As a researcher, how do I comply with the Pennsylvania Supreme Court ruling on informed consent?
The Pennsylvania Supreme Court’s ruling in Shinal v. Toms,1 states that physicians have a duty, which cannot be delegated, to disclose information required to obtain patients’ informed consent for procedures stipulated in the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act.2
Category (5) of the MCARE Act, which includes, “Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner,” may implicate procedures conducted within the context of research. While Quorum aims to assist sites with following local regulations, the principal investigator is ultimately responsible for complying with state laws. As such, we recommend that Pennsylvania investigators work with local experts and legal counsel to meet the requirements of the Court’s decision and the MCARE Act.