Ohio Admin. Code 3701:1-66-17 - Medical screening and research
This rule provides standards for self-referral screening and medical research. Notwithstanding paragraph (B) of rule 3701:1-66-02 of the Administrative Code:
(A) Any
person proposing to conduct a self-referral screening program using radiation
generating equipment shall not initiate such a program without prior approval
by the department. When requesting such approval, that person shall submit
information on a form prescribed by the department. If any information
submitted to the department becomes invalid or not current, the department
shall be immediately notified in writing.
(B)
No person shall
use radiation-generating equipment to conduct
Any research using
radiation-generating equipment on human beings
shall be approved by an
unless the research has been approved by an
institutional review board (IRB) as required by June
23, 2005, Title 45, CFR, Part 46 (as effective on
the effective date of this rule and April 1,
2014, Title 21, CFR, Part 56 (as effective on
the effective date of this rule) .
(C) Nothing in this rule relieves registrants
from complying with the other requirements of this chapter.
Notes
Promulgated Under: 119.03
Statutory Authority: ORC 3748.04
Rule Amplifies: ORC 3748.01, 3748.02, 3748.04, 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Prior Effective Dates: 02/15/2001, 07/03/2006, 06/20/2010, 07/01/2014, 05/15/2015
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