ICEHR adheres to the principle of proportionate review as outlined in the TCPS2 (2014) (Article 2.9). Therefore, the degree of scrutiny that an ethics application receives is determined in relation to the degree of risk to which study participants may be exposed (See also Article 6.12).
Risk is assessed using the TCPS2 definition of minimal risk; in which the probability and magnitude of potential harms that may be associated with participating in the research is no greater than participants may encounter in related activities in everyday life.
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
New ICEHR applications for ethics review are 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 determined to be of minimal risk proceed through the delegated review process. Those proposals deemed to pose greater than minimal risk to the participants may be recommended for further review by the full committee.
Regardless of the level of the review, the ethical requirements for approval do not change and are applicable to all research involving human participants.
Research 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, Chair, Vice-Chair and/or the Ethics Officer may discuss the review with the researcher.
The Chair and/or the Ethics Officer 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.
Submission and review of ethics applications is ongoing via the researcher portal, and decisions from delegated reviews are communicated to the Ethics Officer and the Chair on a daily basis. The decisions of the delegated review teams are reported at the next committee meeting.
Annual Updates, Requests for 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 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 submit an Amendment Request in which they outline the proposed modifications prior to implementation.
Annual updates and amendment requests must be submitted via the "Events" function of the researcher's (or other project team member's) Researcher Portal account. For more information and assistance on Post Review Application management a training video (HERE) and manual (HERE) have been posted under the "Human Ethics" menu of the Researcher Portal main page.
Departmental Review of Student Research as Part of Course Work
Departmental review of student research as part of course work is a form of delegated review (TCPS 2; Article 6.12) and is addressed separately.