4765-6-04. Research study impacting scope of practice

(A) The board may allow emergency medical responders, emergency medical technicians, advanced emergency medical technicians, and paramedics to perform services beyond their respective scopes of practice, as set forth in Chapter 4765. of the Revised Code and rules 4765-12-04, 4765-15-04, 4765-16-04, and 4765-17-03 of the Administrative Code, pursuant to a board-approved research study.

(B) An entity applying to become a board-approved research study, in furtherance of paragraph (A) of this rule, must meet the following requirements:

(1) Submit a research proposal to the board, which shall include, at a minimum, goals and objectives, training requirements, participating entities, and implementation plan;

(2) Submit a written statement from the medical director(s) of the EMS organization(s) or training program(s) that supports the research study;

(3) Submit a written statement regarding how the research proposal contains activities outside the scope of practice and outline the mechanisms by which EMS providers will be trained in such skills or activities;

(4) Submit evidence that an institutional review board has approved the research study;

(5) Propose clear starting and ending dates for the research study;

(6) Agree to brief all participants on the specific boundaries within which the research study can or cannot be conducted;

(7) Upon request, appear before the board and/or board committees to answer additional questions or present additional information regarding the research study;

(8) Agree to maintain documentation of EMS providers participating in the study throughout the duration of such study.

(C) The board is not obligated to approve a proposed research study. In addition, the board may amend the elements of a proposed study, including changing the starting and ending dates, before approving such study.

(D) Following completion of a board-approved research study, an entity must do the following:

(1) Submit a final written report, with conclusions and recommendations, to the board;

(2) Upon request, appear before the board and/or board committees to answer questions or present additional information regarding the research study.

(E) The board is not obligated to accept the entity's recommendations to permanently amend the scope of practice for EMS providers, based on the results of the research study.

(F) This rule does not apply to prehospital research conducted within the current scope of practice.

Five Year Review (FYR) Dates: 1/11/2019 and 12/31/2023
Promulgated Under: 119.03
Statutory Authority: 4765.11
Rule Amplifies: 4765.35, 4765.37, 4765.38, 4765.39
Prior Effective Dates: 05/29/2008, 05/29/2014

Prior History: (Effective: 05/29/2014
R.C. 119.032 review dates: 03/14/2014 and 03/13/2019
Promulgated Under: 119.03
Statutory Authority: R.C. 4765.11
Rule Amplifies: R.C. 4765.35, 4765.37, 4765.38, 4765.39
Prior Effective Dates: 5/29/08)