According to the Pennsylvania Patient Bill of Rights, 55 Pa. Code 5100.54 (Article VI.2(d)):No patient can be the subject of any research, unless conducted in strict compliance with Federal regulations on the protection of human subjects. Patients considered for research approved by the facility will receive and understand a full explanation of the nature of the research, the expected benefit, and the potential risk involved. Copies of the Federal regulations will be made available to patients involved in, or considering becoming involved in, research or their advocates. Patient research conducted in State facilities or funded by State monies requires prior approval of the Deputy Secretary of Mental Health.
Researchers proposing to conduct research in such facilities should detail in their protocols how they will comply with these requirements and will include a copy of any necessary approvals from the state.