Research Involving Subjects in Long Term Facilities

Commonwealth of Pennsylvania law specifies under 28 PA Code Section 201.29 (o): "Experimental research or treatment in a nursing home may not be carried out without the approval of the Department (i.e., PA Department of Health) and without the written approval of the resident after full disclosure.”  For the purposes of this subsection, "experimental research" means an experimental treatment or procedure that is one of the following:

  • Not a generally accepted practice in the medical community;
  • Exposes the resident to pain, injury, invasion of privacy or asks the resident to surrender autonomy, such as a drug study.

The IRB will ensure that PA Department of Health approval is included in any submission which meets these criteria