clinical trials - Whats in there for me?

Having an idea of what you can expect from taking part in a study can help relieve some of your concerns and make things go more smoothly. The first thing you will need to do is give your informed consent to participate.

Informed Consent
The people running the study are required to get your written,informed consent before you take part in any way (often even before you have any needed tests to see if you are eligible for the study). In the informed consent process, the researchers (doctors or nurses) will explain the details of the study to you and answer all of your questions and concerns.

You are then given a written consent form to sign. While consent forms are not all the same, they should include the following:

The reason for the study (what the researchers hope to find out)
Who is eligible to take part in the study
What is known about the new type of treatment
The possible risks and benefits of the new treatment
(based on what is known so far)
Alternative treatments that may be an option for you
The design of the study (whether it is randomized, double blinded, etc.)
How many and what types of tests and doctor’s visits are involved
Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.) and for the costs if you need additional care as a result of the clinical trial
A statement about how your identity will be protected
A statement about the voluntary nature of the study and your right to leave the study at any time without fear of compromised -care
Contact information if you have further questions
Before you sign the consent form, ask questions. Be sure someone from the research team goes over the form with you in detail. Efforts are made to make consent forms as understandable as possible, but there still may be terms or ideas that are confusing to you. You may want to bring someone along with you to the meeting to make sure all your concerns are addressed.

Be sure you understand what is involved and what is expected of you. You may want to explain what you heard back to your doctor or nurse to make sure you got it right. Recent surveys have shown that while most people are satisfied with the informed consent process, over half do not understand some of the main points on the consent form.

Finally, don’t be rushed into making a decision. Take the consent form home with you if needed. Get opinions from trusted family members and friends. If possible, you may want to get a second opinion from another doctor as well.

whats in here for me...