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Research studies and clinical trials must follow CCDHB, New Zealand, and global ethical and technical guidelines. We can help you ensure your research adheres to these regulations.

Research Advisory Group – Māori (RAG-M)

Māori review of research is a legislative and ethical requirement for research conducted in Aotearoa/New Zealand.

The Research Advisory Group – Māori (RAG-M) review all research in the Greater Wellington Region. RAG-M is a subcommittee of the Māori Partnership Board (MPB).   Through this group we are able to engage with representatives of the local iwi to consider research proposals from a Māori perspective.

Health and Disability Ethics Committees (HDECs)

Health and Disability Ethics Committees (HDECs) are Ministerial committees whose function is to secure the benefits of health and disability research by checking that it meets or exceeds established ethical standards. In doing so, the HDECs must act in accordance with the procedural rules contained in the Standard Operating Procedures for Health and Disability Ethics Committees.

ICH - GCP Training

The International Council of Harmonisation (ICH) Good Clinical Practice (GCP) is the international ethical and quality standard describing the responsibilities and expectations for the conduct of research involving human participants, including the design, execution, recording and reporting of clinical trials.

The standard is consistent with principles that have their origin in the World Medical Association’s Declaration of Helsinki and, compliance provides assurance of the protection of the rights of research participants, the integrity of study data and the conclusiveness of study results.

ICH-GCP European Medicines guideline document for good medical practice (external link)

Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand Part 11:

 

Last updated 25 November 2019.