Clinical Trial Qualification: Informed Consent, Healthy Volunteers

December 08, 2022
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In part one of this two-part blog series, we went over some of the main reasons why participation in clinical trials is typically limited. There are some simple explanations for this, including the goal of targeting populations that adequately represent the groups who suffer from a given condition, and it’s important to know about these basics if you’re considering applying to become a trial participant.

At AGA Clinical Trials, we’re happy to offer numerous clinical trials currently enrolling, including resistant hypertension, blood devices, and many others. In today’s part two of our series, we’ll look at some additional factors that play an important role here: Informed consent and the participation of healthy volunteers in many trials.

The Role of Informed Consent

One very important element that must be in place before you can participate in any kind of clinical research trial is informed consent. This document outlines the basics of the study you’ll be participating in, including what will be expected of you and what risks may be involved. It’s vital that you read and understand this document completely before signing it and committing to participation in a trial.

It’s also important to remember that this document is not a contract, but rather is meant to protect you alone. It does not bind you to any specific outcome, and you can withdraw from the study at any time for any reason with no repercussions.

If you’re interested in learning more about our current clinical trials or about the process of informed consent, we encourage you to contact us at AGA Clinical Trials today.

Healthy Volunteers

For many clinical trials, a vital population that’s utilized consists of healthy volunteers. These individuals do not have the condition or disease that is being studied, but they are still essential to the process. Healthy volunteers typically participate in what are known as Phase I clinical trials. These studies are very important, as they help to determine the safety and tolerability of a new medication or treatment before it is ever used on patients.

While healthy volunteers may not have the condition being studied, they must still usually meet all of the other eligibility requirements for a given trial. In addition, it’s important to remember that even though these studies are considered to be very low risk, there is always some element of risk involved in any kind of clinical research trial.

For instance, if a given study is looking to ascertain whether a new medication will be effective for a specific condition within a given patient age range, researchers may utilize healthy volunteers of that age to test the medication’s tolerance. Allowing in healthy volunteers that are outside that age range, however, would skew the results of the study and would not be beneficial.

As with any other kind of clinical trial, healthy volunteers must provide their informed consent before participating. This document will outline the risks and expectations of the study in detail so that you can make an informed decision about whether or not to participate.

If you’re interested in learning more about qualification and eligibility for our current clinical trials in Miami, contact us at AGA Clinical Trials today. We’ll walk you through the process and help you to determine if participation is right for you. We’ll also ensure you’re up to speed on our current enrolling trials and which might be right for you, whether you suffer from a specific condition or are looking to become a healthy volunteer.

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