Barbara Roberts, Homeopath

Informed Consent

This is something that gets bandied about a lot. But what is informed consent, and what is the history behind it?

Hippocrates talked about consent in Ancient Greece. While the Hippocratic Oath is the most well known of his writings, he had others as well. One of these was the Aphorisms. The first Aphorism said “The physician must be ready, not only to do his duty himself, but also to secure the cooperation of the patient.” Unfortunately that term “secure the cooperation” leaves plenty of room for interpretation, including the paternalistic “I’m the doctor, I know best” attitude that prevailed for centuries. There are medical ethics writings available from the 18th and 19th centuries which epitomise the “Doctor knows best” culture.

Flash forward to the 1940s, the Nuremberg trials of Doctors after World War II was a horrific look at some medical experiments done in the name of “science.” Out of the Nuremberg trial came the Nuremberg Code- first and foremost “the voluntary consent of the human subject is absolutely essential.”

The first actual use of the term “informed consent” was in the decision from the US court case Salgo v. Leland Stanford, Jr. University Board of Trustees (1957). The main decision in this was not that consent hadn’t been given, but that a full understanding of risks and benefits had not been disclosed first.

There were more court cases around the world, looking at issues around consent and the information required first, and whether inadequate consent was negligence or assault. Whether medical practice changed soon after those cases is not clear, but often lasting change takes time.

In New Zealand informed consent had a spotlight on it after the National Women’s Cervical Cancer Scandal, where women with cervical cancer were not informed they were part of a research trial, and some died or had needless pain and suffering as a result. The subsequent Inquiry was headed by Judge Silvia Cartwright; her recommendations in 1988 included an amendment of the Human Rights Act to incorporate patient rights, and the formation of an independent Health Comissioner. Change took time, but in 1994 the Health and Disability Comissioner Act was passed and in 1996 The Code is Health and Disability Services Consumers’ Rights was made law.

While I recommend EVERYONE should read this who uses ANY health service in New Zealand, for the purpose of this already long post we are only going to discuss Right 6: Right to be fully informed.

This is what it says:

(1) Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including—

(a) an explanation of his or her condition; and

(b) an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and

(c) advice of the estimated time within which the services will be provided; and

(d) notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and

(e) any other information required by legal, professional, ethical, and other relevant standards; and

(f) the results of tests; and

(g) the results of procedures.

(2) Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, needs to make an informed choice or give informed consent.

(3) Every consumer has the right to honest and accurate answers to questions relating to services, including questions about—

(a) the identity and qualifications of the provider; and

(b) the recommendation of the provider; and

(c) how to obtain an opinion from another provider; and

(d) the results of research.

(4) Every consumer has the right to receive, on request, a written summary of information provided.

What is not discussed in that right is that true informed consent also needs to take into account three things-

Competence, Information and Voluntary.

To give informed consent a person must be Competent- so if unconscious someone else must give consent, but this is a grey area when it comes to teenagers, elderly people with dementia, and even in some acute situations.

There needs to be a disclosure of information. While it is not possible for a Doctor to condense all their years of knowledge into a short consultation so you have the background to understand, they should be giving unbiased information of risks, benefits and alternatives.

And finally, it must be Voluntary. There should be no coercion from others, whether Health Professionals or family members. This also applies to the time needed to make the informed decision. You have a right to take your time to fully consider the information you have been given.

Even in the past 15 years there have been changes in the way Health Professionals discuss things with patients. In Pharmacy when I was training we talked about Compliance- in other words the patient taking the medicine as the doctor prescribed. Fortunately these days there is a move towards Concordance- where Health Professionals and patients work together to have a plan that is best for both parties. I hope that this change continues on, to make Healthcare an informed decision for patients and a partnership with Healthcare providers for the betterment of everyone.

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