Expired PAR-08-213: Methodology and Measurement in the Behavioral and Social Sciences (R21)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
Eunice Kennedy Shriver 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 Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.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/)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/index.aspx)

Title: Methodology and Measurement in the Behavioral and Social Sciences (R21)

Announcement Type
This is a reissue of PA-06-343.

Update: The following updates relating to this announcement have been issued:

May 16, 2016 - This PA has been reissued as PAR-16-261.
September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.
June 24, 2010 - See Notice NOT-TW-10-008 Notice to Highlight Current NIH Funding Opportunities that Promote Research on the Human Health Effects of Climate Change.
March 24, 2010 - See Notice NOT-OD-10-074 The purpose of this Notice is to inform applicants of changes related to directing inquiries and contact information.
December 21, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program Announcement (PA) Number: PAR-08-213

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.396, 93.399, 93.213, 93.233, 93.837, 93.839, 93.865, 93.121, 93.115, 93.853, 93.361, 93.866, 93.273, 93.173, 93.279, 93.286

Key Dates
Release/Posted Date: July 22, 2008
Opening Date: September 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): 30 days prior to standard application due dates
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The goal of this Funding Opportunity Announcement (FOA) is to encourage research that will improve the quality and scientific power of data collected in the behavioral and social sciences, relevant to the missions of the participating NIH Institutes and Centers.
The participating NIH Institutes and Centers invite qualified researchers to submit research grant applications aimed at improving and developing methodology and measurement in the behavioral and social sciences through innovations in research design, data collection techniques, measurement, and data analysis techniques.
Research that addresses methodology and measurement issues in diverse populations, issues in studying sensitive behaviors, issues of ethics in research, issues related to confidential data and the protection of research subjects, and issues in developing interdisciplinary, multimethod, and multilevel approaches to behavioral and social science research is particularly encouraged, as are approaches that integrate behavioral and social science research with biological, physical, or computational science research or engineering.
Mechanism of Support. This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with PAR-08-212 and PAR-08-214, which solicit applications under the NIH Research Project Grant (R01) and Small Research Grant (R03) award mechanisms, respectively.
Funds Available and Anticipated Number of Awards. 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. The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration, and costs of the applications received.
Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
Application Research Strategy Length: The R21 application Research Plan component of the PHS398 (Item 3) may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See http://grants.nih.gov/grants/funding/funding_program.htm
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Include Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).
Renewals. Exploratory/developmental grant support is for new projects only.
Application Materials. See Section IV.1 for application materials.
General Information. 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/
Hearing Impaired. Telecommunications for the hearing impaired are 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. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 Contacts
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 behavioral and social sciences offer significant, fundamental insights into the comprehensive understanding of human health, including disease etiology and treatment, and the promotion of health and well-being. To encourage the investigation of the impact of social and behavioral factors on health and disease, the participating Institutes and Centers (ICs) invite qualified researchers to submit research grant applications on methodology and measurement in the behavioral and social sciences. Methodology and measurement encompass research design, data collection techniques, measurement, and data analysis techniques. The goal of this program announcement is to encourage research that will improve the quality and scientific power of data collected in the behavioral and social sciences, using humans or animals, relevant to the missions of the NIH ICs. Research that addresses methodology and measurement issues in diverse populations, issues in studying sensitive behaviors, issues of ethics in research, issues related to confidential data and the protection of research subjects, and issues in developing interdisciplinary, multimethod, and multilevel approaches to behavioral and social science research is particularly encouraged, as are approaches that integrate behavioral and social science research with biomedical, physical, or computational science research or engineering. Because the focus of this program announcement is developing methodology, rather than addressing a single, health-related research question, applicants are encouraged to propose approaches that would be broadly applicable to basic or applied behavioral and social sciences research related to health. Applicants are strongly encouraged to contact the Program Contact for Scientific/Research issues (see Section VII., Agency Contacts) of the IC that most closely matches their research focus to determine the IC's interest in the research topic.

This Funding Opportunity Announcement (FOA) encourages applications addressing four general areas of methodology and measurement research in the social and behavioral sciences. These areas, discussed in detail below, include research design, data collection techniques, measurement, and data analysis. Within the broad spectrum of research defined by these areas, applicants are particularly encouraged (but are not required) to consider studies that address one or more of the following key issues:

Methodology and measurement issues in developing innovative interdisciplinary, multimethod, and multilevel research designs for use in behavioral and social science research, with special emphasis on both developing new technologies and addressing the analytical complexities associated with the integration of behavioral, social, and biological data.
Methodology and measurement issues in research relating to diverse populations, for example, populations that are distinctive by virtue of age, gender, sexual orientation, ethnicity, culture, including culture-specific medical systems, socio-economic status, literacy, language, or disability.
Methodology and measurement issues in studying how dramatic changes in economic, social, environmental, physical, or political context affect human health and well-being, including developing new methods if older ones are no longer valid in the face of significant changes in populations and societies over the last several decades.
Methodology and measurement issues in studying potentially sensitive behaviors, such as sexual behavior and abortion, and covert or illegal behaviors such as drug use, abuse, and violence.
Methodology and measurement issues that facilitate incorporating measures of social environment with genetic data or enhance bringing genetic measures into studies of social epidemiology.
Methodology and measurement issues concerning ethics in research, with emphasis on the topics of informed consent, assessment of risk and benefit, and selection and retention of subjects, and ensuring subjects' confidentiality.

Multidisciplinary and interdisciplinary approaches are strongly encouraged. Potential applicants are urged to explore the ideas and methods developed in social science and behavioral fields other than their own and to consider the development and integration of behavioral and social science measures with those of the biomedical, physical, or computational sciences or engineering. Consulting relevant literature and collaborating with colleagues from other disciplines may provide important opportunities for cross-fertilization in developing improved methodology and measurement.

A. Research Design

Research design determines how well a research plan can accomplish stated purposes and test hypotheses. How the research is designed depends on the central research questions. Thus, research design encompasses many decisions including the sampling plan; selection of appropriate study designs, methods, procedures and measures; and, assuring confidence in the study's internal and external validity. An innovative sample design or sampling frame can be the centerpiece of a research design. Examples of topics within research design are, but are not limited to, the following:

Conceptual design strategies appropriate for the study of culture in the context of health. This may include but is not limited to studies of culture (and cultural change) associated with specific ethnic groups, professional affiliations, or medical systems as well as studies of the interaction of different cultures within a health-related context.
Designs that will allow for the meaningful integration of biological, behavioral and social science data (e.g., to study interactions among genetics/genomics, behavior and the social environment).
Designs to improve causal inference from non-experimental and quasi-experimental research and natural experiments.
Research to improve the efficacy of multilevel designs.
Methods for improving the design and evaluation of community-based research and intervention trials (e.g., health promotion/disease prevention programs).
Conceptual, methodological, and ethical issues in designing studies that use different sources of information; for example, studies comparing self- and third-party reports (e.g., from participants' family or friends).
Designs to improve and compare various approaches to economic analysis, including cost analysis, cost-effectiveness, cost-benefit, and conjoint analysis for improving decision-making in health policy and health care systems.
Designs to improve the inclusion of underrepresented groups in research; examples of such groups include women; children; the elderly; ethnic and racial minorities; sexual minority groups; geographically isolated groups; mentally or physically impaired or disabled populations; immigrants and refugees; and language minority populations - that is, individuals who do not speak the most common language or languages in a country or region (e.g., in the United States, individuals who speak neither English nor Spanish).
Designs that enable prediction of potential consequences of policy changes on behavior and health.
Designs that will allow for the assessment of the active components of multi-level interventions.
Ethical considerations in research design including, but not limited to issues of informed consent, assessment of risk and benefit, confidentiality, and selection and retention of subjects.
Methods for archiving and disseminating complex datasets, especially longitudinal datasets, datasets including social network data, and datasets including geographic identifiers, so that the identities of study participants are protected and so that the datasets can be used by investigators who were not part of the original research team.
Alternatives to randomized, controlled trials, including studies to investigate the feasibility, validity, and benefit of incorporating subject (e.g., clients, patients, families, clinicians) preference in intervention design and outcomes assessment; issues regarding blinding; and design of placebo and other control groups.
Methods to improve the design of clinical research for enhancing quality of patient care (e.g., studies linking patient-reported outcomes data with medical records and/or billing information to improve patient-provider communication, patient decision-making, or clinical decision-making).
Methodology to ensure the integrity and consistency of data obtained in multi-site studies.

B. Measurement Issues

Developing and validating research instruments and questions are vitally important for collecting reliable information, and have obvious impact on data validity and reliability. For example, health care practitioners must collect reliable reports of symptoms from their patients in order to accurately diagnose disease. In addition, data collection instruments and questions developed for a particular age, gender, or cultural group may not be valid for other groups. For example, a dietary history questionnaire developed for Americans of European descent may not contain the foods commonly eaten by Americans of African, Asian, or Hispanic descent. Specific consideration of the processes underlying potential bias in self-report data collection remains a measurement issue. Such processes include perceptual, cognitive, cultural, demographic, motivational, and affective influences on self-report data. Finally, continued improvement and innovation in developing and validating data collection instruments are important for all types of research settings, ranging from the clinical interview and observational study to the survey. Examples of measurement issues include, but are not limited to, the following:

Development of instruments or technologies that measure behavior objectively or reduce self-report burden (e.g., accelerometers for the measurement of physical activity).
Development and refinement of measures, instruments, or surveys used in behavioral and social science research that fill a gap in research needs, with an eye toward developing and validating core sets of items to reduce redundancy across research projects.
Instrument design issues in studying age, gender, and race/ethnicity, including methods of studying self-identification of race/ethnicity, as well as the psychometric properties underlying data collection instruments.
Measurement issues in using technology such as computer assisted data collection, web-based technology and personal digital assistants (PDAs).
Studies examining the ways to combine or integrate various psychometric methods, such as Item Response Theory, Rasch, Computer Adapative Testing, and classical test theory.
Direct and indirect measurement of attitudes, values, self-esteem, and other psychological variables. This includes examination of economic values, including willingness-to-pay, as a means of evaluating benefits, including health services.
Development of instruments that assess not only degree of change, but also rate and variable direction of change.
Development of objective measures of components of the built environment that impact health and of measures for assessing interactions between people and the built environment.
Measurement strategies to identify shared cultural models or schemas, and tools for systematic measurement of neighborhood social patterns.
Methodology for validating Geographic Information System (GIS) data obtained from different sources.
Methodology to measure fidelity to behavioral interventions, including the development or adaptation of behavioral and interpersonal measures to better assess the fidelity of community-based and multi-site behavioral interventions.
Development of measures of self-management of chronic illness and disability and of family management of chronic illness and disability among children.
Development of behavioral and social science measures that can be used for efficient data collection in clinical practice-based, research networks.
Methodology to capture the behaviors of health care providers in clinical settings.
Methods that incorporate relevant biological, physical or computational measures into behavioral and social science research.
Development of measures for evaluating quality of life near the end of life in a variety of populations, and refinement of existing measures through longitudinal studies and across various disease states.

C. Data Collection Techniques

Data collection techniques are the tools and procedures scientists use for implementing research designs and obtaining measurements. Methods for collecting research data have an important impact on data validity and reliability. For example, studies have suggested that use of self-administered instruments can facilitate the reporting of sensitive or illegal behaviors. Innovative methodologies can also open the door to the collection of new or more complex types of data by behavioral and social scientists. For example, recent developments in computer-assisted interviewing have permitted more complex question sequences in survey research, and the development of hand-held "beepers" programmed for data entry have permitted the collection of time-specific data on activities such as cigarette smoking. In addition, implicit measures have allowed researchers to examine processes of which people themselves have been unaware. Continued improvement and innovation in data collection methods are important for all types of research settings, including clinical interviews, observational studies, participatory action research, and surveys. In addition, more research is needed to understand how various methods work in diverse populations, and how they can be modified to address the specific needs of populations. Potential topics within data collection techniques include, but are not limited to the following:

Data collection techniques featuring unobtrusive, user-friendly, wearable devices and those utilizing WiFi technology that improve measurement of behavioral phenomena in the real-world setting in which they typically occur and at the moment when the phenomena of interest actually occurs (i.e., ecological momentary assessment). Methodologies and technologies related to co-occurring biological and behavioral processes are of particular interest.
Improved technologies for data collection, including automated collection and reporting technologies, such as computer-based data collection and computer adaptive methodology, and research on how the method/mode used to collect data affects the quality of the data in a variety of populations and substantive areas.
Methods to improve data collection in surveys and, epidemiologic self-report studies, ethnographic and other qualitative studies, participatory action research methods, and multi-method studies; this may include new approaches to instrument design and manipulation of method and mode of data collection, length, setting, and interpersonal factors in data collection exchanges.
Methods to develop innovative gold standards to assess and improve the accuracy of self reports, in the absence of health record checks (a possible consequence of the Privacy Rule of the Health Insurance Portability and Accountability Act).
New methods for qualitative research; methods for validating narrative or text-based analyses; techniques for validating and replicating findings from qualitative research, including collection strategies, development of coding protocols, and techniques that facilitate the integration and validation of qualitative and quantitative measurement.
Methods to reduce sampling, survey, and item non-response bias in research studies, including techniques to improve the coverage of relevant populations in household surveys, to increase the voluntary participation of eligible subjects, to reduce attrition in longitudinal studies and clinical trials, and to improve response rates on sensitive items.
Techniques for collecting contextual data (e.g., neighborhood composition, peer group characteristics, geographic and environmental information) and for operationalizing the boundaries and/or reach of particular social, economic, physical, and cultural contexts.
Data collection techniques that address the needs of special populations (e.g., physically or mentally disabled, non-literate populations, non-English speaking populations, the homeless, the incarcerated, children, the elderly, critically ill patients) and that address how these methods affect data quality and completeness across diverse populations.
Issues surrounding the collection of self-report data from different settings (e.g., alone, in groups), different collection methods (e.g., oral, written), from different parties (e.g., participants, third parties), and the use of implicit and explicit measures.
Development of better data collection techniques for studies that involve populations which are small or difficult to access, such as the terminally ill or families caring for disabled children.

D. Analytic Methods

Analytic methods encompass the concepts and techniques used in analyzing data and interpreting and reporting results. The goal of new and improved analytic methods is to improve estimation, hypothesis testing, and causal modeling based on scientific data. Challenges include developing techniques that distinguish underlying regularities from the noise created by variability and imprecise measurement; developing causal inferences from non-experimental data; improving both the internal validity and external validity (generalizability) of measures and studies; and developing appropriate analytic techniques for use with new kinds of data and new approaches to behavioral and social science research, and meaningful integration of behavioral and social science data with those obtained from the biological, physical, computational sciences or engineering. Examples of topics within analytic methods include, but are not limited to the following:

Research to improve the analysis of longitudinal data -- in particular, the analysis of correlated data, the modeling of different sources of error, and techniques for dealing with missing data at various levels of aggregation.
Methods for improving the analysis of multicultural, community-based multi-level intervention trials (e.g., health promotion/disease prevention programs).
Methodological research to improve the analysis of complex survey data, including the statistical modeling of non-response and other survey errors.
Analytic issues in and innovative techniques for improving causal inference from non-experimental research.
Analytic methods for integrating evidence from qualitative and quantitative research, such as research examining the complex relationships among multiple sources of information on a single construct (e.g., self- and third-party reports, clinical examinations and testing, laboratory tests, and other record sources).
Analytic methods that appropriately model social structures, social processes, and spatial relationships such as social networks, social influence, diffusion, and contextual effects.
Statistical procedures for accurately estimating multilevel models.
Development of novel mathematical and computational techniques for analyzing and modeling behavioral and social processes, such as hybrid modeling approaches that take advantage of features of both aggregate- and individual- level modeling.
Methods for improving the analysis of non-independent data, such as data examining processes in interactions between couples, families, or other groups.
Developing sophisticated analytic methods that take into account complex probability designs used in epidemiological research.
Analytical methods to incorporate geographic and built environment measures into behavioral and social science research.
Expanding current psychometric methodologies to handle the types of data collected in behavioral and social science research, e.g., multidimensional data, shorter scales, non-normal score distributions, mixed response format, and complex survey structure.
Methods for the detection and analysis of non-linear or discontinuous changes in response to treatment.
Improvements or new approaches to nonlinear analysis e.g., systems dynamic modeling, agent-based modeling, network analysis and other simulation techniques.

Relevant Research Links

The Office of Behavioral and Social Sciences Research (OBSSR) released its most recent strategic plan in 2007, The Contributions of Behavioral and Social Sciences Research to Improving the Health of the Nation: A Prospectus for the Future. Currently available at http://www.thehillgroup.com/OBSSR_Prospectus.pdf, this document specifies the role of methods, measurement and systems thinking in advancing next generation behavioral and social science.

One dimension of emergent trends aims at incorporating the complexity of multilevel systems, requiring approaches that are transdisciplinary in scope. In 2007, OBSSR and several ICs collaborated with the Centers for Disease Control and Prevention Syndemics Prevention Network to sponsor the 2007 Symposia Series on Systems Science and Health. The series webcast and slides are available at http://obssr.od.nih.gov/Content/Lectures+and+Seminars/Systems_Symposia_Series/SEMINARS.htm.

In 2006, on behalf of the NIH Roadmap for Medical Research (http://nihroadmap.nih.gov), OBSSR organized the NIH Roadmap Interdisciplinary Methodology and Technology Summit. The purpose of the summit was to identify the gaps and opportunities in developing research methodology and technology that lie at the intersection of behavioral and social sciences and other disciplines. A second purpose was to showcase research under a pair of NIH Roadmap RFAs supporting methodological innovation in social and behavioral sciences research. Webcasts of the two-day event and additional information about the Summit can be accessed at: http://nihroadmap.nih.gov/interdisciplinary/summit0806/

The persistence of health disparities and promotion of health equity remain central concerns for the nations health, demanding advances in methods and measurement in social and behavioral research. Applicants specifically concerned with research involving language minorities (e.g., people who do not speak the most common national language or languages) should see the 2001 report on the conference, Diverse Voices - The Inclusion of Language-Minority Populations in National Studies: Challenges and Opportunities, sponsored by National Institute on Aging, the National Institute of Child Health and Human Development, and the National Center on Minority Health and Health Disparities: http://www.nichd.nih.gov/publications/pubs/diverse_voices.cfm.

In addition, the following reports may be useful references on contemporary dimensions in social and behavioral research on health, including human subjects concerns:

Genes Behavior and the Social Environment: Moving Beyond the Nature/Nurture Debate (2007). Committee on Assessing Interaction among Social, Behavioral, and Genetic Factors in Health. L.M. Hernandez and D.G. Blazer, Eds. Board on Health Sciences Policy, Institute of Medicine. Washington DC: The National Academies Press. (http://www.nap.edu/catalog.php?record_id=11693).

Putting People on the Map: Protecting Confidentiality with Linked Social-Spatial Data (2007). Panel on Confidentiality Issues Arising from the Integration of Remotely Sensed And Self-Identifying Data. M.P. Gutmann and P.C. Stern, Eds. Committee on the Human Dimensions of Global Change, Division of Behavioral and Social Sciences and Education. Washington DC: The National Academies Press. (http://www.nap.edu/catalog.php?record_id=11865).

Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003). Panel on Institutional Review Boards, Surveys, and Social Science Research. C.F. Citro, D.R. Ilgen, and C.B. Marrett, Eds. Board on Behavioral, Cognitive, and Sensory Sciences; National Research Council. Washington, DC: The National Academies Press. (http://newton.nap.edu/catalog/10638.html).

New Horizons in Health: An Integrative Approach (2001). Committee on Future Directions for Behavioral and Social Sciences Research at the National Institutes of Health. B.H. Singer and C.D. Ryff, Eds. Board on Behavioral, Cognitive, and Sensory Sciences, National Research Council. Washington, DC: National Academy Press (http://www.nap.edu/catalog/10002.html).

Rebuilding the Unity of Health and the Environment (2001). Roundtable on Environmental Health Sciences, Research, and Medicine. K. Hanna and C. Coussens, Eds. Division of Health Sciences Policy, Institute of Medicine. Washington, DC: National Academy Press. (http://www.nap.edu/books/030907259X/html/).

Qualitative Methods in Health Research: Opportunities and Considerations in Application and Review (2001), Office of Behavioral and Social Sciences Research, National Institutes of Health. Bethesda, MD. NIH Publication No. 02-5046 (http://obssr.od.nih.gov/Documents/Publications/Qualitative.PDF).

Use of the R21 Funding Mechanism

The evolution and vitality of the social, behavioral and biomedical sciences require a constant infusion of new ideas, techniques, and points of view.These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

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. Applications submitted under this mechanism should be exploratory and novel.These studies should break new ground or extend previous discoveries toward new directions or applications.Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism.Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses the modular as well as the non-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 3.4, Modular Budget Component, of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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
The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribally Designated Organizations
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
U.S. Territory or Possession
Indian/Native American Tribal Governments (Other than Federally Recognized)
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations)
Other(s):
- Eligible Agencies of the Federal Government
- Faith-based or Community-based Organizations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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

Exploratory/developmental grant support is for new projects only.

Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or 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/applicants/get_registered.jsp) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/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 can submit an electronic application, as follows:

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

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 support@grants.gov

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 commons@od.nih.gov

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(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons.In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 organization/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: GrantsInfo@nih.gov.

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/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, 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
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

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

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

Request budgets in U.S. dollars;
Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)(see NOT-OD-06-096);
Not include any charge-back of customs and import fees;
Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028, March 29, 2001);
Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements)

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:September 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): 30 days prior to standard application due dates
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

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(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity announcement

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:

Richard Conroy, Ph.D.
Program Director
Division of Applied Science and Technology
Democracy Plaza II, Suite 200
Tel: 301-402-1486
Fax: 301-480-1614
E-mail: conroyri@mail.nih.gov

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

PD/PI Credential (e.g., Agency Login)

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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Organizational DUNS

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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

R21 applications will use the modular as well as the non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year. Foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Item 3 of the Research Plan of the R21 application may not exceed 6 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.
Renewal (formerly competing continuation or Type 2) applications are not permitted.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Not applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 Public Health Service (PHS) referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

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 rating;
Receive a written critique; and
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 and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.

Because the Research Plan component is limited to 6 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place 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, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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 meritorious impact/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.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed measurement or methodological development hold promise for addressing significant scientific problems, including, if applicable, significant problems beyond those specifically addressed in this application?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project develop or employ very novel concepts, approaches, measures, methodologies, tools, or technologies? Is the proposed measurement or methodological development unconventional and very innovative? Will the methodological innovation improve answers to existing questions, or expand the range of questions that can be asked?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? To what extent does this project propose: developing measurement strategies or methodologies that have not been tested or used before; and/or developing approaches that improve on existing techniques, methods, or methodologies?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

Data Sharing Plan. Not Applicable
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

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/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 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.

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.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

General Inquiries regarding the scope and content of this program announcement should be directed to:

Deborah H. Olster, Ph.D.
Deputy Director
Office of Behavioral and Social Sciences Research (OBSSR)
National Institutes of Health
Suite B1C19, Bldg. 31; MSC 2027
31 Center Drive
Bethesda, MD 20892-2027
Phone: 301 402-1147
FAX: 301 402-1150
E-mail: olsterd@od.nih.gov

Direct inquiries regarding PROGRAMMATIC ISSUES, including questions of research areas of particular interest to individual Institutes and Centers, should be directed to the staff of the appropriate Institute or Center, as listed below:

Debra Babcock, M.D., Ph.D.
Systems and Cognitive Neuroscience Cluster
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Boulevard, Room 2108
Bethesda, MD 20892-952
Telephone: (301) 496-9964
Fax: (301) 402-2060
Email: db390r@nih.gov

Dr. Susan Marden, PhD
Division of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 496-9623
Fax: (301) 480-8260
Email: mardens@mail.nih.gov

Page Chiapella, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 2044, MSC 9304
Bethesda, MD 30892-9304
Telephone: (301) 443-4715
Fax: (301) 443-8774
Email: pchiapel@mail.nih.gov

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Center for Population Research
6100 Executive Blvd., Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1175
Fax: (301) 496-0962
Email: rclark@mail.nih.gov

Richard Conroy, Ph.D.
Program Director
Division of Applied Science and Technology
Democracy Plaza II, Suite 200
Tel: 301-402-1486
Fax: 301-480-1614
E-mail: conroyri@mail.nih.gov

Judith A. Cooper, Ph.D.
Deputy Director
National Institute on Deafness and Other Communication Disorders (NIDCD)
Director, Division of Scientific Programs
6120 Executive Blvd., MSC-7180
EPS, Suite 400-C
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
Fax: (301) 402-6251
Email: cooperj@nidcd.nih.gov

Jody Engel, MA, RD
Program Analyst, Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD 20892
(use Rockville, MD 20852 for courier, FedEx, etc.)
Telephone: (301) 402-9846
Fax: (301) 480-1845
Email: engeljo@mail.nih.gov

Bethany Griffin Deeds, PhD, MA
Deputy Branch Chief, Epidemiology Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd. Rm 5142
Suite 5153 MSC 9589
Bethesda, Maryland 20892-9589 (if by US Postal Service)
Rockville, Maryland 20852 (if by other delivery service)
Phone: 301-402-1935
Email: deedsb@nida.nih.gov

Kimberly Gray, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
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
Email: gray6@niehs.nih.gov

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 (NHLBI)
6701 Rockledge Drive, Room 8120, MSC 7936
Bethesda, Maryland 20892-7936
Telephone: (301) 435-0407
Fax: (301) 480-1773
Email: jobej@mail.nih.gov

Jonathan W. King, Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Email: kingjo@mail.nih.gov

Sandra Anne Mitchell, PhD, CRNP
Division of Cancer Control and Population Sciences (DCCPS)
National Cancer institute (NCI)
EPN, Room 4020, MSC 7344
6130 Executive Boulevard
Bethesda, MD 20892-7344.
Telephone: (301)-435-6750
Email: mitchlls@mail.nih.gov

Melissa W. Riddle, Ph.D.
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health
6701 Democracy Blvd.
Room 646, Mail Stop 4878
Bethesda, MD 20892-4878
Telephone: 301-451-3888
Email: riddleme@mail.nih.gov

Catherine M. Stoney, Ph.D.
National Center for Complementary & Alternative Medicine (NCCAM)
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475 (for express mail, use 20817)
Telephone: (301) 402-1272
Fax: (301) 480-3621
Email: stoneyc@mail.nih.gov

2. Peer Review Contacts:

Robert Freund, Ph.D.
Scientific Review Officer
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 3200
Bethesda, MD 20892
(for express courier service use 20817)
301-435-1050
FAX 301-480-0940

3. Financial or Grants Management Contacts:

Mr. Bryan S. Clark, MBA
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01A, MSC 7510
Bethesda, MD 20892
Telephone: (301) 435-6975
Fax: (301) 451-5510
Email: clarkb1@mail.nih.gov

Dr. Becky B. Costello
Office of Dietary Supplements
6100 Executive Blvd., Suite 3B01
Rockville, MD 20892-7517
Telephone: (301) 435-2920
Fax: (301) 480-1845
Email: CostelloB@mail.nih.gov

Mary Daley
Chief, Grants Management Branch
National Institute of Dental and Craniofacial Research (NICDR)
6701 Democracy Blvd
Room 658, Mail Stop 4878
Bethesda, MD 20892-4878
Telephone: 301-549-4800
Fax: 301-480-3562
Email: daleym@mail.nih.gov

Chris Davis
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd., MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469
Telephone: (301) 451-4786
Email: davisch@mail.nih.gov

Mr. Donald Ellis
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD/EC-22
Research Triangle Park, NC 27709
Phone: (919) 541-1874
Fax: (919) 541-2860
Email: donaldellis@niehs.nih.gov

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: (301) 443-3891
Email: jfox@mail.nih.gov

Ms. Randi Freundlich
National Institute of Nursing Research (NINR)
Office of Grants and Contract Management
6701 Democracy Blvd., Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5974
Fax: (301) 402-4502
Email: freundlichr@mail.nih.gov

Ms. Pamela L. Mayer
National Institute of Neurological Disorders and Stroke
Grants Management Branch
6001 Executive Boulevard, Room 3254
Bethesda, MD 20892
Telephone: (301) 496-4207
Fax: (301) 451-5635
Email: pm27v@nih.gov

Ms. Lesa McQueen, M.Sc.
Grants Management Specialist
Grants & Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Ste. 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Voice Mail: (301) 496 5000 or (800) 952 7951 #90332
Fax: (301) 402-3672
Email: Lesa_McQueen@nih.gov|

Mr. Christopher Meyers
Grants Management Officer
National Institute on Deafness and other Communication Disorders
EPS, Rm 400 C
6120 Executive Blvd, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: meyersc@mail.nih.gov

Ms. Daisey Parker
Grants Management Specialist
National Institute on Drug Abuse
Grants Management Branch
6101 Executive Boulevard
Suite 270 MSC 8403
Bethesda MD 20892-8403
Telephone: (301) 443-6710
Fax: (301) 594-6847
Email: dparker@ngmsmtp.nida.nih.gov

Ms. Denise Payne
National Heart Lung and Blood Institute
Epidemiology and Clinical Applications Grants Management Section
Two Rockledge Center, Room 7155
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 594-9529
Fax: (301) 451-5462
Email: denisepayne@mail.nih.gov

Mr. George A. Tucker, M.B.A.
Chief Grants Management Officer
Division of Extramural Research and Training
National Center of Complementary and Alternative Medicine (NCCAM)
National Institutes of Health
Department of Health and Human Services
II Democracy Plaza, Suite 401
6707 Democracy Boulevard, MSC5475
Bethesda, MD 20892-5475
Telephone: (301) 594-9102
Email: tuckerg@mail.nih.gov

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Plaza South, Suite 243
Bethesda, MD 20892
(For express / courier service only: Rockville, MD 20852)
Telephone: (301) 496-8634
Fax: (301) 496-8601
Email: crystal.wolfrey@nih.gov

Section VIII. Other Information

Required Federal Citations

Vertebrate Animals:
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 (45 CFR 46) 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).

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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. 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.

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.

Inclusion of Women, Minorities, and Children:
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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA 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. 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/.