Ethics review process

Reviews by the full Ethics Committee

Applications are divided into two categories:

• Health & Social Science (H&SS) applications
• Drugs & Interventions (D&I) applications

H&SS applications are reviewed by members of the Ethics Committee.

D&I applications are reviewed first by the Research Review Committee and then by the Ethics Committee.

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 post comments online through 'ERA' two weeks before the Ethics Committee meeting. These comments are made available to the researchers via ERA 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.

Drugs & Interventions (D&I) applications

Research Review Committee (RRC) members receive only drugs, devices and interventions applications, e.g. drug trials (including CTN and CTA) and invasive studies.

Each application is assigned to two primary reviewers for detailed attention. Members are expected to familiarise themselves with all D&I applications so they can contribute to discussion of the project.

Two non-scientific members of the Ethics Committee are assigned to each project as secondary reviewers. Their role is to identify ethical issues and examine the PICFs to make sure they describe all risks and procedures accurately.

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-human studies.

Main Ethics Committee meeting

Before the main meeting, all Ethics Committee members are notified of an agenda with interview information, reviewers' comments, researchers' responses and updated applications. The agenda is posted on ERA.

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 (2023).

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 (or a member of the RRC) presents a summary of the project and raises any outstanding issues. The assigned secondary reviewers, or any other members, comment on any issues that may have emerged during the course of the review.

Projects may be approved subject to further changes to the application. These are normally reviewed by the Ethics Officers, but responses to significant issues will be referred to the Chairs of the committees or the allocated reviewers for their review and recommendation.

Review of single site, Alfred Health or a single Alfred Research Alliance affiliated site low risk projects

The project is sent to a single Ethics Committee member for review. If the subject matter requires further review, an expert member's or independent person's opinion is sought. On occasion, the Chair of the Low Risk Committee is called upon for advice.

If the research is deemed not to be low risk, researchers will be advised the project will be reviewed by the full Ethics Committee. 

Review of projects involving specific categories of participants

Position statements outline the Ethics Committee's approach to reviewing:

• research involving children and young people
• research involving Aboriginal and Torres Strait Islander people
• research conducted overseas

Ethics approval

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

Research is monitored through progress reporting and audit. Researchers are obliged to submit annual Progress Reports and a Final Report upon completion of the research.

Once completed, research records are to be archived under the requirements of the Alfred Health Archiving Policy.

Alfred Health Governance

Site governance documents will be reviewed concurrently, but independent of the Ethics Committee.

Alfred Health site authorisation (as notified on ERA) must be obtained before a research project can commence at Alfred Health.