The Department process for applying for ethics approval is outlined in the flowchart below:
Essential elements of ethical review
Checklist for Committee Members
- Does the study team have the qualifications and expertise required to complete the study?
- Does the study team have adequate resources to complete the study?
- Does anyone on the study team have a conflict of interest?
- Has adequate scientific review been completed?
- Will the study be conducted outside New Zealand, and if yes, has local review approval been submitted?
- Will any vulnerable populations (children, prisoners, pregnant women, cognitively impaired, educationally or economically deprived, etc) be included in the study? If yes, what additional protections have been put in place to protect them?
- Is participant selection equitable, i.e., the research does not exclude unnecessarily groups who might benefit from the study (for example, Māori), and does not unnecessarily burden one group over others?
- Are protections in place to protect participants against coercion or undue influence in the recruitment and informed consent processes?
- Are recruitment materials (Advertisements, Information Sheets etc) appropriate?
- Is payment to the participants appropriate?
- Are the risks to participants well explained and minimised to the extent possible?
- Are potential benefits, both direct personal benefits and societal benefits, clear?
- Are the risks reasonable when balanced against the potential benefits of the study?
- If the study involves more than minimal risk, is the safety monitoring plan provided adequate? Is it clear who will monitor the reports of adverse events and consider stopping rules, if appropriate?
- Are all risks to personal privacy described and minimised?
- Is the data protection plan adequate to minimise the chance of a breach of confidentiality?
- What is the plan for reporting of unanticipated adverse events or other problems to the ethics committee, to ensure that the risks of the study do not need to be reconsidered?
- Will consent be obtained from some or all of the study participants? If yes, will the consent be written (signed), or obtained orally? If no, is a waiver of informed consent appropriate?
- From whom will consent be obtained? If the study involves a child or vulnerable adult, how will the study team assure that the appropriate person is providing consent?
- Does the consent form include all the required elements of informed consent?