What to Expect - Diabetes Clinical Trials

When you volunteer to participate in clinical trials through OU Health Harold Hamm Diabetes Center in Oklahoma City and Tulsa, your safety takes priority as the highest concern. Researchers at the Diabetes Center and the federal government follow strict rules for compliance at all levels.

Safety, Approval & Monitoring

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and worth any potential benefits. The IRB, a committee of physicians, statisticians, patient advocates and other members of the community, reviews the protocol, or study plan, to ensure the study is ethical and participants are not likely to be harmed. If a study appears to cause unexpected harm to participants, or if evidence shows the risks outweigh the benefits, the IRB is empowered to stop the study.

In addition, researchers and physicians conducting a clinical trial, including those of us at Harold Hamm Diabetes Center, are bound by strict rules designed, monitored and enforced by the National Institutes of Health (NIH) and the Federal Drug Administration (FDA). Any breach of these rules could result in serious consequences for the researchers, up to and including criminal prosecution. There is always an approved protocol associated with every trial, and we are required to follow it exactly as written.

Trial Enrollment Process

First, we’ll ask you several questions about your health and will typically schedule an appointment with you to conduct a screening. The data we collect from you helps determine whether you’re eligible to enroll in one or more of our current studies.

After we determine you’re eligible to participate, you have the opportunity to decide whether you want to. The decision to volunteer in a clinical trial is a very personal one. However, there are guidelines to protect study participants. Testing in humans is permitted only in volunteers who have been briefed about the purpose of the study as well as the potential benefits and hazards of trial participation. This is called informed consent. It is the responsibility of the trial’s medical team to explain the risks to potential study participants.

You’ll receive an informed-consent form with detailed information about the study, including its length, the number of visits required, medical procedures and medications included. It also explains expected outcomes, potential benefits and possible risks. The IRB provides these forms, so every study participant, no matter where they are in the world, has identical information.

Take time with the informed-consent form and discuss trial participation with your physician and family. To guide your decision process, the NIH developed the following questions, which your Diabetes Center trial coordinator and your personal physician can help you answer:

• What is the purpose of the study?
• What is required of me?
• What is my role in the study? Am I a healthy volunteer or a patient volunteer?
• Will the study directly benefit me?
• Will the study benefit others?
• Are there risks? If so, what are they and what are the chances that they will occur?
• What discomforts are involved?
• What is the total time involved?
• Are there other inconveniences?
• Have I discussed participation in the study with those who are important to me, such as family and friends?
• Do I wish to participate in this study?

Be sure you feel comfortable with your answers before signing the informed-consent form.

What if I enroll and then change my mind?

The informed-consent form is not a contract. Your participation is 100% voluntary, start to finish. You may leave a study at any time for any reason.

Why should I volunteer for clinical trials at Harold Hamm Diabetes Center?

With a variety of trial sites available, your participation here offers several benefits.

At Harold Hamm Diabetes Center – a center of excellence at the University of Oklahoma – our academic research component carries significant weight among the worldwide clinical trials community. Many diabetes-related studies choose only a few sites in the world, based on their specialized diabetes expertise. Our center commonly ranks highly among these select few.

Also, when you’re a clinical trial volunteer at the Diabetes Center, you’re in the care of diabetes professionals, not just medical professionals. All of our staff undergoes intensive, ongoing training in diabetes and its complications. We go the extra mile to leverage your clinical trial as part of your life-long diabetes treatment, not simply a temporary investigation. We want you to feel comfortable and grow healthier while you’re with us. At the Diabetes Center, you’re surrounded by exceptional diabetes patient-care resources, should you ever need them.

Clinical Trials in Oklahoma City & Tulsa

Take the first step toward participating in a clinical trial at Harold Hamm Diabetes Center in Oklahoma City by enrolling in our Volunteer Registry. Once you join the Registry, you’ll receive up-to-date information on clinical trials of potential interest to you, with no obligation to participate.