The plaintiff in the case of Shinal v. Toms sued her neurosurgeon after a surgical complication caused her to suffer a stroke, permanent brain injury, and partial vision loss. The malpractice suit was based on lack of informed consent. The Informed Consent Form (ICF) that Ms. Shinal signed with the Physician Assistant did not explain the differences in risk between a partial removal and a more aggressive complete removal of her benign brain tumor. Ms. Shinal claims that she would have decided on the less aggressive partial removal had she understood the difference in risks during the informed consent process.
Although the lower court ruled in favor of Dr. Toms, Ms. Shinal appealed to the Pennsylvania Supreme Court. In a reversal, the Court ruled that it is exclusively the physician’s duty to provide the information necessary to obtain informed consent and that this is not a task that can be delegated. The Court stated, “… we hold 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.” (Shinal v. Toms Appeal p. 40)
As part of the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act of 2002, Pennsylvania Statute 40 § 1303.504.504(a) (Informed consent) states:
“… 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:
(1) Performing surgery, including the related administration of anesthesia.
(2) Administering radiation or chemotherapy.
(3) Administering a blood transfusion.
(4) Inserting a surgical device or appliance.
(5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.” 40 P.S. § 1303.504(a)
What does that mean for the informed consent process for clinical trials?
Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard. It is clear from the wording of MCARE that a Nurse Practitioner or Physician Assistant would not be considered eligible to directly obtain informed consent. What is unclear, however, is whether an Investigator may delegate consent to a sub-Investigator who is a physician.
Opponents to the law are concerned that requiring the Investigator to conduct the informed consent process instead of delegating to their study coordinator could slow down enrollment drastically and place an undue burden on their already heavy schedules. However, a medically qualified individual should be present to answer questions that the study coordinator may not be qualified to do. This law ensures the oversight of the Investigator as required by FDA regulations and The Statement of Investigator.
Several Pennsylvania health organizations are studying the impact the Pennsylvania Supreme Court ruling will have on PA’s healthcare systems and are looking into possible new legislation changes to mitigate the impact. Perhaps these health organizations will prove successful in providing suggestions or legislative clarification for the clinical trials consent process.
-The Clinical Pathways Team and Jennifer Lawyer