Ontario Colleges Multi- college Ethics Review Process On behalf of the Multi-college ethics working group Lynda Atack, Centennial College Jill Dennis, St. Lawrence College Jane McDonald, Conestoga College Richard Rinaldo, Georgian College Neil Wilkinson, Niagara College Presented By Otte Rosenkrantz, Expert Panel member, Fanshawe College

Pulling together: Developing and evaluating a multi-college research ethics application process A report to the Applied Research and Innovation Centre, Centennial College. October 25, 2014

The multi-college ethics review process Given the increased interest in and focus on applied research in the Ontario college system, the HAR Research Ethics Subcommittee (RES) proposes that a multi-college ethics review process be implemented Streamline ethics review for the researcher Decrease workload for individual college REBs Serve to assist less experienced REBs in the practical implementation of TCPS 2 ethics guidelines.

Assumptions College REBs that agree to participate in the multi-college review process do so in good faith. Those who review applications through the multi-college process as part of the Expert Panel are from colleges that agree to adhere to the requirements of TCPS2 (2014). Members of the Expert Panel have completed the TCPS2 tutorial. Individual college REBs are responsible for all research conducted under their auspices.

The Multi-college process A researcher wishes to conduct educational research at several colleges. The researcher submits the common application form to College A – generally his or her home college – noting that the research project is a multi-college project. The REB Chair from the receiving college (College A) screens the application to be sure it is minimal risk research. The REB Chair confirms with the researcher that he/she wishes to use the Multi-college review process and signs the agreement with the researcher.

The Multi-college process The REB Chair or REC from College A notifies the E P Lead that an application for multi-college research has been received and sends all information to that Lead. The EP Lead recruits two other member of the panel to review the application and requests that they review the application within 10 working days. EP members are asked to comment only on substantive issues and are also asked to note which changes are required from their perspective. EP members take a proportionate approach to ethics review as suggested in TCPS2 (2014).

The Multi-college process The EP Lead communicates with the researcher, suggesting any changes that might assist in ethics approval of the project. When the researcher has made the suggested changes, the EP Lead provides the researcher with a letter of recommendation and all approved documents (Information and Consent letter etc.) as a pdf file. The researcher communicates directly with each college to determine other requirements of specific colleges (e.g. institutional approval, locally responsible investigators, or further paperwork).

The Multi-college process The researcher forwards the completed common application to each college at which he/she desires to conduct research, including letter of recommendation from the expert panel and all supporting documents. The application is reviewed by the Chair of the individual REB who then determines ethical acceptability and, if appropriate, issues the certificate of ethical approval to the researcher. Each college at which the research is conducted continues to be responsible for research conducted under its auspices.

The Multi-college process Note that where there is substantive disagreement among the members of the EP and no common ground is found, the Panel lead will communicate with the researcher and with the REB Chair of College A to suggest that the Panel is unable to comment on the acceptability of the application. The application then reverts to individual review as the researcher wishes. If the researcher chooses not to make changes suggested by the EP, she or he may withdraw from the multi-college process. The EP lead will inform the REB Chair from the originating College that the researcher no longer wishes to participate in the multi-college process.

The Multi-college process Copies of all documents including EP reviewer feedback forms and records of changes made are forwarded by the EP lead to the originating College REB Chair or REC for storage as per their usual protocols. The original documents are maintained by the EP lead as per the Terms of Reference.

The College Pilot Sites Centennial Conestoga Confederation Fanshawe George Brown Georgian Niagara Sheridan

The Expert Panel An expert panel, composed of five REB Chairs who volunteered to sit on the panel for the first two years, was formed. Members had to have a minimum of two years’ REB review experience, however, most had five to ten years’ REB experience. A lead for the panel was identified. The lead’s role was to receive the ethics application referrals from the pilot site, send out a call for reviewers (each review required three reviewers), coordinate the review and feedback to the researcher, issue the recommendation letter to the researcher

Evaluation Goals and Data collection The goals of the evaluation report were to identify strengths, barriers and limitations in the new, proposed ethics review process. What is the demand for the multi-site process? How well is the new process working/being adopted? What steps were required at individual colleges to implement the process? What is the impact on REB Chairs and REB members at the individual colleges? What is the impact on the expert panel members’ workload? What are the REB and college system challenges with the new process? What are the advantages of the new system? What local college and cross system supports are needed to sustain the process? What activities are required to roll the process out to all college REBs in Ontario?

Data collection Survey tool Expert panel interviews Research directors/VPs interviews Feedback from REB Chairs/Managers at pilot sites Expert panel metrics (No. of applications; no. recommended for approval; time needed for reviews; time for applications to move through the system)

Results Five applications sent to the EP during the six month project Average review time by the EP was 9 days. The EP largely agreed on issues related to ethics and panel members reported that the referral, review and recommendation process functioned well. Researchers reported a positive experience with the EP Mixed results and researcher dissatisfaction with the college REB process Approval times for 21 reviews demonstrated large variation in review time: Seven (33.3%) were reviewed in 0 to 2 days. Seven (33.3%) reviewed in 3 to 8 days however, Two (9.5%) took 18 to 25 days and five (23.9%) were very slow, taking 44 to 54 days. Main reasons for delays: REB requests that researchers/entire team complete TCPS2 training, request for more documents, and summer closures.

Discussion The purpose of this project was to develop and test a multi-college ethics review process that would ensure quality and be feasible to conduct in the Ontario community college system. That goal was achieved: a new process, including terms of reference for the expert panel, was developed and tested. That willingness to participate was encouraging and can be interpreted as a recognition by some colleges of the need to improve the multi-college ethics review process.

Discussion The relatively low volume of applications was the result of two factors, the usual summertime slowdown/closure of college REBs and lack of researcher awareness of the new process. The researchers agreed that the common application form was very helpful and most reported a positive experience with the EP. Researchers made it clear that they would prefer one REB for multi- college ethics application approvals. Foundational to future success will be both the EP and the REBs doing their job well and in a timely manner. The ongoing support of the Heads of Applied Research committee will be continue to be important

Thank you Dr. Lynda Atack Dr. Otte Rosenkrantz