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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov)
Office of Research on Women’s Health (ORWH), (http://www4.od.nih.gov/orwh/)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.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 Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)

Title: Community Participation In Research (R21)

Announcement Type
This is a modification of PAR-05-026 which was previously released December 2, 2004.

NOTE: For the May 17, 2006 receipt date, applicants for both R01 and R21 grants must use PAR-05-026. which requires submission of applications using PHS 398 and the paper format. This PAR is effective only for the May 17, 2007 receipt date.

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 SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines provided 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 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-06-247

Catalog of Federal Domestic Assistance Number(s)
93.393 (NCI), 93.837 (NHLBI), 93.865 (NICHD), 93.121 (NIDCR), 93.113 (NIEHS), 93.361 (NINR), 93.226 (AHRQ), 93.262 (NIOSH), 93.273 (NIAAA), 93.242 (NIMH), 93.173 (NIDCD), 93.837, 93.838, 93.839 (NHLBI), 93.279 (NIDA)

Key Dates
Release/Posted Date: March 17, 2006
Opening Date: March 17, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 17, 2007
Application Submission Date(s): May 17, 2007
Peer Review Date(s): October-November, 2007
Council Review Date(s): January-February, 2008
Earliest Anticipated Start Date: April 2008
Expiration Date: May 18, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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

The goal of this FOA is to support research on health promotion, disease prevention, and health disparities that is jointly conducted by communities and researchers. This FOA invites NIH exploratory/developmental grant (R21) award mechanisms.

Community-based participatory research (CBPR) is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions - communication of results). CBPR is characterized by substantial community input in the development of the grant application (http://www.niehs.nih.gov/translat/cbpr/cbpr.htm).

Community-partnered approaches to research promise to deepen our scientific base of knowledge in the areas of health promotion, disease prevention, and health disparities. Community-partnered research processes offer the potential to generate better-informed hypotheses, develop more effective interventions, and enhance the translation of the research results into practice. Specifically, involving community and academic partners as research collaborators may improve the quality and impact of research by:

For the purpose of this FOA, community refers to populations that may be defined by: geography; race; ethnicity; gender; sexual orientation; disability, illness, or other health condition; or to groups that have a common interest or cause, such as health or service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with public health concerns. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community. While not an exhaustive list, organizations as varied as Tribal governments and colleges, state or local governments, independent living centers, other educational institutions such as junior colleges, advocacy organizations, health delivery organizations (e.g., hospitals), health professional associations, non-governmental organizations, and federally qualified health centers are possible community partners.

Additional Resources

Community Based Participatory Research: Assessing the Evidence (2004) Vishwanathan M, et. al., (ed.) Agency for Healthcare Research and Quality: Rockville, MD

Community Based Participatory Research for Health (2003) Minkler M, Wallerstein N (ed.). Jossey Bass: San Francisco, CA

Successful Models of Community Based Participatory Research (2000) O Fallon L, Tyson F, Dearry A. (ed.) National Institute of Environmental Health Sciences: Research Triangle Park, NC

Institute of Medicine: Promoting Health Intervention Strategies from Social and Behavioral Research (2000) Smedley BD, Syme, L (ed.) National Academy Press: Washington, DC

RESEARCH OBJECTIVES

Several institutes and offices within NIH, CDC and AHRQ have joined together to support this initiative. Applications should be relevant to both the objectives of the FOA and to at least one of the participating organization’s general research interests. Researchers are strongly encouraged to both review the general research interests of the participating institutes supporting this announcement and to review the examples of topics of interest specific to CBPR (shown below). As additional research areas are welcome, prospective applicants are encouraged to contact the relevant program administrator for this CBPR FOA as listed in the INQUIRES section of this announcement prior to preparing an application.

While not an exhaustive list, CBPR projects focused on the following areas of health promotion, disease prevention and health disparities are encouraged:

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

In accordance with the goals of the New Freedom Initiative, AHRQ is interested in community-based participatory research efforts targeted towards increasing health promotion and prevention of secondary conditions in persons with disabilities through community-partnered evaluation of supports and access, and developing or assessing strategies to improve quality of care and reduce disparities for persons with disabilities.

Persons with disabilities are individuals that have limitations in major life activities. Secondary conditions may be multi-dimensional, and include non-medical events (i.e. isolation); conditions that affect the general population (i.e. obesity); and problems that arise at any time during the lifespan, (i.e. inaccessible examination equipment) (CDC, 2003) Community-based research partnerships with disability advocacy groups offer the opportunity to address the self-identified priorities of persons with disabilities; examine access to services and facilities; develop and test patient-centered approaches; or adapt evidence-based or prevention strategies to meet the needs of persons with disabilities.

Research proposals may include examination of:

NATIONAL CANCER INSTITUTE

DHHS recently announced a trans-HHS report entitled: Making Cancer Health Disparities History (http://www.chdprg.omhrc.gov/). In this report, a broad coalition of scientists, practitioners, community and patient advocates organized by the NCI identified several research themes that would best be addressed through a CBPR model. These include but are not limited to:

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations for the prevention of work related injury and illness. NIOSH provides national leadership to prevent work-related illness and injury through research, education, training, and prevention/intervention. One of the National Occupational Research Agenda (NORA) priorities is Special Populations at Risk. These populations are defined as groups of workers who have (1) biological, social, or economic characteristics that place them at increased risk of developing work-related conditions and (2) inadequate information collected about them in the past. They may be disproportionately exposed to hazards and unusually vulnerable to exposures. And they may have less access to or lower quality of care after acquiring an illness or injury. These special populations include minority workers, female workers, younger and older workers, workers with medical or genetic susceptibility, workers with disabilities, immigrant workers, and migrant and agricultural workers. These populations are often employed in some of the most dangerous occupations including farming, mining, manufacturing, and day labor. Some work-related illnesses identified include silicosis, lead poisoning, musculoskeletal disorders, and pesticide-related illnesses. Many conferences and reviews have contributed to identifying the health and safety research needs of these unique or special populations at risk (National Occupational Research Agenda Update July, 1997; 1998). However, community involvement and contributions in identifying workplace injury and illness concerns has been limited.

In addition, there is an identified need for minority and underrepresented professionals who bring multi-cultural and multi-ethnic experiences to address the research needs of these specific worker populations. The NIOSH is committed to the support of programs designed to increase the number of underrepresented, minority, and female scientists participating in occupational health and safety research. Therefore, applications from under-represented individuals are encouraged to apply.

Types of research that may be proposed include, but are not limited to:

In addition to the preceding areas of emphasis, R21 research projects might be particularly suitable for addressing such issues as the following:

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

NICHD is interested in research projects of child health and development that are community based, community level and/or community participatory. Studies are encouraged that examine:

NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

The U.S. Surgeon General’s Report Oral Health in America acknowledges the consequential disparities in oral health status that exist within vulnerable populations and affects important aspects of quality of life including substantial pain, inability to chew and diminished social interaction. Increasingly oral health is associated with systemic health including low 5- year survival for those with oral and pharyngeal cancer, the relationship between tooth loss and nutritional outcomes, and the bi-directional relationship between periodontal disease and diabetes. Racial and ethnic minorities, the poor, those with acquired or developmental disabilities, the immunocompromised and frail and dependent elders often suffer the worst oral health. The Report is emphatic that to improve quality of life and eliminate oral health disparities health professionals, individuals and communities must work together. The National Institute of Dental and Craniofacial Research’s Plan to Eliminate Craniofacial, Oral and Dental Health Disparities focuses the research community’s attention on oral infectious diseases (Early Childhood Caries, coronal caries, and periodontal diseases) and oral and pharyngeal cancer http://www.nidcr.nih.gov/NR/rdonlyres/54B65018-D3FE-4459-86DD-AAA0AD51C82B/0/hdplan.pdf

Examples of the types of research that would be responsive to this program announcement include but are not limited to:

Proposals involving a clinical trial design will not be considered responsive to this PAR for the NIDCR.

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

To help reduce the burden of environmentally associated diseases and health conditions, NIEHS promotes the use of the CBPR process to: 1) provide the scientific basis for understanding the impact of the environment on human health; 2) translate this information into prevention and intervention strategies; 3) evaluate the efficacy of prevention and intervention strategies; and 4) communicate the results to the public and improve public health. For further information on the CBPR Program at NIEHS, see: http://www.niehs.nih.gov/translat/cbpr/cbpr.htm. There are disproportionate sightings of hazardous waste facilities, landfills and manufacturing/industrial facilities in underserved or vulnerable communities (based on race, ethnicity, gender, immigration status and/or SES). In many of these communities, there are disparate outcomes from exposures based on individual susceptibility that may result in a variety of adverse health outcomes such as birth defects, premature birth, diabetes, cancer, cardiovascular), pulmonary, and auto-immune diseases. NIEHS encourages a broad, comprehensive approach to this problem that emphasizes both education and research. Examples of projects that would be considered responsive to this PAR include but are not limited to the following:

These community-based prevention/intervention research projects should expand our knowledge and understanding of the potential causes and remedies of environmentally related disorders, while at the same time enhancing the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Projects are encouraged to include a comprehensive plan to have an ongoing evaluation from the inception of the project to its completion including but not limited to an assessment of the partnership among various team members and policy and public health impact. It is highly recommended that proposals make recommendations for future activities, beyond the period of current funding, to assure continued participation of community members in research and service programs addressing environmental injustices.

NATIONAL INSTITUTE OF NURSING RESEARCH

The National Institute of Nursing Research (NINR) has a history of encouraging community-partnered research to promote health and to decrease health disparities. NINR’s scientific program areas (http://www.ninr.nih.gov/) include neurofunction and sensory conditions, reproductive health and child health promotion, immune responses (including HIV/AIDS) and oncology, cardiopulmonary health, chronic illness management, and end-of-life care. Developmental and intervention research in any of these areas that clearly incorporate communities as partners would be of interest to NINR. The following are potential examples of research related to this program announcement. These examples are not listed in any priority order and are not to be viewed as exhaustive or all-inclusive.

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in community participation in interventions to reduce heavy drinking and alcohol-related problems and promote healthy lifestyles in communities, especially where health disparities exist. Community- based participatory research has the potential to reduce development of alcohol use disorders, alcohol-related injuries and fatalities and delay or prevent underage drinking and alcohol-related problems such as violence, unplanned pregnancies, sexually transmitted diseases, and alcohol-related medical and psychiatric disorders. These are areas in which the active participation of both communities and researchers may enhance the development of innovative research approaches. Community involvement facilitates the development and testing of interventions in settings that are particularly relevant to health promotion as well as reducing health disparities. Research is also needed on the relative effectiveness and acceptability of different implementation strategies in diverse population groups.

Research is needed to develop and test community-level strategies that reduce alcohol-related problems and their consequences, including person-focused interventions and changes in alcohol policy, regulation, or pricing. Interventions that can be transferred to other communities are especially important. Interventions should be acceptable to communities, feasible in terms of available economic and technical resources, and sustainable over time. Suggested strategies include, but are not limited to:

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Increasing evidence demonstrates the important role of individual and community level behaviors in influencing the course of cardiovascular, lung, and blood diseases. To promote the development of innovative strategies for improving public health, the NHLBI encourages scientific research that includes the community of interest in the determination of the goals, design, implementation, and interpretation of the research. Research is needed not only to develop and evaluate new intervention strategies, but also to test the feasibility and effectiveness of community-based participatory approaches to the research endeavor. Examples of potential research topics that would be responsive to the NHLBI’s interest in this PAR include, but are not limited to, the following:

NATIONAL INSTITUTE OF MENTAL HEALTH

The National Institute of Mental Health (NIMH), http://www.nimh.nih.gov, has a long history of concern and action related to health disparities and racial/ethnic populations as well as other underrepresented groups (i.e., women, children, disabled) for both its mental health and HIV/AIDS research agendas. Disparities research for mental health and HIV/AIDS outcomes takes into consideration relevant complex factors that influence disparities in services, particularly across special population groups, as well as women and children, and persons living in rural and frontier areas. A range of effective preventive interventions that can be transferred to the community must be implemented in view of the burden from unequal access to health care resources, disproportionate impact of comorbid conditions, and marginalization of subpopulations within these communities. Additionally, disparities in services research addresses care delivered in a variety of settings such as the specialty mental health sector, the general medical sector, and community settings (e.g., schools). Also, it supports research that examines innovative services interventions (e.g., community-based participatory methods, faith-based) to overcome disparities related to mental health and HIV service delivery and use.

Some types of research areas that may be proposed include, but are not limited to:

NATIONAL INSTITUTE ON DRUG ABUSE

The National Institute on Drug Abuse (NIDA), http://www.nida.nih.gov/, has a long tradition of involving the community in its efforts to understand, reduce, prevent, and treat drug abuse and its adverse health and social consequences. Involving community partners and collaborators in drug abuse and HIV/AIDS research, for example, has informed NIDA’s efforts to develop and implement culturally appropriate, community-based HIV/AIDS outreach interventions to avert the spread of new HIV infections among drug users, particularly in communities where health disparities exist. When drug abuse prevention and treatment programs are developed with the community’s participation, the community becomes instrumental in their successful implementation and acceptance. Community-based participatory research has contributed to NIDA’s mission to improve the effectiveness of drug abuse prevention and services programs in reaching persons at highest risk.

NIDA is interested in community-based, community level, and/or community participatory research on drug abuse, drug addiction, and drug-use related health and social consequences, and in the development of effective strategies to promote drug-free lifestyles, prevent drug abuse and its consequences, and eliminate health disparities. Studies are encouraged that examine:

NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

The National Institute on Deafness and Other Communication Disorders (NIDCD) supports basic and clinical biomedical and behavioral research in the communication sciences of hearing, balance, smell, taste, voice, speech and language. In April of 2004, the NIDCD sponsored a workshop on Translational Research in Hearing and Balance. Recommendations focusing on emergence into clinical practice included the need to increase dissemination of research evidence (i.e., promote systematic reviews of evidence, identify evidence needs in priority areas), promote the use of participatory research methods (i.e., alignments with advocacy groups), and continue to support research in health communication. The minutes from that workshop are available: (http://www.nidcd.nih.gov/funding/programs/tr/trminutes.asp)

NIDCD participation in this program announcement is an effort to be responsive to the workshop recommendations. NIDCD is interested in research projects in hearing, balance, smell, taste, voice, speech and language that include community participation. Examples of such studies include:

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH exploratory/developmental grant (R21) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The evolution and vitality of biomedical, behavioral and clinical research requires a constant infusion of new ideas, techniques, and points of view. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, techniques, models, tools, agents, targets, methodologies, technologies, and applications that have the potential to substantially advance biomedical, behavioral and clinical research on health-related topics. The R21 mechanism is intended to encourage new, exploratory and developmental research projects by providing support for the early stages of their development (i.e., in extending previous discoveries toward new directions or applications, etc.).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards.

This funding opportunity 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. 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 SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

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. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs.

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. Awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

R21 applications may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two-year period. For example, you may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of your project. Normally, no more than $200,000 may be requested in any single year. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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:

Applications from foreign institutions must conform to the NIH’s policy for foreign grants. See http://grants2.nih.gov/grants/policy/nihgps/part_iii_5.htm.

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 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

The investigators for each research proposal must define the relevant community or communities for their study using a set of tangible and explicit criteria. The criteria can include a common interest, identity, characteristic, or condition. They must also clearly identify who from that community will be included as participants in the research process. It is typically ideal in participatory research for the community in which the study is based to be involved in all or most phases of the research process. In some cases, however, it may not be possible for participants to be involved in all phases, or participants themselves may choose not to be involved in one or more phases. The absolute minimum involvement that can still be considered as participatory research is for participants to be involved at the front end of the study in helping to identify the research questions of most importance to the community, and then also at the back end in helping to interpret and apply the research findings to ensure that they maintain their relevance for the community. The investigators for each proposal must identify in which phases of the research community members are engaged as participants.

Applicants must describe an existing or proposed involvement with one or more community-based organizations. This connection is essential to the development of community-based approaches and should also enhance the potential for long-term impact of the project. It is also essential that all facets of the project design be educationally and culturally appropriate, as well as appropriate to participants ability. Letters of support from each partnering community, that describe the working relationships with the researcher, should be provided.

Required Personnel

Although a single institution or organization must be the applicant, a multi-institutional arrangement (consortium) is possible. Such consortia, entailing active participation by more than one organization, are encouraged if there is clear evidence of close interaction and responsible partnership among the participants.

It is important to note that, because of the wide range of health problems to be addressed and the diversity of affected communities, applications must include at least one of each of the following:

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download a SF424 (R&R) Application Package and SF424 (R&R) 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:

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

2) Organizational/Institutional Registration in the eRA Commons

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

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 than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes 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 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 in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget
PHS398 Modular Budget

Optional Components:

PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH and CDC R21 use ONLY the PHS 398 Modular Budget. AHRQ R21 applicants must use the detailed Research & Related Budget.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date (s): April 17, 2007
Application Submission Date(s): May 17, 2007
Peer Review Date(s): October-November, 2007
Council Review Date(s): January-February, 2008
Earliest Anticipated Start Date: April 2008

3.A.1. Letter of Intent

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

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 at the beginning of this document.

The letter of intent should be sent to:

G. Stephane Philogene, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
31 Center Drive
Building 31, Room B2-B37
Bethesda, MD 20892
Telephone: (301) 402-3902
FAX: (301) 402-1150
E-mail: [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 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 that 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 (http://grants.nih.gov/grants/policy/policy.htm).

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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

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.

Specific Instructions for Modular Grant applications

Applications requesting direct costs in each year of $250,000 or less (excluding consortium F&A costs), must be submitted in a modular budget format using the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically Section 5.4). 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.

Application Characteristics

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

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

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/index.htm and 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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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:

The following will be considered in making funding decisions:

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 principal investigator 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?

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: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent 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?

Period of Support: The appropriateness of the requested period of support in relation to the proposed research.

2.C. Sharing Research Data

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.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.

3. Anticipated Announcement and Award Dates

Not applicable.

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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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:

Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1524
Fax: 301-427-1562
E-mail: [email protected]

Robert C. Freeman, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2073
Bethesda, Maryland 20892-9304
For FedEx use Rockville, MD 20852-1705
Telephone: 301-443-8820
Fax: 301-443-8614
E-mail: [email protected]

Sabra Woolley, Ph.D.
Program, Director, Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4078
Rockville, MD 20852
Telephone: 301-435-4589
Fax: 301-480-2087
E-mail: [email protected]

V. Jeffrey Evans, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07
Bethesda, Maryland 20892
Telephone: 301 496-1176
Fax: 301-496-0962
E-mail: [email protected]

Amy M. Donahue, Ph.D.
Acting Chief, Translational Research Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS Room 400C
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
E-mail: [email protected]

Ruth Nowjack-Raymer, M.P.H., Ph.D.
Director, Health Disparities Research Program
Director, Health Disparities Research Program
Division of Clinical Research and Health Promotion
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-43J
Bethesda, MD 20892-6401
Telephone: 301-594-5394
Fax: (301) 480-8322
E-mail: [email protected]

Jared B. Jobe, Ph.D.
Health Scientist Administrator
Behavioral Medicine and Prevention Scientific Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8120
Bethesda, MD 20892-7936
Overnight mail zip code: 20817
Telephone: 301-435-0407
Fax: (301) 480-1773
E-mail: [email protected]

Kimberly Gray, Ph.D.
Scientific Program Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-0293
Fax: 919-316-4606
E-mail: [email protected]

David M. Stoff, Ph.D. (AIDS related applications)
Division of AIDS and Health Behavior Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd, Room 6210
Bethesda, MD 20892-9619
Telephone: 301-443-4625
Fax: 301-443-9719
E-mail: [email protected]

Carmen Moten-McKen, Ph.D. (non-AIDS related applications)
Division of Services and Intervention Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd, Room 7129
Bethesda, MD 20892-9631
Telephone: 301-443-3364
Fax: 301-443-9719
E-mail: [email protected]

Martha L. Hare, Ph.D., R.N
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 (Courier: 20817)
Telephone: 301-451-3874
Fax: 301-480-8260
Email: [email protected]

Adele M. Childress, Ph.D., M.S.P.H.
Program Administrator
Office of Extramural Programs
National Institute of Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1427, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2509
Fax: (404) 498-2571
E-mail: [email protected]

G. Stephane Philogene, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
31 Center Drive
Building 31, Room B2-B37
Bethesda, MD 20892
Telephone: (301) 402-3902
Fax: (301) 402-1150
E-mail: [email protected]

Eleanor Z. Hanna, Ph.D.
Associate Director for Special Projects and Centers
Office of Research on Women’s Health
Office of the Director
National Institutes of Health
Executive Plaza South 150A
6120 Executive Blvd
Bethesda, MD 20892-7116
Telephone: (301) 435-1573
Fax: (301) 402-0005
E-mail: [email protected]

Elizabeth Y. Lambert, M.Sc.
Epidemiology Research Branch
Division of Epidemiology, Prevention, and Services Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 5169, MSC 9589
Bethesda, MD 20892-2589
Telephone: (301) 402-1933
FAX: (301) 443-2636
E-mail: [email protected]

2. Peer Review Contacts:
Not applicable.

3. Financial or Grants Management Contacts:

Marc Milton Pitts
Grants Management Specialist
Agency for Healthcare Research and Quality
OPART/GM
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1704
FAX: (301) 427-1462
E-mail: [email protected]

William Caputo
Grants Management Specialist
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3027
Bethesda, MD 20892-9304
Express Mail: Rockville, MD 20852-1705
Telephone: (301) 443-2434
FAX: (301) 443-3891
E-mail: [email protected]

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
6120 Executive Blvd
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: (301) 435-7547
E-mail: [email protected]

Victoria Connors
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-402-6579
FAX: 301-402-0915
E-mail: [email protected]

Christopher Myers
Grants Management Officer
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS Room 400B
Bethesda, Maryland 20892-7180
Telephone: 301-402-0909
Fax: 301-402-1758
Email: [email protected]

Mary Daley
Grants Management Branch
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
Fax: 301-480-3562
Email: [email protected]

Donald Ellis
Grants Management Specialist
IEHS Grants Management Branch
P.O. Box 12233, MD/EC-22
Research Triangle Park, NC 27709
Telephone: 919-541-1874
FAX: 919-541-2860
Email: [email protected]

Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard
Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: [email protected]

Bob Pike
Chief, Grants Management Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7152
Bethesda, Maryland 20892
Telephone: 301-435-0171
Fax: 301-480-0422
E-mail: [email protected]

Teresa Marquette
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-2177
FAX: (301) 451-5651
Email: [email protected]

Robin Solow
Contracts Management Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6428
E-mail: [email protected]

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse
6101 Executive Blvd., Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: [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 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). 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 SF424 (R&R); 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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

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 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.

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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