Several federal government agencies, including the FDA, oversee the conduct of clinical research in the United States. The following are some of the actions that have been taken to protect patient safety:
Institutional Review Boards (IRB) must review and approve each study and each study site. Their job is to protect the rights and safety of research participants. IRBs are made up of physicians, scientists, and non-medical members of the community. They have the authority to approve, modify, or stop any study at any time based on all available information about its safety. Among other things, the IRB reviews and approves the Informed Consent Form.
The Informed Consent Form is key for the protection of the rights and welfare of each research participant. The informed consent form explains everything you need to know about the study. You should read it carefully and ask as many questions as you need to fully understand what it says. The informed consent will explain about the study drug, describe the procedures that are part of the study and explain any risks involved. It is your right to be fully informed about the study before you give consent to participate.
Privacy Rule under HIPAA
The US government created the Privacy Rule to protect your personal health information from being used or shared. You may have signed a HIPAA form at your doctor's office. In the same way, you will be asked to sign a HIPAA authorization form before you participate in this study. This form will explain what health information will be collected from you and how that information will be used.
The research team will need to use your health information to carefully manage your participation in this study.
