Expired PA-06-343: 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 Child Health and Human Development (NICHD), (http://www.nichd.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 modification of PA 05-090 which was previously released April 15, 2005.

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

July 22, 2008 - This PA has been reissued as (PAR-08-213).
October 10, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

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

Program Announcement (PA) Number: PA-06-343

Catalog of Federal Domestic Assistance Number(s)
93.399, 93.213, 93.837, 93.865, 93.115, 93.853, 93.361, 93.866, 93.273, 93.173, 93.279

Key Dates
Release/Posted Date: April 14, 2006
Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of applicant institution/organization).
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: May 2, 2008 (now May 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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 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.
This funding opportunity will utilize the R21 mechanism, but will be run in parallel with FOAs of identical scientific scope that will utilize the traditional research project grant (R01) or competitive supplements to R01, R37, U01 or P01 projects (PA 05-090) or which will utilize the R03 small grant mechanism (PA 06-344).
The R21 is not renewable.
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 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 2 years. Direct costs are limited to $275,000 over an R21 2-year period, with no more than $200,000 in direct costs allowed in any single year.
Eligible organizations: For-profit and not-for-profit, public or private organizations, units of state and local governments, eligible agencies of the Federal Government, domestic or foreign institutions/organizations, faith-based or community-based organizations, Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.
Eligible Project Directors/Principal Investigators (PDs/PIs): Any individuals from the applicant institutions who have the skills, knowledge, and resources necessary to carry out the proposed research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Applicants may submit more than one application, provided they are scientifically distinct.
See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:

For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites:

SF424 (R&R) Application and Electronic Submission Information at http://grants.nih.gov/grants/funding/424/index.htm; and
General information on Electronic Submission of Grant Applications at http://era.nih.gov/ElectronicReceipt/.

Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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 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 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 NIH Institutes and Centers (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. 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 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 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. Culture may include but is not limited to ethnic group, professional affiliation (e.g., culture of biomedicine), culturally-specific medical system, or interaction of multiple sub-cultures within a health-related context.
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 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).
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).
Designs that will allow for the assessment of the active components of multi-level interventions.
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 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, calibration, and refinement; instrument design issues in studying age, gender, and culture, including methods of studying culture and 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).
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 instruments or technologies that measure behavior objectively or reduce self-report burden (e.g., accelerometers for the measurement of physical activity).
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.
Methodology to objectively measure the cultural and social environment (e.g., imaging devices to measure social interactions), including aspects of the community environment that influence health.
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 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:

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 of particular social, economic, physical, and cultural contexts.
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.
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.

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.
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.

RELEVANT RESEARCH LINKS

Potential applicants specifically concerned with research regarding the inclusion of 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 June, 2000 the Office of Behavioral and Social Sciences Research held a conference "Toward Higher Levels of Analysis: Progress and Promise in Research on Social and Cultural Dimensions of Health." Following the conference, a panel of scientists developed an ambitious research agenda on the social and cultural dimensions of health. A program announcement based on the panel's recommendations for substantive research has been issued by OBSSR and can be found at: http://grants.nih.gov/grants/guide/pa-files/PA-05-029.html. However, the research agenda also included detailed recommendations relating to needed methodological research related to the social and cultural dimensions of health. Potential applicants are encouraged to consult this report, available at http://obssr.od.nih.gov/Conf_Wkshp/higherlevel/conference.html.

In September, 2001, NIH sponsored an International Conference entitled: Stigma and Global Health: Developing a Research Agenda. The recommendations included 1) encouragement of research intended to develop methodological, evaluative and analytic tools for studying stigma and its consequences with respect to health, and 2) development, evaluation and optimization of interventions to prevent or mitigate the negative effects of stigma and discrimination on health. In both areas it was recommended that the social and cultural dimensions of stigma and its manifestations be included. Applicants are encouraged to refer to the stigma conference website: www.stigmaconference.nih.gov for further resources and information.

In addition, the following reports may be useful as general references on behavior and social sciences research as it relates to health:

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

Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (2001). Committee on Health and Behavior: Research, Practice and Policy, Board on Neuroscience and Behavioral Health, Institute of Medicine (http://books.nap.edu/catalog/9838.html).

From Neurons to Neighborhoods: The Science of Early Childhood Development (2000). Jack P. Shonkoff and Deborah A. Phillips, Editors; Committee on Integrating the Science of Early Childhood Development, Board on Children, Youth, and Families, National Research Council (http://books.nap.edu/catalog/9824.html).

Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences (2000). Terry C. Pellmar and Leon Eisenberg, Editors; Committee on Building Bridges in the Brain, Behavioral, and Clinical Sciences; Division of Neuroscience and Behavioral Health, Institute of Medicine (http://books.nap.edu/catalog/9942.html).

Expanding the Boundaries of Health and Social Science: Case Studies in Interdisciplinary Innovation (2003). Frank Kessel, Patricia Rosenfield and Norman Anderson, Editors. New York: Oxford University Press.

Rebuilding the Unity of Health and the Environment (2001). Kathi Hanna and Christine Coussens, Editors; Roundtable on Environmental Health Sciences, Research, and Medicine, Division of Health Sciences Policy, Institute of Medicine (http://www.nap.edu/books/030907259X/html/).

Cells and Surveys. Should Biological Measures be Included in Social Science Research? (2001). Caleb E. Finch, James W. Vaupel and Kevin Kinsella, Editors; Committee on Population, National Research Council (http://www.nap.edu/books/0309071992/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).

Applicants may also wish to consult the following report on the protection of human subjects in behavioral and social sciences research:

Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003). Constance F. Citro, Daniel R. Ilgen, and Cora B. Marrett, Editors, Panel on Institutional Review Boards, Surveys, and Social Science Research, National Research Council (http://www.nap.edu/books/0309088526/html/).

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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, which was published in the NIH Guide on May 7, 2003.

2. Funds Available

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

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

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. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project, 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 Program Announcement funding opportunity.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, which was published in the NIH Guide.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Units of State government
Units of local government
Eligible agencies of the Federal government
Foreign Institutions
Domestic Institutions
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

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

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

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

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

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

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

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional 1 to 2 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
E-mail [email protected]

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

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

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

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

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

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

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

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

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Charge back of customs and import fees is not allowed.
Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."
Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative and National 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 or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
Letter of Intent Receipt Date: Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

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

3.C. Application Processing

Applications may be submitted 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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt 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 business days to view the application image.

If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
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 the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
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 didn t 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 . Information related to the assignment of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

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

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

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:

R21 applications will use the modular budget format and "Just-in-Time" concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 2-year period. No more than $200,000 in direct costs will be allowed in any single year.
Items 2-5 of the Research Plan of the R21 application may not exceed 15 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.

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

R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism. The following materials may be included in the appendix:
- Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication.
  - Published work: Include only a publication list with a link to the publicly available on-line journal article or the PubMed Central (PMC) submission identification number. Do not include the entire article.
  - Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.
  - Manuscripts published but an online journal link is not available: The entire article may be submitted electronically as a PDF attachment.
- Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
- Graphic images of gels, micrographs, etc., provided that the image (may be reduced in size) is also included within the 15-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Plan for Sharing Research Data

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

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources

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

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique
Receive a second level of review by an appropriate national advisory council or board.

The following will be considered in making funding decisions:

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

The NIH 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 is limited to 15 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.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance
Approach
Innovation
Investigators
Environment
Additional Review Criteria

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

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

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

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

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

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

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

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

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

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

GENERAL INQUIRIES regarding the scope and content of this program announcement should be directed to:

Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
Room B3237, Building 31
31 Center Drive
Bethesda, MD 20892-0183
Telephone: (301) 402-1147
Email: [email protected]

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, MD. Ph.D.
Systems and Cognitive Neuroscience Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2108
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
Fax: (301) 402-2060
Email: [email protected]

Alexis Bakos, Ph.D., M.P.H., R.N., C.
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda MD 20892-4870
Telephone: (301) 594-2542
Fax: (301) 480-8260
Email: [email protected]

Page Chiapella, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2044, MSC 9304
Bethesda, MD 30892-9304
Telephone: (301) 443-4715
Fax: (301) 443-8774
Email: [email protected]

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
Center for Population Research
6100 Executive Blvd., Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1175
Fax: (301) 496-0962
Email: [email protected]

Judith A. Cooper, Ph.D.
Deputy Director, National Institute on Deafness and Other Communication Disorders
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: [email protected]

Jeffrey W. Elias, Ph.D.
Chief, Cognitive Aging
Behavioral and Social Sciences Research
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Email: [email protected]

Elizabeth M. Ginexi, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185 MSC 9589
Bethesda, MD 20892-9589
Phone: (301) 402-1755
Fax: (301) 443-2636
Email: [email protected]

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

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

Bryce B. Reeve, Ph.D.
Program Director and Psychometrician
Outcomes Research Branch
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4005
6130 Executive Blvd., MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 594-6574
Fax: (301) 435-3710
Email: [email protected]

Catherine M. Stoney, Ph.D.
National Center for Complementary & Alternative Medicine
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: [email protected]

Elizabeth A. Yetley, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda MD 20892-7517
Telephone: (301) 435-2920
Fax: (301) 480-1845
Email: [email protected]

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Ms. Cecilia Bruce
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892
Telephone: (301) 496- 5482
Fax: (301) 451-5510
Email: [email protected]

Ms. Diane Drew
National Institute of Nursing Research
Office of Grants and Contract Management
6701 Democracy Blvd., Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-2807
Fax: (301) 480-8260
Email: [email protected]

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: [email protected]

Mr. Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

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: [email protected]

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: [email protected]

Ms. Tanya McCoy
Grants Operations Branch
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 7132, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0183
FAX: (301) 480-3310
Email: [email protected]

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
Fax: (301) 402-3672
Email: [email protected]
Voice Mail: (301) 496 5000 or (800) 952 7951 #90332

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: [email protected]

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: [email protected]

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: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

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

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

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

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

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

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