Human Research Ethics Committee Annual Report 2013-14

The ACT Health Human Research Ethics Committee (HREC) continues its work of reviewing human research proposals to ensure they meet the ethical standards set out in the National statement on ethical conduct in human research (2007), prepared by the National Health and Medical Research Council (NHMRC), the Australian Research Council and the Australian Vice-Chancellors’ Committee. During the reporting period, HREC has been an active contributor to the NHMRC consultation process on the proposed national reforms in research ethics administration.

HREC and its subcommittees aim to provide ethical review and approval in the shortest possible time, conscious of the pressures on researchers and their teams. During the reporting period, HREC reviewed 93 research applications, with an average time of 33.6 days from submission to approval. The Low Risk Subcommittee reviewed 207 submissions.

HREC has continued to prepare for the advent of national programs of single ethical approval of multisite research.

The Research Ethics and Governance Manager, August Marchesi, has continued to represent HREC and ACT Health on the Jurisdictional Working Group that is progressing the single review system.

The Clinical Trials Subcommittee (CTSC), the Social Research Subcommittee (SRSC) and the Survey Resource Group (SRG) have continued to provide HREC with expert advice on the merit and integrity of research proposals. The Low Risk Subcommittee (LRSC), which reviewed more than two-thirds of all proposals received, has been expanded to a core membership of three long-term members, including a medical member, a social researcher and a chair. The aim of this change is to provide more consistency in decisions and a breadth of expertise commensurate with the variety of proposals that come forward. All three current members of LRSC are also HREC members.

In April 2014, Professor John SG Biggs, long-serving HREC Chairman, retired from the committee. I am very pleased to have this opportunity to thank Professor Biggs for his dedication to HREC and to acknowledge the many valuable improvements made by HREC under his leadership. On behalf of HREC, its subcommittees and support staff, I wish Professor Biggs the very best in his future endeavours.

HREC and its subcommittees draw on the expertise available in ACT Health, the wider ACT research community and more broadly the ACT community. The current Chair has an earlier academic background in sociology and anthropology and more recent experience at senior levels in the Commonwealth Public Service.

I would like to thank the members of HREC and its subcommittees for their hard work and dedication to the enterprise of ethical review. On behalf of the committee, thanks is given to the administrative staff, August Marchesi and Gillian Fox, for their tireless work in keeping HREC and its processes operating at the highest standards.

(signature)

Louise Morauta PSM PhD
Chair

Membership of the committee

Professor John Biggs Chairman (resigned April 2014)

Dr Louise Morauta Chair (from April 2014), lay member (2010-14)

Associate Professor Peter Hickman Deputy Chair

Professor Walter Abhayaratna clinical member (cardiology)

Professor Geoff Farrell clinical member (hepatology)

Professor Doug Boer member providing health care (psychology)

Associate Professor Frank van Haren clinical member (intensive care)

Associate Professor Marian Currie member with research experience (nursing and midwifery)

Dr Dipti Talaulikar clinical member (haematology)

Dr Jason Mazanov member with research experience (psychology)

Dr Ray Lovett member with Aboriginal and Torres Strait islander health research expertise

Rev Doug Hutchinson member providing pastoral care

Luke Williamson lay member

Kimberley Baillie lawyer member (alternate)

John Morrissey lawyer member (alternate)

Lyn Todd member with pharmacy expertise

Julie Kussy member with nursing expertise

Number of research projects

During 2013-14, HREC reviewed 93 proposals; 82 were approved. Of the remaining 11 proposals, four were withdrawn by the applicant, four were quality-improvement activities that did not require ethical approval, and three remain in consultation, progressing towards approval.

Meetings

The committee met 11 times from 1 July 2013 to 30 June 2014. Meetings are held monthly.

Subcommittees

The Clinical Trials Subcommittee (CTSC) reviewed 39 proposals, in each instance making recommendations to the main committee.

The Social Research Subcommittee (SRSC) reviewed 40 proposals, in each instance making recommendations to the main committee.

The Low Risk Subcommittee (LRSC) reviewed 207 proposals and approved 172. Of the remaining 35, six were referred for consideration by the main committee, two were withdrawn by the applicant, 19 are in consultation towards approval and, due to a change in guidelines provided by the NHMRC, eight proposals were deemed quality-improvement activities and did not require ethical approval.

The Survey Resource Group (SRG) reviewed 94 proposals. In 60 instances the SRG provided recommendations to either HREC or LRSC. In 34 cases the SRG provided endorsement of projects not requiring ethical review.

Key points arising

Throughout 2013, the Chairman and Manager assessed the readability of participant information sheets submitted with research proposals. In November, Professor Biggs presented the findings of this project at the Australasian Ethics Network Conference in Fremantle, Western Australia. An article has been prepared and publication is pending.