INVITATION TO PARTICIPATE
You are invited to participate in a research study to investigate the effect of LED light on Leber's Hereditary Optic Neuropathy (LHON). The study is titled: "The Effect of NIR-LED Treatment on an in Vitro Model of Leber's Hereditary Optic Neuropathy."
You are asked to participate in this study because you do not have LHON and thus can provide a healthy blood supply to compare with blood from LHON patients. Your participation in this study is voluntary. The research study will be under the direction of Dr. Harry Whelan in the department of neurology. Other doctors and professional staff persons may assist him in this study. The study is sponsored by the National Institute of Health (NIH). Dr. Whelan receives financial support from NIH to conduct the study.
The purpose of this study is to find out what effects (good and bad) the light-emitting diode (LED) device has on cells from patients with LHON. The LED device emits red light that may have beneficial effects on parts of the body. The study is conducted locally.
There will be 35-50 participants enrolled at this site. The research results will be used to determine in treatment with LED light can improve cell function in individuals with LHON, and thus if LED might be used as an LHON treatment.
You will have your blood drawn only once during your participation in the study. A total of ten milliliters (two teaspoons) of blood will be drawn through a needle stuck in your arm. The purpose of the procedure is to treat white blood cells from your blood with LED light and determine how they respond. Your participation in this study lasts only as long as is required for you to donate blood once. This should take less than one hour.
RISKS AND DISCOMFORTS
The known risks of the blood drawing procedure include bruising and infection. The frequency and severity of both risks are low, and both are treatable if they occur.
We hope to gather information that will help people in the future.
As a participant in this study, you will not be responsible for the costs of any study related activities such as clinic visits, tests, or procedures required for the study. The sponsor of this study will pay for any tests, examinations or other procedures that are done solely
for research purposes as previously described. You will not directly benefit from being in this study, but we hope the information learned is valuable to LHON patients in the future.
All study-related procedures will be paid for by the National Institute of Health.
PARTICIPATION IN THE STUDY
Your participation in the research study is entirely voluntary and you may discontinue your participation at any time. If you decide to withdraw from the study, your decision will have no impact on the quality of current or future medical care you receive, academic standing or job status. If you do decide to withdraw from the study, you should discuss this with the study doctor or research staff.
Dr. Whelan or the study sponsor, NIH, may stop your participation in the study at any time for any reason without your consent. This might happen because of new information that the study doctor or the sponsor learns about the safety or effectiveness of the study drug or device.
If you do not complete the study, you must notify Dr. Whelan that you cancel your permission for Dr. Whelan to use your blood for the study. You must notify Dr. Whelan in writing.
If any important new information is found during this study that may affect your desire to continue to participate in this study, you will be told about it right away. You can then decide if you want to continue your participation.
COMPENSATION FOR INJURIES
If an injury occurs as a direct result of your participation in the research, NIH, Froedtert Memorial Lutheran Hospital, and the Medical College of Wisconsin will not pay for the cost of medical treatment. This does not prevent you from attempting to recover these costs
through your insurance company or through the legal process.
If you believe that you are injured as a result of the research being performed, please immediately contact the research doctor, Dr. Whelan at (414) 266-7544.
If you have further questions about this study at any time, you are free to call Dr. Whelan at (414) 266-7544. If you have questions regarding your rights as a research participant, you may contact the MCW Human Research Protection Office Quality Assurance and Compliance Coordinator at 414-456-8844.