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CTSA Regulatory Knowledge Working Group – OHSU Activities

CTSA Regulatory Knowledge Working Group – OHSU Activities. Presented by: Kathryn G. Schuff, M.D. Date: September 12, 2007.

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CTSA Regulatory Knowledge Working Group – OHSU Activities

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  1. CTSA Regulatory Knowledge Working Group – OHSU Activities Presented by: Kathryn G. Schuff, M.D. Date: September 12, 2007

  2. A strong partnership between OHSU and Kaiser Permanente Center for Health Research, providing the opportunity for a wider array of research opportunities and collaborations among a wide array of basic, clinical and population scientists.

  3. Investigator Support & Integration Services (ISIS) (formerly RSO) • Overall mission: • Facilitate the administrative and regulatory aspects of OHSU and KPNW clinical and translational research • Create a Research Ethics Program

  4. ISIS Specific Aims • Provide investigator support: • Prestudy Support Office (PSO) • Grant budget, protocol design, compliance committee submissions, and recruitment assistance • Regulatory Support Services (RSS) • Submissions to FDA (IND, IDE, etc.) • Monitoring services • Data Safety Monitoring Plan and Board administration • Ensure protection of human subjects in studies conducted at the Clinical and Translational Research Center (CTRC) • Streamline regulatory, clinical enterprise, and administrative processes – OHSU, Kaiser, others • Create a Research Ethics Program

  5. Investigator Support and Integration Services

  6. ISIS Personnel

  7. Pre-CTSA Program Status • Clinical Research Program (CRP) • Enhance clinical research at OHSU: • Resource/interface, Educational programs • Clinical Trials Office (CTO) • Budget, IRB submissions • Industry clinical trials only • GCRC Human Subjects Protection Program • Protocol, consent form, DSMP assistance and review • AE and protocol deviation investigation • Audit of selected protocols • Resource for research subject questions/concerns • Policy coordination and education • GCRC studies only • OHSU Center for Ethics in Health Care • Clinical focus • Nascent research mission • KPCHR • Recruitment Core, IRB submissions • Kaiser investigators only

  8. Prestudy Support Office New services for non-industry sponsored studies: IRB application creation/submission Protocol design consultation Recruitment assistance Grant budgeting and assembly Regulatory Support Services New Services: Drafting of Virtual Data Warehouse and Biolibrary protocols Regulatory issues consultation DSMP assistance IND preparation Interinstitutional regulatory assistance Monitoring services Training on self-monitoring Clinical trial registration education SOPs finalized: DSMB administration Monitoring Progress Report

  9. Progress Report • CTRC Human Subjects Protection Program Director: Kathryn Schuff, MD • Real-time protocol deviation and AE review • Investigator education • Available to SRC for protocol review for ethical concerns • Available for research subject concerns • Consent process education and monitoring • Study coordinator and nursing education • OHSU Research Ethics Program: Director: Susan Bankowski, MS, JD (CTSA Liaison)

  10. Educational Initiatives Study Coordinator • Cooperative Educational efforts: OHSU Cancer Institute and OCTRI • Proposed Study Coordinator Classes: • Regulatory history and terminology • Protocol extraction for study set-up • Informed consent (writing and obtaining) • Regulatory Submissions • Regulatory Binder and Source Documents Investigator • Additional training beyond K30 - practical

  11. Progress Report • Clinical Environment Integration - Darlene Kitterman • Research Pharmacy Taskforce • Research Billing Program • Nursing-research interface • EMR support of clinical research • Research administration Integration - Kathryn Schuff • IRB Task Forces • AE/UP reporting policy • Radiation Safety • Repositories and Tissue Banks • Genetic Opt Out policy • Kaiser/OHSU IRB Integration • Reciprocal agreement for accepting training (Responsible Conduct of Research, HIPAA) and Conflict of Interest in Research certification • Training records being made accessible to both institutions • Formal agreement to rely on IRB review near final

  12. OHSU and KPNW Reciprocal Training The OHSU and KPNW IRBs and Privacy Boards have agreed to accept each other's: * Training in human subjects protection (OHSU: Responsible Conduct of Research (RCR); KPNW: Training in Bioethics and Human Subjects Research) * Training in HIPAA * Disclosures of Conflicts of Interest in Research For studies submitted to the OHSU IRB that include Kaiser personnel: Search for Kaiser personnel below. Enter the first few letters of the first or last name and click on the "Go" button. Create a screen shot showing the name and date recertified (Alt-PrtScr, then paste into Word document) and upload into the eIRB with your submission. *Note: In cases where the person may have more than one certification date, use the most recent date. For additional information, please contact Jeannie Lee at Kaiser Permanente Northwest's Research Subjects Protection Office at 503-335-6357 or Jeannie.Lee@kpchr.org. For studies submitted to the KPNW IRB that include OHSU personnel, KPNW IRB staff will verify training of OHSU personnel in the ORIO Compliance Tool. All training and disclosures for all personnel must be current or the submission will not be processed by either IRB.

  13. Kaiser-OHSU IRB Integration Initiative – Case studies Dr. PI from Institution A proposes a dietary evaluation of patients post MI and CABG to assess dietary intake of a new phyto-antioxidant and a dietary intervention to increase the level of the phyto-antioxidant. Would like to recruit post CABG patients from Institution A and Institution B by obtaining a list of subjects who have undergone CABG in the last 1 year to send them a letter inviting them to participate. Subjects will come to Institution A for dietary survey, multiple visits for baseline and follow-up labs and receive the dietary supplement, nutritional counseling. Kaiser: If minimal risk, A would not cede If minimal risk, B would cede OHSU: If A, would not cede If B, would cede but require letter come from OHSU provider

  14. Formalized agreement to rely on each other’s IRB review • SOPs revised • Flow outlined • Supporting forms finalized • Legal agreement drafted • Dual institution eIRB workflow mapped

  15. Proposed model of OHSU-Kaiser eIRB interoperability

  16. Further “Opportunities” • Integration of investigator support services with OHSU Cancer Institute and Pediatric Clinical Trials Office • VA-OHSU Reciprocity agreement VA-OHSU shared eIRB system • OHSU-Kaiser interactions Clinical • Nursing union issues • Financial/budgeting Research administration • Culture clash • Tracking • Evaluation criteria • Managing workload

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