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CTSA27  So you want COMIRB to be your sIRB : What you need to know.

CTSA27  So you want COMIRB to be your sIRB : What you need to know. John Heldens Director, COMIRB February 14, 2019. Learning Objectives. Basic requirements for COMIRB as sIRB PI's additional responsibilities sIRB process and procedures. Basic Requirements for Ceding to COMIRB.

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CTSA27  So you want COMIRB to be your sIRB : What you need to know.

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  1. CTSA27So you want COMIRB to be your sIRB:What you need to know. John Heldens Director, COMIRB February 14, 2019

  2. Learning Objectives • Basic requirements for COMIRB as sIRB • PI's additional responsibilities • sIRB process and procedures

  3. Basic Requirements for Ceding to COMIRB • The University of Colorado, Denver | Anschutz Medical Campus or one of our affiliates must be a site • The non-affiliated site must have an active Federalwide Assurance (FWA) • COMIRB PI must accept additional responsibilities, • COMIRB Director must agree COMIRB can serve as sIRB

  4. Exclusions COMIRB will not assume IRB oversight for non-affiliated institutions under the following circumstances: • For exempt human subjects research, • For non-human subjects research, • For Quality Improvement activities, • For international sites, • For institutions without an FWA

  5. Reasons COMIRB might not serve as sIRB • Risk level of research • Complexity of research • Contractual requirements from relying site (e.g., indemnification) • Concerns about compliance of relying site (e.g., previous non-compliance) • Too many relying sites • No NIH funding

  6. Reasons COMIRB might not serve as sIRB Examples: • Clinical trial involving administration of an investigational drug • Clinical trial of an investigational implantable device

  7. Reasons relying site might not rely on COMIRB • Individual sites may come to different conclusions about COMIRB’s review or determinations • Contractual requirements from relying site (e.g., indemnification) • Local policies

  8. Before study can begin at relying site • An IRB reliance agreement must be signed by Institutional Officials at both the University of Colorado, Denver | Anschutz Medical Campus and the relying institution, and • COMIRB must approve the addition of the relying site, which may include relying site-specific consent forms and other documents Both are needed

  9. Reliance Agreements • Smart IRB • Preferred • Use whenever relying institution is a Smart IRB participating institution • IRB Authorization Agreement (IAA) • Both specify roles and responsibilities of reviewing and relying IRBs, institutions and PIs

  10. Smart IRB

  11. IRB Authorization Agreement

  12. Smart IRB • What is Smart IRB? • Smart IRB is a network of institutional IRBs (564) who have agreed in principle to rely on one another • 23 page reliance agreement

  13. Common Reliances • University of Colorado, Boulder • IAA • National Jewish Health • Smart IRB • Colorado State University • Smart IRB

  14. Process

  15. Process • Contact COMIRB to discuss the study: • Provide protocol and/or funding proposal • Identify sites • Describe activities taking place at relying sites We may discuss strategies to involve external sites without formally “engaging” them in human subjects research.

  16. Options If COMIRB cannot serve as sIRB: • Relying site may conduct their own IRB review, • Another IRB may be identified as sIRB, including a private IRB

  17. Process • If the Director agrees that COMIRB can serve as IRB of record for the study for the non-affiliated site, COMIRB will send the PI in an email. • Contact the relying investigators and ask them to contact their IRB offices about relying on COMIRB.

  18. Parallel After confirming that relying PIs are in contact with their IRB offices: • PI/study team submits amendment to add relying site(s) • COMIRB contacts relying IRB offices

  19. Study team: COMIRB Submission • Complete Attachment A on Application form to indicate an unaffiliated site is relying on COMIRB • Complete and upload the Relying Site Details form • Upload any unique consent forms or other documents from the relying site

  20. Relying Site Details

  21. Relying investigators Investigators at relying sites: • Need to keep their human subjects training up to date according to their local requirements • Need to complete their local COI disclosures • Do not need to be added to our Personnel Form • Do not need POI numbers • Do not need to complete our CITI training • Do not need to complete our COI disclosures

  22. Local documents Relying sites may require their own versions of: • Consent forms • Assent forms • Recruitment materials • Etc. Our PI/study team is required to submit these documents to COMIRB for review and approval.

  23. Workload • Be very thoughtful about the number of sites you ask to rely upon COMIRB. • If each sites requires its own consent form and other unique documents, workload could increase geometrically • COMIRB is not a private IRB and does not have systems or resources to communicate directly with each site PI • All site documentation needs to go through our PI

  24. In the meantime … COMIRB will contact relying IRB offices: • Obtain “Local Context” information, and • Smart IRB Authorization Agreement (preferred), or • COMIRB IRB Authorization Agreement

  25. Institutional officials • Local context information and authorization forms must come from IRB offices and other designated institutional officials. • These forms and authorizations will not be accepted if completed/signed by site investigators. • For UCD, Alison Lakin, Associate Vice Chancellor for Research, signs IRB authorizations

  26. Process COMIRB will distribute fully executed IRB authorization agreements to our PI (through InfoEd) and to the relying IRB office.

  27. Timing • Goal is to approve the COMIRB amendment adding the relying site at the same time IRB authorization is fully executed. • Some IRBs require evidence of our approval of their site before they will sign the IRB authorization agreement • COMIRB tries to be flexible

  28. PI Responsibilities

  29. Additional PI Responsibilities Contact COMIRB: • Provide COMIRB a copy of the protocol and list of sites • Determine which sites are “engaged” in the research and, therefore, require IRB review. • Discuss whether COMIRB can act as the single IRB for all or some institutions participating in this study. • If COMIRB cannot serve as the single IRB, discuss options for selecting an external IRB (e.g., a private IRB or an IRB from one of the participating sites).

  30. Additional PI Responsibilities Develop study oversight plan: • Define roles and responsibilities for communicating and coordinating key information to Relying Institutions • Develop a plan for communicating with collaborators across the lifetime of the study (i.e. regular conference calls, site initiation procedures and training materials).

  31. Additional PI Responsibilities Be engaged and responsive to relying sites: • Promptly respond to questions or requests for information from relying site study teams and relying IRBs • Participate in conference calls regarding the study as requested.

  32. Additional PI Responsibilities Communicate IRB policies: • Provide the relying site investigators with the IRB policies of the Reviewing IRB (COMIRB or Smart IRB). • This includes, but is not limited to, policies for reporting unanticipated problems, noncompliance, and subject complaints.

  33. Additional PI Responsibilities Distribute study documents: • Provide COMIRB with relying site versions of consent forms and authorizations, recruitment materials, differences in protocol • Provide relying site study teams with the IRB-approved versions of all study documents

  34. Additional PI Responsibilities Prepare and submit IRB applications to COMIRB on behalf of all sites, including: • Initial reviews, • Relying site amendments, • Investigator updates, • Relying site local reportable events (e.g., unanticipated problems, or potential serious or continuing non-compliance), and • Study-wide information for continuing review.

  35. Additional PI Responsibilities As part of managing the IRB submissions: • Have a mechanism in place to obtain and collate information from relying site study teams regarding local variations in study conduct, such as recruitment materials and process, consent process and language, and subject identification processes.

  36. Additional PI Responsibilities • Notify relying site investigators of all COMIRB determinations and communications, including: those for initial review, continuing review, amendments, and reportable events. • Significant new findings that may relate to subjects’ willingness to continue participation, • Requirements to re-consent subjects.

  37. Additional PI Responsibilities If a Relying Site Study Team does not provide the Lead Study Team (or designee) with the required information before the continuing review application is submitted to COMIRB, reports the absence of this information as part of the continuing review and notifying affected relying site study team of lapse in approval for their site and any applicable corrective action plans.

  38. Additional PI Responsibilities Providing access, upon request, to study records for audit by the University of Colorado, Denver | Anschutz Medical Campus, a relying institution, and/or other regulatory or monitoring entities.

  39. Additional PI Responsibilities Follow all requirements of relying Institutions with regard to ceded review, such as ensuring administrative requirements for documenting ceded review have been met before study activation occurs at the relying institution.

  40. Reasons COMIRB might cease serving as sIRB • Inadequate oversight of relying sites by PI/study team • Inadequate oversight/compliance by relying sites • Relying site terminates reliance

  41. Quiz Will COMIRB always serve as sIRB for multi-site research? • No, if COMIRB cannot assure adequate oversight of the study, COMIRB will not serve as sIRB If we receive an NIH award for multi-site research, is COMIRB required to serve as sIRB? • No, a sIRB plan is required, but COMIRB is not required to be the sIRB. Alternatives include asking a private IRB or an IRB from one of the involved sites to serve as sIRB

  42. Quiz If COMIRB is the sIRB, does that mean the relying sites’ IRBs do not have to be contacted? • No, relying IRB offices or designated officials must be contacted regarding IRB reliances • Relying institutions will not enter into IRB reliances blindly, and will not delegate that authority to their PIs

  43. Quiz You have received a fully executed IRB authorization agreement for a relying site but COMIRB has not approved the additional site. • Can research begin at the relying site? • No COMIRB has approved a relying site but you have not received a fully executed IRB authorization agreement. • Can research begin at the relying site? • No

  44. Tip for Success • Consult with COMIRB early • Make sure relying site investigators have communicated with their local IRBs about pending reliance before COMIRB contacts thei IRB offices • Keep Attachment A and/or Relying Site Details form up-to-date

  45. Questions?

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