Informed Consent: Liability Risks Greater for Sites Than Sponsors

As the “owners” of informed consent forms, sites are more prone to liability risks than sponsors. “At the end of the day, it’s their form, their name, their hospital or academic medical center,” Mark Rogers, an attorney with the Rogers Law Firm, said at a recent FDAnews webinar. “They will have final sign-off approval, so there’s more of a liability exposure for study sites than for sponsors.”
Clinical Trials Advisor