CTSA Regulatory Knowledge Working Group OHSU Activities

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

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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

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Investigator Support and Integration Services
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ISIS Personnel
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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

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Progress Report

• 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

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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)

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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

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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

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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_at_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.
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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

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Formalized agreement to rely on each others IRB
review

• SOPs revised
• Flow outlined
• Supporting forms finalized
• Legal agreement drafted
• Dual institution eIRB workflow mapped

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Proposed model of OHSU-Kaiser eIRB
interoperability
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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