(1) The research facility designee will prepare and submit for Department approval an application as designated by the Department detailing explicit information regarding the scientific studies to be conducted including the:
- (a) purpose of the study;
- (b) research protocol for the project;
- (c) description of the data needed from the database to conduct that research;
- (d) plan that demonstrates all database information will be maintained securely, with access being strictly restricted to the designee and research study staff; and
- (e) provisions for electronic data to be stored on a secure database computer system with access being strictly restricted to the designee and research study staff.
- (2) Application will be reviewed by the Department's Institutional Review Board and recommendation made to the director for or against approval.
- (3) Director will determine approval status of the application.
KEY: prescription drug database, controlled substances, substance abuse database
Date of Last Change: November 5, 2023
Notice of Continuation: February 20, 2024
Authorizing, and Implemented or Interpreted Law: 58-37f-301(2)(f)