Understanding Informed Consent

What You Need to Know Before Committing to a Clinical Trial

Informed Consent [by: Luke Scroggins]

Before receiving treatment in a clinical trial, the FDA requires that each patient sign an Informed Consent document stating that they understand and accept the expectations, risks, timelines, and compensations associated with that trial.

If you are like me, unfamiliar paperwork and medical forms can be intimidating. At one time or another we have all simply “scrolled to the bottom of the page, and checked the box.”

With an informed consent, however, it is extremely important that you as a patient understand exactly what is being asked of you, both for your safety, and the integrity of the research data.

When going through the Informed Consent, a research professional familiar with the study protocol will lead you one-on-one through a discussion about the process of the study, and answer any questions you may have.

Do not be shy! This is your time to ask questions, and it is important that you do!

Although it is the research professional’s job to go over everything on the Informed Consent, there are a few things you want to make sure you understand before signing. What is the timeline for the study? How often are the visits? What should you expect at each visit? What is being asked of you while you are at home? What are the risks? Is there any compensation?

You should only consent to participating in a study if you are fully informed about the study and you completely agree to all of the requirements. Patients who drop out and do not complete a study are not eligible for full compensation and their research data is compromised at great cost to the sponsors of the trial.

It benefits both you and the research team to be fully informed before committing to a study, so keep asking questions – we are here to help!

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