Exploring appropriation of “surplus” ova and embryos in Indian IVF clinics

Abstract

IVF clinics have emerged and are proliferating even in small towns of India. There is hardly any regulation or oversight regarding what happens to “surplus” ova and embryos, the potential raw material for embryonic stem cell research. India is an emerging economy where both public and private initiatives in stem cell research exist and are proliferating. There is a lack of transparency regarding the supply of stem cells required for research. Based on empirical research, the article provides insight into the practices and policy relating to the appropriation of human ova/embryos by IVF clinics and health (research) institutions. It also investigates the regulatory structures to govern procurement and ownership of ova/embryos, and whether they are likely to be adequate and effective. It concludes that the existing guidelines are not binding, lack legislative authority and adequate monitoring mechanisms, leaving the practice in IVF clinics to self-regulation. This creates a potential for exploitation of ova/embryo donors.

Keywords:

• ova appropriation
• governance
• India

Introduction

Clinics providing in-vitro fertilization (IVF) have proliferated even in small towns of India. Not only Indian infertile couples are flocking to these clinics; India is a major destination for couples from abroad seeking donor eggs and surrogates to fulfill their desire for a child. IVF clinics are also the potential suppliers of ova and embryos for stem cell research. India is an emerging economy, where both public and private initiatives in stem cell research exist and are proliferating, riding on the second wave of globalization in the biomedical and information technology industry. Public–private partnerships are also being undertaken. Research in India is not only dependent on national or foreign private enterprise and capital; there is a huge investment also by the Indian government in this sector. The Department of Biotechnology has supported more than 30 programs of stem cell research so far, including the establishment of “stem cell city clusters” (UK Stem Cell Initiative 2005). It announced its intention to create a biotechnology industry that would generate US$5 billion in revenues per year and one million jobs by 2010 (Jayaraman 2005 cited in Salter et al. 2006). The National Task Force on Stem Cell Research was established in April 2005 to take these plans forward. Gaining and maintenance of trust through appropriate governance and accountability structures is crucial for success and further development at a national and international level, since India has become a global center for clinical trials both for its own industry and for contract research organizations working on behalf of foreign companies (Salter et al. 2006, Frew et al. 2007, Sunder Rajan 2007). However, there is a lack of transparency regarding procurement of human ova and embryos required for research.

My focus here is on the appropriation of raw materials (e.g. ova and embryos) required either for IVF practice or for the early stage research in stem cells. I look at the clinical practice in IVF clinics to understand the process of procurement of ova/embryos and clients' views regarding donation. Further, I discuss regulatory structures for governing the procurement and ownership of eggs/embryos in place, and examine other ethical issues regarding ova appropriation for IVF treatment and for stem cell research.

Research methodology and methods

Data was obtained through empirical research conducted in New Delhi and Mumbai during 2002–2004 and again in January 2009. Interviews using qualitative research methods were held with (a) 28 women/couples attending two selected IVF clinics; (b) 17 IVF specialists at 10 clinics; and (c) three regulators. Only three of the 10 clinics had their own research labs. Most IVF clinics were not involved in research; the researcher did not inquire whether they had links with other research labs. Permission from and access to the couples in various stages of IVF treatment was obtained from the IVF specialists and individuals in question and the latter were interviewed while waiting for their turn to see the specialist in the clinic. The interviews were in a semi-structured open-ended format, which allowed women/couples to relate their experiences of the IVF treatment. Questions pertained to demographic details, information regarding the IVF process, their own experience of it, who should decide what happened with their reproductive material, whether they would be willing to donate their “surplus” eggs either to another couple or for research, and their use of the consent forms. Also, consent forms used by the clinics were requested, and when obtained analyzed. All interviews were fully transcribed, after which major themes were identified, and relevant excerpts selected.

Procurement of ova for research

The major source of ova for research is women undergoing infertility treatment requiring ovarian stimulation and egg retrieval. There is an enormous increase worldwide in the number of women seeking assisted reproduction including IVF. Women enrolled in IVF programs are administered fertility drugs to hyper-stimulate the ovaries to ripen (multiple) eggs. Doctors have retrieved as many as 44 eggs (normally one egg matures in every menstrual cycle). Ova and embryos are not merely a “gift of life,” but also a “gift of potential knowledge to a medical researcher” (Waldby and Mitchell 2006).

Initially, the ethics of procurement of ova for research was never seen as an important issue even by bioethicists; concerns regarding the moral status of the embryo overshadowed this aspect. The media, and even the scientific journals, were “as silent on the issue as if human eggs grew on trees” (Dickenson and Alkorta Idiakez 2008, 127). Dickenson (2006, cited in Dickenson and Alkorta Idiakez 2008, 127) argues “much bioethical analysis simply ignored the way in which ‘the lady vanishes’ in the SCNT stem cell technologies.” Few ethnographic studies deal with the procurement of eggs for research (Thompson 2005, Roberts 2007, Bharadwaj and Glasner 2009) and what qualifies an embryo to be regarded as spare (Scully and Rehman-Sutter 2006, Svendsen and Koch 2008).

After it came to light in 2005 that South Korean research led by Hwang Woo-Suk involved fabricated data and the unethical procurement of over 2,200 eggs (Kim 2008), those advocating the need for setting international standards regarding ova procurement have been increasingly vociferous; this, however, appears to be a challenging task as in different countries the regulatory frameworks, legal norms and legislation – from the rather permissive to more tolerating regimes – regarding egg donation are diverse, if they exist at all. In many countries, including Spain and the US, mainly young university students are recruited as egg donors for infertile women and paid a handsome fee ranging from US$800 to US$5,000 respectively. Apparently, Harvard university scientists are finding it difficult to persuade women to donate eggs for research, as it is illegal to pay them when eggs are used for research purposes (Dizikes 2007), whereas Spanish donors would rather donate for research than IVF, given the confidentiality implications of donating gametes for reproduction (Dickenson and Alkorta Idiakez 2008).

In the UK, the Human Fertilisation and Embryology Authority (HFEA) agreed on 21 February 2007 to allow women to donate their eggs for research provided strong safeguards were in place to ensure that women were properly informed of the risks of the procedure and protected from coercion. Both altruistic donation or in conjunction with their IVF treatment are allowed, and they are eligible for discounted IVF services and compensation for actual costs incurred such as transportation up to £250 (HFEA 2007). The HFEA is keen to remove obstacles to donation. A public consultation on a market in gametes began in January 2011 running for three months. The results will be made available in May 2011 (Cook 2010).

Even when women are paid thousands of dollars, as in the US, for reproductive purposes, the procedure is referred to as “egg donation” to avoid the connotation of a market in human eggs (Resnick 2001). Haimes (2008 cited in Haimes and Taylor 2009, 2142) opines “there is a strong case for using the more neutral language of ‘provision.’” It is difficult to strictly define the lines defining the various modes of transactions – donation, gift, altruism and commerce – in body parts and tissues. While the sale of solid organs is illegal in most countries, including India, ova, semen, blood and other body fluids and tissues do not fall under the legislation because of their regenerative quality. Also, transactions in these body parts are relatively unregulated, primarily due to the idea of individual autonomy (Dickenson and Alkorta Idiakez 2008, Gupta and Richters 2008), which, it is believed, can be taken care of through informed consent procedures. The new guidelines of the International Society for Stem Cell Research (ISSCR 2007) legitimize both reimbursement of direct expenses and financial compensation for women who supply eggs for research. They recommend that decisions about paying women for their eggs should be left to local oversight committees.

Ova appropriation in Indian IVF clinics

According to recent media reports, there are about 350 fertility clinics in India, some of which provide state-of-the-art facilities, while others in semi-urban areas function as satellite clinics. In contrast to the 1990s, with wider availability of IVF and donor eggs, in recent years Indian women even in their late 40s and 50s are seeking IVF. Women are hyper-ovulated to ripen multiple follicles. The eggs are harvested to produce the maximum number of embryos in-vitro, more than the number transferred in women. In India, doctors replace three to five embryos, especially in women above 35, or if there is a history of previous failures (two to three IVF cycles) (interview material). Because affordability of patients is low, this works out cheaper, increasing the chance of success per cycle. Most clinics run donor-recipient egg-sharing programs. Both women are said to benefit from this egg-sharing method. Usually, poor patients exercise the option to donate their eggs in exchange for their treatment costs being shared either by the receiving couple or by the clinic.

To the researcher's remark during interviews that university students in the US were selling their eggs to pay for their education, one patient remarked “the government should reduce the fees, so that students would not have to sell their eggs,” while another iterated “according to our tradition it is not proper to sell eggs.” An IVF specialist mentioned that it was difficult to find (non-patient) women willing to donate their eggs, because the process is painstaking. It requires a woman to undergo a series of tests and take injections for 12 days to hyper-stimulate the ovaries, after which the eggs are harvested. Few women want to go through this for nothing. Another reason mentioned by a fertility specialist was that egg extraction involves trans-vaginal ultrasound for egg harvesting. “You wouldn't have that kind of girls [as in the US and Spain] coming forward, you know, to take 20 injections. Because most of the work we do is internal, doing a trans-vaginal ultrasound for an unmarried Indian girl and egg pick-up wouldn't be acceptable” (interview Dr J).

However, recently the media report a new trend that fertility specialists are receiving requests for egg donation from young elite Indian college students and single working women – women who want to earn quick money to maintain their expensive lifestyles (Sharma 2010). Also, the recent economic downturn resulting in job losses seems to be driving some housewives to resort to egg selling to balance family budgets and lifestyles (interview Dr A). This phenomenon needs further research.

Consent forms and obtaining consent

Most clinics claim to use a consent form which women and their husbands undergoing assisted reproduction procedures must sign before treatment can begin. In some cases the consent form is part of an information booklet. As one service provider said: “Actually, ours is like a booklet. So, when they go through it, they have to sign the entire booklet” (interview Dr I). Most clauses on the form mention (1) techniques to be used; (2) that the risks and failures at various points of the procedure have been explained to clients; and (3) an achieved pregnancy is not guaranteed. Remarkably, the same form is also used to register an agreement between the different parties (client/donor/hospital) involved regarding the use of “leftover” eggs; there is no separate form for cryopreservation or use of “leftover” or donor eggs/embryos. In practice, this means that unless clients sign the consent form treatment cannot begin, and once they have signed it they have also relinquished their rights to their own leftover eggs/embryos.

I tried to procure sample consent forms from IVF specialists. While some were cautious and reluctant to oblige, making up some excuse or other, some others did make the form available to me. Here are a few samples of the clauses on the consent forms of some of the leading clinics in Delhi and Mumbai regarding use of “leftover” eggs/embryos:

We understand that extra oocytes/embryos will be dealt with by the clinic at their own discretion for cryofreezing/donation/scientific research. (Kamala Polyclinic & Nursing Home, Mumbai)

We are willing to give away the immature eggs for research in case they do not mature in vitro after 48 hours of incubation in appropriate media.

We are willing to give the unfertilized eggs for research, which fail to fertilize in vitro following IVF or ICSI. (INKUS IVF Centre, Mumbai)

We both understand that the disposal of unused oocytes/embryos shall be at the discretion of the IVF unit. (Sir Ganga Ram Hospital, New Delhi)

As one service provider put it:

We have a consent form, no legal agreement. We have no separate form for consent regarding cryopreservation. The same consent form is used for donation. (Dr F)

In 2003 the following notice appeared on the wall of the IVF unit of a renowned private hospital in New Delhi.

Note:

Patients are hereby informed to make the payment for cryopreservation done on due date.

Cryopreservation of embryos is valid for six months from the date of cryopreservation which can be renewed on payment of renewal charges within the last month of Validity Period. Failure of which authorizes laboratory to treat the embryos as discarded.

Charges are as follows:

Cryopreservation charge: 15,000 Rupees. (valid for first six months)

Renewal charges: 3,000 Rupees. (valid for next six months from last month of first validity period)

Thus, patients pay for storage of their embryos. If they fail to pay, after two reminders the clinic may use the embryos for donation to other couples or for research. “Discard” may mean any of the following: destroy, sell, use for research, etc.; effectively it means a transfer of custody of embryos from the “donors” to the IVF clinic on the expiry of a fixed time period. This was confirmed by one of the IVF specialists at this hospital.

It is clear from the above examples that the majority of women undergoing IVF are unwittingly being asked to donate or relinquish ownership over their “spare” or “supernumerary” eggs/embryos without realizing that these are a potentially valuable resource having a “biovalue” (Waldby and Mitchell 2006) or “biocapital” (Sunder Rajan 2007).

I asked couples undergoing treatment whether they had signed a consent form, regarding use of leftover eggs/embryos. Many remembered signing something, but not exactly what was written on the form.

On the second or third day we signed something; even today. We believe them (doctors) and have confidence in them. So, we don't read the terms and conditions, or say “delete this or that, and only then we'll sign.” (PKG, husband)

Another (male) replied:

Yes, we signed. It's a printed form; so, you can't change anything.

I don't know what they do with the extra eggs. Generally they say they discard them. Naturally, they can't keep so many containers; otherwise the hospital would be full of them. (P, female)

I asked women/couples undergoing IVF whether they would be prepared to donate their eggs.

Mr S: My wife wouldn't be.

Researcher (R): Would you consider selling them?

Mr S: No. If there is a choice we would prefer donating them, but not selling.

R: In the US, female students are selling their eggs.

Mr S: We wouldn't do that.

R: And what about donating them for research?

Mr S: Sure.

(Mr JNS, husband of woman undergoing IVF)

I asked whether they expected that their consent would be taken, if their leftover eggs were donated to some other woman/couple, or used for research.

(1) BK (husband): See, when we make offerings [money] in the temple, the priest may drink away the money. We don't check it out.

R: Would you allow your spare eggs to be used for research?

SK (wife): No problem, if it is for the good of others.

(Couple undergoing IVF)

(2) R: Would you consider donating the extra eggs?

AP: Eight eggs have been retrieved. I would like to keep the extra embryos for a second pregnancy. After that I would be happy to donate …We don't expect payment, because we earn enough.

(Woman who had undergone IVF, six weeks pregnant)

(3) R: Would you donate embryos for research?

MG: I was asked to donate and donated 8–9 cryopreserved embryos, because I already have twins … I don't mind if anything can be done for science.

(Dr MG, gynecologist, who had given birth to twins after IVF)

(4) R: Would you donate the extra eggs for research?

V: Yes, why not? As long as the hospital does not use them commercially. If I donate, the hospital has to donate also. If not, I object to it.

(Woman undergoing IVF)

From the interview material it emerged that most women/couples were under great physiological and psychological pressure. They were too preoccupied with the IVF treatment and their desire for a child and had given little thought to what would be done with their eggs/embryos once they had achieved their goal. Often they did not ask, neither were they informed how many eggs had been harvested or the number of embryos created. If there were sufficient eggs available for their own use (later attempts if needed), many couples felt “the extra eggs have no value for us.” Also, they did not desire payment for the “donated” eggs. Having gone through so much trouble themselves, helping other couples in a similar predicament or helping science to come up with solutions to infertility were reasons often-mentioned by women/couples undergoing IVF to donate their eggs. The (high) costs for cryopreservation was a reason for letting it lapse. Patients did not have much idea about what “research” entails.

Few patients had read the consent forms carefully. In practice, it emerges that the primary function of consent forms is to protect the practitioner from liability, not to protect the patient from injury or abuse. Also, more importantly, they serve to transfer custody – contractual “ownership” – of embryos from patients to IVF clinics, either actively or by default.

Dr M, at the National Institute for Research in Reproductive Health, Mumbai (a public sector institute), then President of the Indian Society of Assisted Reproduction was very critical of some of the practitioners in her field:

In India, if you go to the best of clinics, you'll find that most of them don't bother to take consent. They think they are doing humanitarian work to suit themselves, which is not what I practice; I practice science the way it should be practiced … Dr X tells the patient: “Maybe I will transfer only three of your embryos.” The patient asks “what will you do with the rest of my embryos?” Dr X says: “I'll throw them out. I'm not going to preserve them.” Whether she preserves them, or gives them to someone else, this is her own business, not ours. We would have three times the practice if we were to give the eggs away, because we have a large IVF program … We do cryopreservation, we also do donor-recipient cycles and I have currently a stem cell research program, where frozen embryos with the consent of donor are used. Our center is registered with NIH [National Institute of Health] in America.

Several IVF practitioners I interviewed told me they followed guidelines prepared by the Federation of Obstetric and Gynaecological Societies of India, the European Society of Human Reproduction and Embryology or the American Fertility Society, although these claims cannot be verified.

Regulation and governance in India

Government policies regarding stem cell research are shaped differently in different national regimes. Unlike the law and practice in countries such the UK, US, Belgium, Israel and Singapore, which are well regulated, India does not have an official policy in place yet, although some guidelines (DBT-ICMR 2007) in this regard exist.

The first set of guidelines were prepared by the Indian Council of Medical Research and the National Academy of Medical Sciences (India), posted on their website, circulated among practitioners, and finally published in 2004. These guidelines were further sharpened in 2007 (DBT-ICMR 2007) to address both ethical and scientific concerns to encourage responsible practices in the area of stem cell research and therapy. They include a special section on the procurement of gametes, blastocysts or somatic cells for the generation of hES cell lines. Only surplus, spare and supernumerary eggs may be used for research after informed consent is obtained from both spouses. These can be collected only in registered Assisted Reproductive (IVF) Clinics. Clauses and sub-clauses in section 11 are relevant here. According to them:

Consent for donation of supernumerary embryos should be obtained from each donor at least 24 hours in advance and not at the time of donation itself. Even people who have given prior indication of their intent to donate blastocysts that remain unutilized after clinical care should give fresh informed consent at the time of donation of the embryo for establishment of hES cell line. Donors should be informed that they retain the right to withdraw consent until the blastocysts are actually used in cell line derivation (Clause 11.2).

There should be no commodification of human oocyte, human sperm or human embryo by way of payment or services, except for reimbursement of reasonable expenses incurred by the person (amount to be decided by IC-SCRT/IEC. Similarly, no payments should be made for donation of somatic cells for use in SCNT except for reimbursement of direct expenses incurred for attending the clinic (Clause 11.3).

Women should be informed about potential hazards and complications that are related to the hormonal induction process and be provided appropriate healthcare in case of complications arising from the procedure (Clause 11.4).

The attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells preferably should not be the same person. To facilitate autonomous choice, decisions related to the creation of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research (Clause 11.5).

In the context of donation of gametes or blastocysts for hES cell research or therapy, the informed consent process, should at a minimum, provide the following information:

A statement that the blastocysts or gametes will be used to derive hES cells/cell lines for research purposes (Clause 11.6a).

…

A statement that neither consenting nor refusing to donate embryos for research will affect the quality of present or future medical care provided to potential donors (Clause 11.6j).

Apart from an institutional ethical committee, a nodal body for review and monitoring, the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) was proposed. All institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC-SCRT through the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) (Clauses 4.0 and 4.1).

The DBT/ICMR 2007 guidelines do not have legislative authority and the ad hoc character of the proposed monitoring and enforcement agency make it no more than a paper tiger. This leaves clinicians and researchers free to practice some sort of “self-regulation.” Most people (including some providers of IVF) are skeptical of guidelines having the intended effect on the practice in clinics and research centers, particularly in the private sector (interview material). “Guidelines are at best good practice and, at worst, just scraps of paper,” according to a lawyer in the Supreme Court of India specializing in corporate law and regulatory issues in biotechnology. Moreover, existing guidelines cannot be enforced on private organizations that do not receive government funding (Mudur 2005). Private clinics make use of this regulatory vacuum to do as they like and justify their activities in the name of “helping mankind” and putting India on the global stem cells research map. An often cited case is that of Dr Geeta Shroff, an obstetrician/gynecologist who specialized in IVF in the early 1990s, but is not doing IVF any more. I interviewed her in 2007. Dr Shroff began her research in stem cells in 2000 at Nu Tech Mediworld in New Delhi, a registered genetic center which started as a fertility clinic. She claims that she created a stem cell line with only one “leftover” embryo. The conditions under which the eggs were procured, whether consent from the women involved was obtained, and its validity, remain unanswered questions, considering she has not made these issues transparent even to the ICMR (interview regulator).

Jayaraman (2001 cited in Bharadwaj and Glasner 2009) confirms that India is being increasingly seen as an embryo surplus nation. In an environment which at the moment is almost free for all, and with the rapidly increasing fertility interventions for both the local and international market, and with evidence of the growing fertility tourism, India is likely to become a stem cell “hub.” Also, “the Church in Western countries perceives using embryos to extract stem cells as murder. This, in conjunction with lax regulations on such research, has given India an obvious edge” (Pandeya 2007 cited in Bharadwaj and Glasner 2009, p. 104). The influence of the Church on the perceived status of the embryo and its influence on stem cell research policy varies in different countries. In India, abortion is widely practiced as a family planning measure and also within pre-natal management of pregnancy by all religious groups (Gupta 2010). There have been hardly any debates on the moral status of the embryo, even within the Christian and Muslim communities, traditionally perceived as opposed to abortion.

In the wake of setting up the hESC line research at Reliance Life Sciences Laboratory and the National Centre of Biological Sciences in 2001 and its associated publicity, the government announced a “crackdown” on the trade to counter the international view of India as “an embryo surplus” nation (Salter et al. 2006). The claims of self-regulation made by IVF practitioners, that they follow international guidelines (those of the American Fertility Society and HFEA, UK) in this regard, and lack of transparency and monitoring of this highly lucrative burgeoning fertility industry, leave the question unanswered whether the ova/embryos were procured ethically.

Discussion

In many countries ova donation for research purposes lacks any governance framework whatsoever, at either national or international level. It may be clear from the interviews above that in Indian IVF clinics there is little regulation and even lesser oversight regarding what happens to “surplus” ova/embryos. Women/couples undergoing IVF procedures often neither ask nor are told how many eggs have been harvested or the number of embryos resulting from the procedure (interview material). Thus, the potential for exploitation is high. As Waldby (2008, p. 20) argues, “the existing exploitative procurement networks for reproductive oocytes could readily be used to obtain research oocytes as well, if no measures are taken to prevent this.”

Also, one may ask whether the practice of reduction of treatment costs for ova/embryo donors is acceptable and does not imply an indirect inducement for agreeing to give away their supernumerary ova/embryos. Most of the interviewed women undergoing IVF procedures were not keen to sell their eggs; they would rather donate. Traditional cultural ideas and socialization encouraging altruistic donation seemed to influence their decision (Gupta and Richters 2008). Ova and embryos, because of their highly minuscule nature, unlike semen or other body parts and tissues, are a less visible or tangible entity. Perhaps this, too, plays a role in the fact that women sign away and transfer their rights to their use to other women/couples undergoing infertility treatments and IVF clinics. Bharadwaj's ethnography of Indian IVF clinics reveals that the informed consent process could be problematic, but service providers and research scientists believe that, if counseled properly, donors see nothing wrong in giving up “spare” embryos for research. Therefore, the crux of the issue lies in counseling and preparing the donor to accept the renunciation of embryos as something good and worthy (Bharadwaj and Glasner 2009).

Hoffmaster (2006 cited in Ballantyne and de Lacey 2008, p. 149) argued that “The stressful circumstances within which the donation of eggs is requested means that they may be susceptible to feelings of obligation and duty that may unduly influence their decision to donate.” Women undergoing IVF are dependent upon good relations with their service providers in the hope of a successful outcome of their treatment. The hierarchy between doctors and patients is not conducive to asking questions regarding the fate of their surplus reproductive material. They would not like to jeopardize this relationship and may agree to donate for this reason. In India, the hierarchical relationship is based not only on the classic doctor–patient relationship; rather cultural acceptance of (moral) authority of physicians and other factors such as class, caste, and education gap, which create a power distance, play a role as well (Glasner 2009, Gupta 2010).

Egg donation does not present any prospect of therapeutic benefit for women undergoing IVF. In fact, it threatens the therapeutic process, because women may have to go through repeated cycles of stimulation for egg retrieval if they give away their “surplus” eggs and do not have them fertilized and have the extra embryos cryopreserved. Besides, they run the risk of ovarian hyperstimulation syndrome (including an increased risk of ovarian cancer) and compromised future fertility and its psychological consequences. These risks are often played down, as was the case with the researchers of the report (IOM-NRC 2007), which amounts to misinforming women.

Also, it is difficult to establish whether women are receiving increased hormonal dosage to optimize the “yield.” A study in the Lancet (Heijnen et al. 2007) offered convincing evidence that the best standard of treatment for IVF should not need to involve doses of hormones at the levels routinely used in gathering eggs for research. “Mild” or “natural” treatment strategies were proved in a clinical trial to produce as good pregnancy rates as high-dosage therapies. Yet, IVF specialists in India are doing hyper-stimulation and harvesting a large number of eggs.

Drawing on a research ethics framework approach to egg donation advocated by Hyun (2006) Ballantyne and de Lacey (2008, p. 145) argue:

The principle of “just participation selection” requires that research subjects be selected from the population that stands to benefit from the research. Based on this principle infertile women should be actively recruited to donate eggs for fertility-related research only. It is unethical to exclusively or predominantly recruit infertile women to donate eggs for stem cell research that concerns general medical conditions. It is preferable to recruit women from the general population to donate eggs for such research, and these women should be viewed as healthy volunteers. To avoid exploitation, these donors should receive compensation for both the direct and indirect costs associated with their donation.

Taking into account actual and prospective regulations, egg donors for research have been characterized in at least four different ways: as subjects of research, participants in clinical trials, organ donors, or mere tissue or “raw material” providers. To offer them appropriate protection, a new category of research participants – research donors must be recognized (Magnus and Cho 2005). “With such fundamental epistemological disagreement on the status of egg donors and egg donation, it is hardly surprising that governance is unsatisfactory” (Dickenson and Alkorta Idiakez 2008, p. 132).

Baylis and McLeod (2007) argue that all payment schemes that aim to avoid undue inducement of women risk the global exploitation of economically disadvantaged women. The commodification of ova and embryos and the potential exploitation of women “donors” is a matter of grave concern; so is the risk to their health due to hyperstimulation. What is imperative is not only implementation of regulation but oversight and monitoring of clinical and bioethical standards that will strengthen consent procedures and reduce such risks to women who agree to provide ova/embryos for research. To this end public awareness and engagement through debates on this expanding area of research need to be initiated.

Acknowledgements

The research on ova appropriation for this article was conducted within a research project “Body parts, property and gender,” funded by a grant from The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO), project number WB 52-871 during the author's affiliation as post-doctoral researcher at Leiden University Medical Center. Sincere thanks are also due to the pregnant women/couples and other respondents who agreed to speak to me. Finally, I thank the anonymous reviewers and Margaret Sleeboom-Faulkner for their very useful comments and suggestions, which helped to improve the manuscript.