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Reports

University of Ontario Institute of Technology Research Ethics Board Review Report – Summary

September 26, 2015

  • Preamble

    The University of Ontario Institute of Technology (UOIT) commissioned an external review of the governance of and administrative support to the Research Ethics Board (REB). The review was conducted and the report prepared by Susan Marlin (consultant) in July and August 2015. The consultant was provided with the review terms of reference (TOR), relevant policy, procedures and other documentation. Meetings were arranged with key UOIT stakeholders. 

    The purpose of the review was communicated to the consultant by the provision of the Terms of Reference (TOR) by the Vice-President Research, Innovation and International. The consultant conducted interviews during the period of July 21st and July 22nd 2015. 

    The full report describes the purpose of the review and the review process, Governance of the REB, REB Operations, and REB Office Resources. Although there was an attempt to keep these sections separate, overlap was unavoidable. Each section begins with observations which are based on both documentary review and interviews, and is followed by discussion and recommendations. 

    Members of the UOIT community who participated in the review, without exception, did so in a constructive manner. A significant interest in REB activities and high quality and ethical research was evident throughout the review process. 

  • Purpose of the Review

    The purpose of the external review (see Appendix 1: External Review) was to review and assess the following: 

    1) The governance structure for the Research Ethics Board 

    2) The operations of the Research Ethics Board 

    3) The resources and administrative support provided to the Research Ethics Board by the University 

  • Review Process

    All university stakeholders were strongly encouraged to participate and were provided with the opportunity to attend open sessions, have one-on-one meetings and provide written feedback. A number of individuals were interviewed either by telephone or in person at UOIT on July 21st and 22nd, 2015. Several written submissions were reviewed as well as documents relating to research ethics review at UOIT. Additional details are provided here: 

    UOIT Interviewees: 

    Past REB Chair and Past Vice- Chair; 

    Current members of the REB (N = 4); 

    Ethics and Compliance Officer; 

    President; 

    Provost & Vice-President Academic; 

    Vice-President Research, Innovation & International; 

    Director of Research Services; 

    Research Services Staff (N = 6); 

    Senior administrators (Deans) (N = 7); 

    Faculty members (N = 3). 

    Written Submissions Received and Reviewed: REB member (N=1); Faculty (N=4) 

    UOIT Documentation reviewed included: 

    Research Ethics Policy, Approved June 2013, UOIT Board of Governors;

    Research Ethics Board Standard Operating Procedures (SOPs): 

    100 series (REB Administration) 

    200 series (REB Operations); 

    UOIT Website – Research Ethics Board information (for Faculty and Students); 

    Research Board Terms of Reference, approved March 11, 2015; 

    Role of UOIT Board of Governors, UOIT website; 

    Academic Council mandate, UOIT website; 

    Job Information Questionnaire, Ethics Compliance Officer, date submitted April 21, 2015; 

    Job Posting, Ethics and Compliance Officer, posting date April 11, 2012; 

    Table comparing REB Workloads & Staffing, South Ontario REB Working Group (December 2014) 

    Memorandum from Chair and Vice-Chair REB to President dated April 24, 2015; 

    Slide Deck, REB Meeting with President dated November 26, 2014. 

  • A. Governance Structure for the Research Ethics Board

    Regarding the governance structure for the REB, the following recommendations are made: 

    Recommendation 1: 

    The President clarify and make explicit the roles and responsibilities of the VPR portfolio in determining resources and overseeing the operations of the Research Ethics Board. 

    UOIT policies and procedures reiterate and clearly recognize the independence of the REB in decision making with respect to this relationship. 

    Recommendation 2: 

    UOIT REB Conflict of Interest procedures be revised to recognize the potential for conflicts between the institution and REB decision making, and how potential conflicts will be investigated and managed. 

    Recommendation 3: 

    An annual report of REB activities be prepared in a timely manner and be made available to the UOIT community. 

    Recommendation 4: 

    UOIT consider implementing an annual researcher survey, or utilize other mechanisms, to solicit feedback regarding REB processes and institutional support for researchers conducting research involving human subjects. 

    No Recommendation 5 was provided 

    Recommendation 6: 

    The REB work with university administration to develop a process for receiving and managing complaints from the UOIT community regarding REB processes. 

    Recommendation 7: 

    The institution and the REB develop regular communication channels and reporting mechanisms. The development of these channels and mechanisms should include key parties such as the REB, REB Staff, Office of Research Services and the Vice-President Research and be reviewed and approved by the President. 

    Recommendation 8: 

    SOP development and approval processes should consider the content of individual SOPs and consult appropriately to ensure responsible parties are engaged and SOPs are complaint with applicable internal procedures and internal and external standards. 

    Recommendation 9: 

    The REB, through the Chair or Vice-Chair, contribute to clarifying performance and service expectations of key Research Ethics personnel. 

  • B. Operations of the Research Ethics Board

    To support the effectiveness and efficiency of the Research Ethics Board review process, the following recommendations may be considered: 

    Recommendation 12: 

    The process of reviewing and finalizing REB SOPs be clarified and codified. The CAREB/N2 Standard SOPs be consulted as part of this process. 

    Once final, REB SOPs should be made accessible to the UOIT community (e.g., posted on an accessible website), and procedures relevant to researcher activities emphasized or further communicated in documents easily accessible to researchers. 

    Recommendation 13: 

    The process for delegated review of initial applications be revisited with the objective of engaging REB members more effectively in the process and building their capacity. The roles and responsibilities of the REB Chair and Vice-Chair be reviewed to ensure responsibilities meet the needs of the REB and are allocated between the two positions, REB members and the ECO in a manner that respects the capabilities and time availability of each position. 

    Recommendation 14: 

    Create additional educational and training opportunities/materials for the REB members to increase capacity and understanding of the TCPS and related ethical guidelines. 

    Create pathways to provide learning opportunities for the REB, such as sharing the feedback from researchers in response to research ethics review. 

    Recommendation 15: 

    Membership on the REB be reviewed to ensure there is a sufficient number of REB members, representing key areas of research. 

    Contributions of REB members be recognized and supported within their Faculty, ensuring total service/administrative commitment is within the 20% allocated to service. 

    Recommendation 16: 

    Research conducted within undergraduate and graduate courses, including FBIT Capstone program, be assessed to seek options for either significantly improving the content of REB applications before the ECO or REB is approached, or the implementation of an alternative approach to REB review at the Faculty level. 

    Recommendation 17: 

    In keeping with the institution’s responsibility for establishing an REB or REB(s) and arrangements/agreements to review research, a delegated Board of Record process be considered by UOIT, especially for projects primarily conducted in hospital settings or other institutions where the institution has signed the Agreement on the Administration of Agency Grants and Awards by Research Institutions. 

  • C. REB Office Resources

    Taking into account the workload comparison, the valued contributed of the ECO towards quality and compliance, as well as measures recommended above to increase the quality of REB submissions and the effectiveness and efficiency of the REB, the following is recommended with regard to REB Office resources: 

    Recommendation 18: 

    The workload of the ECO be restructured by:

      • Removing the responsibility for the Animal Care Committee 
      • Removing the responsibility for the administrative processing of annual renewal; however, oversight responsibility for the annual renewal process should remain 
      • Distinguishing between coordination/administrative/screening back up for the ECO, and back up for REB substantive issues (e.g.. determining delegated/full board review, advising on applications, review comments or TCPS compliance). 
      • Assign REB coordination/administrative back up to consistent administrative capacity in Research Services and back up for substantive issues to the REB Chair or Vice-Chair. 

    Recommendation 19: 

    The role of the ECO outside of compliance be recognized by considering a title that better reflects the role, e.g., REB Coordinator. 

    Recommendation 20: 

    Focussed, expert and temporary resource be hired to develop educational resources and tools to support the conduct and review of research involving human subjects at UOIT such as:

      • revised/updated SOPS. 
      • tools and resources such as consent templates and instructions for form completion. 
      • educational resources such as webinars, researcher/REB member TCPS guides. 
      • policy or guidance regarding specific issues as required. 


Appendix 1

  • External review of Governance of and Administrative Support to the Research Ethics Board

    Consultant: Susan Marlin 

    UOIT will undertake an external review of the Research Ethics Board. 

  • Purpose

    The purpose of the external review is to assess the governance structure and the operations Research Ethics Board. In addition, the external review will evaluate the resources and administrative support provided to the Research Ethics Board by the University. 

    Specifically, the external review will review and assess the following: 

      • Governance structure of the research ethics board 
      • Operations of the Research Ethics Board 
      • UOIT policies related to the Research Ethics Board 
      • Standard Operating Procedures of the Research Ethics Board 
      • Level of administrative support and resources provided to the Research Ethics Board. 

  • Process

    The consultant will meet with the following UOIT stakeholders:

      • Chair and Co-Chair of the Research Ethics Board 
      • Members of the Research Ethics Board, as available 
      • President and the Vice-President Research, Innovation & International 
      • Ethics and Compliance Officer 
      • Director, Research Services 
      • Faculty members/Deans/researchers, if available
      • Research Data Coordinator (Research Services). 

    The consultant will review: 

      • UOIT research ethics policy 
      • UOIT research ethics web site 
      • UOIT research ethics Standard Operating Procedures 
      • Research Ethics Board Annual Report and other related documentation (e.g., minutes, sample of protocols and correspondence related thereto). 
  • Deliverables

      • Provide a written report outlining the review and assessment conducted 
      • Provide recommendations to the university on ways that the University may improve the governance, operations, and administrative support of the Research Ethics Board.


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