If you join a trial, you have certain responsibilities to the trial researchers. The researchers should also respect certain rights that you have.

Your rights when you join a trial

First and foremost, no-one should force you or pressure you into entering a trial. It is a choice that you alone can make after you have received and understood all the
facts about the study. You have the right to get understandable answers to any questions that you may have before you agree to enrol.

Once you have entered the trial you have the right to withdraw from it at any time without this affecting the regular medical care you receive. You do not have to give any reason.

Feel free to ask about the results of any tests that you have to take during the trial. You will probably want to keep track of your progress in the trial to help you decide whether to continue in the trial or not. But bear in mind that many trials are double-blinded, meaning that neither you nor your doctor knows which arm of the trial you are in. So even your doctor may not be told the results of some of the tests performed upon you.

Finally, you should always be able to contact someone out of clinic hours with any important concerns or urgent questions you may have about the treatment, its side-effects or any other symptoms.

The responsibilities of joining a trial

The researchers have set up the trial to answer specific questions. Nobody gains if the trial is unable to answer those questions. So it is important that you follow the rules of the trial as far as possible, and tell your doctor if you cannot follow any of them. For example, if you find it difficult or forget to take trial tablets, it is best to let the researchers know so that they can interpret the trial results properly.

Even though all the tests and restrictions might seem like a lot of trouble, they are designed to protect you against unknown side-effects, and to get reliable information about the treatment. Making an effort to follow the rules of the trial can help everyone.
It may be helpful to ask the researchers to spell out your responsibilities at the start of the trial. For example, you may find that you have to miss a clinic visit, or you might forget to take the trial drug. Check whether these may affect your rights to continue in the trial.

For safety reasons, it is worth taking some time to tell the researchers about any relevant aspects of your medical history, such as previous drug allergies or any other treatments you are currently taking. You may also be asked if you are taking any recreational drugs.

It is important to tell the researchers about any new symptoms you may experience, even such things as rashes and headaches. These may seem unimportant at the time, or you may suspect that you are on a placebo and that therefore these are not side-effects of the drug. However, you may be wrong. It is your responsibility to tell researchers in order to give them the maximum information with which to judge the harms and benefits of the treatment.

The best protection against serious side-effects during a clinical trial is to learn about the symptoms of possible side-effects. Promptly notify the investigators whenever there is a change in your health – even if it is only a headache or rash.

Deciding not to join a trial

If you decide not to enter the trial, or if you decide to leave the trial after it begins, you still have the right to the same medical care that any other person receives.

Remember that you are not necessarily saying 'no' to all clinical trials. Make sure that you keep up-to-date about other options and new trials.

Leaving a trial

You and your doctor might decide that you stop a trial treatment if your condition is getting worse and the therapy is not helping you. Do not feel bad about leaving trials because of side-effects. This information will help others in the future.

The researchers will usually want to continue to follow your progress after the trial, even if you left it early. This helps them to interpret the results of the trial accurately.