On this page:

• Introduction
• Research Objectives
• Structure of the (Phase II) ICRC
• Mechanism of Support
• Eligible Institutions
• Individuals Eligible to Become ICRC Co-Directors
• Special Requirements
• Structure of the Cooperative Agreement
• Review Criteria

Introduction

The ICRC initiative will be issued in two phases. The Phase I ICRC (PICRC) solicits applications for planning grants (R21) that will be awarded by September 15, 2003. NCCAM anticipates issuing an RFA for the Phase II initiative in 2004. The currently envisioned research objectives, structure of, and review criteria for the Phase II ICRC are summarized here as an aid to applicants in developing PICRC applications. Only those applicants who successfully complete a PICRC award may apply for the Phase II ICRC.

Top

Research Objectives

Background
In some regions of the world, the infrastructure for scientific complementary and alternative/traditional medicine (CAM/TM) research is not well developed, and many international applications to NIH are hampered by a lack of experience on the part of the proposed Principal Investigator with cutting-edge research methods or with NIH procedures. These disadvantages may impede the development of a core group of CAM or TM researchers. Conversely, while many U.S. CAM/TM investigators possess the scientific expertise, experience and sophistication to obtain NIH support, they may lack a comprehensive understanding of, or access to, traditional medical systems and practices and the professional connections to study them in situ.

Objectives
The objective of the ICRC initiative is to enhance collaborative studies of such practices at their sites of origin to:

• Encourage exchange of scientific and clinical methodologies between researchers from the participating countries and the CAM/TM and conventional medical researchers.
  
  
• Establish whether these systems, as practiced in their traditional settings, or as assimilated in the U.S., are beneficial to health and wellbeing.
  
  

The expectation is that the ICRC will lead to the submission of more competitive research grant applications from the foreign institution(s) to NCCAM and other Institutes/Centers.

Top

Structure of the (Phase II) ICRC

The collaborative paradigm will be effected through the partnership of two ICRC Co-Directors, one U.S.-based and one foreign-based, who together will organize, administer and lead a program comprising three inter-related research projects and at least one core.

Awards will be made to the U.S. Co-Director's institution to support a collaborative research program that will be carried out mainly at the foreign collaborator's research site. Support will be available for research related to alternative medical systems that originated in the geographical area of the foreign institution(s).

Leadership of the ICRC
The U.S. ICRC Co-Director (the Program Principal Investigator) and the foreign ICRC Co-Director will jointly identify and select key personnel and allocate and monitor funds. They must each possess demonstrated capability to organize, administer and lead a complex research program, and have a productive track record in the independent conduct of research. The U.S. P.I. will be responsible for overseeing the entire ICRC program. The U.S. P.I.'s other research funding must include support from NIH, and s/he must have demonstrated sensitivity in cross-cultural collaboration and preferably, experience in international research. An External Advisory Committee (EAC) will provide guidance to the Co-Directors and will provide feedback on ICRC progress to NCCAM. An Internal Steering Committee (ISC) will provide for frequent communication and sharing of information, and for regular adjustment of focus within the ICRC.

Research projects
Each ICRC will include three inter-related projects focused on the science of alternative medical systems and practices, or components thereof. Each project must be conducted primarily at the international site(s), although, where required by availability of infrastructure, some research components of one or more of the projects may be conducted at the U.S. institution(s). Each project is to be co-directed by a foreign and a U.S. NIH-funded project co-P.I. Both foreign and U.S. project co-P.I.'s must have academic appointments as full-time employees of their respective institutions and must demonstrate the ability to commit adequate effort to the proposed ICRC project.

Eligible areas of research
Research related to alternative medical systems or component practices that are endemic to the region of the foreign institution are eligible for consideration. Ayurveda and traditional medical systems from Asia, Africa, the Middle East and South or Central America are examples of alternative medical systems. Some additional eligible topics are described in the NCCAM Strategic Plan, nccam.nih.gov/about/plans/fiveyear/fiveyear.pdf, Appendix I, pages 27 through 29. These lists should not be considered to be comprehensive, restrictive, nor in priority order. Eligible projects may span the continuum from basic, through translational, to clinical (including Phase I and Phase II, but not Phase III clinical trials) and behavioral research.

Core(s)
Each ICRC will include a required Administrative Core that will 1) administer the total research effort and 2) coordinate a program for the training and career development of P.I.'s, young researchers, and administrative staff. The training and career development program is to include mentoring of students, fellows, interns, residents and other clinical and research personnel in CAM/TM concepts and methodologies and in conventional research methodology (which may include analytical methods, molecular biological methods, clinical trials planning, statistical methods, ethical practices, grant writing and understanding of the U.S. research funding system). Training and career development activities may also include, but are not limited to: provision of a CAM/TM seminar series presented by experienced, outstanding scientists; information on the promotion system and rewards for research accomplishments; and development of mechanisms to allow for regular professional networking of investigators with their international peers. The training and career development program should also include mentoring of administrative personnel.

Additional, optional cores may be requested to support, e.g., clinical research, biostatistics, and molecular biology. Optional cores must be utilized by at least two projects. A clinical core would be justified if two or more component projects involve clinical research. Special attention should be paid to establishing locally relevant but internationally respected standards and procedures for verifying informed consent.

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. Two related considerations that should be detailed if applicable are 1) the degree to which currently funded investigators, within or outside the ICRC, will use and benefit from core resources and; 2) the degree to which the resources will promote new and/or expanded CAM/TM research efforts locally, regionally and/or internationally. Each core is to be directed by a faculty investigator (the Core P.I.).

Top

Mechanism of Support

The ICRC will use the NIH U19 Cooperative Agreement, a mechanism for multiple project awards. In the NIH cooperative agreement award mechanism, the P.I. retains the primary responsibility and dominant role for planning and directing the proposed project, with NIH staff being substantially involved as a partner with the P.I.

Top

Eligible Institutions

Applicant Institutions Only U.S. organizations will be eligible to apply. Institutions having any of the following characteristics will be eligible to submit applications:

• For-profit or non-profit organizations;
  
  
• Public or private institutions, such as universities, colleges, hospitals, and laboratories;
  
  
• Units of state and local governments;
  
  
• Eligible agencies of the Federal Government;
  
  
• Offers, or is affiliated with, an institution that offers, Ph.D., M.D., D.O., D.C., N.D. and/or equivalent degrees.

Participating Foreign Institutions
Participating foreign institutions will be required to have one or more of the following characteristics:

• Non-profit public or private institutions, such as universities, colleges, hospitals, and laboratories;
  
  
• Units of national or local governments;
  
  
• Offers, or is affiliated with an institution that offers, Ph.D., M.D., D.O., D.C., N.D. and/or equivalent degrees.

Top

Individuals Eligible to Become ICRC Co-Directors

Both ICRC Co-Directors will be required to demonstrate the skills, knowledge, and resources necessary to carry out the proposed research, and must meet the following additional eligibility requirements. The U.S. scientist must have current NIH funding and be a U.S. citizen, non-citizen alien national, or permanent resident of the U.S. The foreign Co-Director will be required to hold a permanent position at an eligible public or private non-profit institution (see Eligible Institutions, above) that will allow him or her adequate time and provide appropriate facilities and support to conduct the proposed research. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities will be encouraged to apply.

Top

Special Requirements

The application will be required to demonstrate that the following special requirements related to institutional infrastructure and environment of all participating institutions are satisfied.

Institutional Infrastructure The foreign institution will be required to demonstrate that it has the requisite staff (e.g., grants management, administrative, and technical), clinical and/or laboratory facilities, patient populations, geographic distributions of space and personnel, etc.) to perform the proposed research, or indicate how they will be obtained.

Institutional Environment The foreign research sites/institutions will be required to document adequate commitment of resources and facilities to sustain and support the ICRC, including documentation showing that the Co-Director will be freed from other duties, where necessary, to allow him/her to dedicate the requisite effort to the ICRC without adverse impact on tenure or promotion. The applicants will be required to present evidence that appropriate opportunities exist for career advancement for all participating investigators.

Top

Structure of the Cooperative Agreement

The administrative and funding instrument used shall be a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NCCAM scientific and/or programmatic involvement with the awardee is anticipated during performance of the activities. Under the cooperative agreement, NCCAM supports and stimulates the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partnership role, but 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 for the activity resides with the Awardee for the project as a whole, although specific tasks and activities in directing and carrying out the studies will be shared among the Awardee, other study investigators, NCCAM staff, and the External Advisory Committee, described below.

In addition to primary authority and responsibility for all research activities within the ICRC (including appropriate and required documentation of research, and of compliance with all relevant regulations and policies (both U.S. and local/foreign) and retaining custody of, and primary rights to, the data developed under this award, subject to Government rights of access consistent with current DHHS and NIH policies), the awardee will also have the primary responsibility for maintaining effective and substantial research collaborations with the foreign collaborators. Accordingly, the Awardee will be responsible for arranging quarterly meetings of all ICRC participants. Project Co-P.I.'s of the three research projects will also be required to meet no less than monthly. Although in person meetings should be held at least semi-annually, intervening meetings may be via telephone, video and/or web conferencing.

The awardee will have the primary responsibility for establishing an Internal Steering Committee (ISC), which will consist of the ICRC Co-Directors, the U.S. and foreign project Co-P.I.'s, an appropriate authority(s) from the foreign institution(s) (e.g., the Dean of, or Vice President for Research, or other similar high-ranking official), and the appropriate NCCAM staff 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, data sharing, and research training for ICRC researchers. Training needs at the foreign research site(s) must be clearly described, as must the actions that will be taken to meet these needs.

NCCAM will appoint a staff member to administer each U19 Cooperative Agreement. NCCAM staff will establish and coordinate regular meetings of an External Advisory Committee (EAC), in consultation with the ICRC Co-Directors. The EAC will be composed of an NCCAM staff member (as an ex officio member), up to five external advisors with appropriate scientific expertise to provide advice relative to the objectives of the program, and one advisor with fiscal experience relevant to administration of international scientific collaborations. The EAC will serve as the primary advisory board of the ICRC, and NCCAM will rely on the EAC for objective evaluation of the Program.

Top

Review Criteria

The review process may require site visits or that investigators come to NIH to meet with reviewers (reverse site visit).

The following aspects of the ICRC will be evaluated:

• Individual Research Projects
• Cores
• ICRC Co-Directors
• Resources and Environment
• Program Synergy
• Overall Program
  
  

• Individual Research Projects
  Review criteria for the individual research projects will be the same as those given for PICRC pilot projects. Review criteria for additional components of the Phase II ICRC follow.
  
  
• Cores
  Each core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:
  
  
  • Technical merit and justification of the proposed core;
    
    
  • Qualifications, experience, and commitment of the personnel involved in this core;
    
    
  • Adequacy of plans for the integration of the various research projects with the core;
    
    
  • Utilization of the core by the ICRC research projects. While not required, potential for use of core services by other investigators should be noted.
  
  
  Administrative Core: the following will also be evaluated:
  
  
  • Adequacy of plans for interaction among investigators, and the integration of the various exploratory/developmental research projects with the administrative core;
    
    
  • Scientific and administrative structure, including internal procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review;
    
    
  • Value of the proposed training experiences as they relate to conduct of the proposed research and to preparation for independent CAM/TM research;
    
    
  • Qualifications and experience of those providing the training experience;
    
    
  • Appropriateness of plans to encourage the professional networking of key personnel and their participation in a challenging research milieu.
  
  
  
• ICRC Co-Directors: the following will be evaluated:
  
  
U.S. ICRC Co-Director:


• Strength of the U.S. Co-Director, particularly history of NIH research funding, academic qualifications, expertise and research productivity;
  
  
• Appropriateness/adequacy of time commitment by the U.S. Co-Director.
  
  
Foreign ICRC Co-Director:


• Qualifications, experience and commitment of the foreign Co- Director and his/her ability and commitment to devote appropriate/adequate time and effort to provide effective leadership;
  
  
• Prior (past five years) and current support for research relevant to the present application;
  
  
• Adequacy of the process and plans for recruiting minorities and women as faculty, fellows, students and study participants.
  
  
• Resources and Environment will be evaluated on:
  
  
  • Adequacy of staff (e.g., grants management, administrative, and technical), clinical and/or laboratory facilities, patient populations, and space allocated for the research at the foreign institutions(s), or on plans to obtain appropriate resources;
    
    
  • Documentation from a senior official at each participating institution (e.g., President or Dean) attesting to institutional support for the ICRC and outlining the steps, processes and procedures taken or to be taken by the institution to promote the ICRC's success (e.g., administrative and technical). The letter should also address commitment to provide appropriate resources and policies for the administration of an ICRC (e.g., grants management), and for effective collaboration on research and training;
    
    
  • Evidence that an ICRC award will augment and strengthen the existing research infrastructure;
    
    
  • Documentation showing that the foreign ICRC Co-Director will be freed from other duties, where necessary, to allow him/her to dedicate the requisite effort to the ICRC without adverse impact on tenure or promotion;
    
    
  • Clearly defined chain of responsibility regarding decision making and the day-to-day administration, coordination, and evaluation of the ICRC;
    
    
  • Evidence of clear institutional commitment to investigator and administrator career development;
    
    
  • Appropriateness of opportunities for career advancement for all participating investigators;
    
    
  • Appropriateness of plans to promote international scientific exchange and to enrich the intellectual research milieu.
    
    
• Program Synergy
  
  The potential for scientific impact of the proposed ICRC should be greater than the sum of its component research project and cores, i.e., the proposed components should interact synergistically to add value to the ICRC as a whole. In particular, program synergy will be evaluated on:
  
  
  • Scientific and/or programmatic synergy between projects, and between projects and proposed core(s);
    
    
  • The nature (type) and scope (depth) of the scientific collaboration between the international and the U.S.-based research teams within each research project;
    
    
  • Demonstration of an effective relationship among collaborating institutions, including documentation of current relationships, as well as the functions, commitments and contributions each collaborating member will bring to the proposed project;
    
    
  • The nature, scope, and effectiveness of the plans for communication, coordination, and collaboration among research project investigators (international and U.S.).
    
    
• Overall Program
  
  A single numerical priority score will be assigned to the ICRC application as a whole.
  
  In assigning the priority score for the application as a whole, although primary emphasis will be placed on scientific merit, innovation, and past productivity (where applicable), significant consideration will also be given to strength of core(s), leadership ability of the P.I.s, institutional commitment, program synergy, and the potential for the ICRC team to further the stated goals of the ICRC.
  
  An application in which the reviewers considered 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 be recommended for "no further consideration."

Top