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To many, the term "informed consent" can sound intimidating. Literally, the Informed Consent is a document that says you fully understand and agree to participate in a clinical research study. Yet, it is much more than a document; it is a process that must be conducted per the laws on research. This process is put in place to protect the safety and rights of each person who chooses to participate in a clinical research study.
Informed consent is a voluntary agreement to participate in a clinical research study. Once a participant has met all required study criteria, the consent process must take place before enrollment. The document must include enough information for the participant to make an informed decision about whether to participate. This information will consist of why the study is being conducted, what procedures will be done, the length of the study and that participation is voluntary. Some additional examples of information found in the informed consent document are:
A study staff member, such as the clinical research coordinator (CRC), will conduct the informed consent interview. They will review the document in detail, line by line, with the potential participant. They must give enough time for the person to review and understand the document, along with answering any questions that may arise. If a person wants to discuss the material with their healthcare provider, and spouse or loved one, they will be allowed as much time as they need. The study personnel may ask consent related questions to make sure the person has a full understanding.
The study staff will also inform the participant of their ability to withdraw consent at any time, even if all visits have not been completed. Additionally, any updates on study protocol, procedures, or risks during the study duration will require participants to be reinformed and sign an updated consent. To read more information about the informed consent process, feel free to visit the FDA website.
At Centex Studies, we recognize that volunteers are the lifeline of our business and every clinical research study. If you would like to speak with someone about questions regarding the clinical research process, our experienced study staff would love to help. Contact a member of our team at (281) 918-0048 or view our list of currently enrolling studies here.
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