Clinical Research

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. They may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease.

When considering volunteering for a clinical trial, it is important to make an informed decision. Here are a few frequently asked questions to help you decide if a clinical research trial is right for you.

1. What can volunteers expect if they choose to participate?
2. What is informed consent?
3. What are my rights as a participant?
4. What are the benefits and risks of joining a trial?
5. Does information remain confidential and private?
6. What happens after the trial?

What can volunteers expect if they choose to participate?

In most clinical research trials, medical information will be collected, such as medical history, medications, dietary and lifestyle habits, environmental exposures, and family history. A detailed description of what is expected of you will be outlined in the informed consent form along with specific information about the clinical research trial.

What is Informed Consent?

Informed consent is the process by which a volunteer confirms their willingness to participate in a particular clinical research trial, after having been informed of all aspects of the clinical research trial that are relevant to the volunteer's decision to participate.

Your Rights as a Research Volunteer:

1. Be informed of the nature and purpose of the clinical research trial.
2. Be explained the procedures to be followed in the clinical research trial and any drug or device to be utilized.
3. Be given a description of any discomforts and risks reasonably to be expected from the clinical research trial.
4. Be explained any benefits to the subject reasonably to be expected from the clinical research trial, if applicable.
5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
6. Be informed of other medical treatment, if any, available to the subject after the clinical research trial if complications should arise.
7. Be given an opportunity to ask any questions concerning the clinical research trial or the procedures involved.
8. Be instructed that consent to participate in the medical clinical research trial may be withdrawn at any time and the subject may discontinue participation in the medical clinical research trial without prejudice.
9. Be given a copy of the signed and dated written consent form.
10. Be given the opportunity to decide to consent or not to consent to a medical clinical research trial without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the volunteer's decision.

What are the benefits and risks of joining a clinical research trial?

Every clinical research trial has its own unique set of risks and benefits involved and will be discussed during the Informed Consent Process.

Will my Protected Health Information (PHI) remain confidential?

Your Protected Health Information (PHI) used in a clinical research trial will be kept confidential, as required by federal and state laws.