R438-15-16. Blood Spots

  (1) Blood spots become the property of the Department.

  (2) The Department includes in parent education materials information about the Department's policy on the retention and use of residual newborn blood spots.

  (3) The Department may use residual blood spots for newborn screening quality assessment activities.

  (4) The Department may release blood spots for research upon the following:

  (a) The person proposing to conduct the research applies in writing to the Department for approval to perform the research. The application 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. When appropriate, the proposal will then be submitted to the Department's Internal Review Board for approval.

  (b) The Department shall de-identify blood spots it releases unless it obtains informed consent of a parent or guardian to release identifiable samples.

  (c) All research must be first approved by the Department's Internal Review Board.