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Legally and ethically, researchers must explain what a trial involves before you agree to take part. They will provide you with the contact information of a doctor, nurse, or study assistant who can answer further questions if you have them.

Information the research team must tell you before participating in a trial:

• The goals of this trial
• Treatment groups (active and placebo)
• Risks and side effects
• Benefits and drawbacks
• Tests or check-ups you will have
• How often you will have follow-up appointments, where, and for how long
• Whether the researchers would like to keep any blood samples, tissue samples, or other samples for future research
• Where you are likely to have treatment and whether you will need to stay in a hospital
• Who to contact if you have any questions, side effects or emergency situation

Advantages of Clinical Trials to Consider 

1. Healthy volunteers, who usually participate in earlier phases of the study, are often paid for their time and inconvenience. Later-phase studies usually don't pay for participation, as it is usually deemed unethical to pay people for their participation in later-phase studies.
2. You are helping to improve treatments for people in the future, making life better for the next generation.
3. You may only have a treatment (or part of the medication) as part of a trial. 
4. The new treatment may work better than the standard treatment for you.
5. You may need to have more frequent and longer check-ups, additional blood tests, scans, or other tests, and extended access to a doctor. These measures can help identify other health conditions, such as heart attacks, tumours, aneurysms, and others, at an earlier stage.

Drawbacks of Clinical Trials to Consider

1. You may have to do some paperwork or logging of your symptoms.
2. Longer check-ups and additional tests might disrupt your schedule.
3. It may cost you time and money, for example, bus fares, parking, etc. You should ask if they will be reimbursed.
4. You may have more blood tests and scans/x-rays involving radiation or other tests with associated risks.
5. As with any treatment, unexpected or severe side effects may occur. Although there is less risk in later-phase clinical trials, they still exist.
6. You may not know whether you are in the active or placebo treatment group.

All trial treatments are thoroughly researched in laboratories before human testing, and by Phase 3, doctors have more information, reducing the risk of harmful side effects. The research team will inform you about the treatment and potential side effects, but some risks remain, and they will discuss this with you before you join the trial.

Participant Protection in Clinical Trials

UK and European regulations require the trial's funding organisation or pharmaceutical company to provide indemnity cover insurance.

What is Indemnity cover?

Indemnity cover is insurance that compensates participants for harm or injury suffered as a result of their involvement in a clinical trial.

Regulations require this coverage to ensure that any adverse effects or damages incurred during the trial are financially addressed by the trial's funding organisation or pharmaceutical company.

If you were seriously harmed during the trial due to something in the study, such as a problem with the medication, you can be compensated.

The clinical trial company and the sponsor will insure you for that, which can take many forms. 

In practice, several different bodies may provide cover for you:

1. The NHS is liable for any clinical negligence if you have treatment in an NHS hospital or clinic as part of a trial.
2. Universities provide insurance for university researchers if any harm results from the trial design.
3. Pharmaceutical companies are responsible for insuring against any harm caused by the medicines being investigated.

Before entering the trial

Before participating in the trial, participants must sign the consent form to say they have been told and understand what participating in the trial means.

• You can't enter a trial without signing your informed consent.
• You can ask any questions you like and bring someone along with you, and all your concerns must be addressed.
• You can also think about it at home.

Remember that you can say no to joining the trial. It is entirely voluntary.

Screening

Once participants have signed consent, they undergo a screening process to determine whether they are suitable for the study and whether the trial is right for them.

This involves different health tests, depending on the study (the tests vary significantly).

These can be temperature measures, blood tests, ECGs, blood pressure, urine tests or more invasive tests such as endoscopies, biopsies, scans, etc. The detailed information will be in the patient information sheet for this specific study.

During the Clinical Trial 

You can continue asking questions and getting answers while in the trial and stop participating at any time. 

If you decide to stop participating in clinical trial

Please tell your designated contact if you decide to stop participating in the study. This will help the research team understand what happened and ensure that you are well.

Concerns or changes during clinical trials

You will be given a point of contact to answer any of your concerns and an emergency contact.

You can withdraw from a trial at any time without giving a reason. This will not affect your ongoing care or treatment in any way. Your GP will be informed of your participation in the study. You and your GP will be informed if any health issues are identified as part of the study.

Navigate to other pages about clinical studies:

1. Clinical Trials Explained: Learn the basics

2. Clinical Trials Process: Start to Finish

3. Types of Clinical Trials

4. Accuracy and Safety in Clinical Trials

5. Phases Of Clinical Trials

6. Clinical Trial: Key Participant Information

7. Clinical Trials Community Questions