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.
