Section 6551 - Application Process for Requests for Biospecimens and/or DataThis section establishes requirements for the application process that must be followed to obtain biospecimens and/or GDSP data related to the biospecimens, and to obtain live birth, fetal death, and/or death data linked to the biospecimens. This section also establishes requirements for the application process that must be followed to obtain CBDMP data, whether or not it is linked to biospecimens.
(a) The researcher shall convey in writing to staff of GDSP, CBDMP or MCAH the following information: (1) A request for biospecimens and/or data,(2) A description of the research project,(3) The name and title of the researcher and the phone number, email address, and institution name at which the researcher may be contacted.(b) After receiving the request described in subdivision(a), the Department shall provide to the researcher information and procedures for accessing SIS.(c) The researcher shall use the SIS system to transmit the following items: (1) The grant application or a detailed research protocol which describes the specific aims, significance, methods and analyses of the research project.(2) A copy of the approval letter received from the California Committee for the Protection of Human Subjects (CPHS), including subsequent modifications and renewals if any.(3) A copy of the application that was transmitted to CPHS to obtain approval for this research request.(4) A signed data use and confidentiality agreement establishing that the researcher shall comply with all state and federal privacy and confidentiality laws.(5) A description of the methods that will be followed in order to maintain the confidentiality of the biospecimens and/or data.(6) The curriculum vitae of the researcher.(7) A current approval letter from the State Registrar of Vital Statistics for projects that require vital records data as set forth in Sections 102430(a)(4) and 102430(c) of the HSC.(8) A description of the biospecimens needed for the research project, identifying whether they are Newborn or Prenatal biospecimens and the number of biospecimens required for the research project.(9) A description of the data needed for the research project(10) The name and address to which to send the biospecimens and/or data.(11) A description of the requested packing materials for the biospecimens.(12) A description of the requested method of shipment of the biospecimens.(d) Upon completion of the research study, the researcher shall: (1) Return all unused portions of the biospecimens to the Department after completion of the research study. Biospecimens should be sent via courier service with tracking number and must include a packing list of biospecimen barcodes that are being returned and the total number of biospecimens included in the shipment.(2) Destroy all data received from the Department after completion of the research study.(3) Destroy all residual products obtained during the analysis of the biospecimens received from the Department after completion of the research study.(4) Researchers conducting studies that perform whole genome sequencing or whole exome sequencing shall not link sequence data derived from biospecimens received from the Department to any other databases.Cal. Code Regs. Tit. 17, § 6551
1. New article 2 (section 6551) and section filed 5-20-2014 as an emergency; operative 5-20-2014. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2014, No. 20). Pursuant to Health and Safety Code section 124977(d)(2), this regulation shall not be repealed by OAL and shall remain in effect until revised or repealed by the department.
2. Editorial correction of HISTORY 1 (Register 2014, No. 45).
3. Statement of compliance pursuant to Health and Safety Code section 124977(d)(1) as to 5-20-2014 order filed 1-21-2015. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing pursuant to Government Code section 11343.8 (Register 2015, No. 4). Note: Authority cited: Sections 124977, 124991, 125002, 131050, 131051, 131052 and 131200, Health and Safety Code. Reference: Sections 102175, 102465, 124977, 124980, 124991 and 125002, Health and Safety Code.
1. New article 2 (section 6551) and section filed 5-20-2014 as an emergency; operative 5/20/2014. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2014, No. 21). The department must comply with Health and Safety Code section 124977(d)by 11-17-2014 or the regulation will be repealed by operation of law.
3. Statement of compliance pursuant to Health and Safety Code section 124977(d)(1) as to 5-20-2014 order filed 1-21-2015. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing pursuant to Government Code section 11343.8 (Register 2015, No. 4).