Clinical trials and research studies continue to be at the forefront of modern medicine by providing the potential for life-saving treatment options for millions of patients. When a study participant experiences an adverse outcome, however, litigation sometimes occurs.
Clinical trial and research study litigation involves complicated legal questions related to bioethics, the informed consent process and whether the trial or study offers a direct benefit to its participants. Moreover, clinical trials and research involving children and other vulnerable populations often present additional challenges and face greater scrutiny.
At Waranch & Brown, our attorneys have over a decade of experience representing hospitals, research institutions and individual researchers/physicians at every stage of the litigation process. We have successfully counseled our clients on matters related to drafting and implementing research study protocol, obtaining institutional review board (“IRB”) approval, complying with federal agency requirements (including National Institutes of Health and the Office for Human Research Protections), drafting appropriate consent forms and effectively communicating the results of the research to study participants. We also work closely with principal investigators, bioethicists and other medical experts to successfully defend litigation involving clinical trials and research studies.
Please contact us if we may be of assistance in designing, implementing or defending your clinical trial or research study.