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At The Eye Center of North Florida, it is our commitment to stay on the leading edge of eye care. One of the many ways in which we are successful at that, is by participating in physician controlled clinical research studies.
By choosing to participate in one of our clinical research studies:
- You will have access to the leading treatments that may not be generally available.
- You will receive all study-related doctor visits, diagnostic testing, and study treatments at no charge to you or your insurance company. If surgery is required as part of the study, insurance will be billed for the surgery only.
- You will be part of a higher level of care and have repeated access to the physician conducting the study.
- You may be compensated for travel expenses after completing a study.
- If you are interested in participating in one of our clinical studies, it is important to understand:
- You will be contacted by our Research team when we have a study that seems to be well-suited to your ophthalmic condition.
- You will be evaluated to make sure you qualify for the trial. This typically involves a series of questions during a phone call with our clinical study coordinator. Sometimes, we need you to come in to our office so we can do further visual testing to ensure you meet the guidelines of the study. Any testing will be completed at no expense to you.
- If you meet the guidelines for this particular clinical trial, you will meet with our clinical study coordinator.
- Our study coordinator will explain all of the information about this study, including treatment details, risks, benefits and your rights as a research volunteer. You will also be able to ask any questions you may have. If you would like, the physician conducting the study will also be available to discuss any aspects of the study. They can also clarify what you are consenting to as a participant in this study. We want to make sure you completely understand what it will be like to be in this study, as well as the pros and cons of participating.
- Once you completely understand the study and have any questions answered, you will need to decide if you want to participate. If you wish to proceed, we will ask you to sign a legal document indicating you fully understand the study, what we expect of you, and the potential risks and benefits. This document is called the Informed Consent.
- After signing the Informed Consent, you are officially enrolled in the study.
- You will have frequent contact with our clinical study coordinator and our physician who is in charge of the study. They will monitor you closely, keep you well informed, and coordinate any of your office visits.
- When you participate in one of our clinical studies, your eye health will be our foremost priority. Your vision will be in well trained competent hands. Our entire research team is certified in the Protection of Human Services in Clinical Studies and maintain strict adherence to Good Clinical Practice.
- Your safety will also be closely monitored by both the FDA and an independent Institutional Review Board (IRB). The IRB must approve the study and the Informed Consent document. This is to ensure the study is necessary, does not put participants at undue risk, and protects the patient’s safety. The IRB also carefully scrutinizes and frequently monitors every clinical study throughout the entire process. IRBs can stop studies early if unexpected affects occur or if the study is not proceeding as planned.
This information in no way obligates participation in a study. We respect your privacy. All information will be kept confidential, will only be used by only by The Eye Center of North Florida, and will be covered by rules outlined in HIPPA and FDA Protection of Human Subjects Regulations. Information may be changed or deleted by emailing [email protected]
