National Statement on Ethical Conduct in Research Involving Humans
The Australian ethical standard for human research. The medical device regulations require clinical investigations done in Australia to follow it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| Australia | Referenced | - | - | Mandatory for clinical investigation data collected in Australia, as part of the clinical evaluation procedures. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 14155, E6(R3), E8(R1), E9(R1), Declaration of Helsinki. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.