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 research on human beings unless the research has been approved by an institutional review board (IRB) as required 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 requirements of this chapter.

Effective: 12/20/2019
Five Year Review (FYR) Dates: 9/10/2019 and 05/01/2023
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