When do you need to get ethical approval for your research?

I am surprised to have to write on this topic; however, there appears to still be some confusion among a few authors who wish to submit their manuscript to the New Zealand Medical Journal (NZMJ) about whether ethics approval was required for their study. The answer, if you wish to publish in the NZMJ, is that it usually is required, and this should be arranged before the study has been undertaken.

The recommendations of the International Committee of Medical Journal Editors (ICMJE) states, “All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors should seek approval to conduct research from an independent local, regional or national review body (e.g., ethics committee, institutional review board), and be prepared to provide documentation when requested by editors.”¹

The main point of confusion among those submitting to the NZMJ seems to be research undertaken with quality assurance data. Collection of quality assurance data for quality assurance projects are exempt from the need to obtain ethics approval in New Zealand;² however, the secondary use of this data for research does need ethics approval to be published.

Quality assurance projects are undertaken primarily for the purpose of evaluating current or slightly new practices, and the primary aim is to inform current care in a localised scope, rather than generate generalisable information. These data are meant for those involved in the patient care pathway, not those outside of it. Full discussion about this can be obtained here: https://neac.health.govt.nz/national-ethical-standards/part-two/18-quality-improvement

However, when data are acquired for quality assurances projects and are then subsequently used for research and published in the NZMJ, then ethics approval is required. When quality assurance data are published as research in a journal, they are available to those outside of the patient care pathway, and in the case of the NZMJ the data are then available to the public as we have an open access policy. As such, we require ethical approval to be obtained.

If you wish to use quality assurance data in research and publish it in the NZMJ, please obtain ethical approval before you undertake your research.