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.
- 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
Dr Vernon Choy, Acting Chief Executive, Health Research Council of New Zealand
Conflict of interest
Potential conflicts of interest should be declared in the appropriate way and managed in a transparent and appropriate way for the protection of the HRC, the Board and Committee members. All members of the Board and our committees have an obligation to disclose an interest in a matter of the HRC. A ‘matter’ includes any of the HRC's functions to promote and fund health research and any arrangement or contract entered into for research funding. By disclosing interests, members ensure that they are accountable and that integrity and public confidence in the HRC is maintained.
SCOTT contact: Richard Robson, tel: 03 372 9477.
Medsafe contact: Mr Chris James, Manager Clinical Risk Management:
Membership criteria includes:
- Up to seven members appointed on the recommendation of the Health Research Council; these individuals are responsible for proposal reviews.
- The chief executive of the HRC.
- A biostatistician be included, not as a full-time member, but as someone to consult as appropriate.
- A representative to be appointed on the recommendation of the Pharmaceutical Society of New Zealand.
- A nominee of the Ministry of Health attends the AGM for liaison purposes.
Term of Office
Up to three years, appointed members may complete two consecutive terms at which time they would cease to be reappointed for a further three years.
Process for Appointment of Membership
The chief executive formally invites the proposed member recommended by the Committee and confirmed by the HRC Board.
Role of SCOTT
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.
To make an application, the applicant must complete and sign the Application for approval of a clinical trial under Section 30 of the Medicines Act 1981 form (see Forms and templates available at Medsafe).
The applicant seeking an approval under Section 30 of the Medicines Act will also be required to lodge a fee per application payable to Medsafe. In the case of public good research, this may be waived by the Director-General of Health.
Additional: SCOTT Terms of Reference