Section 3: Ethical considerations in the design, development, review and conduct of research. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Section 3

The aim of this section is to provide guidance on the ethical considerations that are relevant to the way that research is designed, reviewed and conducted. This material should be read in conjunction with the Preamble (Purpose, scope and limits, p.6) and Section 2 (Themes in research ethics: risk and benefit, consent, pp 12‑22). This section aims to be compatible with and relevant for many different ways of doing human research. It requires those who conduct and approve human research to consider:

• how the research question/theme is identified or developed
• the alignment between the research aims and methods
• how the researchers and the participants will engage with one another
• how the research data or information are to be collected, stored, and used
• how the results or outcomes will be communicated, and
• what will happen to the data and information after the project is completed.

The guidance in this section identifies common ethical issues that arise in the various phases of research. It is up to each researcher and HREC to apply the guidance to each project, taking account of the four principles of research merit and integrity, justice, beneficence and respect. This guidance facilitates consideration of the risks and benefits of the research and the level of ethical oversight required.

The guidance in Chapter 3.1 is broadly applicable to all fields of research, including those types of research for which additional specific guidance is provided in Chapters 3.2, 3.3 and 3.4.

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.

The elements are:

• Element 1 – Research Scope, Aims, Themes, Questions and Methods
• Element 2 – Recruitment
• Element 3 – Consent
• Element 4 – Collection, Use and Management of Data and Information
• Element 5 – Communication of Research Findings or Results to Participants
• Element 6 – Dissemination of Research Outputs and Outcomes
• Element 7 – After the Project

Researchers who are designing a research project should read all of Chapter 3.1, noting which parts of the guidance are relevant for their project. In addition, if research involves biospecimens, genomics or xenotransplantation, they should also consult the specific chapters on these topics.

Each subsequent chapter in this section provides guidance on additional ethical considerations that may apply to:

• the use of human biospecimens in laboratory based research (Chapter 3.2)
• genomic research (Chapter 3.3)
• xenotransplantation research (Chapter 3.4).

This guidance applies to research, but sometimes the distinction between research and innovative clinical practice is unclear. For example, innovative clinical practice occurs on a spectrum from minor changes at the border of established practice that pose little change in risk to patient safety to novel interventions that should only be introduced as part of an ethically approved research protocol.

Whether an innovative clinical practice should be undertaken only as clinical research may depend on the extent to which the procedure departs from established practice. Importantly, even if the introduction of an innovative practice falls within existing clinical guidance, its implementation and the associated collection of data for monitoring and reporting may require notification to the institution/s where the practice is taking place.

When it is not clear whether an innovation should be implemented only as research, it may be necessary to seek advice from a Human Research Ethics Committee or other institutional review process on the review required for the new intervention.

Researchers planning to do any type of research involving Aboriginal and Torres Strait Islander peoples must consult and follow the advice in the most contemporary versions of Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders and Keeping research on track II as well as the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies. These guidelines embody the best standards of ethical research and human rights and seek to ensure that research with and about Aboriginal and Torres Strait Islander peoples follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

Researchers should also consult the most contemporary version of NHMRC's Statement on Consumer and Community Participation in Health and Medical Research.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.