Who actually approves Research in Aotearoa? Understanding the Ethics Ecosystem

Research ethics in Aotearoa New Zealand is often described as complex, and for many researchers, that feels like an understatement. With the introduction of The Collective as New Zealand’s first private ethics committee, we can appreciate we may have added to this confusion.

In New Zealand, there is no single “ethics committee” that covers all research. Instead, the system is made up of multiple organisations, each with a distinct role. Understanding how these pieces fit together is essential; not just for compliance, but for conducting ethically sound research.

The following gives an overview of how we see the ecosystem.

The system at a glance

At a high level, the research ethics ecosystem can be understood in three layers:

1. Policy and system leadership 

2. Ethical guidance and standards 

3. Ethics review and approval bodies 

Though difficult to put into a simple diagram, we have done our best:

1. Who sets the direction?

System leadership currently sits with organisations such as the Ministry of Health, Health New Zealand and the Health Research Council of New Zealand (HRC).

This is changing with the disestablishment of the HRC by 2028, and it has been signalled that the Ministry of Health will lead the charge in the development of a new National Standard on Human Research. Where the HRC currently has its own legislated Ethics Committee, this committees responsibilities will be moved out to the Ministry of Health.

It is signalled that responsibility will now be managed by their National Ethics Advisory Committee – Kāhui Matatika o te Motu (NEAC), which is an independent advisor to the Minister of Health on ethical issues related to health and disability research and services.

However, I am getting ahead of myself. Focussing on the current system, we see the Ministry and HRC as bodies that:

• Shape national research and health policy

• Set expectations for funded health-research

• Influence how ethics review operates across the system

These bodies do not typically review individual studies, but they define the environment in which those reviews occur, and how they should occur.

It is important to acknowledge that the direction is set from a ‘health’ lens, given that health agencies are the ones who are leading and setting the direction. This has its own implications, but is not the focus of this blog post.

2. Who defines the research ethics review process?

Ethical standards are primarily developed by NEAC, as an advisory committee to the Minister of Health. Other groups, such as the Advisory Committee on Assisted Reproductive Technology (MOH) and the National Artificial Intelligence and Algorithm Expert Advisory Group (Health NZ), provide guidance in more specialised areas.

The NEAC Standards are our human research ethics ‘source of truth’. Though not legislated, they are functionally mandatory for health researchers in New Zealand.

How Ethics Committees should operate is set by a different agent – the HRC Ethics Committee. Though originally set up to manage the ethical obligations for committees who were reviewing research funded by the HRC, the role has devolved somewhat to become a pathway of ‘oversight’ for ethics committee around the motu.

The HRC EC set the guidelines for how committees who wish to be approved by the HRC should function, and have become a default accreditation board. They are seen as a ‘gold-standard’ for committees who review in Aotearoa, with our very own Collective committees currently going through a review process for this approval.

Therefore, these two bodies (HRC EC and NEAC):

• Develop national ethical standards

• Provide guidance on emerging issues

• Inform how committees should act and make decisions

NEAC does not have a pathway for applicants to submit through for ethics review. However, the HRC EC does. It is unknown if this pathway has ever been used by a research team.

The role of individual Institutions

The process does not stop here. Each individual organisation, institution, board or company who manages/operates an ethics review process can develop their own guidelines on how they run the review process, where they still align with the NEAC standards and HRC EC guidelines.

Therefore, this may explain why we see slight variation from institution to institution as to how the process might vary. The NEAC Standards nor HRC EC Guidelines are not as prescriptive as other international standards in this space are.  

3. Who actually approves research?

Ethics approval sits with review bodies such as:

• Health and Disability Ethics Committees (manged by the Ministry of Health)

• Institutional Ethics Committees or IECs (e.g., Universities)

• Independent or non-HRC approved committees (e.g., IHREC or Aotearoa Research Ethics Committee)

Choosing the right pathway for your application requires careful review of the scope of your project. The following diagram can help you understand this a bit better:

Top tip: Applications in scope for HDEC should always be reviewed by the HDEC. Applications which have an researcher listed on them who is affiliated with an institution with an ethics committee must always submit through their institutional pathway.

A common point of confusion: Approvals vs Ethics

So you’ve decided you need a certain committee to review you. Going forward, you may wish to think about other approvals that may be required alongside ethics review.

For example, Health New Zealand locality approvals are often required to access sites, use patient data or conduct research within services.

Likewise, if you are undertaking a clinical trial, additional scientific and regulatory approvals may be required (through Medsafe's SCOTT or GTAC).

However, these are not ethics approvals. They sit alongside ethics review; not in place of it.

Usually, obtaining locality approvals can be done in tandem with your ethics application. However, we suggest you check with your institution, ethics committee or us (info@ihrec.co.nz) if you are unsure.

Why the system feels complex

The system is not designed to be simple, it is designed to be fit for purpose.

Different types of research carry different risks. A single, centralised process may struggle to accommodate this diversity, though we do see examples of this overseas. Instead, Aotearoa has developed a distributed model, where responsibility is shared across multiple bodies.

The challenge then becomes ensuring these systems work coherently with each other, particularly as we evolve and new players emerge (pot calling kettle). With the incoming changes signalled to the system, we hope this can be achieved and any conflicts created are managed.  

Final thoughts

Each part of the system exists for a reason. The challenge is not just navigating it, but understanding it well enough to make informed decisions about where your research fits, and why we do the things we do.