Below is a list of Frequently Asked Questions for Research.
Each study defines a certain population of people by using customized inclusion and exclusion criteria. Inclusion and exclusion criteria are based on many factors, including age, medical history and current medical conditions. Study coordinators can often provide preliminary information over the phone regarding eligibility, but the best way to determine eligibility is by completing an examination with one of the physicians involved in the study.
Patients generally participate in clinical studies because they hope to benefit from the investigational use of a new procedure and because they want to contribute to research efforts that help find new methods to improve vision. Talk to your physician to determine if a clinical study may be right for you.
Some clinical studies do offer price reductions over the comparable standard treatments. The study sponsor, Minnesota Eye Consultants, and/or the participant may pay some of the costs associated with a clinical study. Before participation in a clinical study, a research coordinator will explain all related costs.
The first priority is meeting your health care needs. As a research participant, your responsibilities are to:
Clinical studies conducted at Minnesota Eye Consultants are monitored by an Institutional Review Board (IRB) that is charged with the protection of the rights and welfare of research participants. The purpose of an IRB is to ensure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of individuals who participate in research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., consent documents and participant handouts). Before enrolling in a clinical study, patients will receive a consent document that details information about the research, the procedures involved, the number of visits expected, potential risks and benefits, confidentiality of participation, alternative treatments, the voluntary nature of participation, compensation and study contact information.
People who volunteer to participate in a research study or clinical trial need to understand what is expected of them and why the research is being done. As you think about whether or not to volunteer, it is important that you know that you have rights in place to help protect you. These rights, listed below, will be further explained as you read the study informed consent document.
If you are asked to participate in a research study, you have the right to:
Most medical research begins with studies in test tubes and animals to establish whether or not a technology is feasible enough to warrant further research and to establish a general safety profile. These types of studies are called preclinical studies and are generally conducted in a laboratory environment or animal treatment facility.
Promising technologies may then be applied to human subjects. These types of studies are called clinical studies. Clinical studies are well controlled, usually involve only a select group of doctors, and participants must meet a specific list of requirements in order to participate. Data from clinical studies help doctors determine whether a new technology is safe, effective, and/or better than other technologies. Those technologies that are proven to be safe and effective in a clinical study may go on to receive FDA approval for use in the United States, which then extends the new technology to doctors and patients throughout the nation.