Ethics and governance contacts

There are several certifications and/or recognition schemes that a NSW HREC may fall under. The acceptance into one does not automatically assume acceptance to another.

NHMRC registered:

• A registration of HRECs administered by NHMRC.
• For an HREC to be registered with NHMRC, the institution(s) that established the HREC notifies NHMRC of the HREC’s existence and provides a signed declaration that the HREC will comply with the National Statement on Ethical Conduct in Human Research and any revisions made to it.
• All HRECs are registered. Not all HRECs are certified.

NHMRC certified:

• A scheme managed by NHMRC.
• Certified institutions (that is, institutions and their HRECs) whose ethics review processes have been evaluated and certified by NHMRC against a specific criteria “can” have their ethics review accepted by other institutions participating in the research project.
• Accepting the ethics review and approval of a certified HREC is at the discretion of the participating institution.
• NHMRC certification is not an automatic entry into NMA.

NMA reviewing HREC:

• A partnership arrangement between each state and territory Department of Health since 2011.
• NHMRC certification is a requirement of being a NMA reviewing HREC.
• Each state and territory nominates and advertises which of their certified HRECs are NMA reviewing committees.

NMA receiving site:

• There is no official definition, certification or recognition of a “NMA receiving site”.
• In NSW all public health organisations will accept the ethics review and approval conducted by a NMA reviewing HREC in which their site has been listed.
• The only exception is where the project is specifically excluded from NMA because of state/territory exclusions.

The EPCT Framework covers all early phase trials involving products which are defined as therapeutic goods in the National Health Act including medicines, medical devices of all classes, blood and blood products. Emerging technologies, such as cell therapies are included.

The following instances are out of scope:

• Individual patient use (Compassionate use of medicine). Using therapeutic agents in these circumstances is governed by Clinical Governance within the hospital and Local Health District (LHD) most commonly this will be a Drugs and Therapeutic Committee within the hospital or LHD.
• Trials where the intervention is not a therapeutic goods as defined in the National Health Act (e.g. surgery, allied health physical therapies).

Two HRECs are currently approved to review under the EPCT framework: Sydney Children’s Hospitals Network (SCHN) and Bellberry Limited. While NSW public health organisations require EPCT studies to be reviewed by either Bellberry or SCHN, they are not currently able to accept Bellberry HREC approval for projects outside the EPCT framework, including later-phase clinical trials.