Editor’s Note: A recent Pennsylvania Supreme Court decision has ruled that physicians, not their delegates, should obtain consent for “…administering an experimental medication or device” (40 P.S. § 1303.504). It is unclear how this will impact obtaining consent in a research setting. ACRP reached out to Glenda Guest, vice president of Norwich Clinical Research Associates (NCRA) and member of the ACRP Association Board of Trustees, who offered some initial thoughts.
This ruling will have a major impact on how physicians across Pennsylvania obtain informed consent from their patients. In Shinal v. Toms M.D., 2017 WL 2655387 (Pa. June 20, 2017), the court ruled 4-3 that only physicians, not members of their staff, may obtain informed consent from patients before performing medical procedures.
Similar to the California Research Subject Bill of Rights requirement, the situation in Pennsylvania is another example of state-specific laws of which researchers must be aware because the laws are more restrictive than federal regulations regarding clinical trial informed consent. The decision could be overturned in future court decisions regarding the case, but right now, if one is conducting research in the Commonwealth of Pennsylvania, it appears that you must comply with this requirement. The Pennsylvania Supreme Court decision is not specific to only clinical research informed consent—it covers treatments specified in the Medical Care Availability and Reduction of Error (MCARE) Act—but it does include studies of experimental medications and devices.
The MCARE Act is being interpreted differently between the litigating parties in this case. The major issue appears to be whether a physician may rely on qualified staff to communicate information to patients as part of the informed consent process, in addition to their personal obligation to discuss the procedures and consent with the subject.
There have been two court decisions related to this case. In one decision, the court said that qualified support staff could be delegated the task of providing information to support informed consent, but it specifies that if they do not perform satisfactorily, the responsibility still ultimately resides with the physician. This is how consent is generally obtained in medical practice as well as research.
In the most recent decision, the court indicated that the physician is solely responsible for communication of all information and obtainment of informed consent.
Because the court decision results in a more restrictive requirement than the current clinical research regulations in effect at the federal level, clinical investigators in Pennsylvania should be personally obtaining informed consent until this decision weaves its way through further court proceedings. Because there is dissent in the interpretation of the MCARE Act, we can expect that this will proceed to a higher court on appeal.
Author: Guest Blogger Glenda Guest, CCRA, RQAP-GCP, TIACR, Vice President of Norwich Clinical Research Associates Ltd.