OCREB Governance Committee Meeting Friday November 13, University Ave, Suite 501, Toronto, Ontario Meeting Minutes

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1 Cancer Research Ethics Board MaRS Centre, South Tower, Suite College Street Toronto, Ontario, Canada M5G 0A OCREB Governance Committee Meeting Friday November 13, University Ave, Suite 501, Toronto, Ontario Meeting Minutes Attendees: Voting Members Present: Ex Officio Members Present: (non-voting) Regrets: Raphael (Ray) Saginur (Chair) Derek Cathcart Geneviève Dubois-Flynn Christopher Henley (by phone) Michael McDonald Jim Wright Yooj Ko Janet Manzo Richard Sugarman Mark Whissell Guests: Greg Baker & Dipo Odunsi (OICR Finance) for Agenda Item 4.4 Quorum present? Yes 1. CALL TO ORDER & APPROVAL OF AGENDA The meeting was called to order at 12:10. The Governance Committee Chair welcomed everyone to the meeting, in particular Dr. Jim Wright as a new Committee member. There was one addition to the agenda (Item 4.8) - an informational update on Quebec s new research ethics review model. 2. APPROVAL OF PREVIOUS MEETING MINUTES MOTION (McDonald/Cathcart): To approve the minutes of the Committee s November 15, 2013 meeting. DECISION: Motion carried. 3. BUSINESS ARISING FROM PREVIOUS MEETINGS 3.1. Research Ethics Environment Updates for information Clinical Trials Ontario Clinical Trials Ontario (CTO) is an independent not-for profit organization supported by the Ontario Ministry of Research and Innovation. CTO was established to streamline the start-up and conduct of multi-centre clinical trials in Ontario and thus make Ontario a preferred location for global clinical trials. The key focus for CTO over the last year has been the design and implementation of a Streamlined Research Ethics Review System for multi-centre clinical trials in Ontario. Several developments have moved CTO closer to implementing its delegated board of record model, which will enable any CTO Qualified REB in Ontario to serve as the sole REB providing ethics oversight of a clinical trial being conducted at multiple research sites across the province. OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 1 of 7

2 The CTO REB Qualification Program is a key component of CTO s Streamlined Research Ethics Review System. REB Qualification is an important means to establish the trust needed for one institution to rely on another institution s REB. The qualification requirements are informed by regulations, policies and standards applicable to the conduct of clinical trials and health research in Ontario and Canada. OCREB was the first REB to be qualified under the CTO REB Qualification Program in February The CTO Qualification Review Team is comprised of a CTO auditor and members of a newly-established College of Reviewers. The OCREB Chair, Executive Director and Research Ethics Officer were invited to serve on the College of Reviewers. In January 2014, Infonetica Ltd, a UK-based research software specialist, was chosen to provide the web-based electronic platform that will support the CTO REB model, which is called CTO Stream. CTO Stream is being rolled out in fall 2014 during a pilot phase. CTO anticipates a formal launch of CTO Stream early in The OCREB Executive Director s CTO secondment was extended to March Canadian Cancer Clinical Trials Network (CCCTN) The Canadian Cancer Clinical Trials Network (3CTN) is a pan-canadian initiative that was established to improve the efficiency and quality of clinical trials in Canada, by providing support and coordination for a network of teams at cancer treatment centres and hospitals. With regional participation, 3CTN will enable sites to increase their capacity and capability to conduct academic trials. The 3CTN network structure is proposed to have three components: Network Regional Coordinating Centre (NRCC), Network Cancer Centre (NCC) and Network Affiliated Cancer Centre (NACC). The coordinating centre is the administrative hub of 3CTN and is located at OICR. The phase I activities are complete and 3CTN is in the process of securing the funding and implementing its business plan. Through a formal pan-canadian peer-reviewed process, seven regional coordinating centres and approximately 18 cancer centres have been identified. These centres will work together through regional hubs in support of the 3CTN goals. Planning and implementation of funding and infrastructure of the networks are underway. The OCREB Executive Director served as a member of the peer review panel. In phase II, 3CTN will focus on activities related to the 3CTN milestones and deliverables such as: establishing formal arrangements with organizations such as CTRNet and N2 and creating teams to identify strategies to increase participant recruitment, to increase the number of academic studies, and to implement education and training, best practices, SOPs, etc. 3CTN also is providing access to a clinical trial management system that will facilitate workload management as well as metrics and reporting. 3CTN, in collaboration with CCAN and lay representatives, has developed a formal strategy to include lay representation across all it structures, both at the 3CTN central coordinating office and at all 3CTN member sites Quality Indicators Michael McDonald briefly summarized the abstract of a paper on this topic that is out for publication. There is lots of information about how to speed processes, but no measures of quality. The current focus of indicators is on rules without knowing if that focus provides the relevant outcomes. ACTION: Michael McDonald to circulate paper when published Status of OCREB Oversight of Non-Phase 1 Pediatric COG Studies OCREB continues to work towards becoming the REB of record for non-phase 1 multi-centre Children s Oncology Group trials at the five pediatric centres in Ontario. Meetings were held with Hamilton & SickKids. A signed Letter of Intent authorizing SickKids to use OCREB was received in July. A meeting in London took place on Oct 28. A meeting was held on November 3, 2014 with the investigators at the five pediatric sites as well as representatives from the satellite sites. A meeting will be scheduled with CHEO for early Progress is being made on recruiting members with pediatric expertise to serve on OCREB. Initial training of the OCREB members and staff is scheduled for November 13. Process issues OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 2 of 7

3 that are internal to the pediatric institutions continue to delay this transition, including determining the appropriate affiliation model between the pediatric institutions and the satellite sites i.e., where many of the pediatric study participants receive aspects of study treatment and follow-up. 4. NEW BUSINESS 4.1. Remarks on the Initial Year as OCREB Chair for information The OCREB Chair shared his thoughts about his first year integrating into the day-to-day functioning of OCREB. He was struck by the welcoming character of the staff and Board Members and noted that this generosity, openness and collaborative spirit were hallmarks of OCREB s character. His first steps in adapting to the demands as the Chair of OCREB were to become familiar with the OCREB SOPs and with the use of the electronic system (O2). He highlighted the development of a supportive system that engages the Vice-Chairs and provides for flexible coverage. He also outlined the educational activities he had opportunities to engage in, as well as presentations he gave to stakeholder institutions. He described his involvement with OCREB member orientation and education, with the TCPS2 Research Participant Education Sub Committee and with CTO as a member of the CTO College of Reviewers for CTO Qualification site visits. Overall, he noted that, judging by the degree of requests for consultation, it is clear that OCREB is held in high esteem by stakeholders and other interested parties OCREB Guidelines for the Management of Conflicts of Interest The OCREB Policy & Procedure Committee (P&P) serves as an advisory group to the REB with a mandate to develop, review or propose policy, etc., including the creation of guidance documents. The committee is chaired by the OCREB Research Ethics Officer and is composed of the OCREB Chair, both Vice-Chairs, the Executive Director, at least one Research Ethics Coordinator, other members of OCREB including an ethicist and a lawyer, and ad hoc members depending on the topics under discussion. Over the past few years, there have been instances of potential/perceived/declared conflicts of interest that have arisen both at the full Board level and during expedited review. In reviewing seven case studies, it became apparent that it would be valuable for OCREB to provide more detail and clarity on the processes and policies for the identification, review and management of conflicts of interest. The P&P Committee agreed to draft a framework that would include definitions, principles, a risk matrix to assist in evaluating the degree or severity of the conflict (degree of potential harm), conflict thresholds (e.g., financial) and possible management options. The P&P Committee prepared a set of draft guidelines for managing conflicts of interest (COI). As a supplement to standard operating procedure (SOP) 105B, the Guidelines will assist investigators when submitting an application to OCREB. The Guidelines also assist to OCREB reviewers in assessing COI and in facilitating a consistent approach to managing COI. The COI guideline was presented to the Board at its March 2014 meeting and issued in April. A copy of the guideline was included in the Governance Committee meeting package Progress on Goals & Goals for Progress on goals A document describing the OCREB performance on the goals was included in the meeting materials. The ED provided an overview on the progress on the goals. Operational 1. Target an eight-week average from submission to approval for 90 per cent of the studies submitted to OCREB for initial review by the three academic/cooperative group sponsors working closely with OCREB (PMHC, OCOG, NCIC CTG); As of November 2014, OCREB received 58 new studies, 18 of which were academic/cooperative group studies. Of those, 11 were sponsored by PMHC, NCIC CTG or OCOG. The average time from submission to approval was 9.4 weeks for six of the 10 PMHC, NCIC CTG and OCOG studies approved to date. One study was withdrawn. It took 96 days to receive the final PI response (the Health Canada No Objection Letter) for one PMHC study sponsored study. With that study excluded OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 3 of 7

4 from the metrics, the average time from submission to approval for the five PMHC, NCIC CTG and OCOG studies approved to date was 6.4 weeks, which exceeds the target. However, the averages are subject to change once the statistics for all of the 2014 studies are available. 2. Assess the value and feasibility of increasing the number of OCREB (Full Board) meetings from one to two meetings per month; REBs at five of the 26 institutions served by OCREB meet more than once a month (SMH, UWO, MSH, TOH, HHS). Those REBs receive between 350 and 900 new studies per year, although not all of those new studies would require full Board review. OCREB receives an average of 70 new studies a year, which is roughly equivalent to 140 new studies factoring in the additional centres involved in each study. The remaining 21 REBs meet 10 to 12 times per year. The following factors were considered in weighing the benefits and challenges of increasing the number of OCREB meetings: overall volume and impact on continuity of reviews, on membership, on quorum, on attendance, on budget and on timelines. There does not appear to be sufficient justification to increase to more than one meeting a month at this time considering the amount of effort involved. In reviewing the number of new studies and other submissions by month, there is no consistency in the volume each month and no evidence to support an increase in the number of meetings for select months. This will continue to be monitored. 3. To improve communication and working relationships with sponsors and CROs working with OCREB, meet with a minimum 10 Industry sponsors (and/or their designated CROs) that have three or more studies currently with OCREB, and meet with any academic or cooperative group sponsors that requests a meeting. Approximately 50% of the active studies with OCREB are industry sponsored. There is considerable interaction between industry sponsors and the OCREB office on an ad hoc basis, in particular with the Research Ethics Officer. However, only one formal meeting has taken place to date. There are eight CROs and 18 industry sponsors that have three or more studies with OCREB. Meetings will be scheduled starting with sponsors and CROs that have five or more studies with OCREB. Quality: 4. Conduct needs-assessments with REB members, REB staff and research staff (at the institutional level) with respect to the research ethics education provided by OCREB, and develop an education plan for all three target groups, based on the outcome of the needs assessment. The formal needs assessments have not been conducted yet. An inaugural OCREB education retreat is scheduled for the evening of November 13. Thirty-five OCREB members and OCREB office personnel are registered. Feedback from the retreat, in addition to a needs-assessment survey, will assist in evaluating the OCREB member and staff educational needs. 5. Conduct an assessment of the appropriateness and effectiveness of the current training programs offered by OCREB (e.g., Outreach and O2) and implement appropriate changes based on the outcome of the assessment; A Lunch and Learn was held on September 30 and was attended by 24 individuals from three study sites. Feedback was obtained via a questionnaire: 23 of the 24 attendees were satisfied with the session overall, found it to be a valuable learning tool, would participate in future sessions and would recommend participation to colleagues; 24 of 24 were satisfied with the material presented and indicated their questions were answered. Attendees suggested that these sessions be offered on a regular basis. To date, the following O2 training sessions have been conducted (via webcast and/or in person): 7 provincial application sessions involving 33 participants; 4 centre application sessions involving 30 participants and 3 individual OCREB member training sessions. A questionnaire was introduced in October to obtain feedback from the study staff on the O2 training sessions. The feedback has been positive. The introduction to OCREB portion of the session was noted as OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 4 of 7

5 Mandate: valuable in helping sites understand the OCREB model and the context for the OCREB submissions. 6. Assume responsibilities as the REB of record for all new non-phase I multi-centre Children s Oncology Group (COG) trials to be conducted at the five paediatric oncology centres in Ontario. OCREB continues to work towards becoming the REB of record for non-phase 1 multi-centre Children s Oncology Group trials at the five pediatric centres in Ontario. Meetings were held with Hamilton & SickKids. A signed Letter of Intent authorizing SickKids to use OCREB was received in July. A meeting in London took place on Oct 28. A meeting was held on November 3, 2014 with the investigators at the five pediatric sites as well as representatives from the satellite sites. Progress is being made on recruiting members with pediatric expertise to serve on OCREB. Initial training of the OCREB members and staff is scheduled for November 13. Leadership: 7. Assume leadership in the development of a common optional consent form template (biospecimens and biobanking), working in collaboration with NCIC CTG and the BC Cancer Agency REB. OCREB is leading the revisions to the optional sample consent form template. However, this is on hold pending finalization of the harmonized (OCREB, NCIC CTG and BC Cancer Agency REB) main consent form template. 8. Continue to be an active partner in the ongoing national and provincial research ethics streamlining initiatives: i.e., the 3CTN, the Strategy for Patient Oriented Research (SPOR) and CTO, and in the development of national REB SOPs; Members of the OCREB team (Chair, Executive Director, Research Ethics Officer, Research Ethics Coordinators, O2 Business Analyst) continue to actively participate in a variety of provincial and national ethics-related initiatives such as Clinical Trials Ontario (CTO), the Network of Networks (N2), CAREB, the Ontario Health Study, the Canadian Cancer Clinical Trials Network (3CTN) and harmonization efforts with the NCIC-Clinical Trials Group (CTG) and the BC Cancer Agency REB. The CAREB and N2 organizations released of the first set of collaboratively developed, standardized, Canadian REB SOPs via open access. The REB SOPs are specific to ethics boards that review health sciences research and are compliant with applicable Canadian and US regulatory, and ethics guidance criteria. The OCREB SOPs were used as the template for the national SOPs. The OCREB Research Ethics Officer chaired the N2/CAREB REB national SOP development project. The OCREB Chair is a member of the Research Participant Education Sub-committee of the Panel on Research Ethics Secretariat on Responsible Conduct of Research. The OCREB Chair, ED and REO were invited to serve on the Council of Reviewers for the CTO REB Qualification reviews. CTO asked to have a representative on the NCIC-CTG/BCCA REB/OCREB harmonized consent form committee. The ED was invited to serve on the CAREB Certification Steering Committee. The ED s secondment to CTO was extended to March Goals The OCREB Chair, one of the two Vice-Chairs, the ED and the OCREB office personnel met on October 31, 2014 to review the progress on this year s goals and to set the goals for next year. The draft goals were circulated in the meeting package: OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 5 of 7

6 1. Review all new 2014 studies in which the PI response time was greater than 6 weeks post receipt of the OCREB letter, and identify potential reasons for the delays. 2. For all studies submitted to OCREB between 2012 and 2014, report on the time elapsed from the approval of the study (provincial initial application) to the time of approval of each participating centre, and the reasons for any delays in the submission of the centre initial applications. Additionally, if the information is available, report on the time from the approval of the study to study activation at each centre and to the time of the first study participant s visit. This information will help to determine the value of investing further efforts directed at reducing the time from the submission to the approval of new studies. 3. Review the eligibility (inclusion and exclusion) criteria in the protocols submitted to OCREB over the past 1-2 years to inform the board in their decision-making and review of pre-screening consent forms focused on a single eligibility criteria. 4. Investigate the feasibility of establishing a formal consultative service (i.e., the provision of education resources) that would enhance the researcher/research team s understanding of research ethics and improve the quality of their submissions to OCREB. 5. Identify the types and volume of other forms of multi-centre cancer research (i.e., non-clinical trials). These data would serve as the basis for assessing the feasibility of broadening OCREB s mandate. No changes recommended Financial Summary 2011/12 to 2013/14 (to date) and Budget The following materials were included in the meeting package and summarized by the ED and the OICR financial representatives: Financial actuals FY11-12, and Actual FY YTD Sep, variances and forecast FY14-15 Budget FY15-16 Notes for the forecast and budget Graph showing payroll costs versus number of FTEs 2011/12 to 2015/16 and graph showing year-to-year comparison in number of new studies, active studies and active participating centres from 2004 to 2014@November. MOTION (Cathcart/ McDonald): recommend that the OICR Board approve the OCREB budget for DECISION: motion carried 4.5. OCREB Inaugural Educational Retreat for information An inaugural OCREB education retreat is scheduled for the evening of November 13. Thirty-five OCREB members and OCREB office personnel have registered. The two topics that will be presented are ethical issues related to research in pediatrics and ethical issues related to biobanking, return of results and incidental findings. A presentation at a breakfast session the following morning will be on The Changing Face of Phase I Trials Considerations for Interprovincial REB Review Arrangements for information The Executive Director noted that she has been having informal discussion with UBC about the sharing and streamlining of reviews between the provinces; however, there has been no substantive progress Governance Committee Terms of Reference Noting that the Committee plans to discuss revisions to its Terms of Reference (ToR) during the in camera session, the Executive Director provided her opinions and thoughts on the activities of the Committee to date and her recommended changes to the ToR, for the Committee s consideration Quebec for information Geneviève Dubois-Flynn provided an update on the revised Quebec multi-centre REB review model. Once it goes into effect (estimated to be December 1, 2014), there will be one ethics review for all sites conducted by the REB of Record. A site specific assessment and a research authorization (by the mandated person) will be conducted at each site. OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 6 of 7

7 5. IN CAMERA SESSION The voting members of the Committee met for an in camera session. The OCREB Chair was invited to attend the initial portion of the in camera session to provide a summary of the evaluation results of the Vice-Chairs. There were no motions arising from the in camera session OCREB Governance Committee Meeting Minutes 2014-Nov-13 - FINAL Page 7 of 7

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