ASRM BULLETIN

California Department of Public Health Posts Updated Information on Treating Research Egg Donors


The California Department of Public Health has issued updated information for physicians working with research egg donors. See below for links to the Human Stem Cell Research Program (HCSR) website.

Note that, while these requirements were developed in the context of regulating stem cell research, other medical research utilizing donor oocytes conducted in California is also subject to the California Department of Public Health’s reporting requirements and informed consent requirements. These requirements apply to all egg donation procedures for research that is conducted in California, whether the egg donation procedure takes place in California or in another jurisdiction. When the regulations were being developed, we were told they were not intended to affect clinical practice—egg donation for infertility treatment.

REPORTING FORMS
The HSCR Program has finalized the reporting forms for Stem Cell Research Oversight Committees overseeing human embryonic stem cell (hESC) research and for research projects involving human oocyte retrieval. Annual reporting is required on research involving hESCs and/or human oocyte retrieval that is not fully funded by the California Institute for Regenerative Medicine (CIRM). The reporting forms are now available for download at: http://www.cdph.ca.gov/programs/HSCR/Pages/HumanStemCell
ResearchReportingForms.aspx.

INFORMED CONSENT CHECKLIST
To assist in the informed consent process for research involving human oocyte retrieval, an informed consent checklist is available under “Resources” at: http://www.cdph.ca.gov/programs/HSCR/Pages/HumanStemCell
ResearchReportingForms.aspx.

GUIDELINES
To assist in assessing the type of review and approval needed for various types of stem cell research based on the CDPH Guidelines for Human Stem Cell Research, a reference table is available under “Guidelines” at: http://www.cdph.ca.gov/programs/HSCR/Pages/default.aspx.

STATUTES
Applicable California statutes and legislation can be found under “Legislation” at: http://www.cdph.ca.gov/programs/HSCR/Pages/default.aspx.

The HSCR Program will also be mailing an informational letter to universities, review committees, and biomedical companies regarding reporting requirements and resources available on its website.