Research & Ethics Unit

 Ethics Committee review and approval process
Home > Human ethics > Approval process

Review

Ethics applications are sent for review to Ethics Committee and Research Review Committee members one week before the Research Review Committee meeting.

[Meeting dates]

Drugs & Interventions (D&I) applications
Research Review Committee (RRC) members receive only drugs and interventions applications, e.g. drug trials (including CTN and CTX) and invasive studies.

Members may review all project applications, but each project in this category is assigned to two members for detailed review.

Comments by Ethics Committee members who are not members of the RRC are also considered by the RRC.

An independent expert review may be required for studies that involve unknown or very high risk to participants, such as new procedures, devices or drugs with known safety issues or an unknown safety profile, as in first-in-man studies.

Health & Social Science (H&SS) applications
Each project in this category is assigned to two members to conduct a detailed review. If review of the project requires particular expertise, opinion may be sought from outside experts.

Nominated reviewers email comments to the Ethics Office two weeks before the Ethics Committee meeting. These comments are sent to the researchers, and responses requiring further examination are dealt with by the reviewers in the week leading up to the main Ethics Committee meeting.

Interviews may be requested for any project. If chief researchers cannot attend at the time allocated, they may nominate co-researchers to attend in their place.

Applications not requiring full Ethics Committee review
Applications that do not require full Ethics Committee review are reviewed out-of-session by at least one committee member.  If the project involves no more than low risk, approval is given, but if the risk is greater, the project is referred to the full committee.

Main Ethics Committee meeting
Before the main meeting, all Ethics Committee members are sent an agenda with interview information, reviewers’ comments, researchers’ responses and updated applications.

After general business, the committee splits into two groups, one to discuss the D&I applications and the other H&SS applications. Each committee is fully constituted according to the National Statement on Ethical Conduct in Human Research (2007).

Primary reviewers will have had the opportunity to review and comment on the researchers’ responses and any issues they may have are presented at the meeting for discussion.

For each D&I project the Chair of the RRC presents a summary of the project and raises any outstanding issues. A secondary reviewer who is not a member of the RRC is also appointed to comment on any issues that may have emerged during the course of the review.

Projects may be approved subject to further amendments. These are normally reviewed by the Ethics Office, but responses to significant issues will be referred to the chairs of the committees or the primary reviewers for their review and recommendation.

Project approval

An approval certificate will be issued once there are no further issues.

Approval is ongoing but will lapse if a Progress Report is not received by the anniversary of the approval date, or is not deemed satisfactory by the Ethics Committee.

Researchers will be reminded when their progress reports are due.

[^]


This page was last modified on 06/01/12

© The Alfred 2000 - 2012
E-mail: research@alfred.org.au