Part I Overview Information
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-06-108 , which was previously released December 22, 2005.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-07-248
Catalog of Federal Domestic Assistance Number(s)
93.213
Key Dates
Release Date: March 15,
2007
Letters of Intent
Receipt Date(s): July 13, 2007
Application Receipt
Date(s): August 13, 2007
Peer
Review Date(s): Oct/Nov 2007
Council
Review Date(s): January 2008
Earliest
Anticipated Start Date(s): January 2008
Additional
Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August
14, 2007
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 extensive research project supported by strong preliminary data (comparable to an R01 research project), as well as exploratory/developmental (R21-comparable) 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 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) Program Director(s)/Principal Investigator(s) (PD/PI), who may be from either a CAM or a conventional institution, as defined in Section III.1.A. The PD/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 PD/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 PD/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 (Section VI.2A) of this announcement.
Internal Steering Committee: The Principal Investigator(s) is/are responsible for establishing an Internal Steering Committee (ISC), which will consist of the DCRC I PD/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 (comparable in scope to R21 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 PD/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.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 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(s) 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(s), 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
Both the PD/PI. and the co-PD/PI of each DCRC I must possess the skills, knowledge, and resources necessary to carry out the proposed research and research capacity development goals and objectives of the DCRC I initiative. The principal investigator(s) must be able to commit at least 10% effort in the preparatory/planning year of the award and at least 30% effort in each subsequent year of the award. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
More than one PD/PI may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions). DCRC applications with more than one PD/PI must include onePD/PI each from a CAM and a conventional institution, as defined in Section III.I.A, above.
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require
cost sharing, 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/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility
Criteria
Each DCRC
I 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 PD/PI(s) 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 (or other Core, for multiple PD/PI DCRC) 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 PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-0088.
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
See Section IV.3.A for
details.
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent
Receipt Date(s): July 13, 2007
Application
Receipt Date(s): August 13, 2007
Peer
Review Date(s): October/November 2007
Council
Review Date(s): January 2008
Earliest
Anticipated Start Date(s): January 2008
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)
Telephone: (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)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Martin Goldrosen, Ph.D.
Acting Director of Extramural Activities
National Center for
Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 (use 20817
for private courier services)
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: goldrosm@mail.nih.gov
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.
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 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applicants must:
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PD/PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Form page 1 of the PHS398. All otherPDs/PIs should be listed on the Form page 1 continuation page and assigned the project role of “PD/PI” in the list of personnel on Form page 2.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan for the overview section of the DCRC I application (see below), entitled “Multiple PD/PI Leadership Plan (Section i of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving Multiple Institutions
When multiple institutions are involved in a multiple PD/PI application, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution
Applications Involving Multiple Institutions
When multiple institutions are involved in a multiple PD/PI application, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution.
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 PD/PI(s), 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. Include a separate budget for each participating institution. Subcontracts must be included in the subcontract section of Form page 4 for the prime institution.
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. Include a separate budget for each participating institution. Subcontracts must be included in the subcontract section of Form page 5 for the prime institution.
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 PD/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.
For multiple PD/PI applications, a Multiple PD/PI Leadership Plan must be included in Section i of the overview section of the DCRC I application.
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.
Form page 4 - Detailed budget for initial budget period.
Include a separate budget for each participating institution. Subcontracts must be included in the subcontract section of Form page 4 for the prime institution.
Form page 5 - Budget for entire proposed DCRC I period.
Include a separate budget for each participating institution. Subcontracts must be indicated in the budget for the prime institution.
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 a/the PD/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 PDs/PIs and Project Leaders and co-leaders at an annual, two-day meeting with other NCCAM-funded center PDs/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.
Form page 4 - Detailed budget for initial budget period.
Include a separate budget for each participating institution. Subcontracts must be included in the subcontract section of Form page 4 for the prime institution.
Form page 5 - Budget for entire proposed DCRC I period.
Include a separate budget for each participating institution. Subcontracts must be indicated in the budget for the prime institution.
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 expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
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(s)
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? Please note that
the use of CAM does not in itself constitute innovation.
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator(s)
and other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)? Have
the project leader and co-leader each committed at least the required level of
effort to the project?
Environment: Do the scientific
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) PROJECT DIRECTOR)s)/PRINCIPAL INVESTIGATOR(S)
The PD/PI(s) 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
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 PD/PI(s), institutional commitment, and collaborative environment. 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 may be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.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
N/A.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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 cooperative agreement U 19, 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 below.
2.A.1. Principal
Investigator Rights and Responsibilities
The
Principal Investigator(s) of the Developmental Center for Research on CAM: Phase I (DCRC I) will have the primary responsibility for:
The applicant (awardee) institution and the PD/PI(s) 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:
Have substantial scientific and programmatic involvement with the awardees by providing technical assistance, advice and coordination above and beyond normal program stewardship of research grants;
Participate as an ex officio member of the Steering Committee;
Facilitate the coordination necessary to manage this complex project;
Participate as a non-voting member of the External Advisory Committee;
Participate in monitoring progress of ongoing studies;
Participate in planning and implementing efforts to disseminate information;
Participate in data interpretation and, when appropriate, in the preparation of publications and presentations;
Be subject to the same publication/authorship policies governing all participants in the study, as well as to the official NIH publication policy governing extramural employees.
The NCCAM Program Official:
Will provide normal program stewardship and review the scientific progress of individual research project components and the use of the core resource facilities among the research projects within each cooperative agreement;
Will monitor compliance of the award with the operating policies of the DCRC I program announcement;
Will recommend approval of projects for implementation in years 2-4, based on review by the EAC or other external advisors;
May recommend withholding support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies outlined in this announcement or the Award Statement.
Is responsible for establishing a DCRC I External Advisory Committee (EAC), in consultation with the DCRC I PD/PI(s), and working with the PD/PI to coordinate regular EAC meetings. The EAC will be composed of the Program Official, who will serve ex officio, and up to five external advisors with appropriate expertise to provide advice relative to the objectives of the program. The EAC will serve as the primary advisory body of the DCRC I, and the Program Official will rely on the EAC for objective evaluation of the Program.
The EAC will:
Review protocols and recommend implementation of projects prepared in year 01;
Monitor progress of the research projects;
Monitor the effectiveness of communication and collaboration;
Monitor the use of core resources by DCRC I participants and other investigators;
Evaluate the effectiveness of the DCRC I P.I.; and
Identify problems and suggest possible solutions.
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.
2.A.3. Collaborative
Responsibilities
Internal Steering Committee: The Principal Investigator(s)
is responsible for establishing an Internal Steering Committee (ISC), which
will consist of the DCRC I PD/PI(s) 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.
Each full member
will have one vote. Awardee members of the Steering Committee will be required
to accept and implement policies approved by the Steering Committee.
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.
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
Telephone: (301) 594-8018
FAX: (301) 480-3621
Email: sorkinb@mail.nih.gov
2. Peer Review Contacts:
Martin
Goldrosen, Ph.D.
Acting Director of
Extramural Activities
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: goldrosm@mail.nih.gov
3. Financial or Grants Management Contacts:
George
Tucker, MBA
Office of Grants Management
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Telephone: (301) 594-9102
FAX: (301) 480-1552
Email: tuckerg@mail.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/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. 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 PAR 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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