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Section 125002 Of Article 2. Newborn Screening From California Health And Safety Code >> Division 106. >> Part 5. >> Chapter 1. >> Article 2.
125002
. (a) In order to align closely related programs and in order
to facilitate research into the causes of, and treatment for, birth
defects, the Birth Defects Monitoring Program provided for pursuant
to Chapter 1 (commencing with Section 103825) of Part 2 of Division
102 shall become part of the Maternal, Child, and Adolescent Health
program provided for in Article 1 (commencing with Section 123225) of
Chapter 1 of Part 2 of Division 106.
(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:
(1) Research to 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.
(4) Research to develop and evaluate treatments.
(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department's approved researchers.
(2) Protocol review for scientific merit by the department or another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of Human Subjects.
(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.
(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:
(1) The research project was approved by the State Committee for the Protection of Human Subjects.
(2) The research project's protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:
(1) Research to 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.
(4) Research to develop and evaluate treatments.
(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department's approved researchers.
(2) Protocol review for scientific merit by the department or another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of Human Subjects.
(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.
(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:
(1) The research project was approved by the State Committee for the Protection of Human Subjects.
(2) The research project's protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
