Clinical Trial approval where potential participants lack the capacity to consent

The Clinical Manager of a Hospital, applied to The NSW Civil and Administrative Tribunal for approval to conduct a clinical trial, a double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (CBD) which is an add-on therapy in the treatment of tuberous sclerosis complex (TSC) (GWP42003-P Trial) [2017] NSWCATGD 30. 

The Tribunal was informed that the most common clinical manifestation of TSC is epileptic seizures. In approximately two-thirds of people with TSC, seizure onset occurs in the first year of life. Early management of seizures is considered critical in preventing epileptic encephalopathy and in reducing associated cognitive and neuropsychiatric consequences.

The Co-ordinating and Principal Investigator of the Trial anticipated that the Trial may wish to enrol participants who are aged over 16 years with a decision-making disability. As a result the Tribunal was required to approve the Trial under the Guardianship Act.

The Tribunal approved the trial as it was satisfied that the Trial will not involve any known substantial risks to patients and there have been no reported adverse consequences associated with the use of CBD.  Furthermore, it was noted that the Trial has been approved by the Hunter New England Human Research Ethics Committee on behalf of all participating sites.  

The Tribunal concluded that as it is likely that each of the proposed participants will have a person responsible with whom they are in close regular contact, the function of giving or withholding consent to participate in the Trial should be exercised by the persons responsible, not the Tribunal.

In support of the Application, the Applicant had submitted consent forms and accompanying information proposed to be given to the person responsible for patients invited to participate in the Trial. The Tribunal was satisfied that the form for granting consent and the information available about the Trial, provided sufficient information to enable persons responsible to make an informed decision about whether to provide consent for participation in the Trial.

When seeking the Tribunal’s approval for patients to participate in a clinical trial and who lack the requisite capacity to provide consent, it is important to adduce evidence to support the following:

  • That any risks of the trial outweigh the benefit of treatment to the patient;
  • the drug has reached a stage at which safety and ethical considerations make it appropriate to be made available to patients; and
  • the trial has been approved by a relevant ethics committee and complies with any relevant guidelines issued by the National Health and Medical Research Counsel.

Further, where the consent to participate in the trial is exercised by a person responsible (as defined by the Guardianship Act), there must be evidence to show that sufficient information has been provided to enable that person to make an informed decision to proceed with the trial.  

Post by Monica Pecker and Karen Kumar 

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