The MEND (MEseNchymal coviD-19) Trial: A Pilot, Open Label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care with COVID-19 (Protocol Version 2.0 dated 30 April 2020) [2020] NSWCATGD 17

The MEND (MEseNchymal coviD-19) Trial: A Pilot, Open Label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care with COVID-19 (Protocol Version 2.0 dated 30 April 2020) [2020] NSWCATGD 17

The Tribunal approved the clinical trial because CYP-001 was intended to alleviate symptoms of COVID-19 ARDS, the evidence did not show known substantial risks or risks greater than supportive treatment, the development of CYP-001 had reached a stage where safety and ethical considerations made it appropriate for use in patients unable to consent, the potential benefits outweighed the risks and participation was in patients’ best interests, and the trial had ethics approval. The Tribunal also determined under s 45AB(1)(a) that persons responsible could give or withhold consent because the Participant Information Sheet/Consent Form and Telephone Consent Form provided sufficient information...

Jurisdiction
Australia
Judgment Date
29 June 2020
Procedural Posture
Application for Approval of a Clinical Trial Under the Guardianship Act 1987 (nsw) / Application Heard and Orders Made Approving the Clinical Trial and Consent Mechanism
Outcome
Clinical trial approved under s 45AA(1) of the Guardianship Act 1987 (NSW), and the applicant’s request for person responsible consent under s 45AB(1)(a) was granted.
Legal Topics
['approval of Clinical Trial for Patients Unable to Consent' 'covid 19 Treatment Trial' 'person Responsible Consent' 'best Interests of Patients' 'human Research Ethics Approval']
['guardianship' 'health Law' 'medical Treatment' 'clinical Trials'] ['approval of Clinical Trial for Patients Unable to Consent' 'covid 19 Treatment Trial' 'person Responsible Consent' 'best Interests of Patients' 'human Research Ethics Approval']

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Procedural Posture

Application for Approval of a Clinical Trial Under the Guardianship Act 1987 (nsw) / Application Heard and Orders Made Approving the Clinical Trial and Consent Mechanism

Legal Issues

  1. 1 ['Whether the clinical trial met the requirements of s 45AA of the Guardianship Act 1987 (NSW).' 'Whether consent to treatment as part of the clinical trial should be given by the person responsible for each patient under s 45AB(1)(a) of the Guardianship Act 1987 (NSW).' 'Whether the consent forms and trial information provided sufficient information to enable persons responsible to decide whether patients should take part in the trial.']

Ratio Decidendi

The Tribunal approved the clinical trial because CYP-001 was intended to alleviate symptoms of COVID-19 ARDS, the evidence did not show known substantial risks or risks greater than supportive treatment, the development of CYP-001 had reached a stage where safety and ethical considerations made it appropriate for use in patients unable to consent, the potential benefits outweighed the risks and participation was in patients’ best interests, and the trial had ethics approval. The Tribunal also determined under s 45AB(1)(a) that persons responsible could give or withhold consent because the Participant Information Sheet/Consent Form and Telephone Consent Form provided sufficient information...

Court Disposition

Clinical trial approved under s 45AA(1) of the Guardianship Act 1987 (NSW), and the applicant’s request for person responsible consent under s 45AB(1)(a) was granted.

Orders

  • ['The Tribunal is satisfied that the Clinical Trial meets the requirements of section 45AA(2) of the Guardianship Act 1987 (NSW) and approves the Clinical Trial pursuant to s 45AA(1) of the Act.' 'The consent is effective for Nepean Hospital and Westmead Hospital for the duration of the Clinical Trial.' 'The...