PA Supreme Court Decision & Informed Consent

The Human Research Protection Office is aware of the recent Pennsylvania Supreme Court decision, Shinal v. Toms, in which the Court held that a physician's duty to obtain Informed Consent cannot be delegated.
Current HRPO policy states that research studies involving a drug, device or surgical procedure require a listed physician investigator to obtain the written informed consent unless the IRB grants an exception.  The Toms decision will not affect this policy. The HRPO will continue to operate under this policy and will consider exceptions that are not in conflict with the decision on a case by case basis. (HRPO Policies and Procedures, Chapter 13, Informed Consent and Documentation, Obtaining Consent)
ACGME fellows and residents will be able to obtain informed consent for research using the same rules that govern their ability to obtain consent in clinical care.