R384-203-4. Research Application Process

  (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.