What legal protections are available to those involved in clinical trials?

In Florida, those involved in clinical trials are subject to varying legal protections provided by both state and federal laws. Clinical trials are heavily regulated in order to protect the safety of participants and the integrity of the research. At the federal level, clinical trials must adhere to the regulations set forth by the Food and Drug Administration (FDA). This includes a number of requirements such as disclosing the proper information concerning the risk of participating in the trial, obtaining written consent from the participant, and protecting the confidential information of the participant. At the state level, Florida has enacted a number of laws and regulations to protect the safety and welfare of participants in clinical trials. These laws and regulations establish standards of conduct under which clinical trial sponsors, researchers and institutions must abide. For example, the Institutional Review Board must approve clinical trials performed in the state and informed consent must be obtained from potential participants. In addition, those involved in clinical trials are protected by the Florida Civil Rights Act, which prohibits discrimination on the basis of race, color, religion, national origin, sex, and disability. This law provides potential participants in clinical trials with greater protection from potential discrimination in the selection of the participants. Overall, clinical trials in Florida are subject to numerous legal protections from both state and federal laws, providing potential participants with greater peace of mind knowing that their safety and welfare is being taken seriously throughout the trial.

What legal protections are available to those involved in clinical trials?

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