Ethics and governance – policies, guidelines and resources

What is the rationale for this policy update?
The new Guideline for Low and Negligible Risk Research Review Processes or Exemption from Ethics Review has been finalized to provide greater consistency amongst NSW Human Research Ethics Committees and other relevant parties in interpreting and clarifying the Low and Negligible Risk concepts contained in the National Statement.

What is the revised guideline about?
The Guideline clarifies the requirements for Low and Negligible Risk research under the National Statement and provides a clear guide for researchers, Human Research Ethics Committees and other ethics review bodies to establish levels of ethics review that are proportional to the degree of risk involved with the research activity.

How has the guideline been updated?
The Guideline aids NSW Human Research Ethics Committees in the process of determining the risk and appropriate level of review of Low and Negligible Risk projects with consistency per the National Statement. It has been prepared in consultation with the National Health and Medical Research Council..

Why is the guideline necessary?
The aim of the Guideline is to provide consistency amongst Human Research Ethics Committees and other relevant parties in interpreting and clarifying the Low and Negligible Risk concepts contained in the National Statement, which enables the processing of research projects according to the same Low and Negligible Risk criteria.

What is the rationale for this policy update?
The current Guideline is out-of-date and due for review. The revised Guideline reflects the recent changes made during the 2018 review of the National Statement.

What is the revised guideline about?
The revised Guideline on Requirements of the Human Tissue Act 1983 in relation to research and use of tissue.

How has the guideline been updated?
The key changes include updated references to the National Statement, updated key definitions, and inclusion of the National Code of Ethical Autopsy Practice and The NSW Health Statewide Biobank Consent Toolkit in the key principles section. A decision tree diagram has also been included.

Why is the guideline necessary?
The guideline has been developed to ensure that research involving human tissue and biospecimens is in accordance with the Human Tissue Act, the National Statement, and any other relevant requirements. It provides clarity and consistency for Human Research Ethics Committees assessing research applications involving human tissue.

Policy Directive on Human and Animal Research and the National Health and Medical Research Council Act (NHMRC) 1992 (PD2010_057) is now obsolete (as of 18 September 2018).

What is the rationale?
Relevant and specific legislative and policy requirements affecting human research are set out in individual NSW Health policy directives. On review of PD2010_057, it was deemed unnecessary to have an additional policy that merely provided a generic reference point for overarching Acts and non-Health policies.

For instance, detailed privacy guidance is provided in the NSW Health Privacy Manual for Health Information. The names of the Commonwealth and State Acts dealing with privacy principles and requirements don't need to be listed in a separate research-specific policy.

With regard to legislation and non-Health policies related to animal research, these are primarily the responsibility of the NSW Department of Primary Industries (DPI) and the National Health and Medical Research Council (NHMRC). All relevant requirements are listed in detail on both the DPI and NHMRC webpages as the governance bodies for those legislation, policies, committees and panels. The obligation to follow the law does not depend on the Act being listed in a separate NSW Health policy mandating that obligation.

Where can I find the relevant documents on Human and Animal Research?
Human Research
Policy documents on Human Research that is applicable to the NSW Health system are issued by the Ministry of Health through the Policy Distribution System and can be found at www.medicalresearch.nsw.gov.au/policies-guidelines/

Animal Research
In Australia, the state and territory governments have regulatory responsibility for animal welfare including the care and use of animals for scientific purposes.

The state and national regulatory framework for animal research can be found at:
New South Wales
NSW Animal Research Act 1985 (accreditation of research establishments, animal suppliers’ license) at www.legislation.nsw.gov.au/view/html/inforce/current/act-1985-123
Animal Research Regulations 2021 under the Animal Research Act 1985 (accreditation and licensing, breeding) at www.legislation.nsw.gov.au/view/html/inforce/current/sl-2021-0477

NSW Department of Primary Industries
The Animal Research Review Panel and NSW Department of Primary Industries - Animal Welfare Unit have developed a website. The Animal Research Review Panel Policy & Guidelines are available at www.animalethics.org.au/home

Other jurisdictional legislation
www.animalethics.org.au/legislation/other-australian-legislation

National
The National Health and Medical Research Council (NHMRC) provides national leadership on the ethical, humane and responsible care and use of animals for scientific purposes through provision of guidance in the Australian code for the care and use of animals for scientific purposes (the Code). The Code is adopted into legislation in all Australian states and territories.

The Australian Code for the Care and Use of Animals for Scientific Purposes (currently in the 8th 2013 edition) (the Code) at www.nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposes and, if the research involves the use of non-human primates, the NHMRC Policy on the Care and Use of Non-Human Primates for Scientific Purposes (the Policy), which governs the use of primates in teaching and research at www.nhmrc.gov.au/about-us/publications/principles-and-guidelines-care-and-use-non-human-primates-scientific-purposes

Have more questions?
If you have any further questions about policy and guidelines, please contact the Research Ethics and Governance Unit (email: MOH-researchethics@health.nsw.gov.au).

Policy Directive on external entity agreements (PD2008_046) is now obsolete (as at 15 February 2021).

Why?
NSW Health reviewed Policy Directive on Human Research Ethics Committees: Ethical Review for External Entities (PD2008_046). Based on the consultations we had with NSW PHOs, we believe that this policy causes an avoidable administrative burden. External entity agreements (EEAs) further causes a hindrance for researchers to expand their research project to external sites (to avoid monetary and paperwork burden).

What is the rationale?
1) No other jurisdiction has a similar mechanism (e.g. a pro forma agreement between an external entity and a state PHO)
2) The agreement was originally designed to cover the risk of being sued for a negligent HREC review
3) To our knowledge, neither any NSW LHD HREC nor any HREC in Australia has been hitherto sued.

What about the legal protection?
As per the chapter 5.1 of the National Statement on Ethical Conduct in Human Research, institutions are responsible of providing an assurance of legal protection to all those involved in ethical review of research, for liabilities that may arise in the course of bona fide conduct of their duties in this capacity. For NSW Health purposes, TMF extends this coverage to HREC members.

What if the external entity wants to enter into an agreement?
EEAs are not designed to offer any protection for the external entities. However, if an external entity wants to have EEA in place, it is at the discretion of the LHD to enter into an agreement. However, as of 15th February 2021 the EEA PD is obsolete thus LHDs are no longer required to enter into an agreement with external entities.

Have more questions?
If you have any further questions about policy and guidelines, please direct your inquiries to Yagiz Aksoy from Research Ethics and Governance Unit (email: MOH-researchethics@health.nsw.gov.au) .

The Policy Directive (PD2011_028), addressing Clinical Trial Research Agreements in NSW Public Health Organisations, was due for a review. Following a comprehensive review by the Research Ethics and Governance Unit. Following their assessment as part of the policy cycle, PD2011_028 has been rescinded. In its stead, a new policy directive, PD2023-017 (Research Agreements in NSW Health Organisations), has been developed and is now available https://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=PD2023_017 . The updated Policy Directive (PD2023-017) incorporates the latest research agreements, revised clauses and updated terms.