Screening programmes: Information for researchers planning studies and clinical trials
Information for researchers planning studies and clinical trials in New Zealand that involve Health New Zealand | Te Whatu Ora National Public Health Service (NPHS) Prevention Directorate 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 Health NZ NPHS Prevention Directorate screening programmes or pathways in New Zealand, in order to clarify the requirements in relation to research.
Health NZ identifies the following requirements for the attention of researchers:
1. Research which proposes pathways for trial participants that may mean that they are screened, diagnosed, managed or treated outside of NPHS policies and standards, must be declared to the NPHS 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 NPHS 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 NPHS policies and standards, the NPHS 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 NPHS policies and standards inherent in the study, will also be required by the NPHS. 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.
2. Researchers must declare to the NPHS 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 screening registers. For example, the National Cervical Screening Programme is governed by Part 4A of the Heath Act 1956 under which the programme and researchers have defined obligations.
When communicating with the NPHS regarding a new research project, it would be helpful if researchers could identify if the communication is to:
1. notify the NPHS about the research.
2. ask the NPHS for an appraisal of the research protocol or a specific aspect of a study from a screening programme perspective
3. ask about managing the interaction with an established screening programme for individuals who will be screened/treated differently because of participation in a trial.