Consenting to Research on Behalf of Another Person: Changes to ACT Legislation
In 2016 the ACT Government amended legislation to enable people to give consent to participate in research on behalf of a person who could not give consent themselves. These important amendments will have exciting impact on the ACT research community. Firstly, these changes have made it possible for people who may have wished to take part in research, but are unable to give consent, to participate in research. Secondly, these changes will allow ACT researchers the opportunity to investigate important health and medical research, such as dementia, emergency care and geriatric research, which previously people who cannot give consent for themselves were unable to be involved in.
Under the amended Powers of Attorney Act 2006 and the amended Guardianship and Management of Property Act 1991, consent for participation in research may be given by a person holding an enduring power of attorney (medical and low-risk research), a guardian (medical and low-risk research) and a health attorney (low-risk research only). A health attorney is defined under the second Act as a person who is either
a) the domestic partner of the person concerned,
b) their carer or
c) a close relative or friend of the person
with priority to be given in the order listed. You cannot be a health attorney for a child or a person with a known long term impaired decision-making ability. Please note decision making on behalf of a child (0-17 years old) is with the child’s parent or legal guardian.
DISTINCTION BETWEEN LOW-RISK RESEARCH AND MEDICAL RESEARCH
The amended acts introduce an important distinction at law between low-risk research and medical research. The requirements on researchers and people giving consent on behalf of others vary between these two types of research.
Under the amended legislation low-risk research and medical research are given specific meanings which do not coincide with the distinction drawn in the National Statement on Ethical Conduct in Human Research; the basis of Human Research Ethics Committee (HREC) Review.
Proposals considered by the Low Risk Ethics Committee are also low-risk under the amended legislation, some proposals considered by the HREC as greater than low-risk are also considered low-risk for the purposes of the legislation. Examples of proposals considered by the HREC which are low-risk under the legislation include: research using personal information or personal health information collected during routine health care, non-intrusive examinations for research purposes, observing a person’s activities for research purposes, research comparing the effectiveness of two established standards during routine health care
Please see Powers of Attorney Act 2006 Section 41A (pg28) for the definitions of low risk research and medical research.
REQUIREMENTS FOR LOW-RISK RESEARCH
The amended acts place a number of requirements on researchers and on those holding an enduring power of attorney or a guardianship order in relation to a person for whom consent is being given in relation to low-risk research. These requirements are less onerous than those relating to medical research given the nature of the risk to participants.
The requirements on researchers to provide information to the person giving consent are reflected in the new Participant Information Sheets and Consent form
Consent for participation in Low-Risk Research By Another Person On Behalf Of The Participant
- Participant Information Sheet
- Consent Form
In addition the researcher must arrange for an assessment of the patient’s capacity to consent on their own behalf from an independent doctor. This independent doctor must fill in the new
Independent Doctor’s Assessment of Patient’s Capacity for Participation in Medical Research (Consent by another person on behalf of the participant)
When the form is completed by the independent doctor, the researcher must provide a copy of this form to the person who is considering giving consent before consent is given.
Please note: As of 1 September 2016 an enduring power of attorney or a guardianship order must be indicated for all medical research. Prior to 1 September 2016 an enduring power of attorney or a guardianship order including medical treatment is taken to include medical research.