“The clinical investigator is responsible … for ensuring that legally effective informed consent is obtained from each subject before that subject takes part in the clinical investigation.” FDA Informed Consent Information Sheet

A recent Pennsylvania state Supreme Court decision demonstrated how state protections for patients and research participants interact with federal protections. Federal guidelines say principal investigators (PIs) and their research teams must ensure that research participants understand what could happen during a study, but now in Pennsylvania that duty sometimes may rest solely with a physician. Although the ruling came from a case about an approved surgical procedure, the letter of Pennsylvania law suggests that the decision applies to investigators as well as clinical physicians.

The Pennsylvania case involved a surgery to remove a growing non-malignant brain tumor. The patient discussed the surgery with at least two people, including the surgeon, and signed a consent form. The surgeon then conducted the riskier of two procedures, after which severe complications set in. The medical team and the patient then disagreed on what the patient had understood about her choices and what she had consented to. The patient testified that she would have chosen the less risky procedure if she had understood the potential consequences sufficiently.

  • Medical Care Availability And Reduction Of Error (MCARE) Act

    Mar. 20, 2002, P.L. 154, No. 13 Cl. 40
    Section 504, Informed Consent

    (a) Duty of physicians.–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:

    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.

The Pennsylvania Supreme Court decision found that the surgeon who performed the procedure was responsible for explaining the surgery to the patient:

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.

While the Court’s opinion stemmed from a clinical procedure and much of the law in question applies to medical care, a portion of the MCARE Act does stretch to include physicians using “experimental” treatments and devices. Pennsylvania code defines experimental as “a procedure that deviates from customary standards of medical practice, is not routinely used in the medical or surgical treatment of a specific illness or condition, or is not of proven medical value.” Although not explicitly stated, it would be prudent to assume that, at a minimum, the decision applies to procedures involving administration of (approved or investigational) drugs and devices to human subjects for research purposes.

Pennsylvania sites and researchers now may wonder who must obtain informed consent during a research study, about what that informed consent process must include, and about who cannot assist with the process.

One possible interpretation of the Court’s opinion is that only the Principal Investigator (PI) of a study can provide sufficient information to the research participant to obtain informed consent. In this case the duties of personally conducting the consent discussion(s), of completing the associated forms, and of addressing all of a participant’s questions would fall on the PI.

However, the Court’s opinion also allows for the interpretation that any physician performing a procedure articulated in the MCARE Act must carry out all of the informed consent process. In a clinical trial, this potentially includes physicians other than the PI (e.g. sub-investigators), who may be tasked with administering investigational or approved drugs and/or medical devices to participants for research purposes.

Perhaps there is some flexibility in the majority’s opinion, if it intends that a physician is responsible only for the required elements of informed consent for research (those which are largely governed under federal laws). If so, other relevant, yet non-required, information could be delegated to the study staff to convey to the participant. However, deciphering where that divide may potentially occur, how the process unfolds, and achieving compliance would still fall to the PI.

The Court’s ruling remands the case for a new trial in a lower court, which leaves open the possibility of further modifications.  In the interim, Pennsylvania research sites (and their sponsors) should work with their local compliance departments, institutional officials, as well as regulatory experts to ensure that appropriate best practices are developed and implemented in accordance with this recent law.

 

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