Newborn Genetic Testing & Surveillance System
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1 Oregon Newborn Genetic Testing & Surveillance System State OR Statute/ Rule STATUTE: ORS Title 36, Chapter 433 RULE: OAR Chapter 333 Language Specific to Genetic Testing and Surveillance System Policy to control metabolic diseases; testing; fees; exemptions; waiver of fees; rules. (1) It hereby is declared to be a matter of public policy of the State of Oregon that in the interest of public health and the prevention of mental retardation, every infant, shall be given tests approved by the Oregon Health Authority for the detection of the disease of Exemption Research Authority Consent Required? (3) The testing required by subsection (1) of this section shall not be required if the infant is being reared as an adherent to a to such testing. The person responsible for submitting specimens under the rules of the authority shall be responsible for submitting a statement signed by the infant s parent that the infant is being so reared. The department by rule shall prescribe the form of the statement. Unclear. Oregon Genetic Privacy LAW: Informed consent for obtaining genetic information. (1) A person may not obtain genetic information from an individual, or from an individual s DNA sample, without first obtaining informed consent of the individual or the individual s representative, except: (b) For anonymous research or coded research conducted under conditions described in ORS (2), after notification pursuant to ORS or pursuant to ORS (7)(b); (d) As permitted by rules of the Health Authority for newborn screening procedures; NO Dissent Allowed? YES Copyright Citizens Council for Health Freedom August
2 phenylketonuria and other metabolic diseases. (2) The authority by rule shall specify the diseases for which infants shall be tested under subsection (1) of this section, the appropriate time following delivery for collecting specimens, the manner in which the specimens are to be submitted, the persons responsible for submitting the specimens, the methods of testing and the manner of payment of the fees Religious Exemption from Testing (1) A religious exemption from testing for Metabolic Diseases may be claimed if the infant is being reared as an adherent to in a to such testing. (2)(a) In the event a religious exemption is claimed from the requirements for testing for Metabolic Diseases, the person otherwise responsible for submitting the specimen for testing shall be responsible for submitting a completed statement to the state public health laboratory signed by the infant's parent using the following language: Individual s rights in genetic information; retention of information; destruction of information. (2)(a) A person may use an individual s DNA sample or genetic information that is derived from a biological specimen or clinical individually identifiable health information for research only if the individual: (A) Has granted informed consent for the specific anonymous research or coded research project; (B) Has granted consent for genetic research generally; (C) Was notified in accordance with ORS that the individual s biological specimen or clinical individually identifiable health information may be used for research and the individual did not, at the time of notification, request that the biological specimen or clinical individually identifiable health information not be used for research; or Copyright Citizens Council for Health Freedom August
3 (5) The authority by rule shall prescribe the procedure to be followed in cases where initial testing for metabolic diseases is administered too early to detect these diseases, where the sample submitted for testing is improperly collected and where a sample shows an abnormal result. The authority, within the limits of funds available from fees collected under this section, shall institute a pilot program for follow-up on abnormal test results. STATEMENT OF RELIGIOUS EXEMPTION The undersigned parent of states that this child is exempt from testing for detection of METABOLIC DISEASES in that the child is being reared as an adherent to a to such testing. (D) Was not notified, due to emergency circumstances, in accordance with ORS that the individual s biological specimen or clinical individually identifiable health information may be used for research and the individual died before receiving the notice. Copyright Citizens Council for Health Freedom August
4 Report of cases required; forms to be furnished. (1) All physicians, public health nurses and the administrators of hospitals shall report the discovery of cases of phenylketonuria to the Oregon Health Authority Notice by health care provider regarding anonymous or coded research. (1) A health care provider that is a covered entity as defined in ORS (2)(c) and that obtains an individual s biological specimen or clinical individually identifiable health information shall notify the individual that the biological specimen or clinical individually identifiable health information may be disclosed or retained by the provider for anonymous research or coded research.(3) The notice must contain a place where the individual may mark the individual s request that the specimen or information not be disclosed or retained for anonymous research or coded research before returning the notice to the health care provider. Copyright Citizens Council for Health Freedom August
5 Oregon Genetic Privacy RULE: Informed Consent Procedures (1) Unless exempted by ORS (1)(a)-(f), all persons collecting genetic information must conform to standards of informed consent Retention for the Purpose of Newborn Screening Procedures Oregon Health Authority may retain the blood samples of newborns collected for the control of metabolic diseases, as provided in ORS , for up to one year. Copyright Citizens Council for Health Freedom August
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