Clinical trials that involve use of a new medicine require approval under Section 30 of the Medicines Act 1981. The HRC'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.

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 (for a list of current fees, seeSchedule of fees available at Medsafe). In the case of public good research, this may be waived by the Director-General of Health.

Committee members:

Associate Professor Richard Robson - Chair
Christchurch Clinical Studies Trust
Clinical Professor Murray Barclay
Department of Clinical Pharmacology, Christchurch Hospital
Emeritus Professor Carl Burgess
Wellington
Dr Matthew Dawes
The University of Auckland, Auckland
Professor Stephen Duffull
School of Pharmacy, University of Otago, Dunedin
Associate 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

Terms of reference for SCOTT

Disclosure of conflict of interest

The policy of the HRC is that potential conflicts of interest should be declared in the appropriate way and for any conflicts of interest to be managed in a transparent and appropriate way for the protection of the HRC, the Board and Committee members. All members of the HRC Board and HRC 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 the integrity and public confidence in the HRC is maintained.

Previous financial year

In the 1 July 2012–30 June 2013 year, SCOTT reviewed 124 applications for clinical trials. The average time for review by SCOTT was 11.8 working days.

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