What is clinical research?
Clinical research is the study of disease, injury, and normal aging in humans as well as how those things are affected by medical treatments and interventions. The goal of clinical research is to identify the safest and most effective ways to improve patient outcomes. At UNC, our providers pride themselves on also being cutting edge research scientists which allows them to offer the most advanced care to our patients.
What types of research do we do?
There are many types of research studies, but the most common types that you will encounter in our orthopaedic department are observational studies and interventional studies.
- Observational Studies: these studies observe and document the outcomes of normal standard of care. Patients in an observational study receive exactly the same care as any other patient with the same condition but may have more information, such as patient questionnaires, collected to document the process.
- Interventional Studies: these studies evaluate the use of a new type of treatment such as a drug, device, or a technique. These include the types of studies called clinical trials in which a new treatment is being studied.
Who is conducting the research?
The majority of research is performed by a team but is led by the principal investigator (PI) who is the primary researcher for that study. Co-investigators or sub-investigators are other members of this team who help to conduct the research either by providing the treatment or documenting the results of it. Study coordinators are members of the team that manage all aspects of the study including likely being the person with whom you most often speak. They are key to helping the investigators keep the study going and ensuring that every step is completed.
What should I expect if I am asked to participate in a study?
If a member of our research team asks you to participate in a study, the first step is to review the informed consent with you. This is a time when the entire study is explained to you including what your participation requires and any possible risks of that participation. You will be allowed as much time as you want to ask questions and be comfortable with your decision to participate. When you are ready, you will be asked to sign an informed consent form which is a written version of the explanation that you just received. Informed consent forms have been carefully reviewed and approved by the Internal Review Board (IRB), a group dedicated to evaluating all studies to ensure that they are scientifically sound and protect the safety and privacy of the participants.
After signing the informed consent, you may start the study process outlined in the study protocol at any time. However, if at any point you decide that you no longer want to participate, you may withdrawal without concern for any change in your regular care.
Do I get paid for participating in a research study?
Some, but not all, studies do allow for some compensation for additional time spent that is specific to the study and considered to be outside of the time spent on normal patient care. This depends on the type of study and its sponsorship but will be outlined in the informed consent before you agree to participate.