Information for researchers planning studies and clinical trials in New Zealand that involve NSU screening programmes and/or screening pathways.
This information is provided for the benefit of individuals or groups proposing to conduct research projects that will or may involve National Screening Unit (NSU) screening programmes or pathways in New Zealand, in order to clarify the requirements of the NSU in relation to research.
The Ministry of Health identifies the following requirements for the attention of researchers:
- Research which proposes pathways for trial participants that may mean that they are screened, diagnosed, managed or treated outside of NSU policies and standards, must be declared to the NSU prior to commencement of the trial or study. A copy of the study protocol is likely to be required, and this can be shared with the NSU under a signed confidentiality agreement, if so desired by the research team. Where a trial requires participants to be screened, diagnosed, managed or treated outside of NSU policies and standards, the NSU may seek an assessment of potential clinical risk from an independent expert in the field. Details of participant consent including the wording that will be used to inform potential participants about the deviation from NSU policies and standards inherent in the study, will also be required by the NSU.
The motivation and integrity of researchers in New Zealand are not in question. This requirement to notify, aims to limit the possibility that research undertaken in New Zealand could place trial participants at increased clinical risk in a screening programme context.
- Researchers must declare to the NSU prior to the commencement of the study/trial, any proposal to perform additional screening or diagnostic tests under the research protocol which would not otherwise have been performed. There are legislative requirements under some screening programmes for specific tests to be recorded on NSU Registers. For example, the NCSP is governed by Part 4A of the Heath Act 1956 under which the programme and researchers have defined obligations.
When communicating with the NSU regarding a new research project, it would be helpful if researchers could identify if the communication is to:
- notify the NSU about the research.
- ask the NSU for an appraisal of the research protocol or a specific aspect of a study from a screening programme perspective
- ask about managing the interaction with an established screening programme for individuals who will be screened/treated differently because of participation in a trial.