Donors kept in the dark about stem cell research

The ethical and moral obligation of healthcare workers to provide informed consent to donors is usually vast, and somewhat cut and dried. According to research1 recently released in the journal Fertility and Sterility and based on a government survey, many healthcare providers working within in vitro fertility (IVF) clinics in the United States are going against this ethical and moral obligation. The survey uncovered that IVF clinics across the United States don't find it necessary to inform egg donors that possible embryos made from their eggs might end up being used in stem cell research.

The survey indicates that this practice of not providing informed consent to donors is occurring even with common and widespread opposition to stem cell research. The researchers say that this practice is considered morally offensive by one-third of Americans, yet the practice still continues.

"The survey has nicely uncovered an extant ethical dilemma or better, an ethical miscue: namely, the lack of informing prospective donors that their eggs might be used in embryonic stem cell research," says John Banja, PhD, associate professor, Department of Rehabilitation Medicine, Emory University, Atlanta, says. "Presumably, some donors might be very disturbed to learn that because they believe their eggs will only be used for reproductive purposes."

The results of the survey indicate that of 222 U.S. IVF clinics that responded to the query, 100 clinics accepted donor eggs and provided some excess embryos for research.

The researchers received 66 consent forms from those 100 clinics, which showed that although most egg donor consent forms do inform donors that they will not have control over embryos resulting from their eggs, only 30% inform them that some embryos might be used for research. Even fewer mention stem cell research.

Paul Hofmann, DrPH, president, Hofmann Healthcare Group, consultants of ethical issues, in Moraga, CA, says, "The survey simply confirms an ongoing serious problem with some forms of clinical research, namely inconsistent and incomplete disclosure to individuals who must be informed if they are or may be involved in research activities, either directly or indirectly. Such information is essential to permit informed consent or refusal."

Banja adds, "Informed consent requirements would ethically compel clinics to include disclosure of how donor eggs might be used. I also believe that once having done so, women should be free to donate or refuse to donate their eggs."

Study co-author Gerald Owen Schaefer, BA, researcher, department of bioethics, National Institutes of Health (NIH) clinical center, Bethesda, MD, says in the paper that since possible research use of embryos, especially for stem cell research, may be material information affecting some women's decision about donation, egg donors should be so informed. Hofmann agrees and adds, "Regardless of how her eggs might be used, she must have the right to make an informed decision."

The research concluded that egg donors in the United States, including some who might have a moral objection to research and stem cell research, are not being informed that embryos created with their donated eggs might be used for these purposes. This issue can be corrected with the inclusion of succinct, nontechnical language in egg donor consent forms. (For a sample informed consent form for egg donors, see resource, below.)

This incident also raises the question as to whether ethics committees need to be put in place for such facilities. Banja says, "The committee would advise accordingly that egg donation is a medical procedure not without risks and, hence, demands informed consent; that given the contentiousness of embryonic stem cell research, many women might want to know how their eggs might or would be used as that could be a material factor in their deciding to donate or not."

Reference

  1. Schaefer G, Sinaii N, Grady C. Informing egg donors of the potential for embryonic research: A survey of consent forms from U.S. in vitro fertilization clinics. Fertility Sterility Dec. 22, 2011; epub ahead of print.

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