Current through all regulations passed and filed through December 16, 2024
(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.
