What does “Consent” mean?
The very first step for someone considering taking part in a study is the discussion they will have with the researcher to introduce and explain the trial. This discussion is a process called “Informed Consent’. The use of the word “consent‟ to describe the process does not mean that you have to agree to the trial. Rather it is giving you all the facts you need to make an informed decision about whether or not to take part in the trial. It is OK to say no. If you do agree to take part, it means you have provided your consent based on the information provided to you in writing, verbally, electronically by the trial team and have had all your questions answered.
How should I prepare before discussing a trial with a researcher?
If you know in advance that you are going to discuss a trial with a researcher, it is a good idea to prepare. It is likely that you will be given alot of new information, and it can be hard to remember and absorb it all at once. Therefore you might like to:
- Write down a list of possible questions to ask to bring to the meeting (but don‟t be afraid to ask new questions if you think of new one’s during the meeting).
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring paper to write down the answers to your questions during the meeting, or bring a tape recorder to record the discussion for later. (Note: For privacy reasons, you should ask the researcher if they mind you recording the conversation).
What happens during the consenting process?
The researcher will usually provide written information that could be many pages. Increasingly, electronic systems are also being used to help explain trials.
All information provided in the participant information sheets must be reviewed and approved by a human research ethics committee before you see it to make sure it is providing everything you need to know about the trial in as simple language as possible.
The information sheet will explain why the trial is being done and why you are being asked to take part. It will explain what is being tested, what you will need to do, the potential side effects and benefits, as well as any alternatives to being in the trial, if these exist. It will outline your rights and how your identity and data will be protected in the trial, what happens to the data collected, and contacts for more information.
Sometimes a researcher may accidentally miss telling you something about the trial during the discussion. It is therefore very important that you take the time to read and think about this information, in addition to talking to the researcher.
How quickly do I have to agree (or not) to consent to a trial?
Unless the trial is for an emergency treatment that needs to be given quickly, you should be given the time you need to read the information provided, ask questions and understand the trial. You should be able to take the information home to look through, ask your regular GP or family members for their opinions, and think about whether you want to do the trial. It is OK to ask other people for their opinions about the trial, but remember that those opinions may not be informed by all the facts about the trial, the researchers, your health, or be influenced by their own experiences and prejudices. Ultimately, you will generally need to choose for yourself whether or not to consent, unless a guardian is authorised to act on your behalf.
What if I don’t understand something?
While researchers try their best, they don’t always use language everyone understands. You should ask to have words you don’t understand explained, and researchers expect that you will have questions.
If you have difficulty reading or the language isn’t your preferred language, ask for independent help or and interpreter. It is important that you understand everything before proceeding, so there are no surprises once you are in the trial.
Can I say no?
You have every right to say no to a trial, without explanation. Saying no should not affect your future treatment or the relationship you have with your clinician.
What if I am feeling pressured to say yes?
This is considered unacceptable. You should not feel any pressure or coercion to take part in a trial. In the event you feel you have been pressured or coerced to take part in a trial, report it to the ethics committee as soon as possible.
Once I stay yes, can I ever change my mind?
The decision to consent should be considered a decision you make at the start of the trial, but which is also an ongoing decision. While you continue to do what the trial requires, it is assumed you continue to consent. However, you can leave a trial at any time.
If you do agree to take part in the trial, you should do so with the intent to do what is required until it is finished. If lots of people drop out of a trial, it can put the trial at risk of not reaching an answer. That’s why it is important you think carefully before saying yes whether you are happy to commit to the trial.
Researchers understand however that life happens and unexpected things can happen during the trial which mean you might need to pull out, or withdraw your consent. This is perfectly acceptable, but always talk to the research team first to inform them of your decision so that they can make sure you withdraw from the study safely.