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title: "Ethics guidance documents"
canonical: "https://research.refined.site/space/Research/124616708/Ethics%20guidance%20documents"
format: markdown
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### [ICH-GCP E6 (R3)](https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf)

An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

See also [Good Clinical Practice](https://research.refined.site/space/Research/112492591/Good+clinical+practice)

### [NEAC standards](https://neac.health.govt.nz/assets/Uploads/NEAC/publications/national-ethical-standards-health-disability-research-quality-improvement-2019-v3.pdf)

Set out the ethical requirements that:

▪️ researchers must meet or exceed when undertaking health and disability research and

▪️ health service providers and disability service providers must meet or exceed when conducting quality improvement activities.

The Standards apply whether or not research or quality improvement activities require review by an ethics committee.

### [Health and Disability Ethics Committee (HDEC) standard operating procedures (SOP)](https://ethics.health.govt.nz/operating-procedures/)

The purpose of these standard operating procedures (SOPs) is to support health and disability ethics committees (HDECs) to operate in a way that is:

▪️ *robust*, so that the public can be confident that health and disability research conducted in New Zealand meets or exceeds established ethical standards

▪️ *efficient*, so that ethical health and disability research is facilitated, and so that HDEC resources are used in a way that maximises protection for participants within the resources available

▪️ *transparent*, so that applicants and HDECs can engage with each other with confidence, and so that the HDEC review process can be easily understood by consumers and third parties

▪️ *consistent*, so that applicants can expect to be treated similarly by different HDECs and at different times. 

### [Auckland Health Research Ethics Committee (AHREC) ](http://www.auckland.ac.nz/en/research/about-our-research/human-ethics/ahrec.html) 

University of Auckland information about applying for human ethics approval and links to the Human Ethics InfoHub.  The site also has Information about submitting an application to AHREC, UAHPEC and HDEC.


> ℹ️ See also [Ethics standards and Independent Ethics Committees](https://research.refined.site/space/Research/48332977/Ethics+standards+and+independent+ethics+committees)

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###### Last reviewed May 2026   
Author: Kathryn Tennant