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 Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov
National Institute on Aging (NIA) http://www.nia.nih.gov
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov

Title: Mind-Body Interactions and Health: Restricted Competition for Research Infrastructure Programs (R24)

Announcement Type
This is a modification of RFA-OB-03-004, which was previously released on January 9, 2003.

Request For Applications (RFA) Number: RFA-OD-06-005

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.866, 93.242, 93.853

Key Dates
Release Date:  November 15, 2006
Letters of Intent Receipt Date(s): December 12, 2006
Application Receipt Date(s): January 12, 2007   
Peer Review Date(s): March-April 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date: September 2007
Expiration Date: January 13, 2007

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
 1. Research Objectives

Section II. Award Information
 1. Mechanism(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 and 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. Background

The Public Health Service has documented that many of the leading causes of morbidity and mortality in the U.S. are attributable to social, behavioral, and lifestyle factors (e.g., tobacco use, lack of exercise, poor diet, and drug and alcohol abuse). Numerous studies have also documented that psychological stress is linked to a variety of health outcomes, and researchers and public health officials are becoming increasingly interested in understanding the nature of this relationship. Research has shown, for example, that psychological stress can contribute to increased heart disease and decreased immune system functioning. Other research has demonstrated that cognitions (attitudes, beliefs values), social support, prayer, and meditation can reduce psychological stress and contribute to positive health outcomes. Consequently, over the past decade the National Institutes of Health have increased efforts to encourage and support health and behavior research. Mind-body research is viewed as one component of health and behavior research. In 1999, using funds especially appropriated by Congress to the OBSSR, the NIH issued a Request for Applications (RFA) for Centers for Mind-Body Interactions and Health (OD-99-005) and subsequently awarded five P50 Center Grants. This was followed by funding announcements for R01s, R21s, and R24s in 2003.

During this period, the NIH commissioned a series of reports from the National Research Council and the Institute of Medicine, such as “New Horizons in Health: An Integrative Approach” (National Academy Press, 2001) and “Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (National Academy Press, 2001). These reports include calls for expansion of interdisciplinary health research on mind-body topics.

2. Objectives and Scope

The primary purposes of the Mind-body and Health Research Infrastructure Program are to provide resources to support and advance research that will improve the understanding of mind-body interactions and health, facilitate interdisciplinary collaboration among investigators conducting health-related mind-body research, and promote innovative approaches to mind-body and health research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States in order to contribute to the integration and coordination of mind-body and health research.

The INFRASTRUCTURE AWARD (R24) retains some of the characteristics of traditional P30 and P50 grants. It will provide infrastructure to support a portfolio of mind-body and health research housed in or coordinated by a center or other research unit (hereafter, “research unit” or “unit”) at an institution. However, it is designed to move beyond the traditional center grant mechanism to allow institutions to pursue aggressively scientific opportunities in mind-body and health research and to facilitate partnerships among diverse scientists and institutions. The Infrastructure Award permits a streamlined format that allows more flexible use of funds to address not only the core support needs of existing projects, but also the development of new directions and approaches to mind-body and health research and the translation of research findings into practice. It asks applicant institutions to design and propose infrastructure programs that will serve to advance the interdisciplinary reach, innovation, and impact of their research programs, in addition to serving the existing needs of researchers. It also allows and encourages the development of infrastructure that broadly serves the field of mind-body and health research.

Applicant institutions responding to this RFA must articulate a clear vision for their research unit and its current and future contributions to mind-body and health research. Applicant institutions must identify the central scientific objectives and themes of the unit, and these must be relevant to the NIH mission. Illustrative examples of mind-body and health research topics that fall within the mission are listed below. Applicant institutions are encouraged to consult with program staff listed under INQUIRIES to determine the relevance of other topics to the NIH mission.

3. Research Topics

Three areas of research are emphasized. In addition, special importance is given to mind-body research in diverse racial/ethnic and socioeconomic status populations (e.g., cultural beliefs regarding health; perceived racism and health; distrust of health care systems and health care utilization). The formation of multidisciplinary teams to perform the research of this initiative is viewed as essential. Note that the research questions provided below are examples only and applicants are not limited to addressing only these questions.

a. The first area of emphasis is the effect of cognitions or personality (e.g., beliefs, attitudes, and values; modes of thinking) and of emotions on physical health. Included is research on social, psychological, behavioral, affective, and biological factors mediating these effects. Examples of research questions are: What are the physiological, behavioral, and social pathways by which beliefs, attitudes, and values or particular stress-management interventions affect health? How do emotions, personality, and cognitions interact to affect health?

b. The second emphasis is on determinants or antecedents of health-related cognitions (beliefs, attitudes, or values; modes of thinking; decision-making styles). That is, given that some beliefs and attitudes have been shown to affect health, how are these beliefs, attitudes, and values developed, maintained, or changed?

Specifically, this RFA will support research that addresses issues such as: What contributes to individual differences in the beliefs, attitudes, and values that affect health and biological processes? How are health-related beliefs, attitudes, and values formed, maintained, and changed? How do social class, family, culture, disability, age, gender, or ethnicity influence health-related beliefs, attitudes, values, or cognitive styles?

c. The third is on how stress influences physical health, including: (a) basic research investigating how affect, attitudes, beliefs, and values influence perceived stress, individual differences in the biology of stress, and interactions between stress and behavioral risk factors for disease; (b) behavioral, affective, and biological mediators of the relationship between stress and health or disease, (c) the evaluation of mind-body interventions (e.g., relaxation-based, cognitive therapy, or support group) for physical illness and/or biological functioning, and (d) the translation of successful interventions into programs deliverable in clinical settings. These interventions may be examined alone or in conjunction with other stress management techniques.

Examples of appropriate questions are: Through which psychological or physiological pathways do stress management approaches affect health? What are the effective components in successful stress-management practices? Does the combination of various stress management techniques improve outcome? Are particular stress-management interventions more effective for certain individuals, populations, or health outcomes? Can successful stress-management practices be effectively implemented in natural settings? What are the possible economic implications of utilizing stress management interventions? What are the factors that lead to individual differences in how stress is experienced and managed as well as in the health consequences of stress?

The following are examples of topics of interest specific to the Institutes the have joined with OBSSR in supporting this initiative:

Mind-body interventions represent one of the major domains of complementary and alternative medicine (CAM).  This domain includes CAM practices that intend to facilitate the mind's capacity to affect bodily functions and lessen symptoms of disease.  These diverse practices are of interest to NCCAM and include, but are not limited to, various types of meditation; yoga; tai chi (Taiji); unconventional uses of hypnosis; guided imagery; spirituality and other forms of mental healing. In addition, many traditional medical systems, such as Traditional Chinese and Ayurvedic Medicine, utilize mind-body CAM techniques. NCCAM is also interested in research on practitioner-patient interactions, and in mechanistically-focused investigations of the placebo effect. Specifically related to this RFA, NCCAM is interested in research involving the types of mind-body interventions described above that can help elucidate the mechanisms by which personality, cognitions, emotions, as well as beliefs and attitudes, can affect physical health; and how and whether CAM mind-body interventions can enhance healing and reduce the physical manifestations of illness. NCCAM encourages CAM-related mind-body research that draws upon contemporary tools of neurobiology, neuroimmunology, and neuroendocrinology using state-of-the-art imaging, cellular, genetic, biochemical and molecular approaches.

The mission of NIMH is to reduce the burden of mental illness and behavioral disorders through research on mind, brain, and behavior.  With regard to this RFA, the following are illustrative topics:  Mechanisms accounting for the co-occurrence and co-morbidity of mental disorders with physical disorders; identification of principles motivating and sustaining behavior changes to reduce the risk for co-occurring mental and physical disorders; relationships of pain to mental disorder; interventions to prevent the occurrence of mental health problems in individuals with physical disorders; tests of innovative treatments for individuals with co-occurring mental and physical disorders; social, psychological, and neurobiological factors underlying stress responsivity; "social neuroscience" investigations to uncover mechanisms underlying effects of interpersonal, social and other environmental factors on mental and physical health and disease; influences of cognitive, personality, interpersonal and cultural factors on perceptions of risk, help-seeking, symptom reporting and health-related behavior; identification of neural substrates underlying cognitive functions that influence emotional and stress reactivity; and identification of hormonal, biochemical, and cellular pathways mediating effects of stress and illness on cognition and mood.  Experimental approaches should encompass the range of cutting-edge methods in social and behavioral science as well as neuroscience.

The NIA’s mission is to improve the health and well-being of older Americans through research. The NIA takes a developmental life-course perspective on aging. With respect to the RFA, research areas of interest include: (1) Mind-body effects on acute and chronic health, quality of life, functional capacity, and life expectancy/mortality; (2) How diseases common in late-life (e.g. hypertension, Type II diabetes, osteoarthritis, Alzheimer’s disease) are modulated by physiological, neurological, cognitive, affective, perceptual, and psychosocial factors experienced by the older individual; and (3) Integrative approaches (e.g., social neuroscience, psychoneuroimmunology) to understanding the psychological and neurobiological mechanisms underlying the relations among social connectedness, social isolation, psychological well-being, self-regulation and the health and well-being of middle aged and older adults. Research on how mind-body processes affect health disparities is especially encouraged, as is multilevel/multi-system and interdisciplinary research. Illustrative examples include: mind-body effects on longevity; early life experiences mediated via mind-body interactions and their effects on late life health; mind-body effects that are predictive of adherence to and benefit from an intervention; the cumulative effects of stress on the health of the elderly; the impact of optimism, happiness, or a positive attitude on well-being and health; the emotional and cognitive impact of social exclusion and disruptions to social functioning on health; the percepts and affective responses to one's socioeconomic and occupational environment and their effects on health; and the cumulative impact of extreme stress on health in low resource/low income and in-transition countries

The NINDS is interested in mind-body research relevant to: 1) development of research strategies for stroke prevention and appropriate management of recurrent stroke (behavior modification; life style changes, role of psychosocial variables like stress, depression, coping skills, social support/social isolation); 2) development and evaluation of rehabilitation interventions for neurological disorders (stroke, TBI, neurodegenerative disorders) - physiological behavioral and social pathways influencing rehabilitation outcomes; 3) behavioral and psychosocial intervention in randomized clinical trials of neurological disorders (epilepsy, stroke, TBI, neurodegenerative) - interactions of behavioral and biomedical treatments.

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 R24 award mechanism.

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

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIH Office of Behavioral and Social Sciences Research (OBSSR) intends to commit approximately one million dollars in FY 2007 to fund three new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for total costs may not exceed $1,000,000 per year.   

Although the financial plans of the OBSSR 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.

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:

This is a restricted competition. See 3. Other–Special Eligibility Criteria.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

None.

The most current Grants Policy Statement can be found at: https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Competition for these awards is restricted to the current holders of R21 grants awarded under RFA-OB-03-005 (Mind-Body Interactions and Health: Exploratory/Developmental Research Program). No other organizations may apply. 

To be eligible to apply, the institution must have at least five (5) researchers with a history of research activity related to mind-body and health research in both of the following categories:  (1) externally funded research grants or contracts in the past five years and (2) one or more publications in peer-reviewed journals during the past five years. The "past five years" refers to the 60-month period preceding the application submission date for this RFA. "Externally funded" means funding is received from sources outside the institution; it may include peer-reviewed funding from NIH, NSF, other federal agencies, state and local governments, and private foundations. Include only projects on which the individual has served as Principal Investigator or had substantial involvement, comparable to that indicated by identification of an investigator as "key personnel" on an NIH-funded grant.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at https://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: GrantsInfo@nih.gov.

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 received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): December 12, 2006
Application Receipt Date(s): January 12, 2007
Peer Review Date(s): March-April 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 2007

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Ronald P. Abeles, PhD
Office of Behavioral and Social Sciences Research
National Institutes of Health
Building 31B, Room B2B37, MSC 2027
Bethesda, MD 20892-2027
Phone: 301.496.7859
Fax: 301.402.1150
Email: abeles@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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)

Personal deliveries of applications are no longer permitted (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the OBSSR. Incomplete and non-responsive applications will not be reviewed.

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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new 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 https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Supplemental Application Instructions

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a table of contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily. The Table of Contents should contain the types of information suggested below in three sections: Section I - General Information, Section II - Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents appear in capital letters.

SECTION I. GENERAL INFORMATION

A. FACE PAGE

No special instructions.

B. DESCRIPTION AND PERSONNEL

Abstract of Research Plan. On page 2, describe briefly the objectives of the proposed infrastructure grant and the proposed infrastructure components. The abstract should fit in the space provided.

C. TABLE OF CONTENTS

Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions.

D. BUDGET ESTIMATES

Prepare composite budget tables for the Infrastructure Grant as requested below. Requested funds should not exceed $1,000,000 per year in total costs (i.e., combined direct and Facilities and Administrative (F&A) costs) and not more than three (3) years of requested support. Separate detailed budget tables also are required for each component.

1. Composite Budget

No special instructions.

2. Infrastructure Component Budgets 

Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for each component for which support is requested for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each component.

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support for each component.

Consortium Budgets (if applicable) should be presented as described in Item 1 (Composite Budget). Total Direct and F & A Costs of sub-awardee are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual component budgets and a detailed consortium budget is to be inserted following the appropriate core budget, using Form Pages 4 and 5.

3. Budget Justifications

No special instructions.

E. BIOGRAPHICAL SKETCH

Biographical sketches are required for all key scientific and technical personnel participating in the program.

1. Active Research Staff

List all key scientific personnel in the program. Beginning with the Principal Investigator, and following in alphabetical order, submit biographical sketches as described in the instructions for Form PHS 398. Do not exceed four pages for each person. Note that this information is essential in demonstrating that the applicant institution meets eligibility requirements for a R24 award. (See Section III: Eligibility Information; 3. Other-Special Eligibility Criteria.)

2. Technical Staff

List all technical personnel involved in infrastructure components of the application. In alphabetical order, submit biographical sketches as described in the instructions for Form PHS 398. Do not exceed four pages for each person.

F. SUMMARY TABLE OF RESEARCH SUPPORT

Applicants should present a summary table of the levels of infrastructure and research support received by the unit, by source. This table should show, for the applicant unit as a whole, the total funds supporting research and infrastructure in the unit for the most recent budget year available. Show sources of funds in major categories (e.g., NIH P30, R03, or R01 grants, NSF, Foundations, parent institution, etc.). Note that this information is essential in demonstrating that the applicant institution meets eligibility requirements for a R24 award. (See Section III: Eligibility Information; 3. Other-Special Eligibility Criteria.)

G. RESOURCES AND ENVIRONMENT

Complete the "RESOURCES" section on Form Page 8 for the overall unit. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Use continuation pages as needed.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each section by title, and assign each a capital letter (A, B, C, etc.) that reflects the order in which they are presented in the application research plan.

Page limitations: The length of the sections devoted to the overall description of the program, progress report, research activity, and proposed infrastructure components must not exceed those specified below. Applicants should be concise.

A. PROGRAM OVERVIEW

Summarize the central scientific objectives and themes of the unit. Highlight significant, unique, and/or cross-cutting areas of research. Describe the impact the unit has had on the field with reference to major recent contributions by active researchers in the program, large-scale projects that exhibit positive externalities in the field, creation of interdisciplinary collaborations, training and mentoring of new scientists, scientific leadership of program personnel, or translational activities to improve clinical practice, public intervention programs, and public policy formulation. Summarize the vision of program researchers for the unit's future scientific advances and contributions.

Describe the configuration and governance of the unit and provide an organizational chart. Include information on administrative position of the unit within the larger institution, the authority of the Director, and the use of advisory or user committees. Outline the principles and procedures the unit uses to determine membership in or affiliation with the unit and to allocate resources and grant access to core services. If the unit employs more than one category of membership or affiliation, explain the privileges and responsibilities associated with each. Describe how the NIH support would leverage and interact with all other forms of support contributing to the research activities of the program.

Describe strategies the unit employs for advancing the quality and innovation of its mind-body and health research program over the short and long run. Describe how the unit fosters the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in mind-body and health research. Describe how the unit develops and implements its goals. Describe how the unit assures the development and success of junior scientists.

Summarize the key features of the proposed infrastructure program and explain how each element will advance the quality, productivity, and innovation of the unit's research activities. For Public Infrastructure activities, explain the value and significance of the activities.

Do not exceed 8 pages for this section.

B. PROGRESS REPORT

Prepare a progress report as required in PHS 398 for the currently awarded R21. 

Do not exceed five pages.

C. SCIENTIFIC OBJECTIVES AND THEMES

Describe the themes of the unit's research program and its central scientific objectives for advancing research on these themes. For each highlighted theme:

Discuss the scientific and practical significance of the research theme: how can advances in this area contribute to substantive knowledge, scientific methods, or public well-being?

Describe how current and recent research activity in the unit has contributed to the theme: what scientific accomplishments have program scientists achieved and how have they affected mind-body and health research? Highlight activities that have produced significant innovation and/or interdisciplinary collaboration.

Describe the vision of program scientists for advancing research on this theme. What are the important questions to be answered? What challenges must scientists overcome to answer them? What specific objectives will guide the work of program scientists in this area?

What strategies will program scientists adopt to meet the challenges and objectives relating to this theme? Include discussion of how the proposed infrastructure components will advance research in this area.

Do not exceed 15 pages for this section.

D. RESEARCH ACTIVITY OF PROGRAM SCIENTISTS

Briefly summarize the recent and current research activity of each active program scientist with respect to each of the five points listed below. Use one page per active researcher. Describe the Principal Investigator's research activity first and that of all other researchers subsequently in alphabetical order.

1. Summarize the most important scientific accomplishments of the researcher during the 36 months prior to the receipt date for this RFA (i.e., January 2004 to January 2007). Discuss these accomplishments with respect to their significance, innovation, and actual or potential impact on mind-body and health research.

2. Identify externally funded research projects in which the researcher participated as key personnel during the 36 months prior to the receipt date for this RFA, the amount, source, and period of funding, and the role and time commitment of the individual on the project. Information provided under F. OTHER SUPPORT may be referenced as appropriate to avoid repetition.

3. Briefly summarize relevant working papers and future research plans (e.g., pending and planned research grant applications).

4. Describe how the researcher contributes to the unit's research program: how his or her expertise, disciplinary training, substantive interests, technical skills help to advance the central scientific objectives and themes of the unit. Identify recent, active, or planned collaborations involving this researcher.

5. Describe how the researcher uses (or would use) the proposed infrastructure cores or activities. 

E. COMPONENT DESCRIPTIONS

Describe proposed components in the order listed below. If more than one component is proposed under a given category, assign letters to distinguish the components (e.g., 1.a; 2.c). For each component, provide the name of the Director and describe procedures used to assure cost-efficiency and high quality administrative and research activities. An applicant may request support for one or more of the components (Research Support Cores, Developmental Infrastructures, Research Projects, and/or Public Infrastructures) described below.

Do not exceed five pages in describing each component (core or activity), except for the Research Projects. If any component is described as a collaborative activity (i.e., involving partnership with another institution), applicants may use one additional page to describe how each partner will contribute (e.g., in terms of administration, staffing, and other resources); how each partner will benefit (e.g., in terms of access to services or research productivity); and how decision-making will be shared.

1. Research Support Cores - Describe the objectives, administrative organization (use organizational chart), staffing (including a Core Director and any professional or technical personnel and their duties), space and physical resources, current and projected services, eligibility for and allocation of services, and cost-sharing arrangements. Briefly describe current or planned research activities that will utilize the core services.

Explain how the proposed research support cores will contribute to advancing the central scientific objectives and themes of the research program and how the activities will foster innovation in the program's research. Describe strategies for assuring that research support services effectively respond to and anticipate the evolving needs of science conducted in the unit. Justify the core in terms of scientific impact and cost-effectiveness. Explain what the proposed core services will provide over and above research support that the applicant's institution already provides and why they are essential to meet the needs and goals of the research program.

2. Developmental Infrastructure - Describe the objectives and administrative organization of each type of developmental infrastructure. Describe the impact of the infrastructure on mind-body and health research within the unit. In describing seed grant programs, provide details on program procedures and policies, including review procedures; priorities for allocating funds; requirements for leveraging funds or preparing research proposals to extend or continue the project; size of awards; length of award periods; number of awards permitted to an individual researcher; mentorship arrangements; and cost-sharing arrangements with the parent institution.

Faculty development may include salary and/or research support for new faculty. Describe the probable use of faculty development funds and the ways in which the plan will advance the unit's research objectives.

3. Research Projects - For each component research project, provide a full description of the project following the format presented in Form PHS 398. Begin the presentation of each component research project on a separate, plain page (i.e., don’t use the Face Page form):

Indicate: Project Title, Principal Investigator, title, location, other investigators, consultants, and collaborators, titles (associate professor, postdoctoral fellow, student), and location.

Present an Abstract of Research Plan (use Form Page 2 of PHS 398).

Present the Research Project Plan (do not exceed 15 pages for Sections A-D). Discuss the purpose and nature of the project and its relevance to the program's signature theme(s). Address the following: Specific Aims, Significance, Preliminary Studies and/or progress to date (for competing continuations), if applicable. Discuss the Research Design and Methods. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements. (See REQUIRED FEDERAL CITATIONS, below.) Discuss Human Subjects, Vertebrate Animals, Consultants, Collaborative arrangements, including pertinent letters of assurance and intent. Present a section on Literature Cited.

4. Public Infrastructure - Describe the objective of each activity and the target audience (e.g., mind-body and health researchers, program managers, policy makers). Explain the significance of the activity. Discuss the potential of the activity for advancing mind-body and health research, stimulating innovative or interdisciplinary research, and/or enhancing the effective dissemination and translation of research findings. Describe the unique contribution of the activity compared with other similar activities that may already exist. Describe the administrative organization (use organizational chart), staffing, space and physical resources and current or projected services and activities. Describe the plan for disseminating the resources, services, or products to the target audience. Justify the core in terms of cost-effectiveness and describe short- and long-range plans for supporting the activity.

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 (https://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 expects 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 https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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, https://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.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR in accordance with the review criteria stated below.

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

The goals of NIH-supported research are to advance our understanding of health-related biological, behavioral, and social systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of each project in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria listed below will be addressed and considered in assigning the score for a research project, weighting them as appropriate for each project. Note that the project 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 your project address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field?

(2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics?

(3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

OTHER REVIEW CRITERIA:

A. OVERALL PROGRAM

Two PRIMARY CRITERIA will be used to evaluate the overall scientific merit of an application for a Research Infrastructure Award:

1) Quality of the research program and its impact on the field: Reviewers will consider the significance, innovation, and quality of current and recent contributions of program scientists. Have these contributions produced new knowledge and/or new approaches to research that have significantly expanded, improved or altered the content, methods, and direction of mind-body and health research? In order to create a level playing field for smaller and larger programs on this criterion, reviewers will be asked to take size of the program into account in assessing impact. In other words, while both larger and smaller programs will be expected to demonstrate research activity of high quality, programs with fewer researchers would not be expected to demonstrate the same quantity of research productivity and program impact as programs with a greater number of researchers.

2) The potential future contributions of the applicant program to mind-body and health research: Reviewers will base their assessment of potential on such factors as the current trajectory of research productivity, innovation, and accomplishments; the significance of the applicant institution's central scientific objectives and themes and the plan for advancing them; the program’s plan for encouraging synergy and interaction among mind-body and health researchers; and the applicant institution’s success in contributing to the development of junior investigators.

Applicant institutions proposing only Public Infrastructure activities will be judged on the basis of the secondary criteria below and the detailed review criteria listed below under “Public Infrastructure.”

Three SECONDARY CRITERIA will also be used to assess the overall scientific merit of applications:

1) Quality and potential impact of proposed infrastructure program: Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposed activities, that the proposed program will enhance mind-body and health research, promote new research directions, facilitate interactions across disciplines and substantive areas of study, or advance theoretical or technical approaches. For infrastructure components benefiting audiences outside the mind-body and health research community, reviewers will assess potential impact in terms of improving the accessibility of mind-body and health research to significant audiences and enhancing the appropriate application of research findings to activities that improve health and well-being.

2) Research competence of key personnel: Reviewers will consider the capability and scientific credentials of the Principal Investigator to direct the program and maintain high standards of research collaboration; the specific technical qualifications of core directors; and the scientific accomplishments of all participating investigators.

3) Institutional commitment and environment: Reviewers will assess the nature and level of resource commitment from the institution in which the center is housed and any cooperating institutions, taking into account the institutional context. Reviewers also will consider the academic and physical environment as it bears on research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines.

B. INFRASTRUCTURE SUPPORT COMPONENTS:

Individual elements of the proposed infrastructure program will be evaluated separately based on the criteria below.

1. Research Support Cores

3. Research Projects:

In addition to the standard criteria for R01-like research grant applications, each proposed research project will be evaluated with respect to:

The contribution of the project to advancing the unit’s central scientific objectives and themes and the extent to which it embodies innovative, collaborative, and/or cross-cutting elements of the unit.

4. Public Infrastructure:

Public infrastructure components will be evaluated according to the following criteria:

Applications proposing to undertake any infrastructure activity in cooperation with another institution will be evaluated for the value added by the involvement of other institutions and the appropriateness and adequacy of plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources.

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.

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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. https://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects 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 https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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 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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (https://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:

For general information:

Ronald P. Abeles, PhD
Office of Behavioral and Social Sciences Research
National Institutes of Health
Building 31B, Room B2B37, MSC 2027
Bethesda, MD 20892-2027
Phone: 301.496.7859
Fax: 301.402.1150
Email: abeles@nih.gov

National Center for Complementary and Alternative Medicine

Catherine M. Stoney, Ph.D.
6707 Democracy Blvd, Suite 401, MSC 5475
Bethesda, Maryland 20892-5475
Phone: 301.402.1272
Fax: 301.480.3621
Email: stoneyc@mail.nih.gov

National Institute on Aging

Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging/National Institutes of Health
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Phone: 301.402.4156
Fax: 301.402.0051
Email: nielsenli@nia.nih.gov

National Institute of Mental Health

LeShandra Price, Ph.D.
Psychosocial Stress and Related Disorders Branch
Division of Pediatric Translational Research and Treatment Development
Neuroscience Center, Room 6163
6001 Executive Blvd
Bethesda , MD 20892-9617
Phone: 301.443.5944
Email: lprice@mail.nih.gov

National Institute of Neurological Disorders and Stroke

Debra Babcock, MD., Ph.D.
Program Director, Extramural Research Program
Systems & Cognitive Neuroscience Cluster, NIH/NINDS
Neuroscience Center, Room 2108
6001 Executive Blvd MSC 9521
Bethesda, MD 20892-9521
Phone: 301.496.9964
Email: dbabcock@ninds.nih.gov

2. Peer Review Contacts:

Michael Micklin, Ph.D.
Chief
Risk, Prevention, & Health Behavior Integrated Review Group
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3100 MSC 7808
Bethesda, MD 20892-7808 (20817 for overnight delivery)
Phone: 301.435.1258
Fax: 301.594.6363
Email: micklinm@mail.nih.gov

3. Financial or Grants Management Contacts:

National Center of Complementary and Alternative Medicine
George A. Tucker, M.B.A.
Chief Grants Management Officer
Division of Extramural Research and Training
National Center of Complementary and Alternative Medicine
II Democracy Plaza, Suite 401
6707 Democracy Boulevard, MSC5475
Bethesda, MD 20892-5475
Phone: 301.594.9102
Email: tuckerg@mail.nih.gov

National Institute on Aging

Richard Proper
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Phone: 301.402.7735
Fax 301 402.3672
Email: ProperR@nia.nih.gov

National Institute of Mental Health

Margaret Baritz
Division of Extramural Activities
Grants Management Branch
Neuroscience Center, Room Number 6125
National Institute of Mental Health
6001 Executive Blvd
Bethesda , MD 20892-9605
Phone: 301.443-1341
Email: mbaritz@mail.nih.gov

National Institute of Neurological Disorders and Stroke

Pamela Mayer
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3254
Bethesda, MD 20892
Phone: 301.496.4207
Fax: 301.402.0219
Email: mayerp@ninds.nih.gov

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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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, https://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 (https://grants.nih.gov/grants/policy/data_sharing).

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://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 https://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 https://grants.nih.gov/archive/archive/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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 (https://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 https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 https://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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