What legal protections are available to those involved in clinical trials?
In Virginia, individuals participating in clinical trials are afforded certain legal protections to ensure their rights and safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), any clinical trial protocols must be reviewed and approved by an Institutional Review Board (IRB). An IRB is a panel of medical and non-medical professionals that ensure the safety and rights of trial participants by approving the protocol and any changes made throughout the trial. Additionally, certain legal provisions protect the rights of patients enrolled in clinical trials. These include the National Research Act of 1974, which requires informed consent from participants, meaning that they must be fully informed of all potential risks before agreeing to any trial protocol. Furthermore, the FDA can revoke approval of any trial if it is deemed to put patients in undue risk. Finally, the Health Insurance Portability and Accountability Act (HIPAA) of 1996 provides protection to clinical trial participants by ensuring their privacy in regards to any related health information. With HIPAA, participants have the right to access, inspect, and copy any records pertaining to their trial participation. These legal protections are in place to ensure the safety and rights of clinical trial participants in Virginia. Ensuring that participants are aware of their rights and the potential risks they might face is essential in protecting them and keeping clinical trials safe and ethical.
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