Important reminder: Muscle biopsies may only be performed by a health practitioner
Performing a muscle biopsy is considered to be a ‘Restricted Procedure’ under the Health Practitioners Competence Assurance Act 2003 and the Health Practitioners Competence Assurance (Restricted Activities) Order 2005.
This means that muscle biopsies can only be performed by health practitioner who is registered with the appropriate authority under the Health Practitioners Competence Assurance Act 2003, and is permitted by his or her scope of practice to perform a muscle biopsy.
The Ministry will update its guidance on restricted procedures and its guidance for ethics committees, to clarify that muscle biopsies are a ‘restricted activity.’ (See Ministry of Health website: Restricted activities under the Act).
A breach of this provision is punishable by a fine of up to $30,000 (see section 9 of the Health Practitioners Competence Assurance Act 2003).
Template for participant information sheet and consent form update – February 2019
The HDEC template participant information sheet has been updated to correct the independent health and disability advocate email address.
Please view the Participant Information Sheet and Consent Form Template (Word, 113 KB) to ensure you are using the most up-to-date wording in your study documents.
Guideline on the Regulation of Therapeutic Products – latest edition, November 2018
- Guideline on the Regulation of Therapeutic Products in New Zealand Part 11: Clinical trials – regulatory approval and good clinical practice requirement (pdf, 273 K - Medsafe.govt.nz)
How do I apply for HDEC review?
All applications to HDECs must be submitted through the Online Forms website. This site allows you to answer questions in the HDEC application form, upload documents, request electronic signatures from other parties involved in your research, and track the progress of your application. For more information, check the section HDEC review and approvals: