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  • Content Type: State Statute
  • Topic: Use of Residual Newborn Screening Specimens
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State Citation/Title Ascending Order
(link to state's page)
Topic(s) Summary
California State Statute
opens new window California: Cal. Health and Safety Code 124975 et seq.
Use of Residual Newborn Screening Specimens All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, is confidential and is considered a confidential medical record except for information that the individual, parent, or guardian consents to be released, provided after being fully informed of the scope of the information requested to be released, of all of the risks, benefits, and purposes for the release, and of the identity of those to whom the information will be released or made available, except for data compiled without reference to the identity of any individual, and except for research purposes, provided that pursuant to the Common Rule The research must first be reviewed and approved by an IRB. The health department, any entities approved by the department, and researchers must maintain the confidentiality of patient information and blood samples in the same manner as other medical record information with patient identification and may use it only for approved research to (1) identify risk factors for children's and women's diseases;(2) Research to develop and evaluate screening tests;(3) Research to develop and evaluate prevention strategies; and (4) Research to develop and evaluate treatments. The State Committee for the Protection of Human Subjects (CPHS) must determine if all of the if specified criteria are met for purposes of ensuring the security of a donor's personal information, before any blood samples are released pursuant for research purposes.
Indiana State Statute
opens new window Indiana: IC 16-41-17-10
Use of Residual Newborn Screening Specimens The state health department must develop a system for using, for epidemiological survey and research purposes, any waste blood specimen left over after newborn screening. Waste blood specimens used for the purpose of epidemiological survey may not include the name or other identifying characteristics that would identify the individual submitting the specimen.
Michigan State Statute
opens new window Michigan: MCL 333.5431
Use of Residual Newborn Screening Specimens The statute requires the health department to develop a schedule for the retention and disposal of blood specimens. The schedule must allow for the blood specimens to be used for medical research during the established retention period, as long as the medical research is conducted in a manner that preserves the confidentiality of the test subjects and is consistent to protect human subjects from research risks under subpart A of part 46 of subchapter A of title 45 of the code of federal regulations.
Minnesota State Statute
opens new window Minnesota: MS 2013 Session Law Chapter 82
Use of Residual Newborn Screening Specimens The law requires the Commissioner of Health to evaluate the scientific and medical validity of a comprehensive and sustainable long-term storage and use plan for newborn screening test results.
Minnesota State Statute
opens new window Minnesota: MS 13.386
Use of Residual Newborn Screening Specimens,
Privacy
Genetic information may be collected by a government entity or any other person only with written informed consent, used only for the purposes stated in the consent, be stored only for the duration consented, and disseminated only with an individuals consent. Consent to allow dissemination is only valid for one year or a lesser period if specified in the consent. Newborn screening activities are covered under the law.
Minnesota State Statute
opens new window Minnesota: MS 144.125
Use of Residual Newborn Screening Specimens During the period in which residual newborn screening specimens is retained, the health department may use blood samples and test results for newborn screening program operations. Newborn screening operations are defined to specifically exclude research, public health studies, or the development of new newborn screening tests.
Missouri State Statute
opens new window Missouri: MRS 191.331
Use of Residual Newborn Screening Specimens A residual newborn screening specimen is retained for five years after initial submission to the department. After five years specimens are destroyed. Unless otherwise directed, a biological specimen may be released for anonymous scientific study. At the time of collection, the parent or legal guardian of the child from whom a biological specimen was obtained may direct the department to: (1) Return a biological specimen that remains after all screening tests have been performed; (2) Destroy a biological specimen in a scientifically acceptable manner after all screening tests required have been performed; or (3) Store a biological specimen but not release the biological specimen for anonymous scientific study. A biological specimen released for anonymous study may not contain information that may be used to determine the identity of the donor. The department has authority over the use, retention, and disposal of biological specimens and related information collected in connection with newborn screening tests. The use of such specimens and related information is for public health purposes and must comply with all applicable provisions of federal law. The department may charge a reasonable fee for the use of such specimens for public health research and preparing and supplying specimens for research proposals approved by the department.
Nebraska State Statute
opens new window Nebraska: NRS 71-519
Use of Residual Newborn Screening Specimens The health department must adopt and promulgate rules and regulations relating to the use of residual newborn screening specimens and related information. Use may only be made for public health purposes and must comply with all applicable provisions of federal law. The department may charge a reasonable fee for evaluating proposals relating to the use of such specimens for public health research and for preparing and supplying specimens for research proposals approved by the department. The health department also must develop a pamphlet which explains that residual newborn blood specimens may be used for approved public health research.
New Hampshire State Statute
opens new window New Hampshire: NHS 132:10-a
Use of Residual Newborn Screening Specimens Samples may not be used for other research or DNA testing purposes unless authorized by the parent or guardian.
North Dakota State Statute
opens new window North Dakota: NDCC 23-01-03.1
Use of Residual Newborn Screening Specimens The health council may authorize the use of newborn metabolic and genetic disease screening tests, as provided for in chapter 25-17, for research purposes. The council shall adopt rules to ensure that the results are used for legitimate research purposes and to ensure that the confidentiality of the newborns and their families is protected.
Oklahoma State Statute
opens new window Oklahoma: OS 21-1175
Use of Residual Newborn Screening Specimens Parental consent is required to store, transfer, use or database DNA from any newborn child.
Oklahoma State Statute
opens new window Oklahoma: OS 25-2001
Use of Residual Newborn Screening Specimens,
Privacy
Creates the Parents' Bill of Rights, including the right to consent in writing before any record of a minor childs blood or DNA is created, stored or shared, except as required by Sections 1-516 (pertaining to syphilis) and 1-524.1 (pertaining to testing arrested persons for sexually transmitted infections and HIV) of Title 63 of the Oklahoma Statutes, or unless authorized pursuant to a court order.
South Carolina State Statute
opens new window South Carolina: SCCL 44-37-30
Use of Residual Newborn Screening Specimens Residual newborn screening blood samples may be released for purposes of confidential, anonymous scientific study unless the newborn screening program is otherwise directed. The release of a blood sample must conform with departmental regulations. At the time of testing or at any time after that, the parent or legal guardian of the child from whom a blood sample was obtained, or the child when eighteen years of age or older, may direct the department to: (1) return a blood sample in its entirety and any test results not less than two years after the date of testing; (2) destroy a blood sample in not less than two years after the date of the testing; or (3) store a blood sample but not release the blood sample for confidential, anonymous scientific study. A blood sample released for confidential, anonymous study must not contain identifiable information. If scientific study identifies genetic information that may benefit the child, the department may notify confidentially the parent or legal guardian, or the child if eighteen years of age or older, of this information.
Texas State Statute
opens new window Texas: Health and Safety Code 33.0111 et seq.
Use of Residual Newborn Screening Specimens Reports, records, and information obtained by the health department for newborn screening that do not identify a child or the family of a child will not be released for public health research purposes unless a parent, managing conservator, or guardian of the child consents to disclosure. Newborn screening blood spots and associated data are confidential under law and may only be used as specified. If a family consents to disclosure of nonidentifiable reports, records and information for public health research, any subsequent disclosures must be approved by an IRB or privacy board of the health department and the Health Commissioner or his or her designee. Research for public health purposes is defined to include purposes that relate to cancer, a birth defect, an infectious disease, a chronic disease, environmental exposure, or newborn screening.

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Last Reviewed: June 10, 2014