1. You have the right to say no.

You have the right to refuse to join a study. In fact, no one is allowed to perform research with you unless you have given your permission and signed an informed consent document (sometimes just called a "consent form"). The purpose of an informed consent document is to help you understand everything that will (or could) happen during the study in which you are being asked to participate. You do not give up any of your legal rights when you sign the informed consent document and join a study.

2. You have the right to quit.

You have the right to stop participating in a study, for any reason, and at any time, without losing any of your medical care options.

3. You have the right to know why.

You have the right to know the purpose of the research study that you are being asked to join.

4. You have the right to know the risks.

You have the right to know all of the risks that you are taking if you choose to take part in a study (as well as anything that might be of benefit to you).

5. You have the right to know what else you can do.

You have the right to be told about all other medical options available to you, if you choose not to participate in the study. You have the right to be told if there are any medical options available that may be better for you than participating in the study.

6. You have the right to ask questions and have them answered.

You have the right to ask any question about the study before you join, and you have the right to ask questions as the study continues and after it ends. You also have the right to have all of your questions answered to your satisfaction.

The FDA suggests you to ask the following questions to a study doctor before you join a study:

What is the study trying to find out?

What kinds of tests and exams will I have to take while I'm in the study? How much time do these take?What is involved in each test?

How often does the study require me to go to the doctor or clinic?

Will I be hospitalized? If so, how often and for how long?

What are the costs to me? Will my health insurance pay for it?

What will happen at the end of the study?

Will some type of follow-up take place after my participation in the study ends?

What are my other treatment choices? How do they compare with the treatment being studied?

What side effects can I expect from the treatment being tested?

How long will the study last? 

7. You have the right to take your time.

You have the right to take plenty of time, without anyone pressuring you, to decide whether or not to join a study.

8. You have the right to talk to others.

You have the right to discuss with your doctor, your family, and your friends, whether or not you should join a study. You have the right to receive a copy of the informed consent document to help you make your decision.

9. You have the right to privacy.

You have the right to keep your medical information confidential.

10. You have the right to be treated for injury.

You have the right to receive medical treatment for any injury that might happen to you on a study.

11. You have the right to receive a copy of the informed consent document that you signed.

If you sign an informed consent document, you have the right to receive a copy of that form for your own personal records.

Autor: Paul Matei, Project Manager

Quelle: http://www.sterlingirb.com/participants/rights.html

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