Links and information about the different laws applicable to research.
1. Registration of Clinical Trials
Clinical trials which are initiated in Australia or New Zealand must be registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), prior to recruitment of patients into the trial. Other NHMRC-funded trials which are part of an existing study or which are being conducted overseas must be registered on ANZCTR or an equivalent clinical trials registry such as the US National Institutes of Health ClinicalTrials.gov or the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), prior to the recruitment of patients into the trial.
2. Research Involving Humans
Research involving human participants must be reviewed by a Human Research Ethics Committee (HREC) or an institutional low risk review process in accordance with the National Statement on Ethical Conduct in Human Research 2007 (the National Statement). Consideration must also be given to the Privacy Act 1988.
Human research includes interventional research, non-interventional clinical research, other health research, research involving human biospecimens and research involving information obtained from human beings.
All research involving the administration of drugs, chemical agents or vaccines to humans or devices in humans must be considered by a HREC to assess the appropriateness of their use. If such research is part of an Australian-based clinical trial, then it may need to be notified to or approved by the Therapeutic Goods Administration (TGA), which administers the Clinical Trials Notification (CTN)/Exemption (CTX) schemes. This does not apply to clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval. Further information on the CTN/CTX schemes can be obtained from the TGA website.
In the case of multi-centre clinical trials, the relevant institutions and their HRECs may agree that the primary ethical and scientific assessment be made at one institution/organisation, with notification of the approval to the other institutions/organisations involved. Further information on single ethical review is provided in the National Statement and from jurisdictional health departments.
3. Use of Personal Information in Research Without Consent
The Privacy Act 1988 (Privacy Act) permits the collection, use and disclosure of personal information that would otherwise breach one or more of the Australian Privacy Principles (APPs) for research purposes, if the research is conducted in accordance with the Guidelines approved under Section 95 of the Privacy Act 1988 (s95 guidelines) or the Guidelines approved under Section 95A of the Privacy Act 1988 (s95A guidelines).
The s95 guidelines apply where the proposed research is medical research involving theuse of personal information (including sensitive information) held by a Commonwealth Agency, and it is impractical to seek consent.
The s95A guidelines apply where the proposed research involves the collection, use or disclosure of health information by/or held by an organisation in the private sector, for the purposes of research, the compilation or analysis of statistics relevant to public health or public safety, or the collection of health information for the management, funding or monitoring of a health service; it is impracticable to seek consent; and de-identified information will not achieve the purpose of the research or compilation or analysis of statistics activity.
Research which requires the application of the s95 or 95A guidelines must be approved by an HREC.
4. Research Involving Human Embryos
Research involving certain human embryos requires a licence issued by the Embryo Research Licensing Committee of NHMRC in accordance with the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002.
For further information about the legislation refer to the relevant section on this website or the NHMRC Funding rules on GrantConnect.
5. Research Involving Animals
Research involving the use of animals must comply with relevant state and territory animal welfare legislation and Commonwealth legislation related to biosecurity and compliance with the Convention on International Trade in Endangered Species of Wild Fauna and Flora. Research involving the use of animals must be reviewed and approved by a properly constituted Animal Ethics Committee as being in accordance with the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition 2013.
6. Research Involving Genetically Modified Organisms
Applicants should seek advice from their Institutional Biosafety Committee on the level of authorisation needed for any proposed GMO research. Information on the gene technology regulatory scheme, including the Act and Regulations, is also available from the Office of the Gene Technology Regulator website.
7. Use of Carcinogenic or Highly Toxic Chemicals
Research involving the use of carcinogenic or highly toxic chemicals must adhere to Safe Work Australia’s Code of Practice, Preparation of Safety Data Sheets for Hazardous Chemicals. Further information is available from the Safe Work Australia website.
8. Use of Datasets for Research Purposes
The use of datasets for research purposes must comply with the Minimum Guidelines for Health Registers for Statistical and Research Purposes. Further information is available from the Australian Institute of Health and Welfare website.
9. Therapeutic Goods Act 1989 (Cth)
The Therapeutic Goods Act 1989 prohibits the importation or supply of unapproved therapeutic goods for use in humans unless they are exempted. Item 1 of Schedule 5A of the Therapeutic Goods Regulations 1990 and Item 2.1 of Schedule 4 of the Therapeutic Goods (Medical Devices ) Regulations 2002 allows for the importation of unapproved products under Sections 18, 19, 41HA, 41HB or 41HC of the Act, but they must be stored and not supplied for use in humans until that approval or notification is finalised.
Importation of a product/s for an unapproved use or as part of a clinical trial may be subject to additional restrictions for which additional and separate approvals may be required under legislation governing:
- the Customs (Prohibited Imports) Regulations 1956 (for example, products containing abortifacients, antibiotics, anabolic steroids, growth hormones, narcotics, psychotropic medicines and certain prohibited substances);
- the Biosecurity (Consequential Amendments and Transitional Provisions) Act 2015(for example, materials of biological origin);
- the Environment Protection and Biodiversity Conservation Act 1999 (for example, products originating from endangered species); and
- current arrangements for the prior approval of clinical investigations involving genetically modified materials.
10. Nagoya Protocol on Access and Benefits-sharing
Applicants should be mindful of the Nagoya Protocol to which Australia has been a signatory since 2012. The protocol will establish a legally-binding framework for biotechnology researchers and other scientists to gain access to genetic resources located outside Australia. It also establishes a framework for researchers and developers to share any benefits from the use of genetic resources, or traditional knowledge associated with those resources, with the provider country. More information can be obtained from the Australian Government Department of Environment and Energy website and from the Nagoya Protocol Access and Benefit-sharing Clearing-house (ABSCH).
11. Defence Trade Controls Act 2012 (Cth)
Applicants should be aware of the requirements relating to the supply of controlled technology (‘dual-use’) and the dissemination of intangible technology articulated in the Defence Trade Controls Act 2012, including by way of publication or presentation. More information on the requirements of the legislation can be obtained from the Defence Trade Controls Act 2012, and from the Defence Export Controls (DEC) website.
12. Intellectual Property
Unless otherwise approved by NHMRC, applicants must agree to comply with the National Principles of Intellectual Property Management for Publicly Funded Research.
13. Paid Parental Leave Scheme
Information concerning the Australian Government’s Paid Parental Leave Scheme is available from the Department of Human Services website