Section 6553 - Reasons for DenialA request shall be approved unless the Department Director or designee determines that any of the following conditions exist:
(a) Researcher did not obtain approval from CPHS for the specific research project submitted, pursuant to Sections 124991(h)(2)(A)-(E) of the HSC.(b) Research is not in accordance with Section 124991(g) (1-4) of the HSC.(c) Research hypothesis and/or methods are repetitive of a substantial body of research that is scientifically accepted on the research topic.(d) There are insufficient Department staffing resources to complete the research request.(e) Researcher did not return all remaining biospecimens received from the Department to the Department after completion of a previously approved research study.(f) Researcher did not comply with the Department data use agreement signed by the researcher on a previously approved project(s).(g) Researcher did not destroy all data received from the Department after completion of a previously approved research study, by a Department approved method for destruction.(h) Researcher did not destroy all residual products obtained during the analysis of the biospecimens and/or data received from the Department after completion of a previously approved research study, by a Department approved method for destruction.(i) Researcher did not comply with the Department's requirement that previously approved 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.(j) The research request fails to meet the standards, as applied to peer reviewed publications, for experimental design. Reasons for denial of research requests under this subsection shall include but not be limited to: (1) The study methodology or design would create biased or inaccurate results.(2) Laboratory tests, data and/or analyses are unlikely to address the scientific aims of the research request.(3) Study design uses more biospecimens and/or data than are needed to address the scientific aims.(4) The statistical analysis and/or statistical testing is unlikely to address the scientific aims of the research study.(k) Biospecimens being requested are necessary for Departmental program operations and research activities.(l) The research project requires confidential information or other data from the Office of Vital Records, for which approval has not been granted in accordance with Sections 102430(a)(4) and 102430(c) of the HSC.(m) The research requires release of an excessive number of biospecimens or an excessive amount of each biospecimen such as to preclude other potential research projects.Cal. Code Regs. Tit. 17, § 6553
1. New article 3 (sections 6553-6553.1) 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 102465, 124977, 124980, 12499 and 125002, Health and Safety Code.
1. New article 3 (sections 6553-6553.1) 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).