Our mission - improving, restoring and preserving sight - reflects the purpose of an academic medical center. We combine patient care, vision research and education to accomplish our mission. Research studies are an important part of our mission because they help us learn about the eye in its normal and altered state. This knowledge can lead to improved patient care, therapies and treatments.
Nearly all major medical advances arose through clinical trials. Clinical trials examine new ways to prevent, diagnose, or treat disease. Treatments might use new drugs or a new combination of drugs, new surgical procedures or devices, or new ways to use existing treatments. The ultimate goal of most clinical trials is to determine if the new test or treatment is safe and whether it works.
People participate in research for a number of reasons. Many people participate in order to help others and to contribute to moving our understanding of eye disease forward. Patients with an eye condition also might participate to help others in the future, but they may also participate to possibly receive the newest treatment and to have the additional care and attention from the research staff. Ultimately, the decision to participate in a research study is a personal one.
All research studies have rules about who can and cannot participate. These are referred to as inclusion and exclusion criteria. These criteria may include factors such as age, gender, the type and severity of eye disease, whether they have received any previous treatments, and whether they have any other medical conditions.
Many types of people can participate in research studies. While most people who participate have some type of eye disease, many studies also include healthy volunteers. A healthy volunteer is someone who has no significant health problems. When developing a new tool, such as a new retinal imaging device, healthy volunteers can help researchers learn how well the device works. In clinical trials, healthy volunteers might serve as controls - they would receive the same test, procedure, or drug the patient group receives. Researchers can then learn a great deal by comparing the patient group with the healthy volunteers.
All studies involving human research volunteers must be approved and monitored by an Institutional Review Board (IRB) to ensure that the volunteers who participate are treated ethically and are protected. An IRB is a committee that consists of medical professionals, non-medical professionals, and members of the community.
Before a potential research volunteer decides to participate in a study, it is important to ensure that they have been provided with all of the necessary information in order to make an informed decision. A member of the research team will explain the details of the study. They will review an informed consent document with you, which includes information about the purpose of the study, required procedures, and the potential risks and benefits associated with participating. This process of providing information will continue throughout the study.
If you decide to enroll in a study, the informed consent document will be signed. However, informed consent is not a contract. You are free to withdraw from the study at any time. If you decide to leave a study, you will not be penalized and will still be able to receive standard treatment appropriate for your eye condition.