Category: Ethics

Research Ethics – New Guidance Document Regarding Research Using Social Media Platforms

The Secretariat on Responsible Conduct of Research recently shared the following updates with the research ethics community:

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) Released

The Secretariat on Responsible Conduct of Research has announced the publication of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022). TCPS 2 (2022) replaces TCPS 2 (2018) as the official human research ethics policy of Canada’s research funding agencies (CIHR, NSERC and SSHRC).

TCPS 2 (2022) includes guidance on the following research ethics themes (see also Highlights of changes):

  • Broad consent for the storage of data and human biological materials for future unspecified research (Chapters 3 and 12);
  • Streamlining multi-jurisdictional research ethics review of minimal risk research (Chapter 8)

Copies of TCPS 2 (2022) may be printed or downloaded from the Panel on Research Ethics’ website.

Office of Human Research Ethics – WREM System Update – Applicant Track Changes

A recent Western Research Ethics Management (WREM) system update allows research teams to track their changes within submitted applications. For more information, please see this document on the Office of Human Research Ethics WREM page as well as within the HELP feature on the WREM platform.

If you have any questions, contact wrem@uwo.ca.

Western Research Launches Research Ethics Handbook for Arts and Humanities Projects

Western Research has released a new handbook to help arts and humanities researchers navigate the research ethics review and approval process, and to help provide information about how ethics guidelines may apply to their research. Training and education sessions will be organized this fall to help build on the content provided in the handbook.

The handbook serves as a foundation for continued education and mutual learning for all stakeholders in the non-medical research ethics space at Western.

Updates to the Western Research Ethics Manager (WREM) system

Western Research has updated some of the forms within the WREM system, which will become active at 4pm on January 28, 2022. The updated forms include:

  • The HSREB & NMREB amendment forms;
  • The HSREB/NMREB Continuing Ethics Review Form;
  • The HSREB/NMREB Study Closure form; and
  • The NMREB Initial Application form.

Changes have been made to reflect ongoing feedback from users for clarity, to hopefully reduce recommendations and to assist in expeditious review.

When you log in to WREM you will notice the following message appear in the Work Area at the top of your screen in a pink bar: “Warning: The Project Owner must update your project in order to submit this form.”

The Project Owner (i.e., the user who created the project) will need to accept the update prior to a) submitting an application and/or b) completing an application the study team has been working on when the message appears.

Are there any implications to updating the form(s)?

Consider these three scenarios:

  1. The form has not been submitted, and is still unlocked
    Updating the project will have little to no effect except for any questions that have been updated in the form you are completing. It will not affect the information that has been inputted into questions that have not been updated.
  2. The form has not been submitted, but the form has been locked by a signature request
    Updating the project will break these signatures requests. Once the project has been updated, a signature will need to be requested again to submit to our office for review.
  3. The form has been signed and submitted
    Updating the project will have no effect on any submitted forms.

Registering an application with ReDA

Since WREM’s launch, ongoing confusion has been identified regarding when study teams should submit to ReDA.

If you are conducting a research study that also requires oversight from Lawson Health Research Institute (per criteria), the study team MUST first register the study with ReDA prior to exporting it from ReDA to WREM. For more specific information, please contact Lawson at lawsonapproval@lawsonresearch.com

Further information and contacts

To access WREM training material and FAQs please visit the website and WREM.

If you have any questions, please do not hesitate to reach out to any member of the Research Ethics team, or email ethics@uwo.ca.

Research Ethics Training – Update of TCPS-2 Course On Research Ethics (CORE)

The Secretariat on Responsible Conduct of Research (the Secretariat) wants to inform the research community that the current Tri-Council Policy Statement 2: Course on Research Ethics (TCPS 2: CORE) will soon be replaced by a new version – TCPS 2: CORE-2022. The latter will refer exclusively to the TCPS 2 and will focus on ethics guidance that is applicable to all research involving human participants, regardless of discipline or methodology.

CORE-2022 will consist of nine modules and a knowledge consolidation exercise:

  • Module A1 – Introduction
  • Module A2 – Scope of TCPS 2
  • Module A3 – Risks and Benefits
  • Module A4 – Consent
  • Module A5 – Fairness and Equity
  • Module A6 – Privacy and Confidentiality
  • Module A7 – Conflicts of Interest
  • Module A8 – Research Ethics Board Review
  • Module A9 – Research Involving Indigenous Peoples
  • Knowledge Consolidation Exercise

Each module will include 4-5 quiz questions. These questions will provide users with an opportunity to test their knowledge as they progress through the modules. In addition, the new version will include a knowledge consolidation exercise (KCE) consisting of 25 multiple-choice questions. A CORE-2022 Certificate of Completion will be issued to users following the successful completion of the KCE. The new course will be self-paced and should take approximately 4 hours to complete. It will be possible for users to complete the course over multiple sessions by saving their progress and resuming later. CORE-2022 will be compliant with Web Content Accessibility Guidelines 2.0 (WCAG 2.0) to ensure accessibility for all users.

Migration to CORE-2022 will take place during the week of January 10, 2022. Access to existing CORE registration and course completion information by users and institutions will continue, albeit through CORE-2022’s database. However, there will be no transition period during which both versions are available. Therefore, the Secretariat advises anyone who has started the current version of the course, but has not completed it, to do so by December 31, 2021. This is to avoid losing your progress in the current version.

Questions related to the upcoming migration to CORE-2022 should be directed to the Secretariat at secretariat@srcr-scrr.gc.ca.

Guidance for Acquiring Proof of Vaccination from Research Participants

In response to the recent memo that researchers must obtain proof of vaccination prior to welcoming research participants to campus, the Office of Human Research Ethics (OHRE) has the following guidance:

  • Ensure your study team is familiar with Western’s COVID-19 Vaccination Policy (MAPP 3.1.1)
  • Amendments to research protocols and documents are not required to address this additional institutional screening requirement.  Inclusion/Exclusion criteria, screening scripts and tools, and data collection tools should not be impacted when researchers are solely following institutional policy for on-campus attendance. 
  • Amendments are required if your study objectives newly require the collection of vaccination information as study data OR if your research as a whole must pivot to new methodology (e.g. remote vs in-person visits).
  • The requirements around vaccination should be introduced to participants prior to obtaining informed consent. Ongoing research participants should be notified of the vaccination policy as soon as possible.
  • Documentation of a participant’s vaccination status or exemption should not be part of their study record unless it is approved study data.
  • Ideally, the collection of vaccination information should be centralized within the faculty, school, or department.
  • Do not collect vaccination documents via email, as email is not considered secure (MAPP 1.13). Retain vaccination status information only until Western tells you that it can be destroyed.  As per the previous memo, actual vaccination documentation provided by the potential participant should NOT be retained at all.
  • As per MAPP 3.1.1, children under 12 are not considered visitors. Therefore, there is currently no requirement for research participants under 12 to be vaccinated or to provide proof of negative COVID tests.  However, like all participants they must do Western’s daily symptom screening prior to presenting to campus for research.
  • Consider your participant population because not all will have access to certain technology.  Obtaining verbal confirmation prior to a research participant coming to campus is sufficient if obtaining it ahead of time is not possible. Proof of vaccination documentation need only be shown in-person.

As the OHRE gathers more information guidance document will be updated.  Please consult the Vaccination Confirmation for Research Participants Guidance Document for the most up to date information, scripts and documentation requirements.

Reminder – Mandatory Training for Human Participant Research

Reminder: All study team members, including faculty, librarians, archivists, students, postdoctoral scholars and staff listed on a human participant research project submitted to one of Western’s Research Ethics Boards (REBs), or up for annual renewal, must complete human participant research training.
 
For NEW submissions: No study-related activities can take place until all study team members have completed training, even if a Research Ethics Board approval notice has been issued for your study.

Step 1: Complete training using ONE of the following training options outlined below and save a PDF of your certificate.
 
If you have already completed training using one of the options outlined below, move to Step 2 to submit your certificate. 

Step 2: If you have a .uwo email account, upload your certificate here. (You must be logged into OWL before clicking this link.)

For more information and answers to frequently asked questions, please visit the human research ethics Workshops and Seminars page: Mandatory Training for Human Research.

If you have any questions or concerns, please reach out to Grace Kelly, Manager, Research Compliance Programs and Education, 519-661-2111 ext. 84692.

Human Research Ethics: Video Resources

The Office of Human Research Ethics has a new recorded video and handout for education around human ethics:

Conducting ethical human research: The ABCs

Are you a student conducting research with human participants (incl. their data and/or biological material)? Are you interested in conducting research with humans (incl. the use of human data and/or biological material) in the future? If so, learn about the principles of research ethics and a few practical tips that will help you.

Resources (requires Office365 login)

Mandatory Human Ethics Training – Reminder

Western Research has implemented mandatory human research ethics training for all study team members. This includes faculty, librarians, archivists, students, postdoctoral scholars and staff listed on new submissions to Western’s human research ethics boards.

Proof of completion of one of the acceptable options for training must be uploaded and acknowledged by the Manager, Research Compliance Programs and Education, prior to starting any study-related activities.

Deadlines:

NEW research projects: As of January 1, 2021, all students, faculty, librarians, archivists, staff and postdoctoral scholars listed on new research projects submitted to the human research ethics boards must confirm completion of training prior to beginning any study-related activities.

EXISTING research projects: All students, faculty, librarians, archivists, postdoctoral scholars and staff on existing research projects must confirm completion of training by the time of submission of their Continuing Ethics Review (CER), between January 1 and December 31, 2021.

To access acceptable options for training, information about confirming completion through OWL and answers to frequently asked questions, please visit the human research ethics workshops and seminars page.

Please do not send your certificate of training via email. Your certificate should be uploaded in OWL as per the instructions on the Workshops and Seminars page. As spot checks may be performed, principal investigators must also maintain copies of certificates for all study members.

If you have any questions or concerns, please reach out to Grace Kelly, Manager, Research Compliance Programs and Education, 519-661-2111 ext. 84692.