Patient Safety During Research Trials
Your safety and rights are protected during clinical trials
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
- Confidentiality
- 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.
Interested in participating in our clinical trials
and research studies?
If you would like to be a part of our clinical trials
and research studies, please see our list of active
clinical trials and contact
us. We look forward to
serving you.