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Research volunteers are partners in discovery.
Participating in a clinical trial may enable you to play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Research participants include healthy volunteers and patient volunteers.
A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research with healthy volunteers is designed to develop new knowledge, not to provide direct benefit to study participants. Healthy volunteers have always played a vital role in medical research.
A research volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a volunteer help develop new knowledge. These procedures may or may not benefit the study participants.
Do you have any questions about participating in a trial? Below are some sample questions you may be asking yourself...
- What happens in a clinical trial?
- What are the different types of trials?
- How are research participants kept safe?
- If I am in a trial, will it affect where I get my health care?
- Will it cost me anymore?
Answers to these questions may be found at:
Do you want to see what clinical trials are currently at UMDNJ?
Do you want to contact the Rutgers Clinical Research Organization to help you find a RBHS researcher or find a Rutgers clinical trial?
The Rutgers Clinical Research Organization can help you answer questions. Please contact us at firstname.lastname@example.org.
What is Informed Consent? (Excerpted from the U.S. Food and Drug Administration)
It is not just about reading and signing a form. It is part of a process to safeguard anyone who decides to participate in a clinical trial for its possible benefits and to help clinical researchers evaluate new medical practices and experimental treatments.
To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
- that the study involves research of an unproven drug or device
- the purpose of the research
- how long the study will take
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that FDA may look at study records, but the records will be kept secret
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study, your rights, or if you get hurt
- you can quit at any time.
Informed consents must be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.
Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.