Subchapter I. RESEARCH IN PREHOSPITAL CARE

§ 1001.161. Research.

 (a)  Clinical investigations or studies that relate to direct patient care may not be conducted by providers of EMS unless the investigation or study is proposed to and approved by the Department.

 (b)  A proposal for clinical investigation or study shall be presented to the Department. If the Department concludes that the proposal may have merit, it shall refer the proposal to the Council, and to the regional EMS council having responsibilities in the region where the investigation or study would be undertaken. The Council and the regional EMS council shall have the proposal reviewed by their medical advisory committees and consider the comments of those committees, and shall forward their recommendations to the Department within 60 days after receiving from the Department a request to review the proposal.

 (c)  The Department will approve or disapprove the proposal within 30 days after receiving the recommendations of the Council and the regional EMS council. If the proposal is approved, the prehospital personnel identified in the proposal may function in accordance with the proposal and under conditions specified by the Department during the term of the clinical investigation or study.

 (d)  A proposal shall include and address the following considerations and items in a format specified by the Department:

   (1)  A specific statement of the hypothesis to be investigated and the clinical significance of the hypothesis.

   (2)  A specific description of the methodology to be used in the investigations.

   (3)  An estimated duration of the investigation.

   (4)  Consideration of complications or side effects that may be encountered and how they shall be treated.

   (5)  Consideration of how to assure patient confidentiality.

   (6)  Consideration of obtaining informed consent of the patient.

   (7)  Institutional review board approval when required by law.

   (8)  A letter from the researcher who identifies himself as the lead investigator and assumes clinical responsibility for the investigation.

   (9)  A letter from the physician who assumes clinical responsibility for the investigation.

   (10)  A plan for providing the Department with progress reports and a final report on the investigation or study.

 (e)  The Department may direct that the investigation or study be terminated prematurely for its failure to satisfy conditions of approval.

   The provisions of this §  1001.161 amended September 1, 1995, effective September 2, 1995, 25 Pa.B. 3685; amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247545).