R438-15-15. Blood Spots

(1) Once received by the laboratory, each blood spot becomes the property of the department. (2) The department includes information about the department's policy on the retention and use of residual newborn blood spots in the parent education materials. (3) The department may use residual blood spots for newborn screening quality assessment activities. (4) The department may release blood spots for research to a person if the person submits a written proposal to the department for approval. (a) The proposal shall include a written protocol for the proposed research, the person's professional qualifications to perform the proposed research, and other information if needed and requested by the department. (b) The department shall de-identify each blood spot that the department releases unless the department obtains informed consent from a parent or guardian to release identifiable samples. (c) The department's internal review board shall approve any blood spot research.