Presentation on theme: "Protocol Review Subcommittee Richard Yanagihara, M.D., M.P.H."— Presentation transcript:
1 Protocol Review Subcommittee Richard Yanagihara, M.D., M.P.H. REPORTRichard Yanagihara, M.D., M.P.H.Professor, Department of PediatricsJohn A. Burns School of MedicineUniversity of Hawaii at ManoaSteering Committee MeetingNovember 30, 2008
2 Protocol Review Subcommittee Membership Richard Yanagihara, M.D. (Chair) – University of HawaiiValerie Montgomery Rice, M.D. - Meharry Medical CollegeCarlos Luciano, M.D. – University of Puerto RicoElizabeth Ofili, M.D. – Morehouse School of MedicineV. Craig Bond, Ph.D. – Morehouse School of MedicineBarbara Hayes, R.Ph., Ph.D. – Texas Southern UniversityMiguel Otero, Ph.D. - Universidad Centrale del CaribeAnita Walden – Duke University /DTCC
3 Protocol Review Subcommittee Purpose and ScopeGenerate inter-institutional interest among RCMI schoolsFoster research collaborations among investigators at RCMI grantee institutionsReceive only fully developed protocolsReview, evaluate and prioritize RTRN protocolsWork with the Ethics and Regulatory Subcommittee for generating and distributing Confidentiality AgreementsWork with Core Resources Subcommittee to access expertise of investigators to facilitate multi-center collaborations to assist in response to request for funding
4 STEPSDevelop concept paper and submit to RTRN for considerationReview and approve protocolsDisseminate concept paper via RTRN list serveDetermine interest between parties; facilitate confidentiality agreementsInitiate discussions and protocol development processDevelop protocol and involve DTCC, RSAs, CRCs and RS as appropriateFinalize study protocol – approval from RTRN Steering CommitteeFacilitate contracts, material transfer agreements, etc., as appropriate
5 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 SpecimensInvolves modest funding request (e.g. < $5,000)Involves limited facilitation by DTCC (e.g., web/teleconference support)Warrants expedited review by RTRN Protocol Review SubcommitteeLevel 2 Protocols = Pilot ProjectsInvolves moderate funding request (e.g. > $5K) and/or co-funding from other sourcesInvolves moderate level of DTCC support (i.e. statistical analysis, database development, data management)Warrants full review by RTRN Protocol Review SubcommitteeLevel 3 Protocols = Response to RFAChallenging 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 servicesWarrants development of a mechanism for RTRN expedited review, approval and response
6 Timelines for Approval of Protocols Level 1 – expedited chair review - 4 weeks (submission, review and feedback)Level 2 – full committee review – primary and 2nd ary reviewers assignedSubmission 6 weeks prior to protocol review quarterly meetingResponse to investigator 2 weeks after quarterly meetingNote: resubmission if multi-centers are involvedLevel 3 – Depending on funding source, 6 weeks prior to funding source deadline (RFA)Quarterly Meetings begin during 2nd week of Feb/June/Oct
7 Protocol Review Coordinator Responsibilities: Receive request from investigator (via portal)Confirm receipt to investigatorSubmit request to Protocol Review Subcommittee ChairCoordinate assignments to reviewers on SubcommitteeReceive reviews from Subcommittee membersPrepare and distribute materials for quarterly meetingsSchedule, facilitate and coordinate subcommittee review quarterly meetingsFacilitate the response of subcommittee of RFAsTrack and report on reviewed protocols for Subcommittee members and Steering CommitteeWork w/chair to submit specified reports to Steering CommitteeHave liaison from R-DTCC to the protocol committee
9 Nef Concentration in Serum and Urine of HIV-1-Infected Patients V. Craig Bond, Michael Powell – Morehouse School of MedicineCecilia M. Shikuma, Bruce Shiramizu – University of Hawaii at ManoaInitial Conference Call – January 31, 2008 through DTCC.Publications exchanged.Disclosure Agreements signed by both parties.Second Conference Call – February 19, 2008.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.
10 The Effect of 25 Hydroxy-Vitamin D on Cardiovascular Function Keith C. Norris, MD – Charles Drew UniversityGary H. Gibbons, MD – Morehouse School of MedicineData Technology Coordinating CenterDeveloped 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.
11 Projects in Discussion Stage Transmission of HPV in male-female couples of multiethnic populationsLe’Roy Reese – Morehouse School of MedicineBrenda Y. Hernandez – University of Hawaii at ManoaBipolar DisorderDiAnne Bradford, Chiaki Fukuhara, Falah Shamsa – Morehouse School of MedicineNaleen Andrade, William Haning, Earl Hishinuma – University of Hawaii at Manoa
12 Evaluation of Staphylococcus aureus Colonizing and Infecting Hospital Patients Guliz Erdem - University of Hawaii at ManoaZoe Rodriguez - University of Puerto RicoAnita Walden - Duke University/DTCCInitial Conference Call – April 9, 2008 through DTCCCDC Study – Elimination of Health Disparities through Translational Research – Due on May 2, 2008Disclosure agreement sent to Dr. Zoe RodriguezFollow-up conference call on April 16, 2008Budgets and final write-up due to UH, Grants Development office on April 25, 2008.Submitted to CDC.Study not funded, but hopeful that Drs. Erdem and Rodriguez will work on a similar project soon.