C. Scott Tocher, Interim Counsel
California Institute for Regenerative Medicine
210 Kings Street
San Francisco, CA 94107
RE: Re-comment on CIRM Medical and Ethical Standards regulations
Dear Mr. Tocher,
On behalf of the Pro-Choice Alliance for Responsible Research and the Center for Genetics and Society, we are submitting these re-comments to the proposed California Institute of Regenerative Medicine's Medical and Ethical Standards regulations (17 Cal. Code of Regs §100010 - 100130).
We are especially concerned about the provisions that impact women's health and reproductive decision-making and have noted them first.
Section 100095 Additional Requirements for CIRM-Funded Research Involving Ooctyes
Interfering with the doctor-patient relationship
The intent of the revision of the regulation pertaining to women who provide eggs both for fertility and research purposes was to create clarity, but we are concerned that the new language has not achieved that goal. Instead, the new language raises more questions than it answers, and neither researchers nor fertility physicians have been given guidance as to their responsibilities to their patients. Every fertility physician's first responsibility is to her/her patient who is seeking fertility treatment. Therefore, it is unacceptable and a violation of medical ethics, and law, for a physician to compromise the reproductive needs of the patient, either knowingly or negligently. Inserting new intent language into the regulation muddies those obligations, and may even inappropriately shield physicians from liability if their actions do result in not properly providing the fertility treatments that the patient was seeking. Such a result is an impermissible interference in the physician-patient relationship and should be avoided.
We propose to strike the word "knowingly"
Second, the phrase "the disposition of such oocytes shall not compromise the optimal reproductive success of the woman in fertility treatment" is no more clear as to what it means to compromise that reproductive success than the original language, it just adds another word - "disposition" - and it is not clear what it changes in this context.
Compensation for egg donors - violation of Proposition 71
The new (b)(2) now creates a loophole that violates the plain language of Proposition 71 which prohibits payment for eggs. This new language allows a clinic to pay a woman for eggs for research by creating a legal fiction and an illusory distinction between eggs provided for fertility and eggs provided for research. Common practice in fertility treatment is to pay women per cycle, not per egg, and in fact, paying women per egg would create perverse incentives as happened in South Korea for women to be given higher doses of hormones than necessary. Suppose a woman provides one cycle of eggs from which 10 eggs are retrieved. This new regulation says that if a woman undergoes one cycle and provides 10 eggs, the clinic can pay her for 8 and then pretend that she gave 2 for free! This is nothing but a sham to create compensation for eggs for research, which is against the law. This idea has been discussed many times at the Standards Working Group and at the ICOC and has been rejected consistently and should be rejected now. Only women who provide eggs without any compensation can provide eggs for research.
We propose the following:
(b)(2) A woman providing oocytes for donation for another person's reproductive efforts many not donate any of these eggs to research unless she has received no valuable consideration for her donation of oocytes for either research or reproduction.
Assuring medical care
With regard to the provision of medical treatment for adverse outcomes from the egg provision process, we agree with the clarification that medical treatment shall be provided to women at no cost, however, we believe further clarity is required to ensure that the woman is not required to use her own health insurance. As discussed at length in the Standards Working Group, one option may be for the researchers to purchase health insurance for egg providers, and some of these policies are only secondary payors. There may be consequences for women in the long term for using their own insurance such as reaching a life-time benefits cap sooner, exclusions for pre-existing conditions, etc. For women who have insurance, the decision of whether to use that insurance must be left to the woman.
Therefore, we propose adding a new sentence at the end of (c): If a donor is medically insured, the donor shall not be required to claim any such medical treatment through her own health insurance policy.
With regard to conflicts of interest, as we noted above, the revised language recognizes that professional conflicts of interest can be just as damaging as financial conflicts. We propose that the same language used in the SCRO committee provisions should also apply here.
We propose the following revision:
(e) The physician performing oocyte retrieval shall not have a professional or financial interest in any aspect of the research.
We reiterate our concerns that the inherent conflict of interest between research and infertility physician is irreconcilable, and as recommended by the professional organizations, there should be no exception.
(d) The physician attending to any donor and the principal investigator or other researcher shall not be the same person.
Section 100100 Informed Consent Requirements
We continue to have concerns about the broad requirements as to who must give consent to the provision of umbilical cord, cord blood, and placenta materials. While we appreciate both the justification of scientific rigor and the privacy concerns that a genetic contributor should give consent before his genetic material is used in research, we still believe that the constitution and current practice as noted by the National Marrow Donor Program and the National Academies, require that consent should only be required from the pregnant woman.
We reiterate our concerns that, at the very least, no one other than genetic contributors should be required to give consent. Neither legal parents nor guardians necessarily have any genetic link to the tissue in question, and their consent serves neither a scientific rigor nor a privacy goal. Last, we repeat our objection to the term "genetic parent" as it lacks clarity, can easily be confused with legal parent, and again does not achieve the goals of this section.
If, however, it is decided that for the purpose of scientific rigor and the privacy rights of tissue donors, consent should be obtained from anyone other than the pregnant woman, we have worked with the ACLU on the language they have proposed in their comments and which is repeated below:
The phrase "genetic parent" should be replaced with "genetic contributor" in (f) and (g)
(f) . . . . . For CIRM funded research that uses umbilical cord, cord blood or the placenta to derive covered stem cell lines for purposes other than autologous donation, in order to assure scientific rigor, consent shall be obtained from each genetic contributor. Nothing in this section shall be construed to affect state or federal law with regard to consent in reproductive decision-making.
(i) The pregnant woman shall be informed in writing during the first conversation about donation that (a) donation requires disclosure of the names and contact information of all genetic contributors; and (b) donation requires that genetic contributors be contacted in order to secure their informed consent. Under no circumstances shall a genetic contributor who is not the pregnant woman be contacted if the pregnant woman has not given written informed consent for such contact.
Section 10003 0 - Activities Not Eligible for CIRM Funding:
An additional type of research that has been prohibited in more than 30 countries and that should not be eligible for CIRM funding is inheritable genetic modification of human beings. Therefore we propose adding the following as not eligible for funding:
(f) The transfer of a genetically modified nucleus or stem cell, or an artificial chromosome, into a human oocyte or embryo.
(g) The genetic alteration of a human embryo
Section 100060 SCRO Committee Membership and Function
We appreciate the incorporation of our comments suggesting that, as recommended by the National Academies, at least one member of the SCRO is a non-scientist member of the community, and the inclusion of professional conflicts of interest as the basis for recusal from decision-making.
Section 100070 SCRO Review and Notification
While we all know that cloning human beings is against the law in California, we continue to be concerned that the SCRO review portion of the regulations fails to incorporate sufficient oversight of the use of cloned embryos to facilitate detection of skating too close to that line, or even crossing over it. We propose that in additional to justification for the "number" of oocytes or embryos, that researchers document the steps taken to prevent their misuse.
ADD to (a) (b) and (c)
Document the planned method of obtaining the oocytes or embryos.
If SCNT is used, document what steps will be taken to prevent track the use and disposition of the clonal embryos and prevent their misuse.
We appreciate the importance of having the SCRO member with expertise in assisted reproduction present for review and approval of research involving embryos, and the same requirement should apply to (c) for research aiming to derive or create a covered stem cell line, since such research activities will most likely involve human eggs.
ADD to (c): For such SCRO committee review and approval, the member of the committee with expertise in assisted reproduction shall be present.
In addition, we applaud the requirement for annual review of SCRO approvals, but the added language is unclear as to who will do the review (" (h) SCRO committee approvals shall be reviewed . . . "). The second sentence beginning "The renewal review . . ." is unclear. What does "renewal" mean? The SCRO reviewing itself would not provide the type of accountability that this provision should ensure.
We again recommend that an independent body be responsible for SCRO review.
Thank you for your consideration of these comments. Please feel free to contact us with any questions or for any clarification.
Susan Berke FogelJesse Reynolds
Pro-Choice Alliance for Responsible Research
Center for Genetics and Society