Researchers and sponsors/CROs of biomedical research conducted at locations in Pennsylvania are encouraged to assess the impact of a recent ruling of The Supreme Court of Pennsylvania on informed consent practices. The Court’s June 20, 2017 holding in Shinal v. Toms provided that
“a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. Informed consent requires direct communication between physician and patient, and contemplates a back -and -forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.”
Pennsylvania’s Medical Care Availability and Reduction of Error (“MCARE”) Act provides, at Section 504, that
“except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures: … administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.”
The MCARE Act goes on to describe the circumstances under which informed consent occurs.
The Court, in reviewing the provisions of the MCARE Act, opined that under the Act’s language “the duty to obtain a patient’s informed consent for the several enumerated procedures…belongs to the physician.”
Because the opinion made a comparison between the physician providing information directly versus a patient receiving information from various sources, research teams may want to explore with their own legal counsel the ramifications of study-related information being provided by a non-physician research staff member in advance of the physician’s informed consent discussion with the subject. Because the opinion also specifically references a “face-to-face exchange,” sites may consider the extent to which telephonic support for the consent process has been or will continued to be relied upon.
Regarding consent documentation, the language of many consent forms already in use for ongoing research should allow for documentation of consent by a physician. However, sites may consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject. For sites initiating research projects in Pennsylvania moving forward, Sterling IRB’s administrative team is prepared to provide proactive supportive services to promote compliant consent documentation.
Sterling IRB is available to review any modifications in the consent documentation or study-related consent processes sites find necessary to be in compliance with the new state requirement. Sterling’s Modifications and Amendments Submission Form is available online via the Forms page.
The Supreme Court of Pennsylvania’s opinion in Shinal v. Toms is available in its entirety online via the Court’s website. The full text of Pennsylvania’s MCARE Act is available online via the Pennsylvania Department of Health’s website.
For additional information, please contact Sterling IRB at info@sterlingirb.com or (888) 636-1062.