Policies and procedures

The ethical evaluation of a research project is based on the proportional approach. This approach implies that the level of research evaluation is determined by the level of risk that the research could generate for the participants. Consequently, research activities deemed to be minimal risk are evaluated by the research ethics office (REO) with one or two evaluators, while projects involving a greater risk are evaluated by the committee during its plenary meetings.

In plenary committee

All research projects that present a level of risk for participants are evaluated by the entire REB during the monthly committee meeting, as well as projects involving experimentation with minors or incapacitated adults.

In delegated committee (restricted)

A research project for which the level of risk is lower than the threshold of minimal risk, that is to say that the risks arising from participation in the research are not greater than those incurred in the daily lives of the participants, may be subject to an evaluation by a delegated committee.

Generally, this evaluation is carried out by the chair of the REB and the manager and, when necessary, one or two members of the same REB, experts in the project discipline, may be requested. This type of evaluation takes place outside of plenary meetings.

It is important to note that this method of evaluation does not modify the rigor criteria in the evaluation or the applicable requirements.

According to SOP 402, the decisions of the Montfort Hospital REC are subject to consensus or, failing that, a majority vote. The REB may render one of the following four decisions, following the analysis of the documents received; this decision is transmitted in writing:

• unconditional approval: the REB approves the research activity as presented
• approval
  • conditional = no ethical issues
  • deferred = minor ethical changes

In both cases, the approval of the REB is conditional on the researcher making modifications or clarifications to the research design and/or committing to ensuring the application of the provisions requested by the REB.

• Postponed review: The REB suspends its review when the documents and information provided do not allow it to make an informed assessment of the ethical acceptability of the research activities. The REB asks the researcher to provide the information necessary to continue the ethics review.
• Approval refused: the REB may refuse a research activity when it is established that the conditions under which it is carried out jeopardize the well-being of the participants and that the review is not likely to enable the REB to make a favorable decision.

For any questions or explanations regarding the REB decision, do not hesitate to contact the REO.

According to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TPCS 2, Article 11.10), clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry.

https://www.clinicaltrials.gov/

«All clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE).” (TCPS2,Article 11.10)

For trials funded by federal, provincial, non-profit, or internal or other funding agencies, the principal investigator is responsible for registering the project.

For each of these options, the identified responsible person must update the project registration on clinicaltrials.gov and ensure at least every 6 months that all required information has been submitted.

Note: If the trial is funded by CIHR and NIH, please consult them to confirm which public registry to use.

Please consult the information page of ClinicalTrials.gov.

Studies can be registered before having obtained REB approbation. After obtaining the certificate of ethics approval from the REB, the registry must be updated.

The team must provide the REB with the clinical trial's study registration number (NCT number).

NOTE : Clinical Trials should be registered only once, hence for multicentre project the designated person will register the trial.

“Following registration of their study in accordance with Article 11.10, researchers are responsible for ensuring that the registry is updated in a timely manner with:

• new information (Article 11.8); 
• safety and, where feasible, efficacy reports (Article 11.6);
• reasons for stopping a trial early; and 
• the location of findings