases and disorders;  

o Improve oral health literacy;

o Develop more effective strategies to encourage the appropriate and timely 
adoption of research findings into clinical practice.
 
Examples of studies that may be responsive to this program announcement are 
given below. The list is only for illustrative purposes and is not 
exhaustive. Examples are not listed in priority order. Applicants are 
encouraged to propose other topics consistent with the goals of this program 
announcement.

o   Conduct epidemiological studies to clarify the relation between caries in 
the primary dentition and subsequent caries in the permanent dentition;

o   Conduct longitudinal studies on incidence and risk factors for 
diseases/conditions such as coronal and root caries, and periodontal 
diseases, persistent orofacial pain, salivary gland disease, and oral 
conditions associated with diabetes;

o   Conduct case-control studies to assess risk for orofacial pain or 
craniofacial deformities; 

o   Investigate links between biologic, behavioral, environmental, and genetic 
factors associated with the incidence of oral cancer and survival;

o   Assess knowledge, attitudes, and behaviors of the public and health care 
providers as related to the oral effects of tobacco use, prevention of 
craniofacial injury, and between aging and oral disease or compromised oral 
function;

o   Develop and test methods to encourage attitudes and behaviors which support 
oral health and that can be accepted and sustained in community settings;

o   Study determinants of therapeutic adherence; test and develop methods to 
enhance compliance with therapeutic or preventive oral health care 
recommendations and compliance in clinical trials;

o   Develop and assess measures to increase oral health literacy and enhance 
effective transfer of knowledge to consumers regarding effective prevention 
and treatment of oral disease;

o   Conduct studies to assess the relation of oral health literacy and language 
skills to oral health status and/or treatment outcomes;

o   Conduct studies to enhance communication of oral health information and to 
improve oral health outcomes within disadvantaged and underserved 
populations;

o   Conduct epidemiological studies to investigate environmental and behavioral 
factors that contribute to higher prevalence of oral diseases/conditions in 
disadvantaged and underserved populations;

o   Develop and test community-based approaches for reducing oral 
diseases/conditions, such as oral-facial trauma in adolescents or other high 
risk groups;

o   Develop improved methods to assess personal and social outcomes of dental 
care and identify determinants of motivation to seek professional oral health 
care;

o   Determine the incidence and prevalence of oral and craniofacial diseases 
and conditions in disadvantaged, high risk, and underserved populations for 
whom nationally representative data are unavailable.

MECHANISM OF SUPPORT 

This PA will use the NIH R01 award mechanism. However, if a clinical trial is 
proposed under this PA, the U01 award mechanism will be used. 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. 

SPECIAL REQUIREMENTS 

Intervention studies may be conducted within the scope of this PA. NIDCR has 
established special requirements for applications involving research 
conducted through randomized clinical trials as outlined on NIDCR’s home page 
under the section titled Clinical Trials 
(http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp ).  
  
WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

Direct your scientific questions about epidemiology research issues to:

Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43B
Bethesda, MD  20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov

Direct your scientific questions about behavioral, social science, or health 
services research issues to:

Patricia S. Bryant, PhD
Director, Behavioral and Social Science Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43A
Bethesda, MD  20892-6401
Telephone:(301) 594-2095
Fax: (301) 480-8319
E-mail: patricia.bryant@nih.gov

o Direct your scientific questions about oral health disparities research 
issues to:

Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43J
Bethesda, MD  20892-6401
Telephone:(301) 594-5394
Fax: (301) 480-8319
E-mail: ruth.nowjack-raymer@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 4AN44B
Bethesda, MD  20892-6402
Telephone: (301) 594-4808
FAX: 301-480-3562
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 tilte 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 marked.

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

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).  

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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