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Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story? Hillary B

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Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story? Hillary B Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story? Hillary B. Alberta, Roberta M. Berry, and Aaron D. Levine Introduction Accurately estimating these risks is complicated by the In vitro fertilization (IVF) using donated oocytes has dearth of long-term studies that evaluate the risks spe- proven to be an effective treatment option for many cifically associated with oocyte donation by healthy, prospective parents struggling with infertility, and the presumably fertile, volunteers.6 usage of donated oocytes in assisted reproduction has Payment to oocyte donors also raises ethical con- increased markedly since the technique was first suc- cerns, including the perceived commodification cessfully used in 1984.1 Data published by the Centers of oocytes and the potential exploitation of oocyte for Disease Control and Prevention (CDC) on the use donors.7 Suzanne Holland claims that many find of assisted reproductive technologies (ARTs) in the their sense of human dignity disturbed when parts of United States indicate that approximately 12% of all our bodies that we “associate with our personhood” ART cycles in the country now use donated oocytes.2 are viewed as property and “sold off on the market The increased use of oocyte donation in the United for whatever the market will bear.”8 Similarly, Rad- States has prompted discussion regarding risks asso- hika Rao notes that compensation could be criticized ciated with the process and how best to ensure the because “it treats the sacred components of human life safety of oocyte donors.3 as a form of property, engendering an attitude of disre- Physical risks associated with oocyte donation spect for actual persons.”9 However, others argue that include bleeding, infection, ovarian hyperstimulation payment to oocyte donors is justified as a means for syndrome and a potential, although unconfirmed, compensating donors fairly for their time and physi- increased risk of developing various forms of cancer, cal commitments and for ensuring an adequate supply such as uterine, colon, breast, ovarian, and endome- of donated oocytes for those who suffer from infertil- trial cancers.4 A number of anecdotal reports recount ity.10 Excessive compensation levels, however, raise donor experience of some of these unconfirmed physi- concerns about “undue inducement” and the exploita- cal risks and also recount experience of psychological tion of donors.11 The concern is that very high com- risks, including donor concerns about potential long- pensation may manipulate women into making rash term physical risks and a variety of concerns associ- decisions to proceed with donation without adequate ated with offspring resulting from the IVF procedure.5 consideration of the associated risks.12 Hillary B. Alberta, M.S.P.P., is a doctoral student in the School of Public Policy at Georgia Tech. She holds an M.S. in Public Policy and a B.S. in Biology, both from Georgia Tech. Roberta M. Berry, J.D., Ph.D., is an Associate Professor of Public Policy at Georgia Tech and holds a joint appointment as a Professor of Science & Technology Law, Policy & Ethics at Georgia State University College of Law. Professor Berry holds a Ph.D. in the History and Philosophy of Science from the University of Notre Dame, a J.D. from the University of Wisconsin, and a B.A. in History from Swarthmore College. Aaron D. Levine, Ph.D., M.Phil., is an Associate Professor in the School of Public Policy at Georgia Tech where his research explores the intersection between public policy, bioethics, and biomedical research. He completed his Ph.D. in Public Affairs at Princeton University and also holds an M. Phil. in Biological Sciences from the University of Cambridge and a B.S. in Biology from the University of North Carolina at Chapel Hill. 232 journal of law, medicine & ethics Alberta, Berry, and Levine There is also a broader set of ethical concerns about absence of any medical benefits to the donor,16 and with decision making by potential donors in light of the the incentive of significant financial benefit and, for known and unknown risks. As with any individuals many, the additional incentive of providing altruistic who decide whether to undergo a medical procedure, help to others in achieving an important and deeply it is important that oocyte donors understand both desired result.17 Concerns about incentives to under- the benefits and risks of the donation process and that take medical risks in the absence of medical benefits they have adequate opportunity to consider and weigh might be mitigated by reliance on the safeguards of both before they decide whether to proceed. This con- the ordinary physician-patient relationship in ensuring cern is anchored in the ethical principle of autonomy adequate opportunity to consider the risks. The physi- and the practice of informed consent that aims to cian-donor relationship, however, is atypical. vindicate this principle. This imposes obligations on Judith Daar argues that the nature of the physician- professionals involved in the oocyte recruitment and donor relationship is problematic for accomplishing donation process to inform potential donors of the informed consent. In the usual physician-patient rela- benefits as well as risks and to ensure that they under- tionship, the physician is concerned with the medical stand and consider both before they decide whether benefits and risks for her patient and in ensuring that to proceed. her patient understands and has an adequate opportu- There has been only limited investigation of the nity to consider the benefits and risks before deciding effectiveness of current informed consent procedures whether to proceed. In the oocyte donation process, in ensuring donor understanding and consideration of however, it is the recipients of the donated oocytes the benefits and risks of donation. One retrospective who will realize the medical benefits of the donation survey of oocyte donors concluded that most donors process if they are successfully treated for infertil- did not adequately understand the physical risks — ity.18 Sharon Lerner’s experience posing as a potential including the risks of bleeding or infection and ovar- oocyte donor exemplifies the potential problematic ian hyperstimulation syndrome — before deciding to effects.19 In the course of attending five appointments, engage in the donation process.13 Nancy Kenney and which included medical exams, tests, and counseling, Michelle McGowan found that donors’ retrospective Lerner observed that concern was focused primarily self-reported awareness of the risks associated with on the infertile recipients of her oocytes rather than on the donation process did not correspond with the her as a patient.20 The Ethics Committee of the Ameri- risks they actually experienced.14 In a 2013 prospec- can Society for Reproductive Medicine (ASRM), the tive study, Amanda Skillern, Marcelle Cedars, and self-regulatory association for ART professionals, Heather Huddleston found that the potential donors has recognized and issued guidelines directed to the in their study population showed very good subjec- potential concerns posed by the distinctive context: tive (perceived) and objective (performance-based) understanding of the risks of donation as measured by Once the donation process begins, oocyte donors their informed consent assessment instrument. They become patients owed the same duties present conclude that it is possible to achieve fully informed in the ordinary physician–patient relationship. consent under the conditions reflected in their study, Programs should ensure that every donor has a which included intensive counseling. Potential donors physician whose primary responsibility is caring attended an hour-long audio-visual presentation con- for the donor. Oocyte donor program staff should ducted by a psychologist and a reproductive endocri- recognize that physicians providing services nologist, with encouraged questions during and imme- to both donors and recipients could encounter diately following the presentation. Each donor then conflicts in promoting the best interests of both met individually for 30 minutes with a reproductive parties and should create mechanisms ensuring endocrinologist for medical screening and additional equitable and fair provision of services.21 review of risks with questions again encouraged.15 In the absence of more extensive studies of current Another potentially problematic feature of the deci- informed consent procedures, the adequacy of current sion-making context is the recruitment process for procedures in ensuring that potential donors under- potential donors, which proceeds in a series of stages. stand and consider the benefits and risks of oocyte In some cases, there is a delay of weeks or months donation is uncertain. This uncertainty is of significant between the time a potential donor is recruited and concern in the distinctive context of oocyte donation receives information about the donation procedure in which the risks, benefits, and incentives to under- and the time the donor is contacted to proceed with take risks differ from those in the typical medical con- donation and give formal consent.22 This prompts the text. The oocyte donor undertakes medical risks in the question of what, if any, risk disclosures should be neurosciences • summer 2014 233 INDEPENDENT included at various stages of the recruitment process Franklin Miller and Andrew Shorr note that the U.S. to ensure that the potential donor adequately
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