Sec. 30.03.05.04. Research Supplemental Protocol

A. The EMS Board may approve a research supplemental protocol upon the recommendation of the Executive Director of MIEMSS with the approval of the:

(1) EMS operational medical director and EMS operational program where the research will be conducted; and

(2) MIEMSS Institutional Review Board.

B. An individual seeking to conduct research that would require a supplement to the protocols shall:

(1) Submit the proposed research project and the proposed research protocol, including provisions for the expiration of the research supplemental protocol, to the:

(a) State EMS Medical Director,

(b) EMS operational program where the research is to be conducted,

(c) EMS operational program medical director for the EMS operational program where the research is to be conducted, and

(d) MIEMSS Institutional Review Board; and

(2) Provide further information and meet certain requirements as determined by the MIEMSS Institutional Review Board.

C. The MIEMSS Institutional Review Board shall suspend or terminate approval of a research supplemental protocol that is not:

(1) Conducted in accordance with requirements of this regulation; or

(2) Determined to be associated with unexpected serious harm to research subjects.

D. Upon suspension or termination of approval of a research supplemental protocol by the MIEMSS Institutional Review Board, the Executive Director shall immediately suspend or terminate the research supplemental protocol. The suspension shall be effective pending action by the EMS Board.