California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 6 - California Biobank Program › Article 3 - Approval, Denial, and Revocation of Request › Section 6553.1 - Revocation of an Approved Research Request

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
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).
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.