Your safety and rights are essential to conducting a clinical trial. Our highly qualified, board certified physicians monitor and manage every aspect of a clinical trial and are responsible for following the strict guidelines outlined by the FDA (Food and Drug Administration). These FDA guidelines are set to ensure the safety of the volunteers and the accuracy of the tests.
Each clinical trial and research study is reviewed and monitored by an Institutional Review Board (IRB). The IRB is comprised of scientists, doctors and other local healthcare professionals who oversee our facility. The IRB ensures that the medical trial is done correctly and that volunteers are treated fairly and not subjected to undue risk.
If you are interested in volunteering for a clinical trial or research study, you will be asked to sign an informed consent form. Informed consent is required by the FDA and is an important part of the clinical trial process. Informed consent gives you comprehensive information about the clinical trial before you agree to participate. Informed consent provides you full disclosure of:
- What the clinical trial involves
- The purpose of the clinical research
- The known and possible unknown risks, side effects, discomforts and benefit
- The estimated length of the clinical trial
- Your rights as a volunteer
- Contact information for the duration of the study
By signing the informed consent form, you are acknowledging that you have received the clinical trial information and that you understand it. Informed consent is not a contract and you can leave the clinical trial at any time for any reason. Informed consent protects your rights and encourages a dialogue between you and the healthcare professionals who will be administering the clinical trial. If you do not understand any of what is written on the informed consent form, one of our LICRA healthcare professionals will be happy to explain it to you in further detail.
As a volunteer you will be monitored from start to finish. If any problems should arise during the clinical trial, our physicians are on call 24-hours a day, 7 days a week.