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Monitoring ethics and safety

The Health Research Council (HRC) plays a pivotal role in ensuring New Zealand health research is ethical and safe.

comforting hands

We undertake safety monitoring and provide strategic advice on health research issues, primarily through the work of the following committees: the HRC Ethics Committee (HRCEC), the Gene Technology Advisory Committee (GTAC), the Standing Committee on Therapeutic Trials (SCOTT), and the Data Monitoring Core Committee (DMCC).

We aim to ensure all research involving human participants meets ethical standards, is based on good science, and complies with international best practice. We also require that ethical approval from an approved ethics committee is obtained before any HRC-funded research can commence.

How we do it

  • Our Ethics Committee is responsible for approving all the Health and Disability Ethics Committees (HDECs) and Institutional Ethics Committees (IECs) in New Zealand.
  • We produce guidelines around research with Māori and Pacific peoples, so the rights of participants are respected.
  • The Data Monitoring Core Committee (DMCC) provides objective, independent monitoring of HRC-funded clinical trials in New Zealand, when needed.
  • The Standing Committee on Therapeutic Trials (SCOTT) checks clinical trials for safety and efficacy.
  • The Gene Technology Advisory Committee (GTAC) assesses the scientific merit of studies to transfer genes from one species to another.

More about our Ethics and Regulatory Committees

Ethics Committee

It is the responsibility of the Health Research Council's Ethics Committee (HRCEC) to ensure that independent ethical assessment of any proposed research submitted to us has been carried out by an ethics committee approved by the HRCEC. 

To ensure that appropriate standards are met, the HRCEC has developed a formal approval process in which it reviews and monitors other ethics committees. The HRCEC approves two types of ethics committees:

  1. Health and Disability Ethics Committees (HDECs): HDECs are independent ethics committees administered by the Ministry of Health, which only review health and disability research. The HRC Ethics Committee currently approves four HDECs (Northern A, Northern B, Central and Southern). 
  2. Institutional Ethics Committees (IECs) and other human ethics committees: IECs are established and supported by the institution to which they belong, usually a university, and they review research that’s occurring within their institution, which can span a broad range of research applications involving human participants. The HRC Ethics Committee currently approves 13 IECs.

Our Resource Library has more about the role of the committee and its Terms of Reference.

HRCEC membership:

  • Professor Huia Tomlins-Jahnke - Chair, Māori research 
  • Professor Parry Guilford, Health Researcher
  • Dr Monique Jonas, Ethicist
  • Professor Gareth Jones, Health Researcher
  • Professor Tahu Kakutai, Māori and Indigenous demography
  • Professor Lesley McCowan, Clinician
  • Ms Helen Davidson, Legal
  • Dr Krushil Watene, Ethicist.

​Committee Secretary:  Ms Lana Lon - Project Manager, Ethics

Data Monitoring Core Committee

The Health Research Council's Data Monitoring Core Committee (DMCC) was established to provide objective, independent monitoring of clinical trials funded by the HRC. The DMCC has two main functions:

  1. To review the monitoring plans for trials funded by the HRC and provide advice to the HRC on whether the plans meet best international practice.
  2. To constitute a Trial-Specific Data Monitoring Committee for any trial funded by the HRC where this is appropriate and is requested by the investigators. Trial-Specific Data Monitoring Committees are formed from the DMCC membership, plus additional co-opted members who have expertise specific to the trial.

A third function of the DMCC is to provide apprenticeship-style training in data monitoring to leading clinical researchers and biostatisticians from New Zealand. This approach is recommended internationally as the optimal way of maintaining an experienced data monitoring workforce.

Our Resource Library has more about the role of the committee and its Terms of Reference.

DMCC membership:

  • Professor Thomas Lumley - Chair, Department of Statistics, The University of Auckland
  • Professor Tim Dare, Department of Philosophy, The University of Auckland
  • Dr Mark Jeffery, Department of Oncology, Christchurch Hospital
  • Professor Ngaire Kerse, School of Population Health, The University of Auckland
  • Dr Andrew Moore, Department of Philosophy, University of Otago
  • Dr Mark Webster, Department of Cardiology, Auckland City Hospital
  • Dr Yalu Wen, Department of Statistics, The University of Auckland.
  • Dr Conroy Wong, Department of Respiratory Medicine, Middlemore Hospital.

Committee Secretary: Lana Lon - Project Manager, Ethics

Standing Committee on Therapeutic Trials

Clinical trials that involve use of a new medicine require approval under Section 30 of the Medicines Act 1981. The Health Research Council's Standing Committee on Therapeutic Trials (SCOTT) undertakes scientific assessment of applications to conduct trials and makes recommendations to the Director-General of Health on whether or not trials should be approved.

The majority of applications reviewed by SCOTT are for clinical trials sponsored by the pharmaceutical industry. The review conducted by SCOTT, if required, is a parallel process to the ethical review for clinical trials.

Our Resource Library has more about the role of the committee and its Terms of Reference.

SCOTT membership:

  • Associate Professor Richard Robson, Christchurch Clinical Studies Trust - Chair
  • Emeritus Professor Carl Burgess, Wellington
  • Dr Matthew Dawes, The University of Auckland, Auckland
  • Professor Stephen Duffull, School of Pharmacy, University of Otago, Dunedin
  • Professor Chris Frampton, Christchurch School of Medicine and Health Sciences
  • Dr Sisira Jayathissa, Hutt Valley District Health Board, Wellington
  • Dr Damian Pethica, Auckland
  • Professor Paul Smith, School of Medical Sciences, University of Otago, Dunedin
  • Mr Trevor Speight, Auckland
  • Professor Ian Tucker, School of Pharmacy, University of Otago, Dunedin
  • Dr Chris Wynne, Christchurch Clinical Studies Trust.

Ex officio members:
Dr Alexander Bolotovski, Medsafe, Ministry of Health

Gene Technology Advisory Committee

Clinical trials that involve use of an unregistered medicine, for which the Minister has not given consent for distribution, require approval under Section 30 of the Medicines Act 1981.

The Health Research Council's Gene Technology Advisory Committee (GTAC) undertakes scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated micro-organisms, or viruses or cells into human subjects. It also makes recommendations to the Director-General of Health on whether or not trials should be approved.

Our Resource Library has more about the role of the committee and its Terms of Reference

GTAC membership:

  • Professor Ian Morison, University of Otago, Dunedin - Chair
  • Professor Ian Alexander, Sydney Children’s Hospitals, Sydney
  • Associate Professor Lynley Anderson, University of Otago, Dunedin
  • Professor Peter Browett, The University of Auckland
  • Professor Stephen Chambers, School of Medicine & Health Sciences, University of Otago, Christchurch
  • Dr Jade Hollis-Moffatt, University of Otago, Dunedin
  • Professor Stephen Robertson, University of Otago, Dunedin
  • Associate Professor Richard Robson, Christchurch Clinical Studies Trust, Christchurch.

Supporting best practice in clinical trials 

As demonstration of our commitment to supporting best practice in clinical trials, the Health Research Council is a signatory to the World Health Organization (WHO) Joint statement on public disclosure of results from clinical trials (the Joint statement). The Joint Statement sets out policy and monitoring requirements for mandatory time-frames for:

  • prospective clinical trial registration, and
  • public disclosure of the results of clinical trial research.

We endorse the requirements of the Joint statement as reflective of the ethical and quality standards that must be met by HRC-funded clinical trials. This will enhance the evidence base for clinical medicine both in New Zealand and internationally while simultaneously providing easily accessible information for the public, patients and their whānau.

The HRC’s full policy statement on clinical trial transparency can be found here in our Resource Library

Important ethics and safety documents

Our Resource Library contains documents and guidelines around ethics and safety in HRC-funded research, including how to apply for ethics approval.