FAQs – National Statement on Ethical Conduct in Human Research, 2018
The NHMRC has released an update to the National Statement on Ethical Conduct in Human Research, 2007 (Updated 2018). The changes take effect from 1 January 2019. Our Ethics Committees and researchers need to ensure that the current version is being used in developing research proposals, making submissions for ethics review and undertaking ethics review.
The updated version includes a fully revised Section 3. As a consequence of revisions to Section 3, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, and the Glossary and Index.
Will these changes affect me as a researcher, or are they just administrative?
If you conduct human research, these changes apply to you, regardless of the type of research you do.
What’s new and how does it apply to my research?
Section 3 now contains the following chapters:
- Chapter 3.1: The Elements of Research
- Chapter 3.2: Human Biospecimens in Laboratory Based Research
- Chapter 3.3: Genomic Research
- Chapter 3.4: Animal-to-Human Xenotransplantation
Guidance in Chapter 3.1 is broadly applicable to all fields of research. When designing a research project, you should read all of Chapter 3.1, noting which parts of the guidance are relevant for your project.
Chapter 3.1 is designed around seven elements that are common to most – if not all – forms of research. The chapter starts with considering the ethical issues associated with developing the research scope, aims, themes, questions and methods, and ends with ethical considerations that pertain after the project comes to an end.
If your research involves biospecimens, genomics or xenotransplantation, you should also consult the specific chapters on these topics.
What do I need to do if I have an application with current ethical approval?
Nothing at this stage.
If in the future you submit an amendment, the changes to your approved project will need to be in accordance with the 2018 version of the National Statement. (Keep reading below for an overview of the major changes.)
What do I need to do if I have an application currently under review by one of the Human Research Ethics Committees (HRECs)?
Nothing at this stage.
In some circumstances, the HREC reviewing your research may need to ask you for additional information to ensure that your proposal complies with the 2018 version of the National Statement. If this happens, the HREC will let you know.
What do I need to do if I am working on an application to be submitted in 2019?
Do two things:
- Ensure that you understand and apply the 2018 version of the National Statement to your research proposal. (Keep reading below for an overview of the changes)
- Complete a protocol or project description to accompany your application. If you have applied to the Health and Medical HREC before, this may not represent a change in process to you. Please ensure that you download the latest version of the protocol/project description template from our website. If you have an existing protocol (such as for a multicenter clinical trial), you do not need to complete our template, however please ensure that your protocol meets the requirements of the National Statement.
An important feature of your protocol/project description is that it should now include a data management plan. The requirements for a data management plan are specified in paragraph 3.1.45 of the National Statement.
Will the NHMRC update the Human Research Ethics Application (HREA) to reflect the revised National Statement?
Yes, the NHMRC has indicated that they will update the HREA, including the Project Description template, to meet the requirements of the revised National Statement.
My research involves consenting participants, what do I need to know?
Within Chapter 3.1: the Elements of Research, Element 3: Consent addresses the development of a well-designed consent strategy. It also includes specific requirements for information that should be provided to participants, including through an information and consent document.
If you will be using an information and consent document, please ensure that you download the latest version of the information sheet and consent form template and guidance notes from our website. If you have an existing information and consent document (such as for a multicenter study), you do not need to complete our template, however please ensure that your document meets the requirements of the National Statement.
My research involves secondary use of data or information (such as data available on the internet), what do I need to know?
Within Chapter 3.1: the Elements of Research, Element 4: Collection, Use and Management of Data and Information addresses ethical issues related to generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of data or information.
It includes a section titled ‘Secondary use of data or information’, which includes specific requirements for research that involves access to and use of data or information that was originally generated or collected for previous research or for non‑research purposes (including routinely collected data or information). This includes the use of information about individuals that is available on the internet, such as social media posts.
My research involves biospecimens, what do I need to know?
Chapter 3.2: Human Biospecimens in Laboratory Based Research addresses research involving any biological material obtained from a person (including tissue, blood, urine, sputum, and any derivative of these, such as cell lines).
The NHMRC has advised that Chapter 3.2 (formerly Chapter 3.4) was not revised; however, the Australian Health Ethics Committee (AHEC) approved minor amendments to this chapter to align it with the new structure in Section 3.
Paragraph 3.2.1 advises that for human biospecimens collected for research purposes (including biobanks), there should be ethics review and approval by an HREC of the proposed consent, collection, processing, storage and distribution or disposal. This means that you will need to submit a full application for review by the Health and Medical HREC for this type of research.
My research involves genomics, what do I need to know?
Chapter 3.3: Genomic Research is about research involving genomic data or information that has hereditary implications and/or is predictive of future health in research involving participants, relatives and other family members.
This Chapter includes a decision tree for the management of findings in genomic research and health care, and guidance for the development of an ethically defensible plan for the potential return of findings and individual results from genomic research.
My research involves a clinical trial, what do I need to know?
Paragraph 5.1.6 of the National Statement describes the types of research that require review by a HREC, i.e. a full application rather than a low risk application. This no longer includes interventions and therapies, including clinical and non-clinical trials, and innovations. This means that the type of application you will be required to complete will depend on the risk level of the research, as for many other types of research.
If the University of Tasmania will play a role in your clinical trial, please review the Clinical Trial Governance page for further information on Clinical Trial Authorisation.
What changes has the Research Integrity and Ethics Unit made to implement the revised National Statement?
- Updated our protocol/project description template
- Made a protocol/project description a required document for all new applications
- Updated our template information sheet and consent form and accompanying guidance notes
- Refreshed the wording used in our conditions of approval and approval letters
- Added information to the Health and Medical HREC report form for clinical trials