Consent and research ethics in gene therapy research

Who sits on an ethics committee

The NHMRC registers HRECs, and about 200 across Australia are registered with it. The Therapeutic Goods Act 1989 requires an HREC to review and monitor every clinical trial of unregistered therapeutic goods, so committees that do that work must be notified to the NHMRC and run in line with the National Statement.

Under the 2025 National Statement, an HREC has at least eight members, and every meeting needs each of these categories filled:

1. A chair with suitable experience, including earlier HREC membership.
2. Two community or consumer members with no paid connection to the institution.
3. A person who cares for or treats people for example a nurse, counsellor or allied health professional.
4. A person with a pastoral care role such as an Aboriginal or Torres Strait Islander elder or community leader, a chaplain or a religious leader.
5. A qualified lawyer who, where possible, does not advise the institution.
6. Two people with current research experience relevant to the proposals in front of the meeting.

For a trial that uses an unapproved therapeutic good, the TGA describes the HREC’s work as advising on protocol and design, weighing the product’s risks and benefits, deciding whether the trial is ethical, approving the protocol and monitoring the trial.

Research, or a new kind of treatment?

The National Statement accepts that the line between research and innovative clinical practice is not always clear. It describes a spectrum, from small changes at the edge of established practice that change patient risk very little, to new interventions that belong only inside a research protocol with ethics approval. Where it is unclear whether an innovation should be done only as research, it may be necessary to ask an HREC or another institutional review process for advice.

Consent when the research involves genetic information

Chapter 3.3 of the National Statement covers research that generates or uses genomic information with hereditary implications or that predicts future health, whatever the source material. It describes genomic information as “predictive, unchanging, sensitive and familial”, and notes that results can matter to relatives, can touch on access to insurance and employment, and can reveal unknown family relationships. Research of this kind will, as a general principle, need review by an HREC.

What researchers are asked to think through before seeking consent

• What the research will generate, what it may find, and what is deliberately left out of scope.
• Which findings, if any, will be passed on to participants, and how.
• What the information means for the health of participants and their relatives, and any other effects, such as on insurance, employment or stigma.
• Whether participants could be re-identified, whether the information will be shared with other research groups, and possible future uses, commercial ones included.

What the Statement says about updates, withdrawal, results and data

• Participants should be told that what they learn about the likely impact of their genomic information may change as knowledge grows, and how to get updated information.
• They should be told about the practical limits on withdrawing once data has been analysed or samples shared with other researchers.
• Researchers should not assume that agreeing to take part means agreeing to receive results; where results must be returned, the project is designed that way and says so.
• Participants should be advised that publication or funding rules may require data to go to controlled-access repositories that meet international security standards.

The Statement also says an opt-out approach, where people are included unless they decline, should not be used in genomic research. Relatives who give information or samples become participants in their own right.

Consent to future use of samples and data

The National Statement recognises three kinds of consent for using data or tissue: specific consent, limited to the project at hand; extended consent, for future projects that extend or are closely related to it, or are in the same general area; and unspecified consent, for any future research. Where unspecified consent is sought, its terms and wide implications should be explained clearly and recorded.

Where a person cannot consent for themselves, someone with lawful authority for them decides, and that decision must not be against the person’s best interests. The Australian Clinical Trials website explains how this works for children in trials, covered on rung 03. Rung 06 covers informed consent to treatment, which is a separate conversation with a doctor, and rung 01 covers the laws on embryo research and mitochondrial donation.