Taking part in a research study

Research aims to understand why some people become ill and others do not, what happens when people become ill, and how best to care for people who are ill. New medicines and new medical equipment must be tested to see how well they work and to show that they are safe.

Research is often done with patients as part of their treatment and some research offers you an opportunity to try a different treatment. Some research may not benefit you directly, but you may decide it is worth taking part because it could help other people in the future.

How do I know the study is safe?

All medical research carried out on humans must be approved by a research ethics committee. The committee is made up mainly of doctors and other professionals who meet on a regular basis to look at all proposals for new research studies. Their job is to protect the dignity, rights, safety and well being of people who volunteer to take part in research studies. If they have any doubts about a study they will ask the researcher to make changes before the study can go ahead. The Trust’s R&D Department also review all medical research to ensure that it is in the best interest of the patients.

By the time you are asked to take part in a study this process will be complete. While it is reassuring to know that the study has been given careful consideration by the ethics committee, it is also important that you think carefully about whether participating in the study is right for you. Don't sign the consent form unless you are completely happy to take part in the research and are satisfied that you have answers to any questions you may have asked.

Your rights

If you are invited to take part in research you will be given an information sheet to take away and read and decide whether you want to take part in the study. You can ask the researcher to answer all your questions before you agree to take part in the research.

If you agree to take part, the researchers will ask you to sign a form agreeing to the research (a consent form).

You may want to ask yourself the following questions to help you decide whether or not to take part. Remember, taking part in research is voluntary.

If you speak little or no English, ask for an interpreter or friend to be with you when you talk to the researchers.

I've been asked to take part in a research study, can I refuse?

Taking part in research is always voluntary. You don’t have to give a reason for refusing, though it may help the researchers if you do so. It might be something that they can change or improve in future.

Do I have to decide at once?
No. Take time to think about it. You may want to talk to your family or friends or GP. Whatever they say, the decision is yours.

Can I change my mind once I am in a study?

Yes, you can withdraw from the study at anytime without giving a reason, though it may help the researchers if you do so. All researchers know that you have a right to do this.

Will my care be affected if I refuse to take part or withdraw?

No, your treatment at the hospital will continue as normal if you decide not to take part in the research.

What are the risks in taking part in the research?

Researchers must tell you about any potential problems or side effects from taking part in research. They are trying to find out what medicine or treatments work and if there are possible problems for you arising from them.

At the end of the study

Researchers should tell you whether the study treatment will still be available to you once the study is finished. If it is not they should tell you what will be available instead.

The researchers should also tell you what will happen to the results of the study, where they are likely to be published and how you can obtain a copy.

Details about you from which you could be identified will not be used in any report or publication.

This page was last modified on Wed Apr 11 2012