What is informed consent?
Informed consent is a written agreement that you or your representative signs indicating your willingness to participate in clinical research. This consent is only signed after you have been fully informed of the nature of that research. The FDA requires that every person involved in a clinical research study must provide consent in writing saying that you comprehend and agree to the potential risks involved.
Informed consent may not include any language that appears to free the research physician, the treatment’s manufacturer or the medical institution conducting the research from the normal standard of care for your well being. You should give consent only if you have had enough time to consider whether you wish to participate.
The informed consent process doesn’t just involve the signing of papers. It also requires asking many questions to ensure that you’re fully informed and prepared to make such an important decision. It is not only your right, but your responsibility as a participant in any clinical research study to provide your informed consent.