Application Process, Review and Decisions

Application Process

Researchers must provide an electronic copy of the proposal including all attachments for distribution to the ICEHR members, to:

ICEHR Coordinator
Office of Research Services
IIC-2010c, Burneau Centre for Research and Innovation
Memorial University of Newfoundland
St. John’s, NL A1C 5S7

Submit electronic copy to: icehr@mun.ca

Proposals are assigned file numbers in the order in which they are received by the ICEHR Coordinator, and where possible, will be considered by the Committee in the same order. You should not submit your application to a committee member or the Chair since this may delay the assignment of a file number, and thereby, also the processing of your application.

Researchers are required to submit applications to the Committee for ethics review at least four weeks before they intend to begin the research. Please be aware that incomplete proposals, or proposals that are ethically controversial, may take longer than four weeks to receive final approval.

Please note:

To allow adequate time to complete ethics reviews before the December holiday period, applications will be accepted each year up until the cut-off date of November 30th. Applications received after that date will normally be assigned for review in January.
The period from approximately February until May is a period of very high demand for research ethics review. It is advisable to apply as early as possible for review, particularly during this period.

The Review Process

Proportionate Review

The ICEHR adheres to the principle of proportionate review as outlined in the TCPS 2 (Section 1, D1). 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.

Memorial University’s Policy on Ethics of Research Involving Human Participants have authorized expedited review based primarily on an assessment of the harm expected to arise from the research. The ICEHR conducts either full or expedited review of applications for ethics clearance. The determination of whether a review of a new proposal is conducted by the full committee or through an expedited process is determined by the committee’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, these requirements are applicable to all research involving human participants.

Assessment of Level of Risk of New Proposals

All new proposals for research reviewed by the ICEHR are circulated to all committee members and directed to a team of three members who will act as lead reviewers for assessment of risk and feedback. Members of lead review teams are assigned by the ICEHR's Ethics Coordinator in consultation with the Chair with due regard to members expertise to assess minimal risk for any particular study. The team member assigned as Primary Reviewer is normally a representative from the researcher’s faculty or school or a member with particular expertise relevant to the proposed study.

The lead reviewers promptly communicate their written assessment of risk to the Primary Reviewer with copies to the ICEHR chair and support staff. Those proposals judged to be of minimal risk will proceed immediately to the expedited review process. Those proposals judged to be above minimal risk will receive full committee review.

Full Review

All studies judged to be above minimal risk, as defined in the TCPS 2 (Section C1) are subject to full review by the committee. This judgement may be made by any one or more committee members at any point in the review process. Full review requires that the proposal be discussed at a face-to-face meeting of the committee (TCPS 2, Section 1, D2).

For new proposals assessed to be above minimal risk, the team of lead 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 Primary Reviewer may elect to discuss the review with the researcher. Such discussions are undertaken in consultation with the Chair and other reviewers.

The Primary Reviewer compiles the feedback from any such discussions with the researcher, and of the three lead reviewers 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 for approval without or with specified modifications, or for deferral of the decision or denial, with justifications. The full committee will at this meeting, discuss the proposal and the review by the lead reviewers and offer input before the committee reaches a decision. Following this meeting, the Chair of the ICEHR will send a letter to the researcher on behalf of the committee, granting approval (with or without required modifications), or denying approval (with reasons), or requesting additional information and deferring the decision until this information has been received and reviewed.

Expedited Review

In keeping with the principle of proportionate review, the process of review may be expedited for:

new proposal for research judged to be of no more than minimal risk to participants,
follow-through on modifications required by the ICEHR, annual renewals, and project amendments that the committee views to be of minor nature.

However, the ICEHR reserves the right to undertake a full review if deemed necessary in any of these cases.

New Proposals

Unless you judge your study to be above minimal risk, you do not need to time your application process in relation to the committee meeting schedule. Review of proposals is ongoing, and decisions following from expedited reviews can be communicated outside normally scheduled committee meeting dates. The decision resulting from an expedited review of the committee is then reported at the next committee meeting.

For new proposals assessed to be of no more than minimal risk, the team of lead 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 Primary Reviewer may elect to discuss the review with the researcher. Such discussions are undertaken in consultation with the Chair and other reviewers.

The Primary Reviewer compiles the feedback of the three reviewers and circulates this review in writing to all members of the review committee. This report will specify the level of risk for participants and make recommendations for approval without or with specified modifications, or for deferral of the decision or denial, with justifications. All members of the committee have an opportunity to consider the review by the lead reviewers and offer further comments before the committee’s decision is finalized. The Chair of the ICEHR will then send a letter to the researcher on behalf of the committee, granting (with or without required modifications) or denying approval (with reasons), or requesting additional information and deferring the decision until this information has been received and reviewed.

Annual Renewals, Reports on Amendments and/or Required Modifications

For annual renewals of on-going research, for reports on modifications requested by the ICEHR, and project amendments that the committee views to be of minor nature, a process of expedited review is also followed. This entails review by the Chair and where appropriate, the Primary Reviewer or full team of lead reviewers of the original proposal. In all instances of expedited review, a report to the full committee will be made.

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 expedited review (TCPS 2, Section 1, D1) and is addressed separately.

Decisions of the ICEHR

Decision Making Mechanisms

Normally the ICEHR arrives at decisions by consensus. However, on the occasion when consensus is not achieved, a formal vote will be held and the decision will be based on majority vote of those present. The Chair votes in the case of a tied decision.

All proposals receiving approval through the expedited review process are presented to the full committee for notification. Proposals not delegated to expedited review will be reviewed at the meeting.

Conflict of Interest

Members shall not be present or otherwise participate in the ICEHR discussions of research with which they are associated as principal or co-researcher, as collaborator, or as supervisor of student research, whether the proposal is from a student, faculty member, or external researcher. Similarly, members shall not be involved in the expedited review of research with which they are associated. Members shall also not participate in the review of any proposal where the researcher is someone with whom they have or have had a close personal or financial relationship. It is expected that any members perceiving any other conflict of interest will declare the conflict and excuse themselves from the review of the relevant proposal.

Decisions / Possible Outcomes of the Review Process

The outcome of the review process will normally be one of the following decisions:

Approval without modifications. The research can proceed as proposed for a one-year period, renewable.
Approval with modifications, no report required. Normally this requires minor changes to materials for participants or potential participants. When the ICEHR makes approval contingent on changes to the proposal, it shall provide the researcher with written grounds for the decisions. Once these changes have been made, the research can proceed for a period of one year, renewable.
Decision pending submission of additional and/or revised materials, report required. The review is incomplete pending receipt of additional and/or revised information from the researcher required to fulfill the intention of the TCPS. The ICEHR makes suggestions for additions and/or modifications that should bring the research into compliance with TCPS. The research may NOT proceed until a report detailing intended modifications has been received, reviewed and approved by the ICEHR. Once the revised proposal has been approved, the research may proceed for a period of one year, renewable.
No approval, suggestions for re-submission. The research in its present form does not meet TCPS 2 standards, and the ICEHR has provided the researcher with the reasons for this decision and given the researcher an opportunity to reply before making a final decision. The proposal will have to be re-submitted with substantial changes, reviewed, and approved before research can begin.
No approval, and none likely. The research cannot be undertaken without violation of some of the provisions of the TCPS 2 and the ICEHR has provided the researcher with the reasons for this decision and given the researcher opportunity to reply before making a final decision.

Reconsideration of Decisions

Researchers have the right to request, and the ICEHR to provide reconsideration of decisions affecting a research project. Such request shall be made in writing to the Chair of the ICEHR.

When the ICEHR is considering not approving a proposal, it shall provide the researcher with the reasons for the prospective decision and give the researcher an opportunity to reply before making a final decision.

Appeal Process

If you believe that there has been a procedural problem (e.g.., a conflict of interest of one or more of the ICEHR members) in the consideration of your proposal, you can appeal the ICEHR’s decision. Please refer to Memorial University’s Policy on Ethics of Research Involving Human Participants. The decisions of the ICEHR cannot be overridden by the University, except in the case of a successful appeal on procedural grounds.