Section 3701:1-66-17 - Medical screening and researchThis 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 will not initiate such a program without prior approval by the department. When requesting such approval, that person will submit information on a form prescribed by the department. If any information submitted to the department becomes invalid or not current, the department will be immediately notified in writing.(B) No person will use radiation-generating equipment to conduct research on human beings unless the research has been approved by an institutional review board (IRB) as obligated by 45 CFR Part 46 (as effective on the effective date of this rule) and 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 obligations of this chapter.Ohio Admin. Code 3701:1-66-17
Effective: 12/13/2024
Five Year Review (FYR) Dates: 9/25/2024 and 12/13/2029
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 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, 12/20/2019