Human Research Ethics Committee Annual Report 2015-16

Human Research Ethics Committee Annual Report 2015–16

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), which is jointly developed by the:

  • National Health and Medical Research Council (NHMRC)
  • Australian Research Council
  • Australian Vice-Chancellors’ Committee.

During 2015–16, HREC has been an active contributor to the NHMRC consultation process on developing national reforms in research ethics administration.

The Research Ethics and Governance Office Director, August Marchesi, has continued to represent HREC and ACT Health on the Jurisdictional Working Group that is managing the National Mutual Acceptance (NMA) of ethical and scientific review for multi-centre health and medical research.

The Clinical Trials Subcommittee (CTSC) and the Social Research Subcommittee (SRSC) have continued to provide HREC with expert advice on the research merit and integrity of research proposals. The Low Risk Subcommittee (LRSC) reviews and takes decisions on more than two-thirds of all proposals received.

HREC and its subcommittees draw on the expertise available in:

  • ACT Health
  • the wider ACT research community
  • more broadly, the ACT community. As of June 2016 the HREC comprised:
  • 10 external members
  • seven internal ACT Health members.

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 Secretariat staff, August Marchesi, Matthew Wafer and Gillian Fox, for their tireless work in keeping the ACT Health HREC and its processes operating at the highest standards.

Louise Morauta PSM PhD
Chair

Membership of the Human Research Ethics committee

Table 64 identifies membership of the HREC in 2015–16.

Table 64: HREC membership
Name of member Position
Dr Louise Morauta Chair
A/Professor Frank van Haren Deputy Chair
Current Researcher (Intensive Care)
Professor Walter Abhayaratna Current researcher (Cardiology)
Ms Kimberley Baillie Lawyer member (alternate)
Ms Margaret Blood Lay member
Professor Doug Boer Member providing professional care (until 1 June 2016)
Dr Bianca Calabria Current researcher (Aboriginal and Torres Strait Islander Health)
A/Professor Paul Craft Current researcher (Oncology)
Professor Geoff Farrell Current researcher (Hepatology)
Rev Doug Hutchinson Member providing pastoral care (until September 2015)
Dr David Larkin Current researcher (Nursing and midwifery) (until 30 April 2016)
Member providing professional care (from 1 May 2016)
Mr David Lovegrove Consumer member (new position from December 2015)
Professor Imogen Mitchell Current researcher (Intensive care)
Mr John Morrissey Lawyer member (alternate)
Dr Anna Olsen Current researcher (Social Science)
Rev Neale Roberts Member providing pastoral care (from October 2015)
Dr Louise Stone Current researcher (Social Science)
A/Professor Dipti Talaulikar Current researcher (Haematology) (until September 2015)
Ms Lyn Todd Pharmacist
Mr Luke Williamson Lay member

Meetings of the Ethics Committee and its subcommittees

The committee met 11 times from 1 July 2015 to 30 June 2016. Meetings are held monthly. Subcommittee meeting details are as follows:

  • The Clinical Trials Subcommittee (CTSC), under the chairmanship of Professor Walter Abhayaratna, met nine times during the year. In each instance, recommendations were made to the subsequent HREC meeting.
  • The Social Research Subcommittee (SRSC), under the chairmanship of Dr Jason Mazanov (until October 2015) and Dr Anna Olsen (from November 2015), met 10 times during the year. Again, in each instance, recommendations were made to the subsequent HREC meeting.
  • The Low Risk Subcommittee (LRSC), under the chairmanship of Dr Louise Morauta, met 26 times during the year. The LRSC meets on a fortnightly cycle to enable a faster decision-making process for projects "in which the only foreseeable risk for participants is one of discomfort" (National Statement on Ethical Conduct in Human Research (2007).

Key points arising

Key developments during the 2015–16 year were:

  • A new rule was approved by ACT Health in December 2015, allowing research projects already approved by an NHMRC-certified HREC to be exempt from duplicate ACT Health ethics review processes. As at 30 June 2016, 13 projects had been submitted under this rule and nine approved to begin research at ACT Health.
  • The Powers of Attorney Amendment Bill 2015 passed, marking a positive conclusion to two years of work for HREC and the Secretariat. This amendment will make it easier for residents of the ACT to participate in research where a Power of Attorney or guardianship order applies.
  • ACT Health signed an agreement with the NSW Ministry of Health to sub-license an Information Technology (IT) system, known as AU RED, which is a critical step in facilitating the ACT to join other jurisdictions in the NMA scheme.
  • The first national performance statistics for ethics committees were released and show ACT Health HREC compares very well with other NHMRC-certified HRECs.
  • In 2014–15, ACT Health HREC approved 96 per cent of all proposals within the NMA benchmark of 60 calendar days (with the NMA clock-stop method applied). The comparative national figure for NMA committees for commercially sponsored trials was 82 per cent. • In the 2015 calendar year ACT Health HREC approved 80 per cent of proposals in 34 days (clock-stop applied). The LRSC approved 80 per cent of proposals in 10 calendar days (no clock applied).