Treating physicians in Pennsylvania may once again delegate the responsibility to qualified practitioners for obtaining patients’ informed consent, per Governor Tom Wolf’s approval of SB 425, which was signed into law on June 30, 2021. Effective immediately, Act 61 of 2021 (“Act 61”) amends Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act to clarify who is responsible for obtaining a patient’s informed consent before conducting certain procedures.
Pennsylvania physicians had originally been permitted to delegate the responsibility to qualified staff to provide information to patients needed to obtain informed consent before conducting certain procedures. Then, in June 2017, the Pennsylvania Supreme Court issued a decision in Shinal v. Toms that set new precedent for obtaining informed consent, much to the chagrin of physicians, other providers, and health care organizations. The Pennsylvania Supreme Court held that physicians have a non-delegable duty under the MCARE Act to provide sufficient information to patients in order to obtain a patient’s informed consent in advance of medical procedures. Soon after the Shinal decision was issued, the medical provider and health care community began working on a solution to address the decision’s unintended consequences and impact on provision of patient care.
For example, as noted by the Pennsylvania Association of Nurse Anesthetists, certified registered nurse anesthetists, especially those working without physician anesthesiologists, were no longer permitted to obtain informed consent from patients for anesthesia. Surgeons, who were not anesthesia experts, were now responsible for speaking to patients about anesthesia care, answering questions, and obtaining their consent. Anesthesiologists had to be pulled off other tasks to obtain informed consent, affecting work flows for patient care. Further, in the context of clinical research, federal regulations governing human subjects research and obtaining informed consent have long permitted delegation of informed consent. In the wake of Shinal, informed consent forms for research and related policies and procedures had to be reworked to reflect the non-delegable duty of physicians.
Act 61 does the following:
- Clarifies that while physicians remain responsible for the overall care of their patients, the task of obtaining a patient’s informed consent may be delegated by a physician to a “qualified practitioner.”
- Qualified practitioners include physician assistants, certified registered nurse practitioners, midwives or nurse midwives, and registered nurses (acting within their scope of practice to perform the procedure as delegated by the physician or a registered nurse authorized to administer anesthesia), as well as another physician and a physician participating in a medical residency or fellowship training program.
- Allows health care facilities and physicians to develop policies and procedures regarding informed consent regarding when qualified practitioners other than physicians may obtain informed consent.
- Allows physicians and other qualified practitioners to rely on information provided by another qualified practitioner to obtain the informed consent of the patient and allows this information to be used as evidence in a proceeding where it is alleged that the physician or other qualified practitioner failed to obtain informed consent.
- Provides a “human research exception,” that deems MCARE Act consent requirements met if informed consent is obtained for human research conducted pursuant to approval by an institutional review board or similar entity in accordance with 21 CFR Pt. 50 (relating to protection of human subjects), 45 CFR Pt. 46 (relating to protection of human subjects) and any other applicable Federal laws and regulations.
Health care providers should review their informed consent forms and processes and make any changes necessary to informed consent policies and procedures to reflect the delegation permitted under Act 61. SB 425’s sponsor, Sen. John Gordner, R-Columbia, stated in his co-sponsorship memo that the Shinal decision placed a substantial burden on doctors, hampering “the concept of team-based care” and ignoring the “realities of present-day health care,” as well as taking away a “physician’s medical expertise and judgment in determining how best to serve his or her patients.” Act 61 will help improve efficiency of day-to-day operations, and allow physicians and qualified practitioners to work more cohesively to provide patient care.
 The procedures are: performing surgery, including the related administration of anesthesia; administering radiation or chemotherapy; administering a blood transfusion; inserting a surgical device or appliance; and administering an experimental medication, using an experimental device or using an approved mediation or device in an experimental manner. See 40 P.S. §1303.54(a).