REB Review of Research during the COVID-19 Pandemic
In light of the rapidly evolving circumstances relating to COVID-19, and Trillium Health Partners’ (THP) focus on social distancing and the health of patients, staff, volunteers, and the community, the THP Research Ethics Board (REB) is taking additional measures to protect the safety and wellbeing of research participants, Investigators, and research personnel.
The THP REB is advising Investigators to consider whether their research protocols can be modified or delayed in order to limit personal contacts, laboratory visits or trips into clinics and hospitals to minimize risk to participants, Investigators and study personnel. Specifically, in some research settings in-person participant interactions could be reduced and/or replaced with alternate means of communication (e.g. telephone). Considerations include the nature of your protocol, the type of participants engaged in the research and any additional risk that may arise by switching from in-person to virtual communication.
While the Tri-Council Policy Statement (TCPS2 2018) typically requires review and approval of modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (Article 6.15). Such changes may be implemented but must be reported to the REB at the earliest opportunity (within 5 business days). An “Amendment During Publicly Declared Emergency” submission form has been created to assist in the process for informing the REB of any changes to study activities during this time.
Research personnel should connect with their Principal Investigators or Project Leaders to determine whether their research activities will be modified until the publicly declared emergency is over.
Information on the restrictions implemented on all non-essential on-site research activities at Trillium Health Partners can be found on the COVID-19 Pandemic Research Directives webpage.
Changes to REB Review of New and Ongoing Research during the COVID-19 Pandemic:
The THP REB has reviewed the Tri-Council Policy Statement (TCPS2 2018) and our SOP (5.1.002) relating to REB Review during Publicly Declared Emergencies and continues to monitor trends, best practices and emerging requirements with respect to research ethics review, oversight and operations during publicly declared emergencies. In line with the guidance from TCPS2 (2018) and our SOP (5.1.002), until further notice the THP REB has instituted alternate review procedures as outlined below:
Review of Ongoing Research:
- Research activities not involving, or no longer involving, recruitment or direct contact with participants and have no impact on the clinical platform at THP may continue,
- Research activities involving recruitment or direct contact with participants may only continue if ceasing such activity might pose significant risk to participant safety,
- Major amendments and adverse events related to these studies will be reviewed by an REB subcommittee or the REB subcommittee Chair or designee, as appropriate,
- At the REB Chair or designee’s discretion, and subject to applicable regulations, review procedures may be delayed or temporarily suspended depending upon volume. In such cases, research shall be deemed to have continuing approval until such time that the REB is able to conduct its review.
Review of NEW Research NOT relating to or arising from the COVID-19 situation:
- Any new research not related to the publicly declared emergency will not be reviewed until the emergency is declared over, unless administrative approval for the study from the institution is first granted.
Review of Research RELATED to or arising from the COVID-19 situation:
- If a request to review research related to the COVID-19 situation is received, it will be directed to the REB Chair or REB subcommittee Chair or designee, as applicable.
- Time-sensitive review processes may be followed, such as delegated review as appropriate, review by an REB subcommittee, and/or meetings conducted via teleconference or videoconference.
For further information on whether your study may continue, be restarted or be initiated, please visit the COVID-19 Pandemic Research Directives webpage.
Going forward, the Trillium Health Partners REB requires submission of the Safe Research Practices Form to accompany new study submissions, submissions relating to restarting an already approved research study and amendment submissions (excluding minor amendments)
In order to avoid delays in beginning COVID-19 related research at THP, please also contact the Research Operations Office (ResearchOperations@thp.ca) once the details of your research are known to determine agreement or any other institutional requirements.
Who can I contact regarding REB review and oversight at THP?
Should you have any questions or concerns relating to the REB review and oversight of your research study during this period of time, please email THPREB@thp.ca and we will address your queries in a timely manner.
Anjana Sengar BSc Phm, PharmD, ACPR
Delilah, Ofosu-Barko, BMSc
Chair, Research Ethics Board
Trillium Health Partners
Director, Research Operations
Trillium Health Partners
Adapted from the Canadian Association of Research Ethics Boards (CAREB/ACCER) ‘REB Guidance during COVID-19 Outbreak’.
Trillium Health Partners’ Research Ethics Board (REB) is a body established by and accountable to the hospital’s Board of Directors to independently protect the rights and welfare of human research subjects. The REB is comprised of staff, volunteers, legal representation and ethics and privacy specialists.
The Research Ethics Board maintains active registration with the Office of Human Research Protections.
The REB ensures that all research involving human subjects meets current ethical and scientific standards. All research conducted at Trillium Health Partners must be compliant with the following legislation, guidelines, policies and regulations:
Serious Adverse Events Subcommittee (SAE)
The Serious Adverse Events Subcommittee reviews all serious adverse events. This assists with assessing the general safety of a study (study intervention) in our patient population. The subcommittee specifically follows up on all SAE involving Trillium Health Partners’ patients to ensure all of the appropriate measures were followed in their care and follow-up.
The REB must meet for a minimum of 10 meetings per year. REB meetings occur on the third Thursday of every month from 7:30 a.m. to 10:30 a.m.
Research Applications and Information
When submitting an application to the THPREB for review, please ensure that all required material, as listed below are submitted at the same time.
- Appropriate THP REB submission form;
- All additional supporting study documents (protocols, consents, regulatory documents, CRFs, completed THP departmental impact forms)
Submitting your documents in component parts and/or without the necessary signatures will delay the review process.
Any submissions that are deemed incomplete will be returned to the researcher for modifications before being reviewed by the REB.
Please contact the Research Ethics Board Coordinator at THPREB@THP.CA for any further questions or clarifications.
THP REB Research Application Forms