Section 33-06-16-05 - [Effective until 1/1/2025] Research and testing materialsInformation and testing materials received or generated by the newborn screening program under North Dakota Century Code chapter 25-17 are confidential except as provided by law or regulation.
1. Access to information or testing materials may be obtained only as follows:a. Information may be disclosed for statistical purposes in a manner such that no individual person can be identified.b. Information may be disclosed to the individual tested, that person's parent or guardian, or that person's licensed clinician, responsible clinician, dietitian, metabolic disorders clinic team, screening laboratory, other employees and contractors of the department will need for the information, or to children's special health services within the state department of health for purposes of care coordination and provision of medical and low-protein modified foods.c. Information and testing materials may be disclosed to a person engaged in a research project concerning medical, psychological, or sociological issues provided all of the following conditions are met:(1) Written authorization from the parent or guardian must be obtained by the researcher for the information or testing materials requested.(2) The research project must be sponsored by a public or private college or university; a governmental entity; a nonprofit medical, sociological, or psychological association; or the pharmaceutical industry.(3) The research project must be reviewed and approved pursuant to policies and procedures pertaining to research utilizing human subjects by the institutional review board or equivalent panel of the institution or entity where the research is being done or which is sponsoring the research.(4) Protected health information may not appear in any report, summation, thesis, or other document arising out of the research project.(5) Protected health information may not be provided to a person engaged in a research project until that person has submitted a written proposal explaining and justifying the need to examine such information.(6) The researcher shall agree in writing to pay all costs of the department incurred in providing access to testing materials or other information, including copy or research services.2. Storage, maintenance, and disposal of information and testing materials. a. Information and testing materials must be stored in such a way as to protect the integrity of the materials and the privacy of patients.b. Information and testing materials provided to the state department of health may be retained indefinitely or destroyed according to this subsection.c. Information and testing materials may be destroyed by any available means that preserves individual confidentiality and, for the testing materials, complies with any applicable standards for destruction of human blood samples.d. Information and testing materials may be destroyed based upon the following schedule: (1) Information and testing materials created less than eighteen years before the present date may be destroyed only with the state health officer's prior written approval.(2) After eighteen years, information and testing materials may be destroyed without prior approval.N.D. Admin Code 33-06-16-05
Amended by Administrative Rules Supplement 2016-360, April 2016, effective 4/1/2016.General Authority: NDCC 23-01-03(3), 23-01-03.1, 23-01-04, 23-01-15, 25-17-01, 25-17-02
Law Implemented: NDCC 23-01-03.1, 25-17-01(3), 25-17-02, 25-17-03