Presentation on theme: "Protocol Review Subcommittee REPORT Richard Yanagihara, M.D., M.P.H. Professor, Department of Pediatrics John A. Burns School of Medicine University of."— Presentation transcript:
Protocol Review Subcommittee REPORT Richard Yanagihara, M.D., M.P.H. Professor, Department of Pediatrics John A. Burns School of Medicine University of Hawaii at Manoa Steering Committee Meeting November 30, 2008
Protocol Review Subcommittee Membership Richard Yanagihara, M.D. (Chair) – University of Hawaii Valerie Montgomery Rice, M.D. - Meharry Medical College Carlos Luciano, M.D. – University of Puerto Rico Elizabeth Ofili, M.D. – Morehouse School of Medicine V. Craig Bond, Ph.D. – Morehouse School of Medicine Barbara Hayes, R.Ph., Ph.D. – Texas Southern University Miguel Otero, Ph.D. - Universidad Centrale del Caribe Anita Walden – Duke University /DTCC
Protocol Review Subcommittee Purpose and Scope Generate inter-institutional interest among RCMI schools Foster research collaborations among investigators at RCMI grantee institutions Receive only fully developed protocols Review, evaluate and prioritize RTRN protocols Work with the Ethics and Regulatory Subcommittee for generating and distributing Confidentiality Agreements Work with Core Resources Subcommittee to access expertise of investigators to facilitate multi-center collaborations to assist in response to request for funding
STEPS Develop concept paper and submit to RTRN for consideration Review and approve protocols Disseminate concept paper via RTRN list serve Determine interest between parties; facilitate confidentiality agreements Initiate discussions and protocol development process Develop protocol and involve DTCC, RSAs, CRCs and RS as appropriate Finalize study protocol – approval from RTRN Steering Committee Facilitate contracts, material transfer agreements, etc., as appropriate
Process for Facilitating RTRN Approval of Protocols: To facilitate and expedite RTRN review and approval of protocols, Dr. Easa proposed that studies be categorized into three review levels: Level 1 Protocols = Analysis of Banked/Existing Specimens Involves modest funding request (e.g. < $5,000) Involves limited facilitation by DTCC (e.g., web/teleconference support) Warrants expedited review by RTRN Protocol Review Subcommittee Level 2 Protocols = Pilot Projects Involves moderate funding request (e.g. > $5K) and/or co-funding from other sources Involves moderate level of DTCC support (i.e. statistical analysis, database development, data management) Warrants full review by RTRN Protocol Review Subcommittee Level 3 Protocols = Response to RFA Challenging since it involves short timeline to establish collaborations, contribute sections, review proposal, determine level of RTRN support, develop budgets, etc. Involves contractual arrangements for DTCC services Warrants development of a mechanism for RTRN expedited review, approval and response
Timelines for Approval of Protocols Level 1 – expedited chair review - 4 weeks (submission, review and feedback) Level 2 – full committee review – primary and 2 nd ary reviewers assigned Submission 6 weeks prior to protocol review quarterly meeting Response to investigator 2 weeks after quarterly meeting Note: resubmission if multi-centers are involved Level 3 – Depending on funding source, 6 weeks prior to funding source deadline (RFA) Quarterly Meetings begin during 2 nd week of Feb/June/Oct
Protocol Review Coordinator Responsibilities: Receive request from investigator (via portal) Confirm receipt to investigator Submit request to Protocol Review Subcommittee Chair Coordinate assignments to reviewers on Subcommittee Receive reviews from Subcommittee members Prepare and distribute materials for quarterly meetings Schedule, facilitate and coordinate subcommittee review quarterly meetings Facilitate the response of subcommittee of RFAs Track and report on reviewed protocols for Subcommittee members and Steering Committee Work w/chair to submit specified reports to Steering Committee Have liaison from R-DTCC to the protocol committee
Nef Concentration in Serum and Urine of HIV-1-Infected Patients V. Craig Bond, Michael Powell – Morehouse School of Medicine Cecilia M. Shikuma, Bruce Shiramizu – University of Hawaii at Manoa Initial Conference Call – January 31, 2008 through DTCC. Publications exchanged. Disclosure Agreements signed by both parties. Second Conference Call – February 19, Materials Transfer Agreement (MTA) developed and approved by UH investigators and Office of Technology, Transfer and Economic Development (OTTED). OTTED has forwarded MTA to Morehouse School of Medicine. MTA signed by Morehouse. Serum and urine samples were shipped from UH to Morehouse in June.
The Effect of 25 Hydroxy-Vitamin D on Cardiovascular Function Keith C. Norris, MD – Charles Drew University Gary H. Gibbons, MD – Morehouse School of Medicine Data Technology Coordinating Center Developed LISTSERVs and disseminated information to study teams. Coordinated weekly meetings during planning phase and eCRFs design sessions. Coordinated Portal Training for Pilot Study Teams: Morehouse School of Medicine and Charles Drew University. Organized Workspace Folders on the RTRN Portal. Preparing Work Instructions. HIPAA Training and Certification underway. Will assist with the development of Study Participant Materials.
Projects in Discussion Stage Transmission of HPV in male-female couples of multiethnic populations LeRoy Reese – Morehouse School of Medicine Brenda Y. Hernandez – University of Hawaii at Manoa Bipolar Disorder DiAnne Bradford, Chiaki Fukuhara, Falah Shamsa – Morehouse School of Medicine Naleen Andrade, William Haning, Earl Hishinuma – University of Hawaii at Manoa
Evaluation of Staphylococcus aureus Colonizing and Infecting Hospital Patients Guliz Erdem - University of Hawaii at Manoa Zoe Rodriguez - University of Puerto Rico Anita Walden - Duke University/DTCC Initial Conference Call – April 9, 2008 through DTCC CDC Study – Elimination of Health Disparities through Translational Research – Due on May 2, 2008 Disclosure agreement sent to Dr. Zoe Rodriguez Follow-up conference call on April 16, 2008 Budgets and final write-up due to UH, Grants Development office on April 25, Submitted to CDC. Study not funded, but hopeful that Drs. Erdem and Rodriguez will work on a similar project soon.