Clinical trials
Approvals
If your application is for research involving a clinical trial of a pre-registration medicine, you will also need to apply to the Standing Committee on Therapeutic Trials (SCOTT). SCOTT is a committee of the Health Research Council. It is convened to provide recommendations to the Director-General of Health on the scientific validity of applications for clinical trials on new medicines. All clinical trials involving pre-registration medicines will need the approval of SCOTT to proceed.
The SCOTT application form and details about where to send it are available from:
hrc.govt.nz/about-us/committees/standing-committee-therapeutic-trials-scott
If you need assistance with this, please contact the Research Advisor x6855.
Indemnity and insurance for clinical trials
ACC protection
(Injury Prevention, Rehabilitation and Accident Act 2001)
Clinical Trials which ARE NOT conducted principally for the benefit of a manufacturer or distributor are covered under the Accident Compensation (ACC) legislation (refer to Section 32 of the Act) for 'Treatment injury' arising from the clinical trial on a no fault basis. An exception to the ACC cover is where the participant did not agree, in writing, to participate in the trial hence the importance of complying with this requirement.
The ACC cover does not include pure mental injury i.e ACC only covers mental injury resulting from physical injury.
In the situation where ACC provide cover, a declaration is required from the Principal Investigator at the time of submitting a Regional Ethics Committee approval application.
Insurance protection
For all other Clinical Trials, these will be conducted principally for the benefit of a manufacturer or distributor and accordingly no cover is available under the Accident Compensation legislation.
In these situations, the Sponsor should be responsible for arranging adequate insurance cover, which will require approval by the Regional Ethics Committee. The insurance cover should normally be in the form of a No Fault Clinical Trials Insurance coverage and is the responsibility of the Sponsor. If possible, the University of Otago and the Investigator should request to be added to the Sponsor's insurance coverage arranged.
To facilitate this and the negotiation of the Contract Agreement and Sponsor Indemnity all documentation must be forwarded to the Research and Enterprise Office for review and finalisation with the Sponsor.
If the situation arises where the Clinical Trial involves no Sponsor but rather the University of Otago is conducting the Clinical Trial at their instigation, then there is the possibility the University of Otago could be deemed to be a 'manufacturer or distributor' under the ACC legislation and hence no ACC cover applying.
Any Clinical Trials of this nature must be forwarded to the Research and Enterprise Office for review and, if required, arranging adequate insurance for the participants.
Clinical trials register
The International Committee of Medical Journal Editors (ICMJE) announced that member publications would only consider clinical trials for publication if the trial had been registered on a trials registry before recruitment of the first participant. Member journals of ICMJE include many major medical publications overseas (such as New England Journal of Medicine, Lancet, and JAMA) as well as the New Zealand Medical Journal.
New trials should register before the first participant is randomised; The Australian New Zealand Clinical Trials Register is free-of-charge, meets the ICMJE criteria and is now live and accepting online registrations at anzctr.org.au.
Research involving animals
If you wish to use animals in research, testing or teaching you will need to:
- Obtain approval from the Wellington Animal Ethics Committee
- Order animals from the centralized animal facility
- Obtain details of costs for the purchase and housing of animals
- Attend Module 1 of the Animal Welfare Office Training Programme if you are a new user of experimental animals
- Read the Code of Ethical Conduct for the use of live animals for teaching and research
If you wish to administer anaesthetic, analgesic or antibiotic veterinary or human medicines to animals you will need to:
- Obtain a veterinary prescription (Institutional Drug Administration order)
- Place an order for veterinary medicines or human medicines used in animals
For all these forms and advice please contact the Laboratory Manager:
Ann Thornton
Laboratory Manager
University of Otago, Wellington
Tel +64 4 385 5576
Mob +64 21 034 5532
Fax +64 4 389 5725
Email: ann.thornton@otago.ac.nz
Any other animal enquiries should be made to the manager of the animal facility.
Research involving hazardous substances
According to the Code of Practice for CRI and University exempt Laboratories, a hazardous substance means, unless expressly provided otherwise by regulations, any substance:
1. With one or more of the following intrinsic properties:
- Explosiveness
- Flammability
- A capacity to oxidize
- Corrosiveness
- Toxicity
- Ecotoxicity, with or without bio-accumulation; or
2. Which on contact with air or water (other than air or water where the temperature or pressure has been artificially increased or decreased) generates a substance with any one or more of the properties specified in paragraph (1) of this definition.
A statutory and Regulatory consents and approvals form must be completed for all projects (last sheet of the costing and consents worksheet). For advice on whether your research requires such approvals (Hazardous Substances and New Organisms (HSNO) approval, MAF approval, ERMA approval etc) please contact the Laboratory Manager.
Ann Thornton
Laboratory Manager
University of Otago, Wellington
Tel +64 4 385 5576
Mob +64 21 034 5532
Fax +64 4 389 5725
Email ann.thornton@otago.ac.nz
Postdoctoral fellows, research fellows, research assistants, PhD students, masters' students, 4th-year honours students and technicians must have their projects involving hazardous substances approved by the laboratory supervisors and laboratory manager in order to become an authorised laboratory User.
Research involving hazardous substances also requires a risk assessment and other procedures to be put in place before the research commences (HSNO Act). There is a manual available from the Laboratory Manager which contains information on how to comply with the Code of Practice requirements within the University environment. Please contact the Laboratory Manager for a copy of this.
Laboratory procedures and training
All laboratories at the UOW are HSNO exempt and therefore have specific requirements in order to meet this exemption. All staff and students working in HSNO exempt laboratories must have completed the standard training course on working in these laboratories. Please contact the Laboratory Manager for information about this training:
Ann Thornton
Laboratory Manager
University of Otago, Wellington
Tel +64 4 385 5576
Mob +64 21 034 5532
Fax +64 4 389 5725
Email ann.thornton@otago.ac.nz
Research involving genetically modified organisms
Any research requiring the development, importation or transport of a genetically modified organism requires special approval by the Environmental Risk Management Authority (ERMA). Please contact the Laboratory Manager for the forms and advice:
Ann Thornton
Laboratory Manager
University of Otago, Wellington
Tel +64 4 385 5576
Mob +64 21 034 5532
Fax +64 4 389 5725
Email ann.thornton@otago.ac.nz