Research involving patients who are unable to give consent
The following information will give you an overview of what you need to consider if you're planning on doing research with adults who can't give their consent.
If your research involves people, you must get their consent before you start your project.
Sometimes this isn't possible. For example, people who:
- are highly dependent on medical care
- have a cognitive impairment or intellectual disability
- have a mental illness.
Children under 16 can consent to their own treatment if they're believed to have enough intelligence, competence and understanding to fully appreciate what's involved in their treatment. This is known as being Gillick competent. Otherwise, someone with parental responsibility can consent for them.
The National Health and Medical Research Council (NHMRC) website has:
- information about people dependent on medical care who may be unable to give consent in chapter 4.4 of the National Statement on Ethical Conduct in Human Research 2007.
- standardised participant information and consent forms (PICFs).
There also may also be jurisdictional laws that you'll need to take into account.
Impaired decision-making capacity
The Queensland Civil and Administrative Tribunal (QCAT) may approve clinical research involving people with impaired decision-making capacity.
If the proposed clinical research is approved by QCAT, it's then considered a health matter. After that it's determined under the Guardianship and Administration Act 2000 who may consent to the adult's participation in the research.
When there’s no consent
Waiver of consent
A waiver of consent can only be used for Low and Negligible Research (LNR) if it's been approved by a Human Research Ethics Committee (HREC).
Read the use of confidential information if your research uses potentially re-identifiable or identifiable confidential health information. You may need to make an application under the Public Health Act 2005.
Opt out consent
You can only use an opt out approach if people understand they have to choose not to participate otherwise their information will be used.
Opt out consent can only be used for LNR research that's approved by a HREC. Opt out consent is only valid if you’ve given participants the following information:
- details about your research, including what you’re hoping to achieve
- how their confidential information will be used
- how they can decline to take part.
Read the use of confidential information if your research uses potentially re-identifiable or identifiable confidential health information. You may need to make an application under the Public Health Act 2005.
Consent for future use of data or tissue
You'll need to get HREC approval if you want to use personal information, such as data or tissue in your current research and in future unspecified research.
This may include permission to store personal information in data or tissue banks.
The initial consent must clearly state the terms and wide-ranging implications of them agreeing to the future use of their personal information. These terms and their consent must also be included in your HREC application.
Protocol templates
Make sure you explain what consent methods you’re using in your research protocol.
There is also a widely endorsed clinical trial protocol template on the Standard Protocol Items Recommendations For Interventional Trials (SPIRIT) website.
You can read the ICH Guideline for Good Clinical Practice on the Therapeutic Goods Administration website for more information about designing, conducting, recording and reporting of clinical trials.