NIDCR Exploratory and Developmental Grants in Clinical Research

PA Number: PAR-05-020

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates

Release Date: November 23, 2004
Application Receipt Dates(s): Standard receipt dates for applications, see: http://grants.nih.gov/grants/funding/submissionschedule.htm .
Peer Review Date(s): Standard review dates for applications, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s) : Standard Council dates, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Earliest Anticipated Start Date: Standard award dates, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Expiration Date for R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R21 AIDS and AIDS-Related Applications: May 2, 2006

Due Dates for E.O. 12372
Not Applicable

Executive Summary

Description - The goal of this announcement is to broadly encourage developmental, exploratory, or pilot clinical research to: 1) document oral conditions and risk factors for oral and craniofacial diseases and disorders, 2) investigate new methods of diagnosing oral disease, 3) address behavioral and health promotion topics relevant to oral health, dental care or oral health promotion, and/or 4) identify promising culturally appropriate approaches to prevent and reduce oral health disparities.

Total amount to be awarded – The NIDCR does not have set aside funds for this PA.

The anticipated number of awards – Number of awards are dependent on the scientific merit of the applications received.

Type of mechanism – R21

Eligible organizations include:

Number of applications each applicant may submit The NIH will accept as many "different" applications as the applicant organization chooses to submit. However, NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

The PHS 398 application instructions are 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.

Telecommunications for the hearing impaired: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Nature of the research opportunity - This PA provides funds for exploratory, developmental, or pilot clinical research that can help to expand the scope of the NIDCR's clinical research portfolio and its potential impact on oral health in the U.S. Some relevant aims for exploratory studies include: 1) documenting the prevalence, incidence, and risk factors for oral and craniofacial diseases and disorders, 2) investigating new methods for diagnosing oral disease, 3) examining determinants of behaviors that influence oral health or treatment outcomes and identifying approaches to increase behaviors supporting oral health, 4) identifying culturally appropriate preventive and treatment for reducing oral health disparities, and 5) stimulating research directed at improving the oral health of special needs populations, including those with developmental or acquired physical or mental disabilities, people with mental retardation, people living with HIV/AIDS, and frail or functionally dependent elders. Small pilot clinical trials are not appropriate for submission under this PA.

Background - The NIDCR research activities cover a broad range of diseases and conditions affecting the oral, dental and craniofacial structures. Diseases and conditions of interest to NIDCR as well as prominent gaps in knowledge are briefly described below.

Dental caries is one the most prevalent diseases. It can occur at any age after tooth eruption and primary teeth are especially vulnerable. In the U.S., 18% of preschoolers have experienced dental caries. Although the prevalence of dental caries has declined in the past three decades, this oral disease remains the most common chronic disease in the U.S. By age 17, more than 80% of adolescents are affected by dental caries. However, dental caries is not evenly distributed throughout the population. For example, approximately 25% of children 5-17 years of age experience 80% of dental caries. Studies have shown that the people at highest risk for dental caries are least able to seek help: the poor, the very young, the elderly, and those with compromising medical conditions or disabilities.

Like dental caries, periodontal diseases are an infectious disease caused by bacteria in dental plaque. Periodontal diseases range from mild forms such as gingivitis to severe forms that result in loss of periodontal support and tooth loss. Almost half of U.S. adults ages 35 to 44 have gingivitis which is a reversible inflammation of the gingiva. Approximately one-fourth has the more severe condition of periodontitis that results in periodontal attachment loss. Severe periodontal disease (6 millimeters or more of attachment loss) affects 14 percent of adults ages 45 to 54, and 23 percent of people 65 to 74-years of age. Tobacco use is a major risk factor for the development and progression of periodontal diseases. Furthermore, diabetes, particularly if poorly controlled, increases the risk for periodontal disease.

Overall, data on the prevalence and risk factors for infectious diseases such as dental caries and periodontal disease come from national surveys, which report on white Non-Hispanics, Black non-Hispanics and Mexican Americans. Limited data is available on other segments of the population such as other Hispanic subgroups, Asian and Pacific Islanders, Native Americans, other minority populations, and special needs populations. These data are critical to guide the development of effective and appropriate oral preventive and treatment modalities for people in these population groups. In addition, development and testing of new and innovative diagnostic methods for caries and periodontal diseases are needed to promote effective prevention and early intervention.

Individuals without adequate saliva may experience rampant tooth decay, mucosal infections such as candidiasis, loss of taste, and considerable oral discomfort. Salivary gland dysfunction can occur as a result of Sjögren's syndrome that affects between 1 and 4 million mostly middle-aged women. Many medications are associated with salivary dysfunction and over 30,000 individuals who have cystic fibrosis also are at higher risk for salivary gland dysfunction. In addition, each year, an estimated 40,000 people lose salivary gland function as a result of radiation treatment for head and neck cancer. Limited data exist on the epidemiology of salivary gland dysfunction and such data are needed to appropriately design research to prevent and treat this disorder.

A number of chronic and disabling pain conditions have oral, dental, and craniofacial manifestations. Epidemiologic studies suggest that orofacial pain occurs in at least 10% of the adult population. Orofacial pain by itself or as a symptom of untreated oral problems is often a major source of poor quality of life. Sources of orofacial pain include caries, some types of periodontal diseases, and neuropathic and musculoskeletal conditions. Few well-designed studies on the prevalence, etiology and pathogenesis of orofacial pain of non-dental origin are available. In addition, limited data are available on the underlying causes of muscular and joint facial pain that may involve physiological, behavioral or environmental factors.

Numerous hereditary diseases, syndromes, developmental and acquired disorders have oral and craniofacial manifestations with serious functional, esthetic and social consequences. Craniofacial anomalies are among the most common of all birth defects. Birth defects and developmental disorders can be isolated or may be part of complex hereditary diseases or syndromes. Cleft lip and cleft palate occurs in about 1 to 2 out of 1,000 births in the U.S. Diseases of the bones and connective tissue such as Paget's disease and osteogenesis imperfecta, osteoporosis, and scleroderma can have devastating oral and craniofacial effects. Similarly, ulcers and erosive lesions associated with oral and pharyngeal cancer treatment, immune dysfunction, infectious diseases such as herpes simplex, HIV/AIDS, fungal infection, aphthae as well as dermatologic and hematologic diseases may also have serious oral and general health implications. Additional research is needed to identify risk factors associated with these diseases so that effective means of preventing and treating these conditions may be developed and tested in clinical trials.

Oral facial injuries can lead to disfigurement and oral dysfunction. While it is recognized that leading causes of oral and craniofacial injuries are sport, falls and motor vehicle collisions, there has been limited research on the epidemiology, prevention, and behavioral consequences of orofacial injuries or the behavioral factors contributing to successful craniofacial repair outcomes.

The age-adjusted incidence rate of oral cancer for total oral cavity and pharynx was 10.3 per 100,000 people in 1999 and this represents approximately 3% of all cancers in the United States. The overall five-year survival rate is 53%, and it has not changed in the past thirty years. This five-year survival rate represents one of the lowest five-year survival rates of any of the major cancer sites. These low survival rates may be attributed to the fact that these cancers tend to be diagnosed at advanced stages. Moreover, treatment for these malignancies can be extremely disfiguring and often results in severe loss of function including speech impairment and the inability to swallow. Identification of effective means of screening and early cancer diagnosis is an important priority of the NIDCR. For the purpose of this PA, people with special need include 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. Limited data is available that documents that individuals with these special needs are at increased risk for dental and oral diseases. Such data are critical to guide the development of effective and appropriate oral preventive and treatment modalities for people with special needs.

Applicants are encouraged to review the NIDCR Strategic Plan (http://www.nidcr.nih.gov/AboutNIDCR/StrategicPlan/) issued in 2003 and the NIDCR's Plan to Eliminate Oral Health Disparities (http://www.nidcr.nih.gov/NR/rdonlyres/54B65018-D3FE-4459-86DD-AAA0AD51C82B/0/hdplan.pdf).

Examples of exploratory research that would be responsive to this PA include, but are not limited to the following:

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Exploratory/Developmental (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (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 described in the PHS 398 application instructions.

2. Funds Available

The NIDCR has not set-aside funds for this Program Announcement. The number of awards will be dependent on their scientific merit. Applicants may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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.

2. Cost Sharing

Cost sharing is not required. http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
Not Applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are 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.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10) . 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative Requirements Information for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

All instructions for the PHS 398 must be followed, with these exceptions:

Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed. Competing continuation applications for an exploratory/developmental grant will not be accepted.

Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included.

3. Submission Dates

Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.

3.A. Receipt, Review and Anticipated Start Dates

Standard receipt dates for applications, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): Standard review dates for applications, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s) : Standard Council dates based on receipt, see: http://grants.nih.gov/grants/funding/submissionschedule.htm.
Earliest Anticipated Start Date: Standard award see: http://grants.nih.gov/grants/funding/submissionschedule.htm.

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application must be sent to:

H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone 301-594-2904
Fax: 301-480-8303
Email: George.Hausch@nih.gov

3. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH 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 NIH 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 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 eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

The reviewers may assess the reasonableness of the data sharing plan or the rationale for not sharing research data. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information

1. Criteria
Criteria is listed in the sections below.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NIDCR. An appropriate scientific review group convened by NIDCR 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:

3. Merit Review Criteria

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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 for which developmental, exploratory, or pilot research is needed? Will the proposed R-21 research generate concepts, methods, or findings that would inform subsequent research, including but not limited to a full scale (R01) type study?

APPROACH: Does the applicant identify and address gaps that are critical to ensuring advancement in this clinical research area? 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? To what degree will support of the proposed developmental, exploratory or pilot research assist in the advancement of this clinical research area?

INNOVATION: Is it likely that the developmental, exploratory, or pilot project will lead to additional research that employs 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 developmental, exploratory, or pilot research and full-scale study 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 and / or community support?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be applied to ALL applications in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women Plan - for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

Inclusion of Minorities Plan - for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

Inclusion of Children Plan - for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion?

Data and Safety Monitoring Plan – for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB?

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards : Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate?

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy, http://grants.nih.gov/grants/policy/data_sharing.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Award Notices will be sent by e-mail to the Administrative Official i ndicated in item 12 of the PHS 398 Form.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Direct your scientific questions about epidemiology research issues to:

Maria Teresa Canto, DDS, MPH
Division of Clinical Research and Health Promotion
National Institute of Dental & Craniofacial Research
National Institutes of Health
Building 45, Room 4AS-43D
Bethesda, MD 20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
Email: maria.canto@nih.gov

Direct your scientific questions about behavioral research issues to:

Patricia S. Bryant, PhD
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
Building 45, Room 4AS-43A
Bethesda, MD 20892-6401
Telephone:(301) 594-2095
Fax: (301) 480-8319
Email: patricia.bryant@nih.gov

Direct your scientific questions about special needs populations and oral health disparities research issues to:

Ruth Nowjack-Raymer, MPH, PhD
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
Building 45, Room 4AS-43J
Bethesda, MD 20892-6401
Telephone:(301) 594-5394
Fax: (301) 480-8319
Email: ruth.nowjack-raymer@nih.gov

2. Scientific Review Contact:

H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: 301-594-2904
Fax: 301-480-8303
Email: George.Hausch@nih.gov

3. Financial or Grants Management Contacts:

Mary Daley
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
Fax: 301-480-3562
Email: md74u@nih.gov

Section VIII. Other Information

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:
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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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