2016 Colorado Revised Statutes
Title 25 - Public Health and Environment
Disease Control
Article 4 - Disease Control
Part 4 - Sexually Transmitted Infections
§ 25-4-407. Reporting requirements - research exemption

(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.