Pfizer Post Marketing Safety Reports

From: https://www.healthnavigator.org.nz/health-a-z/i/informed-consent/#Overview

Informed consent is the process of talking about options so you can make an informed decision about your health care. This includes the option of saying no to a treatment or procedure.

Key points:

You have the right to make an informed choice about your health care.

Informed consent is an ongoing process of talking and asking questions between you, your doctor or other healthcare provider and, sometimes, your family/whānau.

To help you decide whether you want a treatment or procedure, your healthcare provider must give you all the information you need to make up your mind.

This includes how the treatment or procedure would help your health condition and what the risks of the treatment are.
There are a few situations where you may be treated without consent, such as in an emergency.

What is informed consent?

Informed consent is the process of talking and asking questions until you have enough information to make a decision about your healthcare options. This includes the option of saying no to having a treatment (such as medicine) or a procedure (such as an operation).

To give informed consent, you must know enough about your condition and the treatment or procedure your doctor or other healthcare provider has suggested. You must have this information given to you in a language and way that you can easily understand. You should have access to an interpreter if you need one.

You also have a right to have someone else with you to provide support while you are talking about your options.

Why is informed consent needed?

You have a right under the law to make an informed choice about your health care. This is one of your rights under the Code of Health and Disability Consumers Rights.

Under the Code, health care may be provided to you only if you make an informed choice and give informed consent. You also have the right to say no to a proposed treatment or procedure, or change your mind about wanting to go ahead with it.

When is informed consent needed?

Your doctor or other healthcare provider must make sure that you have given informed consent for every proposed healthcare service.

When you are going to have a series of similar treatments, eg, dialysis or counselling, your healthcare provider will talk with you before starting the treatment to make sure you agree to it. The consent you give then covers the whole series of treatment.

If the agreed plan changes a lot, a new consent process is needed.

Examples of situations when informed consent is required include:

when you are having surgery (an operation) or other procedure

when you need to have an anaesthetic

if students or observers are going to be there for your treatment

if you take part in research

when any part of your body will be taken out during a procedure

if you will be getting blood or blood products

if you are enrolled in a screening programme

if your doctor wants to prescribe a medicine that has not been approved by Medsafe for use in New Zealand (called unapproved medicines)

if your doctor wants to prescribe a medicine for a different use than that approved of by Medsafe (also called off-label use).

What type of information should I get for informed consent?

Before giving your consent, your doctor or healthcare provider must fully and clearly explain to you:

how this treatment or procedure will help your health condition

what happens during the treatment or procedure

what other options there might be

what you can expect after the treatment or procedure

any risks that may be associated with the treatment or procedure.

You can also ask any questions you want about the treatment or procedure.

What are the different types of consent?

You will need to give either verbal consent or written consent.

Verbal consent means talking about and saying you agree to a particular treatment. This includes when your doctor prescribes an approved medicine for your condition.

Written consent means you need to fill out a form and sign it to show you agree to a particular treatment. This happens for more significant treatments, such as an operation.

How is informed consent gained for children and young people?

For children and young people under the age of 16, consent may be given by a parent, guardian or other person acting in the place of a parent. Depending on the child’s age, they will be involved as much as possible and information will be given to them in a way that they can understand.

A young person aged 16 years and over can consent to their treatment as if they were an adult.

How is informed consent gained for people who are incompetent?

In legal terms, people who cannot decide for themselves whether they want a treatment or not are called ‘incompetent’. This may be because of health conditions such as a brain injury or dementia.

Consent for people who are incompetent may be given by their welfare guardian or a lawyer who has an enduring power of attorney in respect of care and welfare for that person.

What if I didn’t get to give informed consent?

If you have any concerns about not getting a chance to talk about and make an informed decision about a treatment before it was given to you, you can make a complaint. Read more about the Code of Health and Disability Consumers Rights.