So, suppose you want to participate in a clinical trial. When you inquire for more information and decide to come in for a screen visit you will be asked to sign what is called an Informed Consent. But, what exactly is this piece of document?
An informed consent for a clinical trial is a document that explains the risks and benefits to a volunteer about participating in a clinical trial. It is important to read and understand the consent and have time to ask any questions prior to signing the document. The informed consent should be looked as a process where the participant should interact with the investigator and his delegates so all parties understand their responsibilities and rights.
This document is developed by the research institute following FDA guidelines and is reviewed and approved by the Institutional Review Board prior to the start of the subject recruitment process and modified if additional risks or adverse effects are added to the tested product. However, even if you initially sign this document you always have the chance to withdraw from the study at any given time for any reason.
The FDA guidance lists the elements that should be included in the consent and they include:
- A statement explaining that the study involves research and what the purpose of the trial is.
- It should list what occurs at each study visit and if any experimental procedures is involved.
- Description of any potential risks from participating in the study.
- Description of potential benefits to study participants as well and to individuals with similar medical issues not participating in the study.
- Disclosure of other potential alternative treatments to participating in the study.
- Statement about volunteers information and records will be kept confidential and the FDA can inspect the records
- Statement about whether compensation is available if an injury occurs to someone participating in a trial and what process to follow if a medical injury or side effect occurs.
- A statement describing who to contact for study related questions and who to contact in case of injury.
- A statement that research is voluntary and that an individual can discontinue their participation for any reason at anytime without a penalty.
- A statement that research may contain unforeseen risks to both, the participant and potentially to an unborn fetus.
- Circumstances by which a participant can be discontinued from a study without their consent.
- Any potential costs from participating in a study.
- Statement that any knew information that is learned will be disclosed to participants.
- Number of participants in the study.
There are many people that are skeptical about participating in clinical trials because of safety reasons. It is important to remember that the main concern for any study site is to keep subject safe at all times. In my next blog I will discuss more about your safety during these types of studies. Stay tune for more!
-Dr. Howard Schwartz M.D. – Gastroenterologist
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