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Chapter 2. Procuring Of Oocytes For Research of California Health And Safety Code >> Division 106. >> Part 5.5. >> Chapter 2.
The following definitions shall apply to this chapter:
(a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation.
(b) "Oocyte" means a female egg or egg cell of a human female.
(c) "Subject" means any person undergoing AOP or any alternative method of ovarian retrieval for research or for the development of medical therapies, including those who would not meet the definition of "subject" under 45 C.F.R. 46.102.
(d) "Alternate method of oocyte retrieval" means a method of oocyte retrieval that does not involve the pharmaceutically induced manipulation of oocyte production.
(e) "Institutional review board" means a body established in accordance with federal regulations, including Part 46 (commencing with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the Code of Federal Regulations.
(a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation.
(b) "Oocyte" means a female egg or egg cell of a human female.
(c) "Subject" means any person undergoing AOP or any alternative method of ovarian retrieval for research or for the development of medical therapies, including those who would not meet the definition of "subject" under 45 C.F.R. 46.102.
(d) "Alternate method of oocyte retrieval" means a method of oocyte retrieval that does not involve the pharmaceutically induced manipulation of oocyte production.
(e) "Institutional review board" means a body established in accordance with federal regulations, including Part 46 (commencing with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the Code of Federal Regulations.
(a) Prior to obtaining informed consent from a subject for
AOP or any alternative method of ovarian retrieval on a subject for
the purpose of procuring oocytes for research or the development of
medical therapies, a physician and surgeon shall provide to the
subject a standardized medically accurate written summary of health
and consumer issues associated with AOP and any alternative methods
of oocyte retrieval. The failure to provide to a subject this
standardized medically accurate written summary constitutes
unprofessional conduct within the meaning of Chapter 5 (commencing
with Section 2000) of Division 2 of the Business and Professions
Code.
(b) The summary shall include, but not be limited to, medically accurate disclosures concerning the potential risks of AOP or any alternative method of oocyte retrieval, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process or any alternative method of oocyte retrieval.
(c) For purposes of subdivision (a), "written summary of health and consumer issues" means the guide published and updated by the American Society for Reproductive Medicine entitled, "Assisted Reproductive Technology: A Guide for Patients" or an alternative written medically accurate document prepared by a recognized authority on oocyte retrieval for medical research that also meets the criteria included in this section. This alternative document may be one that has been approved and recommended by the State Department of Public Health pursuant to Section 125118 and shall include all of the following:
(1) The document shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications. The document shall be written in layperson's language and shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the document shall be conveyed to the subject orally in easy to understand and nontechnical terms.
(2) The document shall include additional resources for, or list additional sources of, medical information on health and safety issues surrounding oocyte retrieval.
(b) The summary shall include, but not be limited to, medically accurate disclosures concerning the potential risks of AOP or any alternative method of oocyte retrieval, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process or any alternative method of oocyte retrieval.
(c) For purposes of subdivision (a), "written summary of health and consumer issues" means the guide published and updated by the American Society for Reproductive Medicine entitled, "Assisted Reproductive Technology: A Guide for Patients" or an alternative written medically accurate document prepared by a recognized authority on oocyte retrieval for medical research that also meets the criteria included in this section. This alternative document may be one that has been approved and recommended by the State Department of Public Health pursuant to Section 125118 and shall include all of the following:
(1) The document shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications. The document shall be written in layperson's language and shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the document shall be conveyed to the subject orally in easy to understand and nontechnical terms.
(2) The document shall include additional resources for, or list additional sources of, medical information on health and safety issues surrounding oocyte retrieval.
(a) Prior to providing AOP or any alternative method of
ovarian retrieval to a subject for the purposes of medical research
or development of medical therapies, a physician and surgeon shall
obtain written and oral informed consent for the procedure from the
subject. Informed consent for the purposes of this chapter shall
comply with the informed consent requirements of the Protection of
Human Subjects in Medical Experimentation Act (Chapter 1.3
(commencing with Section 24170) of Division 20).
(b) The failure to obtain written informed consent from the subject constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. Nothing in this section shall be construed to relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a subject's informed consent after fully explaining the proposed procedure. The requirement that a physician and surgeon provide the standardized written summary pursuant to Section 125335 is in addition to, and does not supplant, other existing legal requirements regarding informed consent, including, but not limited to, compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20.
(c) This chapter shall not affect the suitability or availability of oocytes procured for research before January 1, 2007, if the oocytes were donated pursuant to protocols or standards that are generally recognized and accepted by national or international scientific bodies.
(d) Any written document required pursuant to this section shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications, and in layperson's language. The document shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the written informed consent document shall also be conveyed to the subject orally in easy to understand and nontechnical terms.
(b) The failure to obtain written informed consent from the subject constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. Nothing in this section shall be construed to relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a subject's informed consent after fully explaining the proposed procedure. The requirement that a physician and surgeon provide the standardized written summary pursuant to Section 125335 is in addition to, and does not supplant, other existing legal requirements regarding informed consent, including, but not limited to, compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20.
(c) This chapter shall not affect the suitability or availability of oocytes procured for research before January 1, 2007, if the oocytes were donated pursuant to protocols or standards that are generally recognized and accepted by national or international scientific bodies.
(d) Any written document required pursuant to this section shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications, and in layperson's language. The document shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the written informed consent document shall also be conveyed to the subject orally in easy to understand and nontechnical terms.
An institutional review board (IRB) that reviews and
approves medical and scientific research shall require all of the
following of any research program or project that comes under its
review that involves AOP or any alternative method of oocyte
retrieval:
(a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the subject will receive and review this written summary.
(b) That it obtain informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342.
(c) That it provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes.
(d) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all subjects prior to the oocyte retrieval procedure.
(e) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a subject, the subject be given a postprocedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure. The subject shall be informed that she has the right to a second opinion if she has any medical concerns.
(f) That it ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the subject and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the subject prior to the procedure.
(g) That it provide a summary informing the subject that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350.
(h) That it provide disclosure if the physician and surgeon and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that he or she carries the interest of both the subject and the success of the research.
(a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the subject will receive and review this written summary.
(b) That it obtain informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342.
(c) That it provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes.
(d) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all subjects prior to the oocyte retrieval procedure.
(e) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a subject, the subject be given a postprocedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure. The subject shall be informed that she has the right to a second opinion if she has any medical concerns.
(f) That it ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the subject and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the subject prior to the procedure.
(g) That it provide a summary informing the subject that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350.
(h) That it provide disclosure if the physician and surgeon and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that he or she carries the interest of both the subject and the success of the research.
(a) A research program or project that involves AOP or any
alternative method of oocyte retrieval shall ensure that a written
record is established and maintained to include, but not be limited
to, all of the following components:
(1) The demographics of subjects, including, but not limited to, their age, race, primary language, ethnicity, income bracket, education level, and the first three digits of the ZIP Code of current residence.
(2) Information regarding every oocyte that has been donated or used. This record should be sufficient to determine the provenance and disposition of those materials.
(3) A record of all adverse health outcomes, including, but not limited to, incidences and degrees of severity, resulting from the AOP or any alternative method of oocyte retrieval.
(b) (1) The information included in the written record pursuant to subdivision (a) shall not disclose personally identifiable information about subjects, and shall be confidential and is deemed protected by subject privacy provisions of law. This information shall be reported to the State Department of Public Health, which shall aggregate the data and make it publicly available, as set forth in paragraph (2), in a manner that does not reveal personally identifiable information about the subjects.
(2) The department shall provide public access to information which it is required to release pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). The department shall disseminate the information to the general public via governmental and other Web sites in a manner that is understandable to the average person. The information shall be made available to the public when the biennial review pursuant to Section 125119.5 is provided to the Legislature.
(1) The demographics of subjects, including, but not limited to, their age, race, primary language, ethnicity, income bracket, education level, and the first three digits of the ZIP Code of current residence.
(2) Information regarding every oocyte that has been donated or used. This record should be sufficient to determine the provenance and disposition of those materials.
(3) A record of all adverse health outcomes, including, but not limited to, incidences and degrees of severity, resulting from the AOP or any alternative method of oocyte retrieval.
(b) (1) The information included in the written record pursuant to subdivision (a) shall not disclose personally identifiable information about subjects, and shall be confidential and is deemed protected by subject privacy provisions of law. This information shall be reported to the State Department of Public Health, which shall aggregate the data and make it publicly available, as set forth in paragraph (2), in a manner that does not reveal personally identifiable information about the subjects.
(2) The department shall provide public access to information which it is required to release pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). The department shall disseminate the information to the general public via governmental and other Web sites in a manner that is understandable to the average person. The information shall be made available to the public when the biennial review pursuant to Section 125119.5 is provided to the Legislature.
Any employee who works in the unit conducting stem cell
research using human oocytes, persons who report to, or are
supervised by, the principal investigator or key personnel of the
project, or both, along with the principal investigator and the key
personnel of the project, and the immediate family members of any of
the above persons are prohibited from being a subject in the
research.
The physician and surgeon performing the AOP or any
alternative method of oocyte retrieval shall not have a financial
interest in the outcome of the research.
Pursuant to guidelines adopted by the Research Council and
Institute of Medicine of the National Academies, researchers shall
offer subjects an opportunity to document their preferences regarding
future uses of their donated materials. The consent process shall
fully explore whether subjects have objections to any specific forms
of research to ensure that their wishes are honored.
Any procedures for procuring oocytes in this state for
research or the development of medical therapies shall meet all of
the standards for subjects included in this chapter. All oocytes
procured outside of this state for research taking place in this
state shall meet these same standards. All egg extractions for
research shall be approved by an institutional review board pursuant
to Section 125341.
No human oocyte or embryo shall be acquired, sold, offered
for sale, received, or otherwise transferred for valuable
consideration for the purposes of medical research or development of
medical therapies. For purposes of this section, "valuable
consideration" does not include reasonable payment for the removal,
processing, disposal, preservation, quality control, and storage of
oocytes or embryos.
No payment in excess of the amount of reimbursement of
direct expenses incurred as a result of the procedure shall be made
to any subject to encourage her to produce human oocytes for the
purposes of medical research.
