Healthcare continues to advance at a startling rate, and one of the key elements of that development is participation in clinical trials and research.

CCNZ supports research by encouraging patients to participate and advertising clinical trials on its website and in the ‘Moving On’ newsletter.

There’s no doubt that participation in research is crucial and can be a wonderful way for a competent adult to actively contribute to the field of medicine. But equally important is that you – the research participant – know what you are getting yourself into.

So before you dive head first into a clinical trial, you must always give ‘informed consent’. But what does that mean, and what does it look like in the clinical research-sphere?

Get the facts

First things first, you need the facts.

Your right to be fully informed about – and make a decision about whether to participate in – research is protected by the 'Code of Rights', a document overseen by the Health and Disability Commissioner. In fact, you will have all the same rights when you agree to participate in research that you would have when undergoing normal treatment.

So what should your health professional tell you, and what questions should you ask?

Well, there are some things health professionals must tell you before proceeding. But the law is never as simple as providing an easy-to-follow ‘checklist’.

You have the right to be told all information that a reasonable person in your situation would expect to be told. The type and depth of information will vary, depending on your health and the type of research, but generally you should expect to be told about the expected risks, side effects and possible benefits of participating. And if you have questions, you have the right to honest answers.

Lots of variables will influence the type of information that is reasonable in a given scenario.

For example, one widely referenced Australian case (Rogers v Whitaker) involved a patient who had surgery on her right eye. She was almost completely blind in that eye, and her surgeon told her it was possible surgery would improve her sight. What the surgeon did not tell her was that there was a 1 in 14,000 risk the surgery would cause her to go blind in her left, good eye. The court said that, while a reasonable patient might not expect to be told about the risk, the patient in the case before it would expect to be told that risk – because if it eventuated, she would be completely blind.

Hopefully the health professionals doing the research will have full knowledge of your particular circumstances – but don’t be afraid to ask questions or tell them about anything you think is important to your participation in the research.

The ‘right’ consent

Once you have all the information you need to make a decision, the health professional will need your informed consent to ensure they have proper legal authority to continue.

Your consent or refusal must be given voluntarily and without pressure from any other person.

The researchers might be excited about their project and keen to get going – but you must be given adequate time to digest and understand the information – and not feel rushed into making decisions. There have been a number of cases where patients’ rights have been breached because the information and discussion only occurred at the last minute before a significant procedure – when the patient really had no choice but to proceed.

Usually it doesn’t matter whether consent is verbal or written, but if you’re participating in research your consent must be in writing. So you’ll be asked to sign a form.

During the research

If you decide to go ahead and participate – good for you! The research team will be keeping an eye on you, and it’s their responsibility to ensure this is a positive and safe experience for you. But you remain in control. If you’re unsure about anything, don’t be afraid to keep asking questions – and if you change your mind about participating, you are entitled to withdraw your consent.

E-learning module on informed consent

Are you a health professional responsible for obtaining informed consent? Do you want to be confident you understand your obligations and patients’ rights?

Claro’s e-learning platform provides a way for health professionals to ensure that they know about their legal obligations – including about informed consent. The e-learning platform is called Clarify.

All Clarify modules are designed to ensure that health professionals understand their legal and ethical obligations. Each module includes downloadable information sheets on the topic; and participants complete an on-line assessment which, if successfully passed, results in a certificate being generated confirming completion. This can be used for CPD or regulatory purposes.

The Clarify modules are one means to satisfy employers that their employees understand the legal and ethical issues they need to know about – and that there is a record that confirms that they have undertaken the training.

The Clarify module on informed consent can be accessed here.