Ohio Admin. Code 3701:1-58-04 - Provisions for the protection of human research subjects
(A) A licensee may
conduct research involving human research subjects only if it uses the
radioactive materials specified on its license for the uses authorized on its
license.
(B) If the research is
conducted, funded, supported, or regulated by a federal agency that has
implemented the federal policy for the protection of human subjects as
specified in 45 C.F.R. Part 46
, as published in the
October 1, 2013, Code of Federal Regulations
(as in effect on the effective date of this rule) , the
licensee shall, before conducting research:
(1) Obtain review and approval of the
research from an "institutional review board," as defined and described in the
federal policy; and
(2) Obtain
"informed consent," as defined and described in the federal policy, from the
human research subject.
(C) If the research will not be conducted,
funded, supported, or regulated by a federal agency that has implemented the
federal policy, the licensee shall, before conducting research, apply for and
receive a specific amendment to its medical use license. The amendment request
must include a written commitment that the licensee will, before conducting
research:
(1) Obtain review and approval of
the research from an "institutional review board," as defined and described in
the federal policy, and approved by the office of human research protection;
and
(2) Obtain "informed consent,"
as defined and described in the federal policy, from the human research
subject.
(D) Nothing in
this rule relieves licensees from complying with the other requirements in this
chapter.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010, 08/10/2015
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