A report by the Chief Medical Officer (CMO) on the carrying out of vaccine trials on vulnerable infants in institutions run by religious orders had raised concerns about whether any informed consent was given for those trials, the High Court was told yesterday.
There was also a concern that medical officers and management in the institutions involved may have consented to the trials in the belief the children were receiving the standard vaccine, not a non-standard one as was the case, Mr Maurice Collins SC said.
A further concern related to whether the trials, which were carried out in 1960, 1971 and 1973, had been appropriately authorised for administration under the Therapeutic Substances Act, the applicable statutory regime at the time.
The CMO had also referred to an absence of documentation relating to the trials and the absence of information to show whether the vaccine used was imported under any licence or permit.
On the basis of the CMO's report, the government had made an order directing a division of the Child Abuse Commission to inquire into the conduct of the trials, counsel said. It was his case that the government had acted within its powers under the Child Abuse Act 2000 to make such an order at that time.
The State was relying on the fact that the subjects of the trials were vulnerable children in institutions, many of whom had no parental protection. The government remained entitled to take the view the trials were appropriate matters to refer to the Child Abuse Commission.
Mr Collins, for the Minister for Education, Ireland and the Attorney General, was opposing an application by Prof Irene Hillary, who was involved in the trials, aimed at quashing the government order directing the commission to inquire into the conduct of the trials.
The inquiry is on hold pending the outcome of the challenge.
The hearing continues today.
