Ethical issues and resources

Assisted Reproductive Technology (ART)

Assisted reproductive technology (ART) is the application of laboratory or clinical technology to gametes (human egg or sperm) and/or embryos for the purposes of reproduction. All reproductive medicine units offering ART services should comply with the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2017) (ART guidelines).

• More information about ART and the ART guidelines

Clinical Ethics

AHEC has developed a Consensus Statement on Clinical Ethics and a resource manual for use by healthcare organisations considering developing a clinical ethics service.

• AHEC Consensus Statement on Clinical Ethics
• Clinical Ethics Capacity Building Resource Manual

COVID-19 Pandemic – Ethics Framework

Decision-making for pandemics: an ethics framework was developed by the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC).  It is designed to support ethical health and medical related decision making and ethical policy development during a pandemic.

For more information or to access the Framework, please visit https://www.nhmrc.gov.au/research-policy/COVID-19-impacts.

• Decision-making for pandemics: an ethics framework 

Ethical guidelines for research involving Aboriginal and Torres Strait Islander Peoples

Information on Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders and Keeping research on track II.

• Ethical guidelines for research involving Aboriginal and Torres Strait Islander Peoples

Our role in the health privacy framework

The primary focus of the NHMRC with respect to privacy is in relation to research, balancing the need for the protection of personal privacy in data, and the need to facilitate access to data for research purposes.

• More information on health research privacy framework

Organ and tissue donation and transplantation

Through the work of AHEC, NHMRC has issued the following ethical guidelines on organ and tissue donation and transplantation:

• Organ and tissue donation after death, for transplantation – Guidelines for ethical practice for health professionals, 2007 (Under review)
• Making a decision about organ and tissue donation after death, 2007 (Under review)
• Organ and tissue donation by living donors – Guidelines for ethical practice for health professionals, 2007 (Under review)
• Making a decision about living organ and tissue donation, 2007 (Under review)
• Ethical guidelines for organ transplantation from deceased donors, 2016.

In 2017, NHMRC commenced a review of the organ and tissue donation and transplantation guidelines for currency, relevance and consolidation:

• More information on organ and tissue donation and transplantation and the progress of the review

Payment of participants in research

NHMRC has developed advice that is designed to provide information for researchers and reviewers of research to assist in decision-making about when payment of participants in research is ethically acceptable.

This advice does not replace or override guidance provided in the National Statement and provides additional information to assist those designing and reviewing human research.

• Payment of participants in research: information for researchers, HRECs and other ethics review bodies

Peer review and ethical review

NHMRC has provided clarification of the relationship between peer review conducted by NHMRC and ethical review conducted by an institutional ethics committee, and the expectations of NHMRC with respect to NHMRC funded research.

• Relationship between NHMRC peer review and ethical review by institutional ethics committees (PDF 420 KB)

Embryo research, stem cells and human cloning

In 2002 the Australian Parliament passed two Acts to legislate on issues around human cloning and research involving human embryos.

• Information about embryo research and the prohibition of human cloning for reproduction
• Information about the Embryo Research Licensing Committee

Quality assurance and evaluation activities

Quality assurance (QA) and evaluation are important to ensure effective work and the best outcomes. However, confusion arises over if an activity is research, evaluation or QA as each may use similar research methods.

NHMRC has developed advice to assist organisations in developing QA policy and appropriate oversight.
•    Ethical considerations in quality assurance and evaluation activities 

Additional resources

Standardised participant information and consent forms (PICFs)

In 2012, NHMRC, in collaboration with the Australian States and Territories, developed templates to serve as a starting point for the development of written PICFs for research conducted in Australia. Information can be added and removed from the templates as required.

Genetic study

• PICF Genetic for Self (DOC 203 KB)
• PICF Genetic for Parent and Guardian (DOC 221 KB)
• PICF Genetic for Person Responsible (DOC 221 KB)

Interventional study

• PICF Interventional for Self (DOC 226 KB)
• PICF Interventional for Parent and Guardian (DOCX 94 KB)
• PICF Interventional for Person Responsible (DOCX 93 KB)

Non-Interventional study

• PICF Non-Interventional for Self (DOC 191 KB)
• PICF Non- Interventional for Parent and Guardian (DOCX 208 KB)
• PICF Non-Interventional for Person Responsible (DOC 253 KB)

Health/Social Science Research

• PICF Health and Social Science for Self (DOC 148 KB)
• PICF Health and Social Science for Parent and Guardian (DOC 164 KB)
• PICF Health and Social Science for Person Responsible (DOC 209 KB)

Consent and Guardianship Laws in Australia

NHMRC has developed resources for institutions, HRECs and researchers to help clarify the major legal and regulatory requirements that apply to human research in Australia, including the publication Consent and Guardianship Laws in Australia.