If you've decided to participate, the first thing to do is to find out as much as you can by asking lots of questions of the researcher who is running the study. We've gathered all the questions you'll need to ask below.
Start with the basics:
- What is the aim of the trial?
- Who is funding it?
- What will I have to do if I take part?
- How will the trial differ from my normal care?
- Where is it being held?
About your treatment
Every clinical trial has its own risks and benefits, and it’s vital to understand these before you give your consent. If you’re taking part in a study for a new treatment, your questions might include:
- What treatment will I get if I don’t take part in the trial?
- What are the possible side effects of my treatment?
- How may the treatment affect me physically and emotionally?
- Who can I contact if I have a problem? Will someone be available 24 hours a day?
- What extra tests or appointments will I have?
- Will I definitely be given the new treatment if I take part? (sometimes researchers will need to compare a new treatment to an existing treatment or no treatment at all)
- What compensation plans are in place if anything goes wrong?
About the commitment you make
- How long is the study expected to last? And for how long will I need to take part? (Some studies may just involve filling out a survey; others might last for years in multiple phases.)
- What will happen if I stop the trial treatment or leave the trial before it ends?
- How much of my time will be needed – including travel time?
- Will I need to take time off work?
- If the trial is testing a drug, will I have to collect it from the hospital, will it be sent to me by post or will I get it through my doctor?
- Will I need extra help from family and friends?
- Will the costs of my travel to the trial be reimbursed?
- Will I have to fill in questionnaires or keep a diary?
About what happens after the trial
- If you’re volunteering for a study, you may wish to know what happens after it ends. So, you might want to ask:
- How long will it be before the results of the study are known?
- How will I find out about the results at the end of the study?
Read the section below about the risks and side effects.
Once you’ve had a conversation about the study with the researcher or your own doctor or nurse, it may be a good idea to take some time to talk it over with family or friends – unless a decision is needed urgently because of your medical condition.
It might also be a good idea to talk to people who have experience of taking part in research.
Health and social care research studies are carefully designed to minimise the risks and maximise the benefits to all who take part, whatever treatment they receive. But this can be difficult, especially when you’re not a health professional yourself.
- Some trials will have very little risk, for example completing a survey or providing samples.
- The risks of a trial may be greater when less is known about the treatment being tested. The treatment may cause side effects that doctors and clinicians cannot predict. These may be unpleasant and, very rarely, can be life-threatening.
Risks and side effects
You should be told everything that the researchers know about any possible risks and side effects and why the trial is necessary, so that you can make an informed choice about whether to take part. All research studies are regulated and should meet ethical approval.
If you take part in a trial you will be monitored regularly during and after the study.
What happens if something goes wrong?
If you decide to take part in a drug trial or more agree to try a new procedure you may want to find out exactly what arrangements have been made for compensation before agreeing to take part.
- It’s rare for patients to be seriously harmed by trial treatments.
- Before any trial can start, arrangements have to be put in place in case something goes wrong and people are harmed.
- Research ethics committees can refuse approval for trials where there is no insurance or other provision for compensation. For more information on this see regulated, approved and funded.
- Drug companies are insured so that, if a patient suffers because of a trial, compensation can be paid.
- Trials funded by other organisations may not have this kind of insurance, but a payment may be made if something does go wrong.
- Individual NHS trusts are responsible for ensuring themselves against damage caused by their own studies.
Giving your informed consent
Before you take part in a trial, a doctor or other researcher should make sure you have given your informed consent. Before you can do this, you will need to understand the purpose of the study and how it affects you, including the main risks and benefits of taking part.
Visit what happens on a study for more information on the questions to ask.
How will my information be used?
- If you enrol in a research study, the research team will collect information as part of that particular study. This information is held by the research team and any information that is collected about you will be kept confidential, in the same way as your medical records.
- The researchers cannot tell anyone that you are in the study without asking you first.
- If your doctor or consultant is not the person who approached you about the trial, it can be helpful for them to be told you are taking part in a study as they will be responsible for your day-to-day healthcare; but they can only be told with your permission.
- Once the study has finished the results are usually published, and often presented at conferences. No name or any information that can identify you will be used in any reports about the study.