November 30, Efficient Startup of Multi-site Research Studies: Central IRBs and National IRB Reliance Platforms

Transcription

1 November 30, 2017 Efficient Startup of Multi-site Research Studies: Central IRBs and National IRB Reliance Platforms

2 Agenda Working with a Central IRB SMART IRB IRBchoice

3 Single IRB vs. Central IRB They mean the same thing: a single IRB of record overseeing all clinical trial sites participating in a multisite study IRB of Record: the IRB that is responsible for the review, approval and regulatory oversight of a research study Term used most consistently in federal guidance, correspondence and other documentation Term focuses on IRB s responsibilities More important than IRB s location or organizational relationship Single IRB relationship can be established in a variety of ways

4 Central IRB Review vs. Local IRB Review for Multisite Studies Local IRB: oversees research at just one location Reviews the protocol-level information and investigator/site qualifications as a single unit Central IRB: oversees research being conducted at many locations Reviews the protocol once on behalf of all sites Reviews each investigator/site submission in the context of the protocol

5 Why Centralized IRB Review? Multiple federal agencies endorse centralized IRB review for multisite research NIH, FDA, OHRP Centralized review = more efficient process Removes duplicative reviews Single IRB overseeing all participating sites = consistent oversight Uniform protocol and informed consent template for all sites Consistent subject protections More reliable study data

6 How Does This Work? Sponsor/CRO submits the protocol and all protocol level documents Approved The institutional site submits site specific documents Approved Smart forms Informed Consent Investigator CV Deferral information (if applicable) Sponsor/CRO has access to all protocol and site approval documents Sites have access to their own approval documents and protocol-level documents the site may need

7 Central IRB Responsibilities Central IRBs have the same regulatory responsibilities as local IRBs 21 CFR 50, CFR 46 Audited regularly by FDA and relying sites AAHRPP accreditation Shows above-and-beyond commitment to quality HRPP

8 Deferral/Agreements When another IRB (not the local IRB) will serve as IRB of record, the local IRB may need to provide documentation of deferral 21 CFR permits deferral of IRB oversight Possible Options for Documenting Deferral IRB Authorization Agreement (IAA) Master Services Agreement, Reliance Agreement or Global IAA Smart IRB or IRBChoice Study specific Required if research is covered by institution s Federal Wide Assurance (FWA) Covers all research reviewed by cirb Can be established in advance of any new submissions No need for other deferral documents National online platform Study specific Documents deferral

9 Responsibilities Schulman Responsibilities Assess investigator qualifications as part of submitted material Assess research education and training documentation for investigators and research staff Maintain registration with FDA and OHRP Notify designated institutional officials of accreditation changes Ensure compliance with ethical standards and regulations in approved research Assume regulatory responsibility for IRB s actions as IRB of record Manage necessary site-specific information for inclusion in the informed consent Approve informed consents that meet the IRB s requirements and maintain review of revisions Provide copies of IRB decisions and rosters Notify institution of serious or continuing noncompliance determinations, unanticipated problems in research, and suspension or termination of IRB approval Local IRB Responsibilities Assess investigator qualifications prior to submission to IRB and report any changes to qualifications that negatively impact subject safety Require and document research education and training for investigators and appropriate study staff Provide appropriate credentialing of staff Maintain the institution s approved FWA(s) Conduct security and privacy review of protocol and informed consent as required for HIPAA (unless cirb is responsible) Ensure investigator compliance and conflict of interest is managed in accordance with IRB requirements Decide whether to participate in a study or to limit an investigator s involvement prior to submitting research to IRB Indicate any relevant state laws or institutional concerns regarding the research in IRB s submission material For more information, see FDA Guidance for Industry Using a Centralized IRB Review Process in Multicenter Clinical Trials Include assessment of local context in IRB submission material to be considered during review of research proposals Report to the IRB any serious or continuing noncompliance, unanticipated problems in research, and other compliance issues potentially impacting human subject protections

10 Most Central IRBs Can serve as a privacy board Will review COI Are the reporting entity if IRB of record Look to the local IRB to be responsible for documenting human subject research protections training Are willing and able to review local context

11 Site Networks Therapeutically focused site networks designed to get studies started faster and more efficiently These networks are becoming more prevalent Networks assemble a roster of sites; these preferred sites get first option to participate Requiring sites to use a single IRB for network studies is becoming more common

12 Therapeutic Specialization Networks: Identifying the Need for Single IRB Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) StrokeNet

13 Evaluating a cirb Partner Regulatory audit history Accreditation Communication structure Submission deadlines and turnaround times Electronic tools References from other institutions

14 Reliance Platforms/Networks

15 Reliance Platforms/Networks Supports multisite single IRB review Minimizes duplicate institutional IRB review Can be used between local IRB and central IRB Single global agreement eliminates need for individual agreements One set of SOPs Online platform Documents acceptance of IRB of record and institutional IRB s deferral Flexibility in designating responsibilities (e.g., COI, HIPAA, documentation) Allows institutions to add comments and specific instructions Serves as a resource and provides training

16 Reliance Platforms/Networks Founded as IRBrely by Dartmouth Synergy (Later joined by Harvard and University of Wisconsin- Madison) Became SMART IRB Funded by NIH/NCATS in preparation for NIH Single IRB Review policy SMART = Streamlined, Multisite, Accelerated Resources for Trials All CTSA institutions initially required to join (330 members) Generates to all parties documenting reliance Ambassadors

17 Reliance Platforms/Networks R13 grant from NCRR initiated exploration IRBshare began, 45 institutions joined RO1 grant from NHLBI, became IRBchoice with 75 members Detailed institutional profile section in portal documentation to all parties Two methods Ceded model Sharing model

18 Reliance Platforms/Networks Differences No QI/QA requirement noted Requires use of online platform No SOPs Two methods Ceded model Sharing model Requires some type of QI/QA process unless otherwise agreed upon by both sites Does not require use of online platform One set of SOPs Extra documents

19 Questions?? Maria Stivers Manager, Institutional Services Office: Mobile: