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
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)

Title: Developmental Centers for Research on Complementary and Alternative Medicine: Phase I (DCRC I)[U19]

Announcement Type
This is a reissue of PAR-03-046, which was previously released 12/19/2002

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

Program Announcement (PA) Number: PAR-06-108

Catalog of Federal Domestic Assistance Number(s) 
93.213

Key Dates 
Release Date: December 22, 2005
Letters of Intent Receipt Date(s): July 11, 2006
Application Receipt Dates(s): August 11, 2006
Peer Review Date(s): October 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: January 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 12, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(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  
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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 National Center for Complementary and Alternative Medicine (NCCAM) seeks applications for Developmental Centers for Research on Complementary and Alternative Medicine: Phase I (DCRC I) using the U19 cooperative agreement mechanism.

The purpose of the DCRC I awards is to promote the development of CAM research expertise and infrastructure, support developmental research projects, and support enhanced communication and partnership-building between CAM and conventional institutions and investigators.  The DCRC I awards are expected to serve as a basis for strengthening future complementary and alternative medicine (CAM) research grant applications. 

Specifically, the DCRC I will provide support for up to four years, including up to $100,000 total direct costs for a first, preparatory/planning year, during which capacities required for the proposed projects (e.g., measurement methodology and/or instruments recruitment strategies, clinical data collection, etc.) may be developed as needed at the participating CAM institution(s), and research plans may be refined.  Support of at least three, but not more than four developmental/exploratory CAM research projects in subsequent years will be dependent on programmatic review of progress in establishing the partnership and achieving planning/preparatory year objectives during the first year. 

An essential characteristic of the DCRC initiatives is commitment of the participating CAM and conventional institutions to ongoing partnership.  NCCAM encourages a multidisciplinary approach to research, which these Centers are expected to reflect. The DCRC I awards are also expected to develop and sustain preliminary research studies that will lead to the submission to NCCAM and other NIH Institutes or Centers of competitive DCRC: Phase II or other grant applications to conduct CAM research.

DCRC I applications are encouraged but not required to focus the proposed research projects around a disease or class of diseases treated using CAM, a specific group of CAM therapies or treatment approaches, or the mechanisms of action of specific CAM modalities.   Centers may also be organized around a theme, e.g., wellness.  These examples should not be considered to be comprehensive, exclusive, nor in priority order.

Given the greater level of coordination required of multi-institution research projects, NCCAM strongly urges regular communication between investigators in DCRC I and suggests that the investigators within the institutions comprising each center hold face-to-face meetings on a regular basis. 

BACKGROUND

The DCRC I initiative constitutes one component of NCCAM’s evolving, multi-faceted Centers program.  Other components of NCCAM’s Centers program include DCRC II awards, available only to applicants that have successfully held a DCRC or DCRC I award, and which support at least one R01- comparable research project, as well as R21-level research projects.  All DCRC awards require collaborations between CAM and conventional institutions.  NCCAM’s Centers program also includes the Centers of Excellence for Research on CAM, International Centers for Research on CAM, and Centers for Dietary Supplements Research. 

NCCAM defines CAM as a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.   NCCAM groups the wide range of CAM modalities into four domains:  1) Mind-Body Medicine; 2) Biologically-based practices; 3) Manipulative and body-based practices; and 4) Energy Medicine.  In addition, NCCAM supports studies of whole medical systems, such as Ayurvedic medicine, traditional Chinese medicine, traditional, indigenous medical systems, and homeopathy.   

Mind-body interventions use a variety of techniques designed to enhance the mind's capacity to affect body functions and symptoms.  Mind-body techniques that are considered CAM include yoga, lifestyle behaviors such as tai chi exercise, meditative strategies such as mindfulness meditation, and some psychological strategies to manage stress.  Also included are therapies that use creative outlets such as visual arts, music or dance. Other techniques that were considered CAM in the past, such as patient support groups, have become mainstream, and are not suitable subjects for research supported by the DCRC program.   

Biologically-based practices for prevention and therapy use foods and their components, diets, and dietary supplements (including botanicals, animal-derived products, probiotics and small molecules) and functional foods.  Applicants planning to propose studies of biologically-based practices should consult NCCAM’s policy on biologically-active agents used in CAM (http://nccam.nih.gov/research/policies/bioactive.htm). 

Manipulative and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body.  Examples include chiropractic or osteopathic manipulation, and massage therapy.     

Energy therapies are of two types: 1) Biofield therapies (e.g., Qi gong, Reiki, and therapeutic touch), which are intended to affect energy fields that surround and penetrate the human body, and 2) electromagnetic-based therapies that involve the unconventional use of electromagnetic fields such as pulsed fields, magnetic fields, or alternating or direct current fields. 

For many CAM practices the mechanisms of action, optimal dosing and efficacy are poorly understood.  Improved understanding of these practices should eventually translate into integrative medical practice.  

Applications substantially similar to DCRC (or DCRC I or DCRC II) or other Centers already funded (listed at http://nccam.nih.gov/training/centers/index.htm) will be given lower program priority.  Applicants who have questions regarding research areas of interest to NCCAM or eligibility for the DCRC I program should discuss potential proposals with the appropriate NCCAM Program Officer.  A list of NCCAM Program Officers by areas of responsibility is available at http://nccam.nih.gov/research/contact/index.htm.

ELIGIBLE AREAS OF RESEARCH 

Projects of potential interest include:

The foregoing list should not be considered to be comprehensive, restrictive, or in priority order.

Applicants proposing clinical studies should consult the Guidelines for NCCAM-Supported Clinical Trials, at http://nccam.nih.gov/research/policies/index.htm.

NCCAM does not encourage applications for Centers focused on a particular population group unless there is a strong scientific rationale for such a focus.

Applicants are encouraged to consult the NCCAM website

(http://nccam.nih.gov/research/priorities/index.htm#5) for relevant information regarding current NCCAM research priorities.   While this list provides areas currently of special interest to NCCAM, applications focusing on other areas will also be accepted.

STRUCTURE OF THE DCRC I

Leadership:  Each DCRC I will be directed by a Principal Investigator (PI), who may be from either a CAM or a conventional institution, as defined in Section III.1.A.  The PI of the DCRC I must also be a Project Co-Leader of one research project and is required to commit a minimum of 10% effort to the Center in the first year of the award and 30% effort (15% to the Administrative Core and 15% to one research project) in subsequent years of the award.  The PI will identify and select key personnel and allocate and monitor funds. 

Project leaders and co-leaders for each research project (at least15% effort each) are to be named from both CAM and conventional institutions for each project. 

An External Advisory Committee (EAC) will provide guidance to the PI and feedback on DCRC I progress to NCCAM staff.  An Internal Steering Committee (ISC) will ensure frequent communication and sharing of information and regular adjustment of focus within the DCRC I.  The composition, duties, and reporting requirements of both committees, as well as further detail on responsibilities of the P.I. are described in the Special Requirements and/or Terms and Conditions section (VI.2A) of this announcement. 

Internal Steering Committee: The Principal Investigator is responsible for establishing an Internal Steering Committee (ISC), which will consist of the DCRC I PI, appropriate investigators from each of the collaborating institutions and the NCCAM Project Scientist in an ex officio capacity.  The ISC will have responsibility for directing and monitoring the progress of the research projects.  In addition, the ISC must develop opportunities for information exchange, and data sharing.  Each ISC member (or their surrogate) will be expected to participate in all committee activities, e.g., videoconferences, conference calls, special subcommittees as may be necessary, etc. Outside ad hoc consultants can be added as desired. If plans call for inclusion of ad hoc consultants, their areas of expertise should be specified, but specific individuals should not be named. 

Preparatory/planning year: The first year of the award is to be used to prepare for the proposed DCRC I research projects and enhance the research partnership.  The activities proposed should add to research capacities required for the projects proposed for the DCRC I.  Proposed activities may include as appropriate: 

The list above should not be considered to be comprehensive, exclusive, nor in priority order, however, awardees and other participating institutions must comply with all relevant cost principles as set forth in the current NIH Grants Policy Statement, available at http://grants.nih.gov/grants/policy/policy.htm.

Continuation of the DCRC I beyond the preparatory/planning year will be dependent on programmatic review approximately nine months after the award date.  The review will consider progress in establishing partnership between the participating institutions, in preparation for the proposed research projects, and in achieving the planning year objectives.  The application should include a detailed timeline of milestones to be reached during the preparatory/planning year. 

Research projects:  Following the initial, planning year, each DCRC I must be comprised of three to four exploratory/developmental research projects at any given time. 

Core(s):  Each DCRC I is required to have an Administrative Core, which must serve all projects within the DCRC I.  The Administrative Core is responsible for day-to-day administration, as well as program coordination and ongoing evaluation of the Center.  

Additional, scientific cores may be included, as appropriate, bearing in mind that each core should be utilized by as many projects as possible, and must be utilized by a minimum of two proposed projects.  If clinical studies are proposed, a clinical core is suggested, to provide expertise and guidance in e.g., data management, biostatistics, and/or clinical trial design/coordination.   Applicants must document that the functions of proposed additional cores are: 1) not otherwise available at any of the applicant institutions or 2) if such functions are available at one of the participating conventional institutions, that the proposed core will provide critical capacity for future research at a participating CAM institution, and that the relevant conventional institutions will contribute appropriate expertise to developing such capacity.  

Applications must clearly demonstrate how each core will serve the needs of the research program, and how each project will use resources of additional cores.  The percent of each core that will be allocated to each project should be clearly indicated.  

Three related considerations that should be detailed if applicable are: 1) the degree to which currently funded CAM investigators, within or outside the DCRC I, will use and benefit from core resources; 2) the degree to which the resources will promote new and/or expanded CAM research efforts and; 3) the process by which core resources will be allocated among DCRC I projects, and between the DCRC I and other currently funded CAM investigators.    

Training: Principal investigators are strongly encouraged to provide opportunities for postdoctoral clinical or basic research fellows (both CAM and conventional) and junior faculty to participate in individual projects as key personnel.  Funds to support intensive, short-term research training experiences of DCRC I personnel (including students, fellows, interns, residents and other clinical and research staff) in either basic or clinical research as an exchange program between CAM and conventional institutions may be included in the Administrative Core.  Such training may include instruction in CAM concepts and methodologies and/or in conventional research methodology (which may include analytical methods, molecular biological methods, clinical trial planning, statistical methods, ethical practices, or grant writing). 

DCRC I funds may not be used for general education of conventional health professional students about CAM, nor may they be used to support major conferences or colloquia.  

Annual meeting: DCRC I PIs and other key DCRC I staff will be expected to participate in an annual, two-day meeting with other NCCAM-funded center investigators in the Baltimore-Washington area.  Travel costs for this purpose should be included in the proposed budget for the Administrative Core.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U19 cooperative agreement mechanism.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the application instructions (see http://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.

The NIH U19 is a cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

NCCAM intends to commit up to $200,000 in direct costs in FY 2007 to fund up to two new non-renewable DCRC I grants for a period of up to four years in response to this initiative.  Although the financial plans of the NCCAM provide support for this program, awards pursuant to this PAR are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Applications requesting more than $100,000 total direct costs in the first year or more than $600,000 total direct costs in any subsequent year will be considered unresponsive and returned without consideration.  At this time, it is not known if this PAR will be reissued; NCCAM may undertake an evaluation of the DCRC program before making a decision regarding its continuation.  Awards pursuant to this PAR may be made as early as January, 2007.

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:

 All DCRC I applications must include a partnership between an eligible CAM institution and an eligible conventional biomedical or behavioral research institution.  For the purposes of this Program Announcement, eligible CAM and conventional institutions are defined in the following manner:

Applicants that have components participating in, or wishing to include in the DCRC I application an institution that participates in a currently funded DCRC, DCRC I or DCRC II must obtain prior permission from NCCAM.

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

This program does not require cost sharing, matching or cost participation as defined in the current NIH Grants Policy statement.

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

3. Other-Special Eligibility Criteria

Each DCRC application must demonstrate that the following special requirements and provisions are met. Requirements are more fully explained under the heading "Supplemental Instructions" in the SUBMITTING AN APPLICATION Section, below.

Leadership: The PI must be able to dedicate at least 10% effort to the DCRC I in the first year of the award, and at least 30% effort to the DCRC I (at least 15% each to the Administrative Core and to at least one research project) in each subsequent year. 

Individual project/Core Leaders and co-leaders must dedicate at least 15% effort to each project or core they will lead, subsequent to the preparatory/planning year. 

CAM institutions must document commitment to collaborative agreements by investigators at biomedical conventional institutions.  Similarly, conventional institutions must document collaborative agreements with investigators at CAM institutions. 

Section IV. Application and Submission Information

1. Address to Request Application Information

The 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) 435-0714, 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.

Applicants must:

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: July 11, 2006
Application Receipt Date(s): August 11, 2006
Peer Review Date: October 2006
Council Review Date: January 2007
Earliest Anticipated Start Date: January 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:

Barbara Sorkin, Ph.D.
Coordinator, Centers for Research on CAM Program
National Center for Complementary and Alternative Medicine (NCCAM)

6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475  (use 20817 for private courier services)
Office: (301) 594-8018
FAX: (301) 480-3621
Email: sorkinb@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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)

At the time of submission, two additional copies of the application must be sent to:

Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  (301) 594-2014
FAX:  (301) 480-2419
Email:  goldrosm@mail.nih.gov

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of 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.
 
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/archive/grants/policy/nihgps_2003/index.htm.
 
6. Other Submission Requirements

Supplemental Instructions: Because the application form has no specific instructions for multi-project applications such as the DCRC I, consisting of research projects and core(s), the following instructions are provided for sections of the application form that address the collaborative or interactive nature of the DCRC I and are to be completed differently than usual.  For all other items in the individual project application, follow the standard instructions.

The instructions below are divided as follows:

This multi-project grant application should be assembled and paginated as a single, complete document. 

DCRC application overview and preparatory/planning year description

Face page.   Items 1 - 15: complete these items as instructed.

Form page 2.  Using form page 2, provide a succinct but accurate description (abstract) of the overall DCRC I application addressing the overall program, and the ways in which the award will enhance CAM research capacity at the participating organizations, especially the CAM schools. Do not exceed the space provided.

Under "key personnel," list the PI, followed by all other key personnel in alphabetical order.

Form page 3 - Table of contents.

Do not use Form page 3; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project, including the cores, with separate review of activities proposed for the first, preparatory/planning year, prepare a detailed table of contents that will enable reviewers to locate specific information pertinent to the overall application, the preparatory/planning year, and each component research project and core.  A page reference should be included for the budget for each project and each core. 

Further, each research project should be identified by number (e.g. project 1), title, and responsible Project Co-Leaders, and each core should be identified by letter, title, and responsible Core Leader.

Form page 4 - Detailed budget for initial budget period.

Use Form page 4 of PHS Form 398 as a composite budget for the entire DCRC application.  Indicate the page location of the composite budget in the "Table of Contents."  Note: An additional Form page 4 must be used for each individual project and core within the DCRC I application.  Narrative justification for individual budget categories should be presented for each of the projects and cores.

Form page 5 - Budget for entire proposed DCRC I period.

Complete the total direct cost line entries for all requested budget periods (years) and the total direct cost for entire period of support for each project and core.

Biographical sketch form page.  Biographical sketches of all professional personnel for all components should be placed after item j of the Research Plan, with the PI’s first, followed by those of other key personnel in alphabetical order.

Resources form page.  Include documentation of national or regional accreditation of participating CAM institution(s) in this section.  Information on resources relevant to individual research projects and cores is to be presented in the individual research project and core sections of the application.

Checklist.  Complete for the entire application and place at the end of the application package.

Other support page.  Do not complete.  Any required information will be requested from successful applicants prior to grant award.

Program overview (research plan).

Foreword:  Include a one-page foreword in which you describe relevant previous collaborative arrangements, if any.

Items a-d (research plan) are limited to 25 pages.  This important, narrative section summarizes the overall research plan for the multi-project application, and provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general aim(s) of the overall research plan and by laying out a broad strategy for accomplishing the goals of the program.  Indicate the contribution of each project and core to the overall concept.  Include a chart showing the percentage of the activities of each core required for support of each project throughout the requested funding period.  Summarize special features in the environment and/or resources of each of the participating institutions that make this application strong or unique.

Provide a description of all the activities to be undertaken and objectives to be achieved during the preparatory/planning year, and describe the process through which this will be done.  Provide a time-line for completion of activities and achievement of objectives, and indicate how each will contribute to success in the proposed DCRC I research projects, to enhancing the ability of the participating CAM institution(s) to succeed independently in obtaining CAM research funding, and to building ongoing, collaborative CAM research.  Specify clearly who will play what roles in the preparatory/planning activities.

Items e-j of the research plan are not included in the 25-page limit.  They should be completed as appropriate following the standard instructions for each item.

Following item j of the research plan, include letters (on institutional letterhead) from each proposed project Co-Leader and Core Leader confirming their role in the proposed DCRC I, as well as from institutional officials confirming their commitment to the project (see Special Eligibility Criteria in Section III.3, above).  

Appendix.  Provide a single appendix for the entire document following all other sections of the application.

Specific instructions for individual projects

A cover page is required for each research project and should include the number and title of the project. ) Use numbers (1,2,3, etc.) to designate individual research projects, give each a title; and provide the names and titles of the Project Leader and of participating investigators. 

All other items on the face page are to be completed following the standard application instructions.

Form page 2. For each proposed project, provide a description (abstract) of the proposed research according to the instructions for form page 2. In addition, the abstract should contain a brief description of how the research project will contribute to attainment of the DCRC I program objectives.

Under "key personnel," follow the standard instructions, listing all key personnel participating in the project, beginning with the Project Leader.  Distinguish co-investigators from other key personnel.

Form page 3. Prepare a table of contents for each research project using form page 3. Since the biographical sketches of all participating investigators will be located at the end of the overall application they should be referenced in the overall table of contents: do not repeat these pages.

Research plan (a-d).  Do not exceed a total of 20 pages for Items a-d in the Research Plan for each individual project.  Tables, charts, graphs, diagrams and figures must be included within the 20-page limit.  Applications that exceed the 20-page limit or NIH requirements for type size and margins (refer to the standard instructions for details) will be returned to the applicant without further consideration.  The 20-page limit does not include Items e-i (Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators).

Item A - Specific aims (typically one page): List in priority order the broad, long-range objectives of the proposed project and describe concisely and realistically the more immediate goals. In addition, state the project's relationship to the DCRC I program goals and how it relates to other research projects within the DCRC I and to the cores.

Item B - Background and significance: Use this section to describe how the proposed research will contribute to meeting the goals and objectives. Explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. In addition to the overall biological significance of the proposed research, this section should indicate the relevance of the project to the theme of the DCRC I.

Item C – Preliminary studies: Inasmuch as these projects are exploratory/developmental, preliminary data as evidence of feasibility are not required.  However, a strong rationale for the choice of problem and approach is required, and relevant data should be cited when available.

Item D - Research design and methods:  Although preliminary data are not required, the conceptualization and planning of each project must be sufficient to allow for an assessment of the project's potential.  The proposed research must be presented in sufficient detail to allow evaluation of the proposed methods.  Appropriate expertise to conduct the proposed research must be included among the key personnel, e.g., for research involving human subjects, statistical and/or clinical trial design expertise (as appropriate) is essential during the design and conduct of research.

Specific instructions for cores

The application must include an Administrative Core led by the PI of the DCRC I.  Other cores may be requested as appropriate.  Each additional core must be utilized by at least two projects. Funding for the overall administrative efforts, including expenses for publications demonstrating collaborative efforts, CAM research training for DCRC I personnel, all travel associated with the DCRC I, communication expenses, etc., should be requested in the Administrative Core.  The Administrative Core budget should include any funds required for the Internal Steering Committee and External Advisory Committee, as well as funds for attendance of the DCRC I PIs and Project Leaders and co-leaders at an annual, two-day meeting with other NCCAM-funded center PIs in the Baltimore-Washington area. 

A cover page is required for each core and should include the letter and title of the core and provide the names and titles of the Core Leader and of other participating investigators.

All other items on the face page are to be completed using the standard instructions.

Form page 2. Provide a Description (abstract) of the core activities and services according to the instructions on form page 2. In addition, the abstract should contain a brief description of how the core services will contribute to attainment of the DCRC I program objectives.

Form page 3. Prepare a Table of Contents for each core using form page 3. Since the biographical sketches of all participating investigators will be located at the end of the overall application (and should be referenced in the overall Table of Contents); do not repeat these pages.

Core Plan

The research (core) plan (items a-d) for each core section is limited to 15 pages.

Item A - Specific aims: State the core's relationship to the DCRC I goals and how it relates to the research projects in the application.

Item B - Background and significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives. Explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. These resources should not duplicate resources already available to study investigators.  In

addition, this section should indicate the relevance of the core activities to the primary theme of the DCRC I, where applicable.

Appendix. A single appendix for the entire DCRC I application is to follow all projects and the core(s).  Order of materials in the appendix should follow that of the application, i.e., starting with materials relevant to the overall program, continuing with materials relevant to the individual projects, and concluding with any materials relevant to the core(s).

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

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

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

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://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, 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 that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NCCAM in accordance with the review criteria stated below.

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

The following will be considered in making funding decisions:

The following aspects of each DCRC I will be evaluated:

1) Preparatory/planning Year Activities

2) Individual Research Projects

3) Cores

4) Principal Investigator

5) Environment

6) Overall Program

1) PREPARATORY/PLANNING YEAR ACTIVITES

 These will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following:

2) INDIVIDUAL RESEARCH PROJECTS

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

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the research contribute to expertise and infrastructure that will enhance the ability of the participating CAM institution(s) to independently contribute to CAM research in the future?

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? Does the proposal include clear objectives and does the approach adequately address those objectives?  For clinical studies, criteria will include the following: Does the proposal include a trial design and sample size that adequately address the objectives?  Does it contain a clear description of interventions, of primary and secondary endpoints, of ethical considerations including monitoring?

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

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

Environment: Do the environments 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? How strong is the evidence that the researchers at the participating CAM and conventional organizations worked closely together in the preparation of the proposal?  Are CAM practitioners included as appropriate?

Based on the evaluation described above, each project will receive a numerical score from 1.0 to 5.0.

3) CORES

Each core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

4) PRINCIPAL INVESTIGATOR

The P.I will be evaluated with respect to:

5) RESOURCES AND ENVIRONMENT 

Each application will receive a merit descriptor for Resources and Environment (outstanding, acceptable, unacceptable) that reflects the following:

Institutional Commitment

Collaborative Environment 

Resources

Adequacy of facilities to support the proposed research, including clinical facilities, laboratory facilities and data management systems, as needed.

6) OVERALL PROGRAM

A single numerical priority score will be assigned to the DCRC I application as a whole. In assigning the priority score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects and past productivity (where applicable), significant consideration will also be given to the likelihood that the activities proposed for the preparatory/planning year will contribute to successful completion of the proposed research and develop the CAM research capacity of the participating CAM school(s), the strength of core(s), the leadership ability of the PI, institutional commitment, collaborative environment and extent to which the projects and core(s) interact with and inform each other. The degree to which the proposed goals of the DCRC I will likely lead to the submission of further competitive grant applications (DCRC II, R21, R01, P01) to conduct CAM research, to NCCAM and other NIH Institutes/Centers or other funding agencies will also be considered.

An application in which the reviewers consider no more than two component research projects to be of substantial and significant scientific merit will not satisfy the requirements for this U19 award, and therefore will not be recommended for further consideration (NRFC).

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

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/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

 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/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 14 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 (http://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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the U19 cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator of the Developmental Center for Research on CAM: Phase I (DCRC I) will have the primary responsibility to:

The applicant (awardee) institution and the PI will be responsible for the collaborative research activities in the DCRC I. The awardee institution will be legally and financially responsible and accountable for the use and disposition of funds awarded, and will attest to the availability of personnel and facilities capable of performing and supporting the administrative functions of the DCRC I.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
Additionally, an agency program official or NCCAM program officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

The NCCAM Project Scientist will:

The NCCAM Program Official:

The EAC will:

The EAC's evaluations and recommendations, in the form of a written annual report, are to be submitted to the Program Official and the DCRC I P.I., and will be used by the Program Official and the DCRC I P.I. to guide and direct the program.  Subcommittees with additional ad hoc advisors may be established by the EAC as necessary in order to meet its planning, priority setting and evaluation responsibilities.  Awardees generally will be expected to accept and implement the recommendations of the EAC; in those situations where implementation of the recommendations is not feasible, the DCRC I P.I. must provide a thorough explanation and rationale to NCCAM.  The first EAC meeting will be convened by the Awardee nine months after the award date.  The EAC will meet annually three months before the anniversary of the DCRC I award date. 

The NCCAM Program Official may also serve as the NCCAM Project Scientist.

2.A.3.  Collaborative Responsibilities

Internal Steering Committee: The Principal Investigator is responsible for establishing an Internal Steering Committee (ISC), which will consist of the DCRC I PI and appropriate investigators from each of the collaborating institutions as full voting members.  The NCCAM  Project Scientist serves as an ex officio non-voting member.  The ISC will have responsibility for directing and monitoring the progress of the research projects.  In addition, the ISC must develop opportunities for information exchange, and data sharing.  Each ISC member (or their surrogate) will be expected to participate in all committee activities, e.g., videoconferences, conference calls, special subcommittees as may be necessary, etc. Outside ad hoc consultants can be added as desired.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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:

Barbara Sorkin, Ph.D.
Coordinator, Centers for Research on CAM Program
National Center for Complementary and Alternative Medicine (NCCAM)

6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Office: (301) 594-8018
FAX: (301) 480-3621
Email: sorkinb@mail.nih.gov

2. Peer Review Contacts:

Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD  20892-5475
Telephone:  (301) 594-2014
FAX: (301) 480-2419
Email: goldrosm@mail.nih.gov

3. Financial or Grants Management Contacts:

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD  20892-5475
Phone:  301-594-9102
Fax:  301-480-1552
Email: gt35v@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 (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.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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 (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.

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

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

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

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

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

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

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

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

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

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


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