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) Any research using radiation-generating equipment on human beings shall be approved by an institutional review board (IRB) as required by June 23, 2005, Title 45, CFR, Part 46 and April 1, 2014, Title 21, CFR, Part 56.
(C) Nothing in this rule relieves registrants from complying with the other requirements of this chapter.
Replaces: part of 3701:1-66-02
Five Year Review (FYR) Dates: 02/01/2019
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02, 3748.04, 4748.05, 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: 07/01/2014