Ethics applications are
sent for review to Ethics Committee and
members one week before the
Research Review Committee
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.
Social Science (H&SS) applications
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.
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.
not requiring full Ethics Committee review
Applications that do not require full
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.
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
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.