§ 25-4-407 — Reporting requirements - research exemption

Colorado § 25-4-407

• Jurisdiction: Colorado
• Title 25: Public
• Art.: Disease Control

Text

(1) The state
board shall approve an exemption from the reporting requirements of section 25-4-405 for a research activity that meets all of the following criteria:

(a) The research activity is fully described by a research protocol;

(b) The research activity is subject to review by and is governed by the
federal department of health and human services;

(c) The research activity has as protocol objectives either:

(I) The investigation of the effectiveness of a medical therapy or vaccine to
prevent infection; or

(II) Basic medical research into the cellular mechanisms that cause sexually
transmitted infections;

(d) The research activity is reviewed and approved by a duly constituted
institutional review board in accordance with the regulations established by the
secretary of the federal department of health and human services;

(e) The research for the research activity has provided information that
demonstrates that the research will be facilitated by an exemption specified in this
section; and

(f) The research activity has been determined to have a potential health
benefit.

(2) The research exemption authorized in this section does not alter the
reporting requirements of persons and researchers who are otherwise required to
make reports when engaged in any treatment or testing outside the scope of or
prior to enrollment in an approved research protocol, including required reporting
of other reportable diseases.

Legislative History

Source: L. 2016: Entire part R&RE, (SB 16-146), ch. 230, p. 899, � 1, effective July 1.