The global codes of conduct and ethics principles for research involving human participants are implemented differently in different countries. This is due, in part, to the fact that governments fund and regulate research through different offices and programs. Countries also have different concerns and priorities. For example, different social and cultural norms and religious customs could translate into different ways of protecting privacy and ensuring informed consent.

Given the different ways in which codes of conduct and ethics principles for human research are presented in different countries, it is important for you to be familiar with:

  • Australian guidelines
  • Your institutional policies
  • The policies, codes or guidelines of other countries in which you conduct research.

National guidelines for protecting human research participants in Australia

The Code requires that research participants be respected (P5); that 'the ethics principles of research merit and integrity, justice, beneficence and respect are applied to human research' (R18); and that Aboriginal and Torres Strait Islander peoples are engaged in research that affects them, with their legal rights, local laws, customs and protocols being respected (P6, R19) (NHMRC, ARC & UA, 2018, p. 4). In line with the principles and responsibilities of the Code, multiple Australian publications cover the requirements and expectations that apply to research with human participants.

Select each question for an overview of the main sources of guidance available in Australia on research involving human participants. Refer to the 'Useful links' pod for links to the guidelines and websites referenced in the text.

Continue on for an overview of the main sources of guidance available in Australia on research involving human participants. Refer to the 'Useful links' pod for links to the guidelines and websites referenced in the text.

 What is the primary standard required for research involving human participants in Australia?

The National Statement on Ethical Conduct in Human Research was developed jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). The National Statement 'sets national standards for use by any individual, institution or organisation conducting human research. This includes human research undertaken by governments, industry, private individuals, organisations, or networks of organisations' (NHMRC, ARC & UA, 2023, p. 6).

 What research does the National Statement on Ethical Conduct in
Human Research apply to?

The National Statement defines 'human research' as research conducted with or about people or their data or tissue. This includes 'the involvement of human beings through:

  • taking part in surveys, interviews or focus groups;
  • undergoing psychological, physiological or medical testing or treatment;
  • being observed by researchers;
  • researchers having access to their personal documents or other materials;
  • the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database' (NHMRC, ARC & UA, 2023, p. 7).
 What are the requirements for the ethical conduct of Aboriginal
and Torres Strait Islander research?

The primary source of guidance is the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Code of Ethics for Aboriginal and Torres Strait Islander Research. This research ethics framework encompasses four principles:

  1. Indigenous self-determination
  2. Indigenous leadership
  3. Impact and value
  4. Sustainability and accountability (AIATSIS, 2020a, p. 3).

The AIATSIS code is supported by A Guide to Applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research.

For human research involving Aboriginal and Torres Strait Islander peoples, the standards in the National Statement on Ethical Conduct in Human Research must be applied. Guidance on applying those standards can be found in the AIATSIS code and guide, as well as in Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (NHMRC, 2018a). This document defines six core principles – spirit and integrity, cultural continuity, equity, reciprocity, respect, and responsibility – that aim to 'ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islander people and communities and of benefit to research' (p. 2).

Another document, Keeping Research on Track II (NHMRC, 2018b), provides advice on how the values and principles of the NHMRC guidelines can be put into practice. The NHMRC Guidelines Framework illustrates how the Code, the National Statement and various guides inform ethical Aboriginal and Torres Strait Islander research (see the 'Useful links' pod).

 What guidelines should be used if I am conducting research relating to assisted reproductive technologies and human embryos in Australia?

The Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (NHMRC, 2023) provide an overarching framework to be referred to by researchers investigating reproductive technologies. The guidelines should be read in conjunction with relevant Australian federal and state or territory legislation. They address research involving:

  • Individuals or couples involved in assisted reproductive technology (ART) activities, including donors of human gametes or embryos involved in embryo research
  • Embryos that are intended for implantation
  • Excess ART embryos
  • Other human embryos (NHMRC, 2023, p. 12).
 What other policies and guidelines are available to researchers
conducting research involving humans in Australia?

The NHMRC website is the authoritative source for the most up-to-date information, guidelines and best practices related to the conduct of research with humans in Australia. If you are involved in conducting clinical trials, or plan to be in the future, you should also be familiar with the specific guidance available for best practices and training.

Various professional organisations also have their own guidelines – for example, the Australian Association for Research in Education released the Code of Ethics for Research in Education.

 Useful links Useful links

NHMRC, ARC & UA (2023) National Statement on Ethical Conduct in Human Research

NHMRC (2018) Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders

NHMRC (2018) Keeping Research on Track II

NHMRC (n.d.) Guidelines Framework

AIATSIS (2020) Code of Ethics for Aboriginal and Torres Strait Islander Research

NHMRC (2017, updated 2023) Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research

NHMRC (n.d.) Research Policy

NHMRC (n.d.) Clinical Trial Reform

Australian Clinical Trials

As well as understanding the relevant national guidelines, you should also ensure you familiarise yourself with your institution's policies and guidelines and apply these to your research. Your institutional ethics or research office is the first place you should turn to for training and advice about the conduct of research involving humans.

 Your context Your context

Make sure to familiarise yourself with your institution's policies and guidelines so you can feel confident about how they apply to your research.

Summary

The importance of the responsible conduct of research involving human participants is globally recognised and defined. For both your own protection and the protection of your research participants, you must follow all the relevant national and local policies, as well as the policies of any other countries in which you conduct your research. Failure to do so may represent a breach, or even a serious breach, of the principles (P5, P6) and responsibilities (R18, R19) of the Code.