Sample Program Structure and Leadership Plan for Multi-PD/PI U19 applications
Sample Program Structure and Leadership Plan for Multi-PD/PI U19 applications (placed in the Center overview section of the application, per instructions for PAR07-248, Developmental Centers for Research on Complementary and Alternative Medicine)
Components of the Developmental Center
The "Developmental Center" is composed of the CAM institution, CAM University, and the conventional institution, AAA Medical School.
Principal Investigators (PDs/PIs are required to devote at least 1.2 person-months (10% effort) during planning year 1, and in subsequent years, at least 1.8 person-months (15 % effort) to the Administrative Core and 1.8 person-months as a project leader)
PD/PI#1: (1.2 person-months during planning year 1, 1.8 person-months as co-leader of Administrative Core, 1.8 person-months as leader of Project 1 during subsequent years). PD/PI#1 will be the contact PD/PI and coordinator of the Center. PD/PI#1 is (brief description of qualifications to be principal investigator and project leader). He will be responsible for the implementation of the research plan at CAM University. He will be the leader of Project 1. He will be the co-leader of the Administrative Core (with PD/PI#2) and will co-chair, with PD/PI#2, the internal steering committee.
PD/PI#2: (1.2 person-months during planning year 1, 1.8 person-months as co-leader of Administrative Core, 1.8 person-months as leader of Project 3 during subsequent years). PD/PI#2… (Brief description of qualifications to be principal investigator and project leader). He will be responsible for overall implementation of the research plan at AAA Medical School, the second principal study site. He will be the leader of Project 3. He will collaborate with PD/PI#1 in the day-to-day operations of the Administrative core, and will be the co-chair, with PD/PI#1, of the Internal Steering Committee (see below). PD/PI#2 will have at his disposal the grants administrative resources of AAA Medical School.
Project leaders (each project is require to have at least one co-leader from a conventional institution and one from a CAM institution, and each co-leader must devote at least 1.8 person-months)
Project 1 will be co-led by PD/PI#1 from CAM University (1.8 person-months) and Dr. X from AAA Medical School (1.8 person-months). Project 2 will be co-led by Dr. X from AAA Medical School (1.8 person-months) and Dr. Y from CAM University (1.8 person-months). Project 3 will be co-led by PD/PI#2 (1.8 person-months) from AAA Medical School and Dr. Y from CAM University (1.8 person-months). Project 4 will be co-led by Dr. W from AAA Medical School (1.8 person-months) and Dr. Q from CAM University (2.4 person-months)
Dr. X is a Professor of Immunology at AAA Medical School (brief description of qualifications to be project leader)
Dr. Y is a Professor of CAM at CAM University (brief description of qualifications to be project leader)
Dr. Q is a Professor of Pharmacology at CAM University (brief description of qualifications to be project leader)
Dr. W is a Professor of Pharmacology at AAA Medical School (brief description of qualifications to be project leader)
Core Leaders
Dr. R (3.6 person-months as leader of Core 2, Analytical Core) Brief description of qualifications to lead this Core.
Dr. V (3.6 person-months as leader of Core 3, Imaging Core) Brief description of qualifications to lead this Core.
Institutional Collaboration and Support
Letters of support are included in Appendix I from each project leader and Core leader and from at least one senior administrator at each of the institutions and departments indicating the level of institutional commitment. Sponsored Programs at CAM University and AAA Medical School have indicated willingness to enter formal consortium agreements. Budgets will be allocated to each institution as detailed in the Budget section. Re-allocation of funds will be considered and determined by a majority of the Internal Steering Committee. Budget oversight will be the responsibility of the Administrative Core.
External Advisory Committee (EAC)
Both PD/PIs will work with the Program Officer at NCCAM to establish and coordinate regular meetings of the EAC. The EAC will be composed of the Program Officer and three external advisors with appropriate expertise to provide advice relative to the objectives of the Center. The EAC will be the primary scientific advisory body for the Center. The EAC will provide written annual reports with recommendations to NCCAM and the PD/PIs.
Internal Steering Committee (ISC)
The ISC will be co-chaired by the two PD/PIs and composed of all project leaders and co-leaders, Core leaders, and the NCCAM appointed Scientific Advisor (an impartial third party). The primary purpose of the ISC will be to share data and information, monitor progress, raise issues and solve problems, review publications arising from the research, and plan for future research. The ISC will make recommendations for policy or protocol additions or changes when necessary. The ISC will develop a policy for determining authorship on publications, based on the relative contributions of the PD/PIs, project leaders and key personnel. Regular meetings of the ISC will take place on a monthly basis, with all members required to attend in person or by phone. Agendas will be prepared in advance of each meeting and minutes will be recorded, circulated and maintained on the secure website.
Communications
In addition to ISC meetings, many additional methods of communication will be used. These include e-mail, a dedicated Center website with password protected section, intranet, teleconferences, and videoconferences, and paper reports.
Travel
Travel between institutions will be a frequent occurrence. The distance is 60 miles and one hour of time. The presence of visitors from either institution is a routine event. Travel will take place as necessary and appropriate to meet the aims of the studies and to ensure a strong collaborative bond.
Program Evaluation
Evaluation of the program will be a regular function of both the ISC and the EAC. Project progress records will be kept in a project database at CAM U and reviewed quarterly. The Research Administrator will prepare and maintain formal subcontract arrangements with each collaborating institution.
Resolution of Conflicts
Conflicts about the scientific direction of the Center or administrative and fiscal matters will be discussed by the ISC, with input from the EAC as needed. Attempts will be made to resolve conflicts by a consensus building process. A formal vote of the ISC (voting members are project leaders, PD/PIs and core leaders) will be used to make decisions, if consensus cannot be achieved. All investigators will then cooperate with the final decision.
Human Subjects and Animal Studies
Adherence to regulations regarding the use of human subjects and animals in research will be the responsibility of research team with individual project leaders assuming the lead responsibility for their specific projects or components. All project leaders have been formally trained in the use of human subjects and animals. IRB and/or IACUC approval will be sought from each participating institution.
Data Sharing Among Center Key Personnel
Data from each project will be available to all project leaders and authorized key personnel via the Center website (password protected). The center website will be maintained as part of the administrative core. The website will include a 'bulletin board/chat room" feature to permit discussion of data and future plans. Data will also be shared and discussed more formally at regular meetings of the ISC. Data will be shared with the outside scientific community via the public version of the Center website and via publications and presentations at scientific and professional meetings.
Changing PD/PIs or Project Leaders, or Changing the Roles of PD/PIs or Project Leaders
If a PD/PI or project leader moves, attempts will be made to transfer the relevant portion of the grant to the new institution. In the event that a PD/PI or project leader cannot continue to carry out his or her duties, a new PD/PI or project leader will be recruited as a replacement, subject to the approval of both the ISC and EAC.
