Becoming a Research Volunteer What Your Participation Means to Medicine, The Community, and You
Which Works Best? You Decide What Is Clinical Research? Research is the scientific process of finding out what new therapies (medications or medical devices) work safely, if they work better than standard therapies, what dosage/application works best, and what side effects have been observed. Successful clinical research leads to drug and device manufacturers gaining approval by the U.S. FDA to market their products to consumers: to us. All medications and medical devices currently available (by prescription or over-the-counter [OTC]) have been required by law to successfully complete clinical trials... with volunteers like you. Volunteers play the most important role of all. Without you, medical advances don’t happen.
Know This • Clinical research answers a scientific question. • Scientists perform research to turn their discoveries into new, cutting-edge therapies. • Other terms for “research” include clinical trials, clinical studies, experiments, or protocols. • Participating in research is not the same as standard treatment. Research is still being tested and is under review, but standard treatment is already FDA-approved and is in your pharmacy.
What About Risk? Of course it exists. But let’s put it in perspective. Risk is part of everyday life. But obtaining as much information as possible beforehand can minimize that risk. As a research participant, you can expect open discussion in plain language, and all concerns explained in a manner that makes sense to you. Understand these terms:
Patient Protection: Volunteers in clinical research are protected by federal law, and the industry is watched more closely than ever.
Randomization: To prevent study bias, neither you nor study staff will know which medication you will get of the treatments being compared.
Placebo: As a healthy volunteer, you may get either
a ‘sugar pill’ or the test drug. If you have the illness being researched, you’ll get either the latest standard therapy, or the new drug being studied, but you always receive some form of treatment.
Side effect: Everything we consume has one, but
your body’s reaction is closely monitored when you participate in a study. From the start, you are made aware of all possible reactions currently known. We’re happy to clarify anything you want to know. Knowledge is power and options can be life-altering. The biggest risk is never finding out.
The Facts Research discoveries improve our lives. Period. Research volunteers are heroes. Period. Clinical research moves us forward and improves the treatment choices we have. It’s on the front lines bringing us new discoveries that would never be possible without human volunteers who test it. But before deciding to volunteer, get the facts. Ask questions about what is expected from you, and what you can expect from your participation. Ask about the procedures involved, as well as how often you have to show up, any restrictions to normal activities, and what compensation you will receive for participating in a clinical study.
Bottom line, it’s your decision. • The risks and benefis must be made plain to you • Your rights and privacy are protected by law • All studies are closely monitored and regulated • You are free to say ‘no’ or ‘bye’ at any time
VESTED INTEREST At some point, you or a family member may want to participate in a clinical study. Sometimes, participation in research can even have direct bearing on the future well-being of those we love. There is plenty of information that may help round up all the facts you need to make an informed decision. We can help identify potential studies of interest to you and walk you through the process. Even hold your hand. Peace of mind is paramount. We get it. We make ourselves available any time.
Generic Questions • What exactly will happen to me in the research? • Will there be any unpleasant side effects? • Will the research help me personally? • Why is this research important?
You have a right to know!
COLOR Disparities Minorities currently have higher rates of death and disease, but generally participate less often in clinical studies. These studies offer the answers that can change health outcomes and improve quality of life for more people, but only if more minorities participate. You can help. Minority participation is important since less is known about the effects of certain medications on minorities if, prior to approval, those studies did not include minorities.
We hope we’re clear on that. Let us know.
Why Participation in Research is Important Research has already led to important discoveries that make our lives better. Some examples include: • Drugs to treat cancer, diabetes & HIV/ AIDS • Ultrasound, X-ray, and other diagnostic tests • Vaccines that protect against disease • Improved medical procedures
Let’s keep it moving! Consider This... A research study may or may not help you personally, or even right now. But in the future, the study results could help you and many other people who need treatment for illness and disease.
For more information, contact: Clinical Ambassador LLC (919) 410-7783 www.clinicalambassador.com
Office for Human Research Protections Toll-Free (866) 447-4777 www.hhs.gov/ohrp email: firstname.lastname@example.org