Content: Announcement List

See the Winter Newsletter for the lastest from the UBC Behavioural Research Ethics Board (BREB).  It includes application tips and reminders for student and faculty.

UBC’s Research Ethics Boards recently clarified their adherence to the Tri-Council Policy Statement on exclusion of individuals from research participation based on language.  UBC’s REBs prohibit the exclusion of non-English speaking individuals from research unless there is sufficient justification for the exclusion. Selection of research participants must be fair and equitable and based on the Tri-Council Policy Statement’s Principle of Justice. For details, go to Policy on Exclusion of Research Participants based on Language.

To provide feedback on this policy, please contact Laurel Evans: laurel.evans@ors.ubc.ca.

The BC Ethics Harmonization Initiative has made considerable progress towards achieving its intended outcomes.  See details in the Final Evaluation Report.

Learn about the new policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials

Abacus Dataverse

UBC Library has implemented robust research data management software – Abacus Dataverse Dataverse is an open source repository designed to assist researchers in the creation, management and dissemination of their data. The Dataverse platform allows management of datasets, metadata, and digital objects and offers support for disposition of sensitive data, which has been collected under ethics approval. The system is opened to UBC researchers, labs and institutes.

DMP Assistant

DMP Assistant software – is a bilingual tool for preparing data management plans (DMPs). The tool follows best practices in data stewardship and walks researchers step-by-step through key questions about data management including data storage, ethics and legislative requirements, data archiving, and future uses. Hosted by the national Portage initiative, DMP Assistant is designed to meet the anticipated Data Management Plan requirements (in English or French) of most major Canadian funders.

Effective September 1, 2016 - for all NEW ethics applications to any of UBC’s six affiliated Research Ethics Boards
In follow up to the Notice of April 18, 2016, please be reminded that all study team members (including Faculty) will need to have completed the TCPS2 online tutorial “Course on Research Ethics” (CORE) that is offered free of charge by the Panel on Research Ethics (PRE). This policy will apply to all researchers (faculty, students, residents, and research staff) participating on studies where the initial application is submitted after September 1, 2016.  Question 1.6 of the ethics application form is being amended to request confirmation that all study team members have completed the course.  As is currently the case for residents, graduate students and research staff, submission of the CORE Certificate will not be required with the new application; however, you may wish to update your RISe profile to include the date you completed the tutorial. 

• Link to the course here or here
• You may also complete the CITI Tutorial on either clinical or behavioural ethics to meet the requirement
• Guidance on updating your RISe profile (will open a Powerpoint file)

If you have experienced difficulty in the past opening the CORE activation code, please note that UBC's IT department has “whitelisted” the link.

If you have any questions or concerns, please contact the Director, Research Ethics | laurel.evans@ors.ubc.ca | 604-827-5113.

In July 2015, the CREB announced the requirement for a scientific / peer review for all studies above minimal risk.  Peer review (sometimes referred to as scholarly or scientific review) is generally understood by UBC's REBs as a review of the importance of the research question (value) and the validity of the methodology. Practices around scholarly review vary between disciplines, fields of research and groups. The primary goal of this requirement is to ensure that above minimal risk research protocols that are submitted for ethical review satisfy the relevant disciplinary standards in terms of both value and scientific validity. It is anticipated that this in turn will facilitate the ethics review process for the REB, reduce the number of provisos and deferrals issued to researchers, and improve the overall success of the research. 

The Scientific / Peer Review Form was updated in March 17, 2017.  

The peer review form must be completed and attached to an application when a protocol:

• Is above minimal risk; AND
• Has not undergone internal or external peer review (includes granting agency approval); AND
• Will be submitted to the UBC CREB.

Note that if your research proposal has received a scientific peer review form from an independent authority in your field of expertise, or from your trainee's supervisory committee, this should be attached to Box 9.8 of the RISe application form.  In these instances, you are not required to also have the CREB Scientific / Peer Review Form document completed.
 

A joint certificate of approval has been launched in RISe for ethics applications that are harmonized under the BC Ethics Harmonization Initiative. Partners in the harmonization initiative are: Fraser Health, Interior Health, Island Health, Northern Health, Simon Fraser University, the University of Northern BC, University of Victoria and all UBC-affiliated REBs.

New certificates will now display each of the reviewing REBs and will show which REB acted as the Board of Record.

Please let us know if you have any questions about the new format or about submitting a harmonized ethics application.
https://ethics.research.ubc.ca/about-human-research-ethics/contact-us
https://bcethics.ca/ (website of the BC Ethics Harmonization Initiative)

The UBC REBs gathered on October 21, 2015 for their annual ethics retreat.  They were joined by the SFU REB as well.

The morning opened with an update from Susan Zimmerman of the Secretariat on Responsible Conduct of Research (SRCR):
Current Issues & Initiatives-SRCR – Susan Zimmerman

The main focus of the retreat was on new and emerging issues in informed consent:
Issues with Informed Consent – Levine & Russell
Participant & REB Perspectives on Informed Consent – Michael McDonald
Big data & international harmonization efforts – Holly Longstaff
Innovation in Informed Consent-Sage Bionetworks Toolkit – Christine Suver

In addition, Nina Preto reported on the experience to date with the interim Incidental Findings guidance which was released in April 2015:
Incidental Findings Interim Guidance – Nina Preto

Please send your additional comments on the guidance to nina.preto@ors.ubc.ca

See the following newsletter for the lastest from the UBC Behavioural Research Ethics Board (BREB).  It includes application tips and reminders for student and faculty:  What's New with the BREB.