Informed consent the process whereby a patient with the capacity and competence to do so, having been given sufficient information, makes a reasoned decision whether to agree or not to a proposed treatment or procedure.
Consent may be given orally or in writing, but filling out forms is not as important as the adequate exchange of information, so that an informed decision can be made. Good communication is integral to this process, as is imparting the concept of risk without paralysing your patient with fear of the consequences. Language barriers, unconscious or intellectually disabled, or the deceased patient, present particular challenges in obtaining informed consent. The competency of minors is important in O&G practice with regard to contraception and abortion where the Gillick principle is applicable.
The question of patient consent exploded into the public arena in New Zealand with the Cartwright Inquiry 1. The Inquiry was set up in 1987 to investigate the treatment of women with cervical carcinoma in situ over a 20-year period at National Women’s Hospital in Auckland. It concluded that the management of the women by Prof Green had been unethical. Firstly, patients were placed at unacceptable risk. Secondly, none of them knew their ‘watch and wait’ clinical management was any different to accepted practice at the time, nor had they expressly agreed to participate. In this issue of O&G Magazine, Rosalie Grivell outlines the principles of bioethics, including safeguarding research participants, and reminds us of the Helsinki Declaration (1964) that requires full explanation and freely given consent to clinical treatment.
The current expectations around informed consent for medical students and supervising doctors in clinical settings are addressed by John Allen. In some instances, explicit consent obtained in writing is indicated, particularly where the patient is to be anaesthetised. When I was a medical student in the mid-1980s (prior to the Cartwright Inquiry) our clinical group was instructed to attend a general surgical operating list. Eight of us lined up ready with gloves on, the male patient anaesthetised and positioned in lithotomy. One by one we did a rectal examination and felt a hard, craggy mass. This opportunity was invaluable for us to learn to better recognise a rectal cancer, but a large student group in theatre would be unacceptable today.
In this issue, Brett Daniels reminds us of the process required for the introduction of new products, drugs and procedures into clinical practice. In June, a Health Select Committee of the NZ House of Representatives made a number of recommendations 2, which included a centralised surgical mesh registry and that medical collages review best practice around informed consent for mesh procedures. A recent RANZCOG communiqué3 released in response to the Health Select Committee’s report is recommended to our readers, which offers guidance about the future use of mesh in gynaecology.
A landmark ruling in the UK Supreme Court in 2015 relates to shoulder dystocia in a diabetic mother resulting in a child with severe disabilities.4 There were red flags in the antenatal history and the court agreed the mother ought to have been given advice about the risks of shoulder dystocia with a vaginal birth, and the alternative of delivery by caesarean section. As a consequence of this case, RCOG is convening a meeting to debate the need to fully inform women of the risks of vaginal birth. Two articles in this issue explore the concept of obtaining consent from all women planning to give birth vaginally. Pelvic floor injury can impact significantly on quality of life. Peter Dietz challenges us to consider fully informing women of these risks when discussing mode of birth.
Informed consent is fundamental to the safe practice of medicine. There are two RANZCOG College statements related to obtaining consent for treatment, each one specific to Australian 5 or New Zealand6 jurisdictions. It is necessary as medical practitioners to be familiar with the legal principles and guidelines that apply tothe state/territory/country where you are practising. Our respective defence organisations give clear guidance in this issue of consent.