Content: Announcement List

In order to successfully upgrade the RISe system to Version 10, RISe will be inaccessible from 5pm  on Friday, June 17 until 5am on Monday, June 20.

There will be no user access during this time.

Please contact your ethics board if you have any concerns about your application.

If you have any questions about the RISe outage, please contact the RISe support desk staff at https://www.rise.ubc.ca/content/contact-us.

Thank you for your patience and understanding! 

Researchers from McGill and Brock Universities are interested in creating meaningful opportunities for communities to be involved in research ethics governance. This two-day (April 7 & 8) Zoom workshop, "Community-Led Research Governance: Envisioning the Future Through Dialogue," will showcase strategies for community-led research governance across Canada.

To learn more and register: https://www.mcgill.ca/biomedicalethicsunit/seminars/april-7-8-2022-work…. 

Community Research Governance Workshop | April 7 & 8, 2022

A reminder will be posted closer to the dates.

As a signatory of the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials, CIHR is committed to advancing open science, research excellence, and greater transparency in clinical trials. To that end, CIHR has introduced new requirements for the registration and public disclosure of the results of clinical trials.

Nominated Principal Investigators receiving CIHR grant funds for clinical trial research on or after January 1, 2022 must comply with the following practices to remain eligible for any new CIHR funding:

• Clinical trials must be registered in a publicly available, free-to-access, searchable clinical trial registry complying with the WHO’s international agreed standards before the researcher meets with the first study participant.
   
• [NEW] Public disclosure of results must be done within a mandated time frame
  • Publications describing clinical trial results must be open access from the date of publication.
  • Summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome).
• [NEW] All study publications must include the registration number/Trial ID (to be specified in the article summary/abstract).

For more information, we invite you to consult:

Overview

CIHR Policy Guide - Requirements for Registration and Disclosure of Results from Clinical Trials

Details and Frequently Asked Questions

By aligning with international best practices for clinical trial reporting, CIHR is proud to demonstrate its ongoing commitment to advance open science and research excellence. Timely disclosure of results reduces waste in research, increases value and efficiency in the use of funds and reduces reporting bias, which should lead to better decision making in health policy and practice.

CIHR is available to assist with interpretation of the new requirements. If you have questions, please contact the CIHR Contact Centre

The TCPS CORE-2022 tutorial has been updated and can be accessed from https://tcps2core.ca/welcome. Changes in this version include integration into the CORE tutorial of “Module A9 – Research Involving Indigenous Peoples.”

Research team members (including faculty, staff and students) are required to have completed a version of the TCPS2 CORE tutorial (or the equivalent CITI course) before embarking on research involving human participants. If you have already received certification for an earlier version of the CORE tutorial, you will not be required to complete the updated version at this time.

Completion of  CORE-2022 is self-paced and is estimated to take approximately 4 hours.

If you have trouble accessing your CORE tutorial account, please contact https://tcps2core.ca/contact-us.

The annual Clinical Research Ethics Symposium took place over two days in October and attracted around 90 attendees to each of three sessions. To watch the recorded sessions, go to: https://www.youtube.com/playlist?list=PLJ8i2T1UQ5OO09GLqMd1D9PxwmhnIGkyS.

Attendees heard from expert panels of clinicians, researchers and patient partners.  A key learning emphasized across all sessions was the need to revise the Clinical Informed Consent Form template. A working group is being launched to address this in the near future. For more information on the event, see the Fall 2021 issue of the Research Ethics BC Newsletter.

For researchers who have used Workspace for storing research data and need to find an alternative, see the updated guidelines: https://arc.ubc.ca/microsoft-onedrive-and-teams-research. Information is included on how and when to use OneDrive and Teams for data storage, in addition to addressing security considerations, long-term data storage recommendations, and providing contact links.

The Tri-Agency Panel on Research Ethics (PRE) proposed policy guidance released in June 2021 related to harmonized ethics review of multi-jurisdictional research. REBC and UBC (on behalf of the affiliated REBs with the exclusion of BCC) recently submitted their response, which wholeheartedly supports the overall objective of a single REB review for multi-site research, but which also identifies numerous issues with the model that the PRE is proposing. Please feel free to contact laurel.evans@ubc.ca (Laurel Evans | Director, Office of Research Ethics, UBC) or tfleming@bcahsn.ca (Terri Fleming | Director, Research Ethics BC) if you have any comments or questions.

Proposed revisions for harmonized ethics review

REBC and UBC response

[*] Research Ethics BC (REBC) supports a provincial, harmonized system for research ethics reviews of multi-jurisdictional studies involving human subjects (i.e. involving the resources, people, patients or data from more than one BC institution). It’s founded on a collaborative effort by a group of BC health research partners to develop the harmonized ethics review models now in use by most BC health authorities and research universities. To learn more: https://www.bcahsn.ca/our-units/research-ethics-bc.

The Offices of Research Ethics on the Vancouver and Okanagan campuses have updated their guidance in anticipation that authorization to resume in-person behavioural research will be fully implemented in the coming months.

Although the safety of research participants continues to be a factor in how research ethics applications are reviewed, the behavioural REBs have eased their requirements in alignment with updates issued by the British Columbia Public Health Officer (PHO) on May 28, 2021.

To learn how your research may be affected, please review the webpage: https://ethics.research.ubc.ca/behavioural-research-ethics/ubc-behavioural-guidance-resuming-person-research-after-covid-19.

We would like to thank departmental heads and others for the support they provided to the BREB in reviewing Supplementary Research and COVID Forms over the last year. These forms are no longer required as part of the research ethics review process.

Beginning 2022, the CREB will focus on re-review of applications that were approved prior to 2010.  An ethics re-review to ensure the study meets current ethical requirements, will be undertaken and communicated individually with each PI and primary contact on the study. 

As per TCPS 2 (2018) Article 6.14 “The REB shall make the final determination as to the nature and frequency of continuing research ethics review in accordance with a proportionate approach to research ethics review.”  “Continuing research ethics review should be understood as a collective responsibility to be carried out with a common interest in maintaining the highest ethical standards: REBs make the final decision about the nature and frequency of continuing ethics review.” 

Researchers will be requested to submit a new application making reference to the originally submitted study. 

Please note UBC CREB may also request re-review of any study if deemed necessary

UBC CREB is also requiring the re-review of registries (data bank) or biobanks 5 years and older in order to align with our new Protocol and consent form requirements as per here