Part I Overview Information

Department of Health and Human Services

Issuing Organization
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov/)
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute for Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD),(http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)

Title: Understanding and Promoting Health Literacy (R03)

Announcement Type
This is a reissue of PAR-04-117, which was previously released June 22, 2004.

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

• October 27, 2006 (PAR-07-019) - This PA has been reissued as PAR-07-019.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).

2) Applicants must complete a verification step in the eRA Commons within two (2) business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number: PAR-06-132

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.121, 93.242, 93.279, 93.286, 93.393, 93.847, 93.865, 93.866, 93.879

Key Dates
Release/Posted Date: March 2, 2006
Opening Date: May 2, 2006 (Earliest date and application may be submitted to Grants.gov)
Letters of Intent Receipt Date: September 13, 2006
Application Submission Date: October 13, 2006
Peer Review Date(s): February March 2007
Council Review Date(s): May-June 2007
Earliest Anticipated Start Date: July 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: October 14, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The ultimate goal of this funding opportunity announcement (FOA) is to encourage the development of empirical research on health literacy concepts and theory as these relate to the NIH public health goal of improving health outcomes for persons with medical and behavioral disorders and conditions.

• This FOA will use the NIH Small Research Grant (R03) award mechanism and runs in parallel with a FOA of identical scientific scope, PAR-04-116, that utilizes the Research Project Grant (R01) mechanism. Note that while the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Deafness and Other Communication Disorders (NIDCD) are participating in PAR-04-117, these NIH Institutes are not participating in this announcement soliciting applications utilizing the R03 mechanism.
• The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.
• The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources.
• Project period and award levels: A project period of up to two years and a budget for direct costs of up to $50,000 per year for a maximum of $100,000 direct costs over a two-year project period may be requested for the R03 mechanism.
• The total amount awarded and the number of awards will depend upon the quality and the number of applications received. Funding decisions will reflect the needs, priorities and mission of the funding Institutes/Centers (ICs).
• Eligible organizations: For-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State government; units of Local government; eligible agencies of the Federal government; foreign Institutions; domestic Institutions; faith-based or community-based organizations; units of State Tribal government; and units of Local Tribal government
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions 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.
• Applicants may submit more than one application, provided each application is scientifically distinct.
• See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at the following Web sites:
• http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (MS Word) and
• http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf (PDF)
• For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Telecommunications for the hearing impaired is available at: 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 of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. 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

Background

Health literacy is a complex phenomenon that involves individuals, families, communities and systems. For instance, consumers, patients, caregivers, or other laypersons may vary with respect to:

• Access (e.g., to audience-appropriate information, media or professionals);
• Skills (e.g., to gather and comprehend health information; to speak and share personal information about health history and symptoms; to act on information by initiating appropriate follow-up visits and conveying understanding back to the information source; to make decisions about basic healthy behaviors, such as healthy eating and exercise; to engage in self-care and chronic disease management);Knowledge (e.g., of health and medical vocabulary, concepts such as risk , the organization and functioning of healthcare systems);
• Disabilities (e.g., sensory, communication, cognitive or physical challenges or limitations);
• The features of their health care providers and the public health systems in which these providers practice (e.g., the communication skills of health professionals, platforms employed for patient education, built environments and signage);
• Other important characteristics including developmental or life stage, cultural, linguistic or educational differences that affect health beliefs, knowledge and communication.

Too often people with the greatest health burdens have limited access to relevant health information. In part, this is due to the complex and cumbersome ways health information often is presented, and due to individuals limited abilities to fully interpret and understand complex health terminology and instructions, and to make personal decisions related to risk avoidance or risk reduction strategies. For instance, to follow health care instructions, patients need to be able to comprehend written and oral prescription instructions, directions for self-care, and plans for follow-up tests and appointments. In addition, health care providers may not communicate effectively with individuals with limited levels of literacy. For instance, achieving informed consent for treatment is difficult when health care personnel cannot explain biological processes or treatment procedures in simplified language and patients cannot interpret health information. These situations hamper the effectiveness of health professionals efforts to prevent, diagnose and treat medical conditions, and limit many health care consumers abilities to make important health care decisions.

Low health literacy is a wide spread problem, affecting more than 90 million adults in the United States (Kirsch, Jungeblut, Jenkins & Kolstad, 1993). Low health literacy results in patients inadequate engagement in, and benefit from, health care advances as well as medical errors. Low health literacy is likely to be a major contributor of adverse health outcomes (AMA, 1999; Baker, Gazmararian, Williams, Scott, Parker, Green, Ren, & Peel, 2002; Baker, Parker, Williams, & Clark, 1998). Research has linked low or limited health literacy with such adverse outcomes as poorer self-management of chronic diseases, less healthy behaviors, higher rates of hospitalizations, and overall poorer health (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999; Schillinger, Grumbach, Piette, Wang, Osmond, Daher, Palacios, Sullivan, & Bindman, 2002; Williams, Parker, Baker, Pitkin, Coates, & Nurss, 1995).

Specific Objectives

This Funding Opportunity Announcement (FOA) invites applications to develop research on health literacy in general areas that include, but are not limited to, the following:

• Modeling and measuring the nature and scope of health literacy;
• Variation in health literacy over the life course or among native and non-native speakers of English;
• Mediators and moderators of low health literacy;
• The impact of low health literacy on health outcomes, diseases, behaviors and treatments, including the contribution of health literacy to informed decision-making, adherence to preventative or therapeutic regimens, utilization of health care services, risk avoidance strategies, and other consumer health-care related actions;
• The identification of effective preventive and other interventions to improve health literacy among populations and to enable the healthcare and public health systems to communicate effectively across different health literacy levels; and
• The development of effective methods and new technologies in health literacy research.
• Applications should be relevant to both the objectives of the FOA and to at least one of the participating Institute’s general research interests. Prior to preparing an application, researchers are strongly encouraged to both review the general research interests of the participating institutes, and to contact program staff of the relevant institutes to discuss the proposed research.

1. Nature and Scope

• Assess the prevalence and causes of low health literacy;
• Identify the nature of the mix of abilities and skills required to be functionally health literate (e.g., including media and health care system navigation skills, etc.), and the roles of basic literacy (i.e., reading, writing, speaking, listening, visual interpretation skills) and mathematics abilities (e.g., graphical interpretation and other quantitative skills) in health literacy.
• Explore the magnitude and variation, by socioeconomic and/or other group characteristics, in accessing, seeking, evaluating, interpreting, and using health information from a variety of sources.
• Examine the problems and factors involved in the presentation and interpretation of quantitative information (e.g., graphic interpretation, risk or probability statistics, the influence of information context and information formats, etc.) from either the provider or user perspective, or investigate how specific health referents, such as basic genetics and/or environmental risk concepts, are best understood and conveyed.
• Create a conceptual model of health literacy or the skill sets that influence the comprehension of relevant health information (e.g., visual information comprehension skills that permit understanding of such visual messages as color-coding, representation of risk, or disease processes).
• Evaluate the different strategies and channels available, including the role of information technologies, that enable consumers to seek, access, and interpret relevant health information effectively, and how these may differ by cultural and health literacy backgrounds (e.g., research on the information seeking or service utilization characteristics among health consumers with different levels of health literacy).

2. Lifespan and Cultural Differences

Applications addressing health literacy as an age-differentiated phenomenon might explore the developmental precursors of low health literacy and the age-related changes in reading and other cognitive skills throughout the life course that may contribute to these difficulties. Research might include, but is not limited to:

• Identify the reading and oral language comprehension skills crucial for the satisfactory acquisition and understanding of basic health information by children, adolescents, and adults of various ages.
• Determining how intuitive or everyday notions of germs, contagion, environmental exposures, disease, drugs, bodily processes and other health-related concepts influence health literacy and consequent illness-prevention behaviors across the life-course, and identifying age-appropriate intervention techniques that can be used to mitigate these problems.
• Examine the role of social and cultural factors in the development of health literacy. For example, how do children acquire health-related knowledge (e.g., through the media, family socialization) as they age, especially those children in households where their parents speak limited English and the children serve as interpreters?
• Explore how the quantity and quality of structured interactions with adult caregivers affects the health literacy of the child from birth to age three.
• Examine the effect of current age-related differences in media use (e.g., children versus elderly) on health literacy.

3. Mediators and Moderators of Health Literacy: Protective and Risk Factors

• Describe how patients information seeking abilities and health information interpretation mediates or moderates the effects of provider practices on health literacy.
• Examine bi-directional communication processes between providers and patients/clients in the health care/health promotion system that affect health literacy, including systemic and cultural barriers that help create and sustain health literacy problems, as well as adaptation strategies used by providers and consumers to minimize health literacy problems. How does patients use of print and electronic health information mediate or moderate their communication with providers?
• Examine how physicians or dentists nonverbal communication influences patients comprehension and implementation of health-related information.
• Examine the influence of social, contextual, and environmental factors (e.g., urban versus rural, housing types, workplace features, social support and social network members, etc.) on health literacy outcomes.
• Examine the media (including TV, radio, movies, newspapers, the Internet, and interactive systems) as a socializing agent of health literacy. For example, determine how newspaper articles, TV drug advertising, soap operas, and medical dramas affect health literacy. How can different media be used to communicate more effectively with consumers varying in health literacy levels?
• Examine the factors that influence the desire for, or processing of, health literacy information. For example, how does self-efficacy in decision making and/or financial planning, time perspectives as presented in socio-emotional selectivity theory, ease of cognitive access via intuitive and reasoning processes, and coping and anxiety reduction behaviors influence the use of, or desire to access, health-care knowledge?

4. Impacts and Consequences of Low Health Literacy

• Examine the relationship between health literacy and health disparities.
• Analyze the role of health literacy in the prevention and treatment of chronic diseases.
• Identify the relationship between health literacy variation and the ability to engage in informed decision making for a variety of health issues, such as chronic disease management or participation in clinical trials.
• Evaluate the magnitude of the problems caused by low levels of health literacy, or by professionals lack of effective communication skills for adapting to the communication needs of consumers with differing levels of literacy.
• Assess the role of health literacy as a mediator or moderator of health-care access across adulthood.

5. Preventative Interventions: Education and Training

• Explore the role of K-12 education systems in increasing levels of health literacy and improving health communication skills. For example, researchers might examine the treatment of health literacy in K-12 health education and biology or general science classes, and assess the effectiveness of such coursework, curricula, and pedagogy on improving health literacy among school-age children, or evaluate the effectiveness of arts-based interventions on children s development of health literacy.
• Assess the role of K-12 education (e.g., in basic literacy skills such as reading, writing, comprehension, speaking, and listening skills, or in mathematics) on health literacy.
• Determine the specific content and components of undergraduate, graduate and in-service training experiences needed to adequately prepare provider groups (e.g., pharmacists, social workers, nurses, dentists, etc.) in communications with low literate patient populations (e.g., assess cultural competence’s effect on provider communication skills, or assess training innovative approaches that allow providers to help patients deal with shame over low health literacy and facilitate negotiating the modern health care system). Examine policies that support the development, implementation and effectiveness of such training experiences. Evaluate the roles of information technology in training to improve health literacy.

6. Other Health Literacy Interventions

• Evaluate the effectiveness of health literacy interventions directed at the general public, different audience segments, patients, providers, or the health care or public health systems. For instance, how can health care systems be designed to better support the information needs of consumers with different levels of health literacy? How effective are interventions within the healthcare system that are designed to increase the access of intended audiences to relevant health information and appropriate materials (e.g., print or audiovisual materials, Internet-based information, translators, library information resources and services, and patient advocates)?
• Examine the development and dissemination of effective information sources and materials for audiences with different levels of health literacy (e.g., how should prevention campaigns be designed to effectively communicate with audiences with differing levels of health literacy?).
• Design and evaluate health literacy diagnostic and/or communication tools to help health care professionals identify, and communicate more effectively with, consumers with different levels of health literacy. For instance, develop and pilot tools and/or strategies to help make complex quantitative health information more understandable (e.g., technology tools for automatically converting health information to a variety of appropriate levels).
• Identify innovative strategies, practices and policies currently in use that can be disseminated immediately to promote health literacy across the various participants in the health care systems.
• Conduct cost/effectiveness analyses of various health literacy interventions.
• Further multi-level health literacy intervention approaches, for instance, by developing paradigms and/or statistical models to test the interaction of such variables as knowledge, prior education, cognitive status, social support, community influence, technology, and health-care access on health-care decisions.

7. Methodology and Research Technology Development

• Assess the efficacy of current methods of health literacy assessment; develop, as needed, audience-appropriate methodologies to understand the prevalence of low health literacy in different populations, the interaction of low health literacy with other demographic and social factors, and the contribution of low health literacy to healthcare costs and health outcomes.
• Identify effective approaches of combining qualitative and quantitative methods to further knowledge of health literacy.
• Identify a core set of constructs, variables, and quantitative measures for conducting health literacy research.
• Develop and pilot new tools and technologies to identify health literacy barriers (e.g., an assessment to distinguish, among persons with low literacy skills, those who have learning disabilities or communication disorders such as auditory processing, aphasia, or hearing loss).
• In the context of understanding and promoting health literacy: develop technologies related to data reduction, data mining, and knowledge extraction; develop tools for meta-databases and integrative services to enhance the utility of existing databases; develop new methods or technologies for timely, appropriate communication of pertinent health information and knowledge (e.g., as seen through the creation of telemedicine, or to enhance patient, doctor, or administrator decision-making regarding health literacy, etc.).

Approaches:

A wide variety of research approaches are encouraged under this Program Announcement:

• Basic research that investigates or describes the nature of health literacy and the magnitude of health literacy problems;
• Applied research addressing issues pertinent to health literacy practices (e.g., systems level interventions) and research-in-practice (e.g., active potential end users participate as supportive research partners);
• Applications also may develop theoretical models, refine research constructs, improve methods and measurements, and establish causal relationships (e.g., between low health literacy and lack of effective health promotion);
• Researchers also may address the effectiveness of interventions, or adapt and test existing programs (including those that are not research-based) to reduce low health literacy and its adverse consequences (e.g., interventions implemented by health care systems and systems outside of health care such as systems of public education).

The research must involve either:

• Health literacy, or one of its many components, as a key outcome;
• Health literacy as a key explanatory variable for some other outcome;
• Methodological or technological improvement to strengthen research on health literacy; or
• Health literacy-focused preventions and interventions.

Studies to develop, or evaluate, the readability or utility of specific materials that are intended for single uses or single audiences are not responsive to this program announcement unless these investigations are integral to testing a significant research hypothesis related to health literacy.

Projects may employ any one or combination of study designs, research approaches, and data collection techniques. Secondary analyses of existing datasets as well as meta-analytic studies are also suitable for this announcement. Multilevel, multidisciplinary, and interdisciplinary research is also encouraged, especially studies that incorporate individual, family, community and societal mediators of health literacy in childhood and adulthood, or state-of-the-art health communication theory and knowledge.

Researchers are encouraged to address ongoing investigations of prevention, healthy living, chronic disease management, patient-based health care, cultural competence, and health disparities to inform the research on health literacy. Research questions can focus on consumers, patients, clients or other population groups; the strategies and tactics used by providers of medical and health information/communication to enable them to effectively reach literacy challenged population; or the influences of health literacy upon interactions between consumers, patients, clients, providers, and organizations or systems.

Additional Resources:

Federally Qualified Health Centers (FQHCs) may provide a valuable resource to applicants interested in responding to this PA, particularly those that have an active collaboration with colleges and universities. These FQHCs include Community Health Centers and Migrant Health Centers across the country. Information may be found at the DHHS Health Resources and Services Administration website for the Bureau of Primary Health Care: http://bphc.hrsa.gov/chc/lookalikes.htm.

The Indian Health Service (IHS) through its direct federal programs, Tribal programs and urban programs serves more than 1.6 million American Indian and Alaska Native people. These programs may also be of interest to applicants. Information can be found at the IHS website at: www.ihs.gov

Reference Report:

The Institute of Medicine’s recent report, Health Literacy: A Prescription to End Confusion (2004) reviews the current body of knowledge about health literacy, and identifies actions for the promotion of health literacy in society. Potential applicants are encouraged to consult this report as a general reference:

Health Literacy: A Prescription to End Confusion. (2004). L. Nielsen-Bohlman, A. M. Panzer, and D. A. Kindig, Editors. Committee on Health Literacy, Board on Neuroscience and Behavioral Health, Institute of Medicine. (Available at http://www.iom.edu/report.asp?id=19723)

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Small Research Grant R03 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing he proposed project.

The R03 mechanism should be used for support of pilot and/or feasibility studies for concepts that are sound and justifiable, but not sufficiently developed for the Research Project Grant (R01) mechanism. The R03 mechanism may also be appropriate for projects involving secondary analysis of existing data; small, self-contained research projects; development of research methodology; and the development of new research technology.

A project period of up to two years and a budget for direct costs of up to $50,000 per year for a maximum of $100,000 direct costs over a two-year project period may be requested for the R03 mechanism.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically the PHS398 Modular Budget component).

Competing renewal (formerly competing continuation ) applications will not be accepted. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions") of a previously reviewed R03 grant application may be submitted. See NOT-OD-05-046, April 29, 2005.

An R03 is not renewable.

Submission of an application under this funding opportunity precludes concurrent submission of any other Public Health Service (PHS) application containing substantially the same research proposal. In addition, these R03 awards may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the PHS.

2. Funds Available

Applications received in response to this program announcement will compete for funds in the general funding pool of the participating NIH ICs. No specific funds have been set aside for this announcement.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

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:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Foreign Institutions
• Domestic Institutions
• Faith-based or community-based organizations
• Units of State Tribal government
• Units of Local Tribal government

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her 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 support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Investigators wishing to apply for an R03 grant should be aware that not all NIH Institutes and Centers (ICs) accept investigator-initiated R03 applications and that the different ICs may have specific purposes for which they use this funding mechanism. Therefore, all investigators should consult the R03 website at http://grants.nih.gov/grants/funding/r03.htm as well as the IC staff listed on this Web site to determine if an R03 application is appropriate.

Information related to the use of R03 awards by ICs that do not participate in this FOA is also listed on the R03 Web site. Additional information about special initiatives involving R03 awards can be found by searching the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/index.html#search, by examining IC Web sites, and by consulting with NIH staff. All investigator-initiated small grant R03 applications described in this FOA will be assigned to the ICs according to standard PHS referral guidelines and specific program interests.

Applicants may submit more than one application, provided each application is scientifically distinct. Small grant support may not be used for thesis or dissertation research.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download an Application Package and Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/GetStarted) and
• NIH eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.
• Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify the application.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different from the DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purpose of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the NIH eRA Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R &R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and the SF424 (R&R) Application Guide (MS Word) or PDF) instructions.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.

There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS 398 Modular Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment Form

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5" x 11."
• Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Security Requirements.

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Opening Date: March 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: September 13, 2006
Application Submission Date: October 13, 2006
Peer Review Date(s): February March 2007
Council Review Date(s): May June 2007
Earliest Anticipated Start Date: July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD/PI
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Susan Solomon, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive, Room B2B37, MSC 2027
Bethesda MD 20892-2027
Telephone: 301-496-0979
Fax: 301-402-1150
Email: [email protected]

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the submission date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within two (2) business days of notification of the NIH validation.

Upon receipt applications will be evaluated for completeness by the Center for Scientific Review , NIH. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit 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 an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

• R03 applications will use the modular budget format and Just-in-Time concepts, with direct costs of up to two $25,000 modules, or $50,000 per year, may be requested for up to two years (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).
• Items 2-5 of the PHS398 Research Plan component of the R03 application may not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
• "Introduction (required for a resubmission application) is limited to one page.
• Preliminary data are not required but may be included if available.
• R03 Appendix materials may include graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is contained within the 10-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.
• Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Research Plan

The Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods components of the Research Plan must not exceed 10 pages. All tables, graphs, figures, diagrams, and charts must be included with the 10-page limit. Be succinct and remember that there is no requirement to use all 10 pages allotted to the Research Plan.

Please note that a Progress Report is not needed.

For resubmission of an application, an Introduction (not to exceed one page) in addition to the Research Plan is required. This Introduction, which is not included in the ten-page limit, must include responses to the criticisms and issues raised in the summary statement. The changes in the Research Plan must be clearly marked by appropriate bracketing, indenting or changing of typography, unless the changes include most of the text. Changes should be summarized in the Introduction.

Appendix. (New and Resubmission Applications)

The appendix may include graphic images of gels, micrographs, etc. provided that the image (which may be reduced in size) is also included within the 10-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix.

Specific Instructions for Modular Grant applications.

All R03 applications must be submitted in the modular budget format. The modular budget format simplifies the preparation of the budget by limiting the level of budgetary detail. Applicants may request direct costs for two $25,000 modules, up to a total annual direct cost of $50,000 per year, for up to two years ($100,000 maximum, four modules of $25,000 each).

The SF 424 R&R Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc) 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.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs 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:

• 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.
• Receive a written critique.
• Receive a second level of review by the appropriate national advisory council or board.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review.
• Availability of funds.
• Relevance to program priorities.

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In the review of small grant (R03) applications, because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in a typical Research Project (R01) grant application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3. , Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

3. Anticipated Announcement and Award Dates

Although there is no immediate acknowledgement of the receipt of an application, applicants generally are notified of the review and funding assignment within 8 weeks.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

The following Terms and Conditions will be incorporated in the NoA and will be provided to the PD/PI as well as to the appropriate institutional official, at the time of award.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually 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:

Rosaly Correa-de-Araujo, MD, MSc, PhD
Senior Advisor on Women's Health
Agency for Healthcare Research and Quality
John M. Eisenberg Building
540 Gaither Road
Rockville, Maryland 20850
Telephone (301) 427-1550
Fax (301) 427-1562
Email: [email protected]

Sabra F. Woolley, Ph.D.
Program Manager
Health Communication and Informatics Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4078
Bethesda Maryland 20892
Telephone: (301) 435-4589
Fax: (301) 480-2087
Email: [email protected]

Jeffrey W. Elias, Ph.D.
Health Scientist Administrator
Chief, Cognitive Aging
Behavioral and Social Research Program (BSR)
National Institute on Aging/National Institutes of Health
7201 Wisconsin Ave. #533
Bethesda, Md. 20892-9205
Telephone: (301) 402-4156
Email: [email protected]

Grace C.Y. Peng, Ph.D.
Program Director
Division of Discovery Science & Technology
National Institute of Biomedical Imaging & Bioengineering
6707 Democracy Blvd., Suite 200, MSC 5469
Bethesda, MD 20892
Telephone: 301-451-4778
Fax: 301-480-1614
Email: [email protected]

Daniel B. Berch, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B05
Bethesda, MD 20892-7510
Telephone: (301) 402-0699
Fax: (301) 480-0230
Email: [email protected]

Patricia S. Bryant, Ph.D.
Division of Clinical Research
National Institute of Dental and Craniofacial Research
Bldg. 45 Rm. 4AS-43A
Bethesda, MD 20892-6401
Telephone: (301) 594-2095
Fax: (301) 480-8322
Email: [email protected]
(Note: Appropriate NIDCR contact if application emphasizes behavioral or social science methods and issues)

Ruth Nowjack-Raymer, MPH, PhD
Clinical Research Branch
National Institute of Dental and Craniofacial Research
Bldg. 45 Rm. 4AS-43J
Bethesda, MD 20892-6401
Telephone: 301-594-5394
Fax: 301-480-8322
Email: [email protected]
(Note: Appropriate NIDCR contact if application emphasizes health disparities)

Dr. Sanford Garfield
Biometry and Behavioral Research Program
Division of Diabetes, Endocrinology, and Metabolic Diseases (DDEMD)
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 685
6707 Democracy Blvd
Bethesda, MD 20892-5460
Telephone: 301-594-8803
Email: [email protected]

Elizabeth Ginexi, Ph.D.
Health Scientist Administrator
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research (DESPR)
National Institute on Drug Abuse
6001 Executive Blvd, Room 5185
Rockville, MD 20892
Telephone: (301) 402-1755
Email: [email protected]

Kimberly Gray, Ph.D.
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
MD EC-21
111 Alexander Drive
P.O. Box 12233
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-0293
Fax: (919) 316-4606
Email: [email protected]

David Stoff, Ph.D.
Chief, HIV & Mentally Ill Program
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Blvd.
Room 6210 MSC 9619
Bethesda, MD 20892-9619
Telephone: (301)443-4625
Email: [email protected]
(Note: Appropriate NIMH contact for applicants interested in promoting health literacy about the causes, risk for, and diagnosis of mental disorders or in health literacy about HIV/AIDS.)

Carmen P. Moten, M.P.H., Ph.D.
Chief, Primary Care in Mental Health Services Research Program
Chief, Disparities in Mental Health Services Research Program
Division of Services and Intervention Research
National Institute of Mental Health
Neuroscience Center, Room 7130
6001 Executive Boulevard, MSC 9631
Bethesda, Maryland 20892-9631
Telephone: (301) 443-3364
Fax: (301)443-4045
Email: [email protected]
(Note: Appropriate NIMH contact for applicants interested in promoting health literacy in the context of mental health services.)

Dr. Hua-Chuan Sim
NLM Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 594.4882
Fax: (301) 402-2952
Email: [email protected]

Susan Solomon, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive Rm. B2B37, MSC 2027
Bethesda MD 20892-2027
Telephone: (301) 496-0979
Fax: (301) 402-1150
E-mail: [email protected]

2. Peer Review Contacts:

Michael Micklin, Ph.D.
Chief
Risk, Prevention, and Health Behavior Integrated Review Group
SRA for SPIP Study Section
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3136 MSC 7759
Bethesda, MD 20892-7759 (20817 for overnight mail)
Telephone: (301) 435-1258
Fax: (301) 594-6363
Email: [email protected]

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Building EPS, Room 243
Rockville, MD 20852
Telephone: (301) 496-8634
Fax: (301) 496-8601
Email: [email protected]

Angelos Bacas
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07F, MSC 7510
Bethesda, Maryland 20892-7510
Telephone: (301) 435-6976
Fax: (301) 480-4783
Email: [email protected]

Mr. Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115
Bethesda, MD 20892
Telephone: (301) 443-0004
Fax: (301) 443-0219
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 and 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.

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 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 funding opportunity 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.

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://grants.nih.gov/grants/policy/model_organism/index.htm). 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/grants/policy/nihgps_2003/index.htm). Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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 (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 (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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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 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.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance 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 Part 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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices

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