R426-4-600. Pilot Projects

(1) A person who proposes to undertake a research or study project which requires waiver of any rule shall have a project director who is a physician licensed to practice medicine in Utah, and shall submit a written proposal to the Department for presentation to the EMS Committee for recommendation.

(2) The proposal shall include the following:

(a) a project description that describes the

(b) need for project;

(c) project goal;

(d) specific objectives;

(e) approval by the provider off-line medical director;

(f) methodology for the project implementation;

(g) geographical area involved by the proposed project;

(h) specific rule or portion of rule to be waived;

(i) proposed waiver language;

(j) evaluation methodology;

(k) a list of the EMS providers and hospitals participating in the project; and

(l) a signed statement of endorsement from the participating hospital medical directors and administrators, the director of each participating licensed paramedic and ambulance provider, other project participants, and other parties who may be significantly affected.

(3) If the pilot project requires the use of additional skills, a description of the skills to be utilized by the field EMS licensed personnel and provision for training and supervising the field EMS licensed personnel who are to utilize these skills, including the names of the field EMS licensed personnel.

(4) The name and signature of the project director attesting to his or her support and approval of the project proposal.

(5) If the pilot project involves human subjects' research, the applicant shall also obtain Department Institutional Review Board approval.

(6) The Department or Committee, as appropriate, may require the applicant to meet additional conditions as it considers necessary or helpful to the success of the project, integrity of the EMS system, and safety to the public.

(7) The Department or Committee, as appropriate, may initially grant project approval for one year. The Department or Committee, as appropriate, may grant approval for continuation beyond the initial year based on the achievement and satisfactory progress as evidenced in written progress reports to be submitted to the Department at least 90 days prior to the end of the approved period. A pilot project may not exceed three years.

(8) The Department or Committee, as appropriate, may only waive a rule if:

(a) the applicant has met the requirements of this section;

(b) the waiver is not inconsistent with statutory requirements;

(c) there is not already another pilot project being conducted on the same subject; and

(d) it finds that the pilot project has the potential to improve pre-hospital medical care.

(9) Approval of a project allows the field EMS licensed personnel listed in the proposal to exercise the specified skills of the participants in the project. The project director shall submit the names of field EMS licensed personnel not initially approved to the Department.

(10) The Department or Committee, as appropriate, may rescind approval for the project at any time if:

(a) those implementing the project fail to follow the protocols and conditions outlined for the project;

(b) it determines that the waiver is detrimental to public health; or

(c) it determines that the project's risks outweigh the benefits that have been achieved.

(11) The Department or Committee, as appropriate, shall allow the licensed or designated EMS provider involved in the study to appear before the Department or Committee, as appropriate, to explain and express its views before determining to rescind the waiver for the project.

(12) At least six months prior to the planned completion of the project, the medical director shall submit to the Department a report with the preliminary findings of the project and any recommendations for change in the project requirements.