ICEHR adheres to the principle of proportionate review as outlined in the TCPS 2 (Article 2.9). Therefore, the degree of scrutiny that an application for ethics approval receives is determined in relation to the degree of risk to which study participants may be exposed (See also Article 6.12).
Pursuant to Memorial University’s Policy on Ethics of Research Involving Human Participants, which authorizes delegated review based primarily on an assessment of the harm expected to arise from the research, ICEHR conducts delegated review of applications for ethics clearance.
Level of Risk Assessment for New Proposals
All new proposals for research reviewed by ICEHR are circulated to all committee members, but assigned to a delegated review team of three members for assessment of risk and feedback to the Chair of ICEHR. The team member assigned as Lead Reviewer is normally a representative from the researcher’s faculty or school, or a member with particular expertise relevant to the proposed study.
The reviewers communicate their written assessment of risk to the lead reviewer, who then makes a recommendation to the Chair. Those proposals judged to be of minimal risk proceed through the delegated review process. Those proposals judged to be above minimal risk may be recommended for full review by the committee.
The determination of whether a review of a new proposal is conducted by the full committee is determined by the delegated review team's assessment of the level of risk for participants in the study.
Regardless of the level of the review, the ethical requirements for approval do not change and are applicable to all research involving human participants.
All studies judged to be above minimal risk are subject to full review by the entire committee. Full review requires that the proposal be discussed at a face-to-face meeting of the committee.
For new proposals assessed to be above minimal risk, the team of delegated reviewers assigned to provide risk assessment and feedback shall complete its review. In instances where it is deemed beneficial to the researcher’s understanding of the review process and/or to facilitate the review process, the Lead Reviewer may elect to discuss the review with the researcher. Such discussions are undertaken in consultation with the Chair and other reviewers.
The Lead Reviewer compiles the feedback from any such discussions with the researcher, and presents this as a basis for discussion at the next full committee meeting. This report will specify the level of risk for participants and make recommendations. The full committee discusses the proposal before reaching a decision. Following this meeting, the Chair of ICEHR will send a letter to the researcher on behalf of the committee, granting approval (with or without required modifications); denying approval (with reasons); or requesting additional information and deferring the decision until this information has been received and reviewed.
Unless your study may be above minimal risk, you do not need to time your application submission in relation to the committee meeting schedule. Review of proposals is ongoing, and decisions following from delegated reviews are communicated outside normally scheduled committee meeting dates. The decision of the delegated review team is then reported at the next committee meeting.
Annual Updates, Reports on Amendments and/or Required Modifications
The TCPS 2 (Article 2.8) requires continued review for the duration of a research project. In keeping with the principles of proportionate review, follow-through on modifications required by ICEHR, annual updates, and project amendments are review by the Chair and/or Vice-Chair, and the Ethics Officer. However, ICEHR reserves the right to undertake a full review if deemed necessary. This entails review by the Chair (and/or Vice-Chair) and the Lead Reviewer or team of delegated reviewers of the original proposal. In all instances of delegated review, a report to the full committee will be made.
Researchers are required to submit an Annual Update Form to request renewal of ethics clearance if the research is ongoing, or to report that the project is completed. Researchers who wish to make changes to their approved project must request an amendment in which they outline the proposed modifications by emailing email@example.com.
Departmental Review of Student Research as Part of Course Work
Departmental review of student research as part of course work is also considered to constitute a form of delegate review (TCPS 2; Article 6.12) and is addressed separately.