Consent for drug trials on coma patients to be reviewed

How the Herald broke the story in May.

Health commissioner will look at process covering critically ill and coma patients.

The rules restricting enrolment of unconscious patients in drug trials without their prior consent will be reviewed - more than seven months after an outcry over planned research at Auckland City Hospital.

The Herald revealed in May that a government ethics committee had approved the Auckland and Christchurch Hospitals treating intensive care patients in the trial without prior consent. The prior assent of relatives will be sought, and the consent of the patients once they recover enough to be considered legally competent.

The trial is to see if a new antibiotic is as good as one already in use.

Up to 4000 critically ill or unconscious patients have been enrolled, without their prior consent, in previous trials comparing different kinds of standard care.

Lynda Williams, co-ordinator of the Auckland Women's Health Council, has said the antibiotics trial shows the patient protections that followed the 1988 Cartwright Report are being flouted.

She has repeatedly pressed the Health and Disability Commissioner, Anthony Hill, to investigate the trial.

In a letter to Ms Williams this month, he states he will hold a "fulsome public information and consultation process", details of which will be released early next year.

Until now, Mr Hill has declined to interfere with the relevant part of the Code of Patients' Rights.

Under right 7 (4), patients not competent to give consent can be treated or enrolled in research if this is in their "best interests" and no one is available who is entitled to give consent on their behalf. Other conditions include making reasonable efforts to discover the patient's wishes.

Dr Colin McArthur, the Auckland District Health Board's clinical adviser on research, has said the antibiotics trial is low risk.

The meaning of "best interests" has not been defined by a court and patients in the trial will receive the extra benefit of earlier diagnosis and additional medical care, underpinning the contention the trial is ethical.

In 2009, the Health and Disability Commissioner at the time, Professor Ron Paterson, recommended right 7 (4) be changed by adding permission for ethics committee-approved research on unconscious patients without their consent when the research "is not known to be contrary to the best interests" of the patient.

He said the absence of this provision "deprives consumers of the benefit of research that may prove to be beneficial and is known not to be harmful".

In June, Mr Hill said right 7 (4) was an important protection for patients and there was no mandate for change so he decided not to take the next steps towards adding the proposed clause.

In his letter this month, however, he said "the time has now come" for wide public consultation on whether change is needed.

Dr McArthur welcomed this.