Who can participate in a clinical study?
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.
Why should I consider participating in a clinical 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.
Are there financial considerations for participating in a clinical study?
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.
What is my responsibility as a research participant?
The first priority is meeting your health care needs. As a research participant, your responsibilities are to:
- Provide a complete and accurate medical history.
- Follow the instructions and advice of your research team.
- Inform your research team if you do not understand information about the study.
- Communicate changes in your medical condition.
- Attend all follow-up study visits as required by the study protocol
How are research participants protected?
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.
What are my rights as a research participant?
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:
- Be told the purpose and details of the research study.
- Have the drugs or devices (tools or pieces of equipment) used in the research study described.
- Have the procedures of the research study and what is expected of you explained.
- Have the risks, dangers, and discomforts of the research study described.
- Have the benefits and advantages of the research study described.
- Be told of other drugs, devices or procedures (and their risks and benefits) that may be helpful to you.
- Be told of medical treatment available to you should you be injured because of the research study.
- Have a chance to ask questions about the research study.
- Quit the research study at any time without it affecting your future treatment.
- Have enough time to decide whether or not to take part in the research study and to make that decision without feeling forced or required to participate.
- Be given a copy of the signed and dated informed consent form.
What are preclinical and clinical studies?
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.