Slide 1 - RTRN

							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 2nd 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 2nd 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, 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.
                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
   Le’Roy 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, 2008.
• Submitted to CDC.
• Study not funded, but hopeful that Drs. Erdem and Rodriguez
  will work on a similar project soon.