Comments – Sunnybrook Health Sciences Centre

Notice

Comments are posted in the language in which they were received.

Dear Secretariat,

Please see attached Letter in response to the TCPS2 Consultation.

Demographics as requested:

  1. Province: Ontario
  2. Affiliation: Academic Health Sciences Centre / Hospital
  3. Capacity: Institutional Administrator along with REB Chair
  4. Discipline: Health Sciences/Clinical Research

Respectfully,

Keitha McMurray (she/her)
Executive Director, Research Integrity & Clinical Research Services
Human Research Protections Program (HRPP), and
Centre for Clinical Trial Support (CCTS)
Sunnybrook Health Sciences Centre and Sunnybrook Research Institute
C8-2075 Bayview Avenue,
Toronto, ON, M4N 3M5
T: 416.480.6100 ext. 88120

Brian James Murray, MD FRCP(C) D,ABSM
Professor, Neurology and Sleep Medicine University of Toronto
Department of Medicine Chair, Research Ethics Board Sunnybrook Health Sciences Center Room C819; 2075 Bayview Avenue
Toronto, Ontario, Canada, M4N 3M5
phone (416) 480-4276
brian.murray@sunnybrook.ca

September 22, 2021

To: The Panel on Research Ethics and the Secretariat on Responsible Conduct of Research

Subject: TCPS2 Proposed Guidance RE: Ethics Review of Multijurisdictional Research

Thank you to the Panel for seeking a public consultation and comments on four documents related to the interpretation and implementation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 (2018)). Sunnybrook’s feedback will be strictly focused on the proposed changes to the document on the “review of multijurisdictional research”. All comments below are supported by the Sunnybrook Research Ethics Board (REB) as well as Sunnybrook as an institution eligible to receive Tri-Agency funding.

Sunnybrook has extensive experience in facilitating multi-institutional research. Sunnybrook cannot endorse the proposed revisions and will not be able to implement them if published as written. The paradoxical outcome of this proposal is that it will impair the longstanding processes that we have established through the Clinical Trials Ontario (CTO) model and will have not only a negative operational impact, but also significantly delay the process by which we can bring ethical research to participants.

The following are key points as to why Sunnybrook is not in favour of these revisions:

We respectfully ask that the Panel seek further consultation on this chapter by directly consulting with stakeholders (e.g REBs, institutions, CTO etc.) Please note that CTO will be providing feedback to the Panel and Sunnybrook has added our name to their letter in support of their position which aligns with ours.

Thank you,

Keitha McMurray
Executive Director, Research Integrity & Clinical Research Services

Dr. Brian Murray
Chair, Sunnybrook Research Ethics Board

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