University of Utah Annual IRB Member Training Ann Johnson, PhD Associate Director Institutional Review Board

Transcription

1 University of Utah Annual IRB Member Training 2016 Ann Johnson, PhD Associate Director Institutional Review Board

2 Overview of NIH policy on the use of a Single IRB for multi site research (and other federal thoughts) Overview of sirb premise and process Overview of the NCATS TIC grant and what that means for Utah Plans moving forward

3 Final NIH Policy on the Use of a Single Institutional Review Board for Multi Site Research available online Requires the use of a single IRB for multi site research funded by the NIH Applies to all competing grant applications received on or after May 25, 2017

4 The goal of this policy is to enhance and streamline the IRB review process in the context of multi site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.

5 Ancillary Reviews Qualifications & Training Compliance & Oversight Human Research Protection Program Conflict of Interest IRB HIPAA Privacy Board

6 Reliance agreement execution Outline the roles and responsibilities between the sirb and the local site Attempts to standardize and streamline Initial sirb review + local review Bringing review times to the mean Ongoing review and monitoring by sirb and locally Continuing reviews, amendments, report forms, auditing

7 Investigator and study team Human Research Protection Program (HRPP) Local IRB Local Conflict of Interest Review Local ancillary committees Local training and compliance

8 How do I interact with the CIRB? What is the communication plan? What does the CIRB expect of me? What requirements does my institution have that are not covered by CIRB review? How do I continue to meet those requirements? Do policies of the CIRB differ from policies of my local IRB and institution? How do I adhere to both sets of policies?

9 What are the terms and conditions of the Reliance Agreement with the CIRB? What are our responsibilities as the local HRPP? What local context concerns, state laws, institutional policies apply to this protocol? How do we communicate this to the CIRB? How do we confirm these local requirements are met? How do ancillary committee reviews get completed our institution? How do we track this protocol as a research project happening at our institution? How do we handle problems that occur at our research site?

10 1. Investigator submits the protocol and associated documents for facilitated review at the local site. Is this a single application to a coordinating body, or separate applications to different groups and committees? 2. All applicable groups/committees review the protocol and documents. A coordinating body for facilitated review? Perhaps. Conflict of interest review Legal review Scientific review Funding and billing review Resources review Etc.

11 3. Groups/Committees provide feedback on the protocol and documents. This may include revisions that need to be made locally or to the overall study 4. Investigators address local feedback and revisions. 5. Feedback and revisions for the overall study are sent to the CIRB. Does the coordinating body do this, or the investigator?

12 There is likely to be an overall consent (and authorization) document for the study. The local site should be able to add local language to key sections. Person to Contact Research Related Injury Statement HIPAA Authorization Others, depending on state law and local policies The investigator should fill this in as part of the initial facilitated review. The local groups/committees should verify it is correct and meets requirements.

13 1. CIRB reviews the overall study and makes appropriate determinations. 2. CIRB reviews the local requirements, feedback, and revisions, ensuring these are addressed and incorporated. 3. CIRB issues approval of the study and of participation of the local site. The CIRB may do all of this as part of an initial review of the study OR may consider the local site as part of an amendment.

14 1. The investigator provides CIRB approval documentation and the final version of the approved documents to the local groups/committees. 2. The groups/committees verify the approval and send a facilitated review acknowledgement. 3. The investigator may begin the research at the local site.

15 Local IRB review may still be required for certain determinations; refer to the terms and conditions of the Reliance Agreement. Local amendments HIPAA determinations Consent documents Shared IRB Reviews would likely have a different process to facilitate the review

16 Gathering all necessary information efficiently Using all necessary information meaningfully Multiple electronic systems Communication barriers Standardizing key policies and processes Collecting reliable and valid metrics Improving review times

17 Funded by the National Center for Advancing Translational Sciences Works in collaboration with the national CTSAs Goal to accelerate the translation of novel interventions to evidence based treatment

18 Three awards: University of Utah Johns Hopkins & Tufts collaboration Vanderbilt & Duke collaboration The three centers will work together to develop processes for sirb model Master contracts Streamline protocol design and procedures Patient engagement

19 Review same components, but for multiple sites Collect local context and review documentation for use by the staff and convened board Provide sirb specific documentation to local sites Open up ERICA to outside users

20 Need for local SOPs on how to defer to a CIRB and complete local facilitated review requirements. Need to consider how CIRB review interplays with local electronic systems and submission processes. Need to have a plan for training and informing research teams and HRPP officers on how to complete local processes for facilitated review. Need to have a plan for ensuring research teams understand differences between CIRB policy and local policy. Need for local SOPs for monitoring compliance at the local site.

21 Update ERICA to allow for better indication of sirb use Electronically track reliance agreements and connect that system to ERICA Educate the research community! Develop guidance and instruction documents Work with TIN partners and other academic institutions to develop best practices and standardizations Engage with multiple institutions to become a more prolific sirb Measure metrics

22 Question & Comments? Thank you!