Permissible Research Activities for Clinical and Community Research Studies

To determine the permissible research activities for your study, please consult the chart below (click to enlarge/open in new tab):

Note: Unless you have an email specifically granting essential status or approval to restart, on site or in person research activities for non-COVID related research studies are not permitted.


How to Obtain Required Approvals to conduct Clinical and Community Research Studies

To learn how to obtain the required approvals to conduct clinical or community research during the publicly declared emergency, please consult the chart below (click to enlarge/open in new tab):

Notes:

COVID-19 related research (whether new studies or amendments to existing studies) must be reviewed and approved by the COVID-19 Research Evaluation Committee (CREC) prior to being submitted for Unity Health REB, CTO or Contracts review. 

Non-COVID-related research that requires on site or in person activities must be reviewed and approved by the Clinical Research Restart Review Committee (CR3C) prior to resuming or starting any on site or in person research activities. 


Notifying the REB of a Planned Protocol Deviation During the Publicly Declared Emergency

About: Use the Planned Protocol Deviation form to notify the REB of temporary changes to approved study procedures as a result of a publicly declared emergency. NOTE: Temporary stoppage of recruitment or of your study due to the publicly declared emergency do not require planned protocol deviation notification; please do not submit these. If your study or recruitment is being stopped for other reasons (safety, efficacy, etc.), please report this to the REB as you normally would.

Process: The planned protocol deviation form consists of two parts.

  • Part 1 of the form is to be completed during the publicly declared emergency and submitted electronically to researchethics@smh.ca
  • Part 1 and 2 of the form must be submitted to the REB in hard copy within 15 days of the end of the publicly declared emergency

Research Ethics Office (REO) Review of Part 1:

  • The REO will review the submission of Part 1 in a timely manner
  • If we have any concerns about your planned deviation, we will outline these in a response email
  • If we have no concerns, you will be notified that Part 1 has been acknowledged and noted to file; we will not be approving Part 1 or any documents that are specific to the planned deviation


Submitting to the REB

The Research Ethics Office at 250 Yonge is closed and all staff are working remotely; no hard copy submissions are being accepted.

COVID-19 Related Research:

New Research Studies not related to COVID-19:

  • New studies that are not related to COVID-19  should be submitted electronically to the REB Inbox (researchethics@smh.ca)

Existing Research Studies:

  • All submissions for existing studies should sent to the REB Inbox (researchethics@smh.ca)
  • Send only one form (with related attachments) per email
  • Include the REB number and submission type in the email subject line (e.g. REB xx-xxx – Amendment)

Investigator Signatures:

  • In lieu of a PI signature, all communications to the REB Inbox should be sent by the PI or by a research team member with the PI cc’d
  • The Co-Investigator signatures and attestations required on staff change forms and new submissions can be digital signatures or email confirmations provided to the Research Ethics Coordinator who is reviewing the submission


REB Approval of New Studies

COVID-19 Related Research:

  • The REB is prioritizing the review and approval of COVID-related research, and encourages researchers to contact the office to arrange a consultation

Studies that do not require onsite or in person research activities:

  • Approval letters for these studies are being issued

Studies that can be temporarily modified to not require any onsite or in person research activities:

  • A Planned Protocol Deviation form that outlines the temporary measures that will be taken to limit or eliminate staff access to Unity Health sites and to convert in-person study activities to telephone or web-based activities must also be submitted; it is expected that at the end of the COVID-19 publicly declared emergency the research activities (recruitment, consent, study visits etc.) would convert to occur as they normally would
  • Once a Planned Protocol Deviation is in place approval letters for these studies will be issued

All other studies: 

  • Approvals for these studies are currently being issued; this is subject to change with the changing risk level of the COVID-19 publicly declared emergency
  • Please be reminded that these studies will require Clinical Research Restart Review Committee (CR3C) Approval prior to conducting any on site research activities.

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