5122-1-06 Research.

(A) The purpose of this rule shall be to establish policies and procedures for the planning, review, administration and coordination of all research projects which are funded by the department, or which utilize patients, staff or records of regional psychiatric hospitals (RPHs) or persons under the managing authority of the department.

(B) The provisions of this rule shall be applicable to all employees of the department and to individuals and organizations carrying out research approved (funded or non-funded) by the department.

(C) The following definitions shall apply to this rule in addition to or in place of those appearing in rule 5122-1-01 of the Administrative Code:

"Applied research" means an original, systematic study designed to answer a specific question, determine why something failed or succeeded, solve a specific pragmatic problem, or to acquire new knowledge and understanding. Applied research has immediate and direct impact on a specific problem.

(D) The department shall institute, encourage and support applied research projects in both communities and RPHs. The projects may include studies of causes, prevention, or treatment of mental illness, and means for enhancing the positive mental health of the citizens of Ohio.

(E) Policy

(1) All research funded by the department shall be reviewed and approved by the office of research and evaluation. Research approved for funding shall be consistent with priorities identified in the department's strategic plan. Depending upon the subject matter of this research, the review process shall also include other individuals such as the department medical director, staff in program offices, and external experts.

(2) All research (funded or non-funded) to be conducted in RPHs under the managing authority of the department, or which involves employees, patients or records of the department, shall be reviewed and approved by the RPH and the office of research and evaluation.

(3) The office of research and evaluation shall be responsible for issuing guidelines for submission of research proposals, and shall periodically distribute the department's research priorities to potential researchers as well as to RPHs and local mental health systems.

(4) The office of program evaluation and research shall specify appropriate procedures for protection of human subjects in research projects, including situations in which written informed consent is required.

(5) The office of research and evaluation shall disseminate reports of findings or outcomes of all funded research projects at the end of each biennium.

(F) Procedure

(1) Applicants for research funding will request approval by submission to the office of research and evaluation of four copies of the research abstract form DMH-RES-617 and four copies of a detailed project proposal. Applicants for no-funds approval will submit two copies of the research abstract form DMH-RES-617 and two copies of a detailed project proposal.

(2) Research proposals which originate from, and are to be carried out at, specific

RPHs operated by the department must be approved by the chief executive officer and chief clinical officer of that RPH prior to submission to the office of research and evaluation for review and approval.

(a) These proposals may include:

(i) Those submitted by employees of the department and which utilize clients, staff, or records of the RPH; and

(ii) Those submitted by researchers who are not employees of the department (e.g. university professors, graduate students, etc.), and which utilize clients, staff, or records of the RPH.

(3) Implementation of approved research which does not originate at the

RPH, and which utilizes clients, staff, or records of an RPH, will be coordinated by the office of research and evaluation with the chief clinical officer and chief executive officer of the RPH.

(4) All approved researchers shall be bound by applicable laws, rules, policies, guidelines, etc. (including but not necessarily limited to state and federal) concerning confidentiality with regard to information obtained from RPH records, staff interviews, or other data collection methods.

(5) Researchers are required to report the status of the research project to the office of research and evaluation on a quarterly basis. The quarterly report will be submitted within ten days of the end of each quarter.

(6) At the conclusion of a project or the end of a key phase of project, a report of findings must be submitted to the office of research and evaluation and the RPH.

Effective: 09/18/2010
Promulgated Under: 111.15
Statutory Authority: 340.09 , 5119.01 , 5119.06
Rule Amplifies: 340.09 , 5119.01 , 5119.06
Prior Effective Dates: 4-24-1978, 7-1-1980, 6-2-1990, 9-24-1998, 9/30/2002, 12/10/2005, 1-14-2008