The following outlines the requirements for written consent which must be obtained prior to participation in a research study as per Chapter 2.2 of the National Statement and TGA Note for Guidance on Good Clinical Practice section 4.8.
- Researchers should obtain independent legal advice if they are unclear as to the legal requirements applicable for obtaining informed consent at each research site.
- If the research involves a multi-centre study, local legal requirements and laws applicable in each site/State must be satisfied.
- Consent is required for participants that are 18 years and older and able to consent.
- Bellberry generally requires specific consent/assent to a child’s or young person’s participation in research from the child or young person whenever he or she has the capacity to make this decision and either one or both parents (depending on the risk involved) or, where applicable, the guardian or person required by law. (per National Statement 4.2.7)
- Bellberry will now accept the term ‘assent’ for children as long as it is defined to mean agreement by a minor to their enrolment in research. The Mature Minors Standard supports the use of this term.
- Third party Consent is provided by a Legally Authorised Representative (LAR) when an adult is unable to consent and for participants aged under 18 years.
- If a participant, or that person’s Legally Authorised Representative (LAR) is unable to read, an impartial person must be present during the entire informed consent process and may assist the participant or LAR during that process, such as by reading aloud the informed consent form. An impartial person is a person who is independent from the trial and any person involved in the trial. As part of the informed consent process the impartial person must attest in writing that the consent form, and any other relevant information, was appropriately explained to and apparently understood by the participant or the LAR, and that informed consent was freely given. (Refer GCP Guideline 4.8.9 and 1.26)
- If the research involves women who are pregnant and the human fetus, children and young people, people in dependent or unequal relationships, people highly dependent on medical care who may be unable to give consent, people with a cognitive impairment, an intellectual disability or a mental illness, people who may be involved in illegal activities, Aboriginal and Torres Strait Islander Peoples or people in other countries, please refer to the NHMRC National Statement on Ethical Conduct in Human Research (2007) – incorporating all updates, Section 4.