Policies and procedures

Standard Operating Procedures

The Hôpital Montfort’s Research Ethics Board (REB) has adopted Standard Operating Procedures (SOPs) developed by the Network of Networks (N2) and the Canadian Association of Research Ethics Boards (CAREB). They are specific to ethics boards that review-research involving humans and are compliant with applicable Canadian and US regulations, and ethics guiding principles. The purpose of those procedures is to promote quality and consistency of the review process among the different REB.

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The following chart list, the adopted SOP and their complement which is specific to Hôpital Montfort, those are called «Procédures de fonctionnement normalisées (PFN) » that research team and their staff should be compliant with. You can click on this link to access a glossary of terms.

Please note that all the PFN are available in French only at this time.

Documents recommandés

Mandatory Training

A role of the Research Ethics Board (REB) is to promote research excellence, more specifically in the evaluation and the approval of research project that will make Hôpital Montfort a hospital of choice.

This practice has for objective to achieve the highest ethical standards to protect the participant in clinical research (justice, respect and well-being) and to standardize the REB practices. The tutorial is reviewing the first eight (8) chapters of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2- 2018), they are describing general practices to protect human subjects participating in research. This is a minimal requirement, since for interventional project or clinical trials the research team have the obligation to complete additional training in order to comply with the laws and regulations governing those research.

It is the responsibility of the primary investigator to ensure that their research team members complete the on-line tutorial. The tutorial is available in both official languages.

When will this training requirement be effective?

As of January 1, 2015, the courseware certificate must be submitted with all evaluation requests (new file, renewal, modification) before the file is evaluated.

Who needs to complete this mandatory training at Hôpital Montfort?

  • Employees of Hôpital Montfort
  • Members of the hospital medical staff and practitioners with privileges
  • Researchers affiliated with Institut du Savoir Montfort (ISM) and Ottawa University
  • Students

Please note

There are additional requirements for researchers and their team when they are running a clinical trails.

Project type

  TCPS2 GCP Division 5
All study submissions to REB X    
Study submission for non-regulated clinical trials X X  
Study submissions for Phase I – IV or natural health product regulated clinical trials X X X

 

REB Review process and the applications of etiquette

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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.

Clinical Trials

Clinical drug trials (Phase I, II, and III) must be approved by Health Canada prior to their commencement. A copy of the Health Canada “No Objection Letter” (NOL) must be forwarded to the REB office, since without it the file will be incomplete. The REB will start the ethical evaluation of the project but without the NOL a final approval of the protocol will not be produced until the file is complete.

According to the Tri-Council Policy Statement (TCPS 2)2022, a clinical trial is “any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to those that directly evaluate the treatment of participants.” (Chap. 11, p.163)

Please refer to Health Canada website.

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

The Application for REB Review now includes a section asking whether a clinical trial has been or will be registered. If there are no plans to register the trial, the PI is asked to justify why registration is not planned.

Clinical trials evaluation fees

Fees charged are for REB review and for the support provided by the Research Ethics Office (REO), not the approval. Please note that projects reviewed by the REB will be billed even if the project will not occur regardless of the cause of non-fulfillment.  

  • Initial Full Board Review ($3 000) - Initial review of the protocol
  • Ongoing review ($500) - Annual renewal done by Full Board or Delegated review
  • Major amendement ($500) - Amendments requiring a Full Board review (incident report, TI and SAE) or changes requested by the industry (protocol amendment, consent form)
  • Increasing the scope of the study ($3 000) - Addition of one or two objectives, therefore a new study

This review fee applies to research projects funded by a third party, individual, private industry or when is contractually responsible, in totality or partially, for receiving data/publication rights and/or access to records for clinical trials that will be submitted to the REB for review.

Example :

  • Pharmaceutical products and medical device
  • Research team submitting a protocol finance by industry
  • Research protocol financed by a Government agency which is not peer reviewed

Form to generate the invoice

Please complete the billing form (for internal use and available in French only at this time) and submit it to the REB Office. This step is part of the submission process (initial or renewal).

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Processing times

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Processing times for file reviews:

  • Full board review – more than minimal risk : 6 to 8 weeks after receipt of the completed file;
  • Delegated board review – minimal risk : 2 to 4 weeks after receipt of the completed file;
  • Delegated board review – administrative review* : 2 to 3 weeks.
*(e.g. minimal risk study approved by another REB when a signed agreement is in place and some secondary uses of data)
 
Please note that the REB retains the right to close any files relating to an ethics application that has been pending for three (3) months or more. Should the researcher wish to pursue with his or her research at the Montfort Hospital, he or she will have to resubmit a new application for ethics approval.

Research project vs. Quality evaluation project

The REB has to review human research conducted under their jurisdiction. By definition research is an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. Whereas, quality assurance or program evaluation activities are intended to assess the performance of an organization or its staff, within the mandate of the organization. The primary distinction between research and quality assurance is therefore, in their respective objectives, rather than the methods used. The REB, based on the definition of research in TCPS 2 (see Application to Article 2.1), will review each case to determine whether it is a quality assessment program or a research project requiring REB review.

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The group members of "A pRoject Ethics Community Consensus Initiative (ARECCI) (formerly The Alberta Research Ethics Community Consensus Initiative)" has identified a lack of guidelines and other resources to assist project leaders in considering the ethical implications of Quality Improvement and Evaluation projects.

Thus, the group develop two tools grounded in ethical principles to aid project leaders and organizations to ensure respect for the rights of participants in these kinds of projects: