Expired PA-05-090: Methodology and Measurement in the Behavioral and Social Sciences

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

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

Announcement Type
This is a reissuance of PA-02-072 which was previously released March 7, 2002

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

November 20, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-060, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R03 (PA-06-344) and R21 (PA-06-343) funding opportunity announcements has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter.

November 23, 2005 (NOT-DA-06-005) - The National Institute on Drug Abuse (NIDA) announces its intent to join PA-05-090.

Program Announcement (PA) Number: PA-05-090

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

Key Dates
Release Date: April 15, 2005
Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htmfor details.
Application Receipt Dates(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.htmEarliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R03 and R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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, 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 program announcement is a re-issuance and revision of PA-02-072.
The total amount to be awarded depends on the scientific merit of applications and the funds available in the general funding pool of the participating NIH Institutes and Centers.
This initiative will use the R01, R03 and R21 mechanisms and competitive supplements to funded R01, R37, U01 and P01 projects.
Eligible organizations include 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, and Native American tribal organizations.
Eligible Principal Investigators include any individuals with the skills, knowledge, and resources necessary to carry out the proposed research.
There is no limit on the number of scientifically different applications that may be submitted.
The PHS 398 application form and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, E-mail: [email protected]. 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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, 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, t he 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 program announcement 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 (listed under WHERE TO SEND INQUIRES) of the IC that most closely matches their research focus to determine the IC's interest in the research topic.

This program announcement 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.
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: http://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 (h ttp://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(s) of Support

This funding opportunity will use the R01, R03, and R21 award mechanisms and competitive supplements to funded R01, R37, P01 and U01 awards. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIH Small Research Grant (R03) mechanism should be used for support of pilot and/or feasibility studies for concepts that are sound and justifiable, but not sufficiently developed for the R01 (research project grant) mechanism. A project period of up to two years and a budget for direct costs of up to $50,000 per year may be requested for the R03 mechanism. Competing continuation applications will not be accepted. Small grant support may not be used for thesis or dissertation research. Only one revision of a previously reviewed small grant application may be submitted. Applicants for the R03 mechanism should follow the guidelines published in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html.

The NIH Exploratory/Developmental Research Grant (R21) mechanism is intended to encourage new exploratory and developmental research projects and/or exploration of novel hypotheses or strategies. The applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 in direct costs may be requested in any single year. Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted. Two revisions of a previously reviewed exploratory/developmental grant application may be submitted as defined in NIH Policy at http://grants.nih.gov/grants/policy/amendedapps.htm. Additional information and guidelines for applications to the R21 mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.

For this Program Announcement, the competitive supplement mechanism is intended to add a component of methodological development to a current NIH award. The work should be a logical extension of the goals and objectives of the parent grant, but should constitute new methodological development. Applications for competitive supplements are not appropriate when the sole purpose is to restore awards to the full level recommended by the Scientific Review Group, if they were administratively reduced by the funding agency.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Applications received in response to this program announcement will compete for funds in the general funding pool of the participating NIH ICs. No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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
Native American tribal organizations

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 programs.

2. Cost Sharing or Matching
Not required.

3. Other-Special Eligibility Criteria

Grants that are eligible for competitive supplementation in response to this program announcement are NIH-funded R01, P01, U01 and R37 awards. The existing award must have at least 12 months of support remaining on the start date requested for the competitive supplement. An application for a competitive supplement will not be accepted until after the original application for the parent grant has been awarded (i.e., after a Notice of Grant Award has been issued), and the supplement may not extend beyond the term of the parent grant. The Principal Investigator (PI) must be the same PI as on the parent grant. Sub-project PIs on P01s and U01s are not eligible to apply for competitive supplements. A research plan redundant with any portion of the studies approved under the parent grant will not be supported under this supplement program.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

3. Submission Dates and Times

Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm. Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Applications will be reviewed and awards will be made according to the standard schedule described at http://grants.nih.gov/grants/funding/submissionschedule.htm.

Letter of Intent Receipt Date: Not applicable

Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

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

3.B. Sending an Application to the NIH

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

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

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

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

5. Funding Restrictions

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

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 or competing continuation 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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Specific Instructions for the R03 Mechanism.

Applicants for the R03 mechanism should follow the guidelines published in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. All instructions for the PHS 398 must be followed, with these exceptions:

Research Plan. Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed; competing continuation applications for a small grant will be not accepted.
Appendix. The appendix may include original, glossy photographs or color images of gels, micrographs, etc. provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix.
Budget. All R03 applications must be submitted in a modular grant format. A project period of up to two years and a budget for direct costs of up to two $25,000 modules or $50,000 per year may be requested.

Specific Instructions for the R21 Mechanism.

Applicants for the R21 mechanism should follow the guidelines described in http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. All instructions for the PHS 398 must be followed, with these exceptions:

Research Plan. Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. Preliminary data are not required but may be included if they are available. A Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted.
Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included.
All R21 applications must be submitted in a modular grant format. Applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined two year award period.

Specific Instructions for Competitive Supplement Applications.

Applicants for competitive supplements should use the PHS 398 form, following the explicit instructions for competitive supplements that are included in the PHS 398 Instructions. These include, but are not limited, to the following:

A supplemental application must have the same title as the currently funded grant.
A supplemental application must have the same Principal Investigator/Program Director as the currently funded grant.
Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed the number of pages stated in the PHS 398.
Provide a one-page introduction at the beginning of the Research Plan that describes the nature of the supplement and how it will influence the specific aims, research design, and methods of the parent grant. This introduction will not be counted toward the page limit of sections a-d of the Research Plan. The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application.
If the supplemental application relates to a specific line of investigation presented in the original application that was not recommended for approval by the Scientific Review Group, then the applicant must respond to the criticisms in the prior Summary Statement, and substantial revisions must be clearly evident and summarized in the introduction.
Submit a supplemental application only for a period within the current period of the active grant. At the time of submission, the supplement request must be within the time period of the original (parent) award period, and any extension must be done before submission. Make the ending date of the supplement's first budget period coincide with the ending date of the budget period that is to be supplemented, regardless of the supplement's beginning date. If requesting supplemental funds for the future years of a currently funded grant, make the future years' budget periods coincide with those of the currently funded grant.
For the budget, show only those items for which supplemental funds are requested. If the initial budget period of the supplemental application is less than 12 months, prorate the personnel costs and other appropriate items of the detailed budget. Any budgetary changes for the remainder of the project period of the current grant should be discussed under the budget justification.
A Progress Report must be provided for supplemental applications. Provide the beginning and ending dates for the period covered since the project was last reviewed competitively. Summarize the previous application's specific aims and the importance of the findings. Discuss any changes in the specific aims as a result of budget reductions. Include the complete references to appropriate publications and manuscripts accepted for publication (not part of the page limitations).
If the supplemental application involves clinical research, then you must report on the enrollment of research subjects and their distribution by ethnicity/race and sex/gender. Any proposed additions to the Targeted/Planned Enrollment Table should be provided, in addition to the current Inclusion Enrollment Table.
Include five collated sets, single-sided, of all Appendix material, in the same package with the application, following all copies of the application. Supplemental applications may include the following materials in the Appendix: up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project; surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents; original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the page limit of Items a-d of the research plan, are also acceptable. No photographs or color images may be included in the Appendix that are not also represented within the Research Plan.

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.

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

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

Sharing Research Resources

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

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

Section V. Application Review Information

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

2. Review and Selection Process

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

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

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

The following will be considered in making funding decisions:

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

The goals of NIH supported research are to advance our understanding of biological and behavioral 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.

1. 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?

2. 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?

3. 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?

4. 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)?

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

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

3. Anticipated Announcement and Award Dates

Announcements and awards will follow the standard schedule that is posted at http://grants.nih.gov/grants/funding/submissionschedule.htm. See Review and Award Schedule.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. NGAs are sent via e-mail to the office of the Administrative Official named in item 12 on the Face Page of the PHS 398 application form. If a grantee is not e-mailed enabled, a hard copy of the NGA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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 256, Building 1
One Center Drive
Bethesda, MD 20892-0183
Telephone: (301) 451-4286
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:

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]

Emmeline Edwards, Ph.D.
Systems and Cognitive Neuroscience Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2109
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
Fax: (30l) 402-2060
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]

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]

Louise C. M sse, Ph.D.
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4080, MSC 7335
Bethesda, MD 20892
Telephone: (301) 435-3961
Email: [email protected]

Shobha Srinivasan, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
RTP, NC 27709
Telephone: (919) 541-2506
Fax: (919) 316-4606
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]

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]

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Ms. Victoria Connors
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]

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 the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (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.

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

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

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

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

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

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

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

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

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NIH Funding Opportunities and Notices