North Carolina Administrative Code (Last Updated: November 13, 2014) |
TITLE 10A. HEALTH AND HUMAN SERVICES |
CHAPTER 41. EPIDEMIOLOGY HEALTH |
SUBCHAPTER A. COMMUNICABLE DISEASE CONTROL |
10A NCAC 41A .0405. EXEMPTION FOR CLINICAL STUDIES
Latest version.
-
An individual enrolled in a clinical trial of the efficacy of a new vaccine preparation or dosage schedule shall be exempted from those requirements of 10A NCAC 41A .0401 and .0402 which conflict with the trial protocol. This exemption shall only apply to individuals who:
(1) participate in a clinical trial whose protocol is approved by the State Health Director, and
(2) fully participate in and complete the clinical trial.
History Note: Filed as a Temporary Amendment Eff. February 1, 1988, for a period of 180 days to expire on
July 29, 1988;
Authority G.S. 130A‑152(c);
Eff. October 1, 1983;
Amended Eff. March 1, 1988.