Every state has their own variation of a Bill of Rights for people who participate in clinical trials. I happen to live and work in California, so I have posted the CA Bill of Rights for you to view below this video. No matter what state you live in, research clinics must follow Good Clinical Practice which the FDA (Food and Drug Administration) enforces. Good Clinical Practice guidelines pretty much have these Bill of Rights covered as well. In this video, I explain what your rights are when participating in a study. It’s your job to be informed, and I hope this helps!
Here are the Bill of Rights:
Experimental Research Subject’s Bill of Rights
California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to:
1.
Be informed of the nature and purpose of the experiment.
2.
Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
3.
Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
4.
Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
5.
Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
6.
Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
7.
Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
8.
Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
9.
Be given a copy of the signed and dated written consent form.
10.
Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.













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August 19, 2010 at 5:26 am
Certainly concur with just what you said. Your explanation was certainly the easiest to comprehend. I tell you, I usually get annoyed any time individuals discuss issues that these people plainly do not know about. You managed to strike the nail on the head and spelled out the whole thing without problem. Maybe, folks could get a sign. Will more than likely be back again to get more. Cheers
Holly
May 31, 2011 at 11:37 am
Should the Bill of Rights be discussed with the subject before the informed consent takes place? Or it doesnt matter which one preceeds the other.
Administrator
May 31, 2011 at 3:49 pm
Bill of Rights, has recently been required to be conducted first before any other consent form. We’ll do a video on this shortly.
Administrator
June 4, 2011 at 12:52 pm
here’s a follow up video to your question about Bill of Rights that we did
http://www.youtube.com/watch?v=LjdDX_1cJII