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§ 6553.1. Revocation of an Approved Research Request.

17 CA ADC § 6553.1Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 4. Preventive Medical Service (Refs & Annos)
Subchapter 9. Testing for Heritable Disorders
Group 6. California Biobank Program
Article 3. Approval, Denial, and Revocation of Request
17 CCR § 6553.1
§ 6553.1. Revocation of an Approved Research Request.
Currentness
An approved research request shall be revoked and the researcher must return all biospecimens and/or destroy all data already received under the research request, to the Department if the Department Director or designee determines that any of the following conditions exist:
(a) The researcher fails to obtain CPHS annual renewal for projects including those involving vital statistics data.
(b) The researcher fails to provide payment for requested biospecimens and/or data received from the CBP.
(c) There has been evidence of use of biospecimens and/or data by the researcher in a manner not approved by the Department, or not identified in the Methods and Protocol Sections submitted to and approved by the CPHS, or otherwise prohibited by law.
(d) Researcher failed to comply with the Department data use and confidentiality agreement signed by the researcher on previously approved project(s).
(e) Researcher did not return all remaining biospecimens to the Department after the completion of a previously approved or revoked research study
(f) Researcher did not destroy all data received from the Department after the completion of a previously approved or revoked research study, by a Department approved method for destruction.
(g) Researcher did not destroy all residual products obtained during the analysis of the biospecimens and/or data received from the Department after the completion of the research study of a previously approved or revoked research study, by a Department approved method for destruction.
(h) Researcher did not comply with the Department's requirement that 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.

Credits

Note: Authority cited: Sections 124977, 124991, 125002, 131050, 131051, 131052 and 131200, Health and Safety Code. Reference: Sections 124977, 124980, 124991 and 125002, Health and Safety Code.
History
1. New 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).
This database is current through 6/14/24 Register 2024, No. 24.
Cal. Admin. Code tit. 17, § 6553.1, 17 CA ADC § 6553.1
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