For those who are new the clinical trials, the process begins with verifying the individual eligibility and discussing the volunteer experience and establishing consent for participation. The Informed Consent form is particularly important because the study volunteer must receive and fully comprehend information pertinent to the study before moving forward with enrollment.
The FDA mandates that prior to every clinical trial, all volunteers must give their consent to participate, either verbally or via written signature. The information contained in the informed consent form typically includes the study duration, the study methodology, any potential risks or benefits, timeline, participant confidentiality and healthcare coverage during the course of the study.
Why do researchers ask for a volunteer’s informed consent before he or she participates in a clinical study?
Researchers work to ensure every study volunteer makes an educated decision about his or her involvement in a given study. Every person has the right to fully understand the study they are signing up for, regardless of race, gender, age or background.
The discussion between the clinic staff member and trial participant provides an opportunity to address any questions and inform the individual. Clinical studies can often extend months, and it is important the patient fully digests the scope of their role. A signed patient authorization accompanies the Informed consent. This provides additional documentation of the individual’s agreement.
At the Orlando Clinical Research Center, we prioritize study volunteer’s comfort. Medical lab professionals receive extensive training to operat our state-of-the-art safety monitoring equipment. We explain our methodology to every participant. We also pride ourselves on the policies we put into place to keep everyone safe — both our staff, and study volunteers.
If you are interested in participating, please tell us a little more about yourself in the Current studies section of the home page and we will respond to you to determine your eligibility for current and future studies.