Clinical Trials
Clinical Trial Participants: How to Obtain Informed Consent
Before enrolling in a clinical trial, human subjects must sign a consent form that details the nature of the study and the types of risks involved. One survey conducted by CenterWatch determined that 30% of participants did not understand that their study could pose additional risks, and 70% did not know what questions to… Read More »
Institutional Review Boards for Clinical Trials
In the United States, clinical trials are reviewed and approved by institutional review boards (“IRBs”). IRBs are most often composed of physicians, scientists, and lay people. They review study protocols and consent documents in order to make sure that the participants’ rights are protected, and that the particular study does not pose a burdensome… Read More »
How to Avoid a Clinical Trial Liability Lawsuit
Over the past few years, litigation against the clinical trial industry has significantly increased. The most well-known suit was filed against the University of Pennsylvania by the family of Jesse Gelsinger, an 18-year-old man who died after participating in a 1999 gene therapy trial. Later information revealed that the investigator in charge of the trial… Read More »
