Minimal risk review
Minimal risk review is intended for studies which pose minimal risk to the subjects’ rights and welfare, which are not in the list of excluded types of projects provided below, and which otherwise comply with the relevant standards relating to such matters as free and informed consent, privacy and confidentiality, appropriate balance of risks and benefits, etc.
The term “risk” is interpreted broadly to include, amongst others, physical, psychological, economic and social risks. Recognizing that the TCPS focuses on a subject-centered perspective, risks to others, such as those conducting the study and their organizations and third parties, may also be considered in the determination of whether or not an Ethics submission can be considered through a minimal risk review process.
Minimal risk review is typically intended to cover projects which utilize such techniques as questionnaires and interviews, where the subjects are fully competent adults, and where the nature of subject matter poses minimal risks. For example, a project involving a questionnaire on child abuse or sexual history would not be deemed as minimal risk and would therefore be subject to full REB review.
The following are examples of research studies that are excluded from the minimal risk review process because they pose greater than minimal risk due to their intrinsic nature and/or use of a vulnerable population, for example:
- Studies involving aboriginal individuals or groups and other vulnerable ethnic communities, groups or individuals;
- Studies involving vulnerable populations such as children, cognitively or mentally challenged individuals, physically challenged persons, individuals not legally competent to give consent;
- Studies where there is a possibility of coercion, for example: studies involving “captive” groups such as employees, students, members of the military, prisoners;
- Studies where not disclosing the purpose of the research at the start of the work could be harmful to the participant(s).
Minimal risk review process
The REB Chair and the Protocol Officer for Ethics will review the Ethics submission to assess whether the proposed research will pose greater than minimal risk to the research subjects. If, in the sole opinion of the REB Chair, the research poses more than minimal risk or raises other substantive ethical concerns, it will automatically be referred to full REB review.
If, on the basis of the initial review, it is determined that the Ethics submission may be of minimal risk, its ethical acceptability will be assessed by 2 REB members who will each provide a written assessment. The REB members will determine whether there are additional risk factors that constitute greater than minimal risk and evaluate compliance with ethical standards. If the both REB members determine that the risk is greater than minimal risk, the Ethics submission will be referred to the full REB review. If the two REB members disagree, and if such disagreement cannot be resolved through discussion between the two REB members and the REB Chair, the Ethics submission will be referred to the full REB review.
The Chair has discretion to nominate an external ad hoc expert when a research study requires specific expertise not available from the regular members of the REB (Article 1.3 d of the TCPS).
For submissions which have been determined to meet the minimal risk criterion and which meet relevant standards of ethical acceptability, the REB Chair may approve the project on behalf of the REB (Category 1a - Approval) or may grant approval conditional on certain changes being made to comply with relevant standards of ethical acceptability (Category II – Conditional approval). Approval may then be granted once conditions are met.
In keeping with the Article 1.6 of the TCPS which states that the REB must continue “to maintain surveillance over the decisions made on its behalf. Principles of accountability require that, regardless of the review strategy, the REB continue to be responsible for the ethics of all research involving human subjects that is carried out within the institution.”, the REB Chair, with the assistance of the Protocol Officer for Ethics, shall inform the REB of all decisions made through a minimal risk review process at the next REB meeting. Such approvals will also appear in the minutes of the meeting.
Timeline
The time required to conduct the minimal risk review process will vary because it is dependent upon the workload and availability of the persons participating in this process, namely the REB Chair, REB members, the Protocol Officer for Ethics, and researchers. Typically, however, a minimal risk review should take approximately 4-6 weeks.
When requesting minimal risk review, researchers must submit applications during the first three business days of the month, using the standard Ethics form. An original plus three copies should be provided.
Researchers are strongly encouraged to contact the Protocol Officer for Ethics prior to submission for advice on whether their Ethics submission may be eligible for Minimal Risk review.
Researchers must recognize that a decision to refer an Ethics submission to full REB review may occasion delays due to the monthly scheduling of REB meetings and may necessitate that the researcher provide additional copies of the Ethics submission.