Informed Consent Forms With Clinical Trials – What Is This?
Posted Jun 02 2010 8:54am
An informed consent is what you sign to begin participation in a trial. This goes over your rights and gives you the benefits and risks of a trial. As Dan says, 25 pages or longer can be required.
Next Dan goes over the 3 most important areas in the video below. Institutional review board is a number where you can communicate and a 24 hour emergency line is provided, aka the IRB.
Clinical trials under the rights portion informs you that it is not truly medical treatment, but rather a trial to collect data and also informs the participant that there are other choices outside a trial for treatment, in other words the legal side covered. This is one good reason to have a PHR handy when signing up for a study. BD
The informed consent is the most important document that a study volunteer will ever sign while participating in a clinical trial. These forms may be somewhat intimidating and could be up to 30 or more pages. Don’t let that scare you or frustrate you! I have broken down these consent forms and found that they ALL have 3 common characteristics, regardless of the trial. 1.) What the study is all about 2.) Contact Info for Study Staff and Ethics Committees 3.) Your Rights