Per Iowa Administrative Code 641 IAC 4:
Retention, use and disposition of residual newborn screening specimens.
Research. A residual newborn screening specimen may be released for research purposes only if written consent has been received by the researcher from a parent or guardian of the child, or the individual adult upon whom the screening was performed, and each of the following conditions is satisfied:
(1) Investigators shall submit proposals to use residual newborn screening specimens to the center. Any intended use of the requested specimens as part of the research study must be clearly delineated in the proposal.
(2) Before research can commence, proposals shall be approved by the researcher’s institutional review board, the congenital and inherited disorders advisory committee, and the department.
(3) Research on residual newborn screening specimens shall be allowed only in instances where research would further: newborn screening activities; the health of an infant or child for whom no other specimens are available or readily attainable; general medical knowledge for existing public health surveillance activities; public health purposes; or medical knowledge to advance the public health.
(4) For specimens collected prior to January 1, 2016, a parent or guardian may send a letter stating that the newborn’s specimen is not to be released for research purposes. This letter shall include the parent’s or guardian’s name, the newborn’s name at birth, and the newborn’s date of birth. The letter of notice shall be sent to the State Hygienic Laboratory at Newborn Screening Program, State Hygienic Laboratory, 2220 S. Ankeny Blvd., Ankeny, Iowa 50023-9093.
Newborn screening program operations. Residual newborn screening specimens may be used for activities, testing, and procedures directly related to the operation of the newborn screening program, including confirmatory testing, laboratory quality control assurance and improvement, calibration of equipment, evaluation and improvement of the accuracy of newborn screening tests, and validation of equipment and screening methods, and the use of linked specimens in feasibility studies approved by the Congenital and Inherited Disorders Advisory Committee for the purpose of incorporating new tests or evaluating new test methodologies.
Prohibited uses. A residual newborn screening specimen shall not be released to any person or entity for commercial purposes or law enforcement purposes or to establish a database for forensic identification.
Public health studies and research may be done only if the researchers follow these guidelines:
- The researcher must obtain informed consent from the parent or guardian for the release of residual newborn screening specimens for research purposes.
- The project must be done to help develop a new newborn screening test or to better understand diseases for the benefit of the general public.
- The baby's name and any identifying details about the baby are removed before the sample is provided, unless the consent specifically allows it.
- The project must be approved by the Institutional Review Board (IRB) where the researcher works to make sure it meets high ethical standards and to ensure that the privacy and safety of the babies is fully protected.
- The project must be approved by the Congenital and Inherited Disorders Advisory Committee to make sure it meets high ethical standards and to ensure that the privacy and safety of the babies is fully protected.
- The project must be approved by the Iowa Department of Public Health to make sure all privacy and confidentiality laws are being followed.
To submit a proposal or find out more information, please contact the INSP Executive Officer at 1-800-383-3826.