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Consent

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.

Click to access the Bellberry sample Consent Form or Consent by a Third Party Form.

  • 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.

Consent Form Requirements expand
Bellberry Limited expects the following points to be addressed. The Consent Form should state clearly to which study it relates and include the following:

  • A statement to the effect that the participant may freely withdraw from the project at any time without prejudice to further treatment.
  • Where applicable, a statement informing the participant that there may be no direct clinical benefit to him/her as a result of the trial.
  • A statement that information collected will be kept confidential, however consent for access for specific purposes such as quality assurance, auditing, research and in the event of a serious adverse event must be obtained.
  • Ensure that the written consent form is signed and personally dated by the participant or Legally Authorised Representative and by the person who conducted the informed consent discussion.
  • Notification of their participation in the study and that any clinically relevant information noted by the trial doctor during the conduct of the trial will be given to treating Doctor/s.
  • I have read, or have had read to me, and I understand the Participant Information Sheet, Version x, dated x.

The participant must be given ample time and opportunity to ask whatever questions occurred to them during the consent process. These must be answered to the satisfaction of the participant or the participants Legally Authorised Representative.

Researchers must renegotiate or confirm participants consent when significant trial related events occur that may affect a participant’s willingness to continue to participate in the trial. (per National Statement 2.2.8)

There should be a signed declaration by the researcher confirming a verbal explanation of the research project, its procedures and risks has been given to the participant and understood by them.

If it is intended to seek permission for use of optional tissue samples (either residue from obligatory tests or fresh tissue sought) a separate Participant Information Sheet and Consent Form must be included for this secondary purpose.  Refer Sample Participant Information Sheet for further details.

Consent Form Requirements for Children and Adolescents expand
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.

A separate information sheet for children and adolescents is required.

The Committee requires reassurance that any participant turning 18 years of age during the study will be re-consented.  This is legally necessary because the young person is then legally an adult and parental consent is no longer operative.