Questions to ask about the study

The patient information sheet (which will be given to you by a member of the research team) is a useful explanation of the study and what is involved. When you have read the sheet you should have answers to the following questions:

Why is the research being carried out?

The researcher should be able to tell you exactly why the research is necessary. You should be given a description of the drug or device and also told the stage of development. If you are taking a drug you should be told the dosage and how to take it. Patients entered into drugs trials should also be given a card (similar to a credit card) with details of the trial which they you should carry with them at all times.

Why have I been chosen?

You should be given an explanation of why you have been chosen to take part in the study. This may be a combination of factors including your current medical condition, age, sex or medical history.

What will happen to me if I take part?

Some studies may take only a few minutes of your time while others may involve one or more extra hospital visits. Occasionally studies can last for several years and you will need to decide whether you will be able or willing to make follow up visits to the hospital.

You should also know what tests or treatments are involved. Some may involve having blood tests, taking medication or some other kind of medical treatment, while other studies may involve simply completing a questionnaire about your health. It is important that you understand exactly what is involved before agreeing to take part.

What are the alternatives?

The researcher should always tell you about the alternative treatments available

Will it affect my lifestyle in any way?

Sometimes if you are taking a certain kind of medication there may be some restrictions to your lifestyle. Occasionally you may have to avoid giving blood, driving, certain foods, other medications or alcohol, and if you are female you may be asked to agree to avoid pregnancy during the study.

What are the side effects?

For any new drug or treatment you should be aware of the possible side effects – these should be written in simple terms to make them understandable. If you suffer from any of these side effects, you should inform your doctor. You should also have a contact name and number of a member of the research team in case of emergency.

This page was last modified on Wed Apr 11 2012