2017 Annual Bioethics Conference Poster Abstracts

Harvard Medical School Annual Bioethics Conference

The Ethics of "Making Babies"

Poster Abstracts Thursday, April 6, 2017 bioethics.hms.harvard.edu

@HMSBioethics #HarvardBioethics

This conference is co-sponsored by the Hastings Center, the Petrie-Flom Center at Harvard Law School, and the Harvard Medical School Center for Bioethics with support from the Oswald DeN. Cammann Fund.

MITOCHONDRIAL REPLACEMENT THERAPY: ISLAMIC PERSPECTIVE Abdullah Aljoudi, MD Imam Abdulrahman Bin Faisal, Dammam, KSA & Harvard Medical School Center for Bioethics, Boston, USA INTRODUCTION Genetic disorders contribute to infant mortality and morbidity especially in some Muslim communities where consanguineous marriage is common. Islam discourages consanguineous marriage and encourages its followers to seek treatments to their diseases, including genetic, without violating their Islamic beliefs.

Muslim bioethicists (scholars, jurists, lawyers, philosophers, physicians, scientists) have always given attention to the ethico-legal challenges of new medical interventions, to provide practicing Muslims with informed advices.

Mitochondrial replacement therapy (MRT), a promising prevention to a serious genetic syndrome, is an example of an intervention that represents ethico-legal challenges to Muslim patients and scholars as well.

The controversial experimental intervention has not yet been discussed in any one of the Muslim formal Fiqh Councils, to best of my knowledge.

In 2016, a Muslim couple which received mitochondrial replacement therapy had their first baby after four miscarriages and the death of two babies. It is not known if they had any consultation with a Muslim scholar before receiving the therapy.

THE AIM

ETHICAL AND LEGAL CONSIDERATIONS

THE ISLAMIC PERSPECTIVES

The aim of this paper is to present and discuss the ethico-legal implications of the mitochondrial replacement therapy from the Islamic perspective.

The Safety and Efficacy: The MRT is a newly developed IVF technique that has been used recently in few cases. No clinical trial to establish its Safety and Efficacy has been done yet.

The Sources for Islamic Ethico-legal reasoning: ‫القرآن‬ • The Quran • Prophet’s teachings ‫السنة‬ • The deductive logic (Ijtihad) based on 1&2 ‫�جتهاد‬ Main Purposes (goals) of Sharia ‫الشريعة‬ ‫مقاصد‬ • Protect & preserve faith (religion) ‫لدين‬ ‫حفظ ا‬ • Protect & preserve life (soul) ‫النفس‬ ‫حفظ‬ • Protect & preserve progeny (lineage) ‫النسل‬ ‫حفظ‬ • Protect & preserve mind (intellect) ‫حفظالعقل‬ • Protect & Preserve resources (property) ‫حفظ المال‬ Main Principles (Maxims) of Fiqh ‫الشريعة‬ ‫قواعد‬ • Principle of intention ‫���بمقاصدها‬ • Principle of certainty ‫بالشك‬ ‫قين�يزول‬ ‫الي‬ • Principle of Harm (injury ) ‫�ضرر � ضرار‬ • Principle of hardship ‫التيسير‬ ‫المشقةتجلب‬ • Principle of custom (precedent) ‫العادة محكمة‬

MITOCHONDRIAL REPLACEMENT THERAPY The human cell has 1000-2000 mitochondria in its cytoplasm producing energy necessary for the cell survival. Each mitochondrion has 37 genes while the nucleus has 100,000 genes.

Inheritance of Mitochondrial DNA (mtDNA) is different from inheritance of Nuclear DNA (nDNA).

The nDNA is inherited from both mother and father sides, while mtDNA is inherited from mother side only.

Two methods used for MRT: 1.

Egg repair by Maternal Spindle Transfer (MST); 2.

Embryo repair by Pronuclear transfer (PNT).

The Genetic Connection: The child born after MRT is described to have "three parents" or "two mothers".

This is misleading since the contribution of mtDNA to the total DNA is < 0.1%.

The Future Genetic Modification: Since mtDNA is inherited from maternal side therefore changes in germline will be through daughters only.

The Genetic Counseling: The couples need to take an informed decision and consent after being provided with all information. The challenge comes from the lack of evidence-based data.

Justice: The couple in-need must be selected carefully to avoid both depriving them from their needs and spending public resources on unnecessary procedures.

In MST the effect on germline entails the vertical transmission of donor mtDNA will continue to future female generations, but not for boys.

Views of Muslim Bioethicists: The MRT has not yet been discussed in a formal Fiqh Councils.

Some Muslim Bioethicists (scholars, jurists, lawyers, philosophers, physicians, scientists) have views based on the mentioned purposes and principles.

The main purposes used were protection and preservation of life and progeny and the main principles used were intention, certainty, harm, and hardship.

Four views were obtained: (*) • Both MRT methods (MST & PNT) are prohibited.

• Both MRT methods (MST & PNT) are permissible provided that the donor in PNT method is another wife of the father.

• MST is permissible but PNT is prohibited.

• Need more information to decide.

See illustrations above.

(*) Personal communication with Prof. Mohammed Ali Albar, Saudi Arabia .

In both MRT methods, the affected couple will have their ovum and sperm cells isolated and an the donor’s ovum with healthy mitochondria is needed.

In MST father’s sperm fertilize the mother’s ovum but not the donor's ovum. The mother's spindle is implemented in the healthy donor's ovum after removing its spindle. Then the father’s sperm fertilize the ovum with healthy mitochondria.

The Legality of the MRT: Currently the only country in the world that legalizes MRT procedure is the UK according to the Human Fertilization and Embryology Authority (HFEA) Act, 2015.

In PNT father’s sperm fertilize both the mother’s ovum and the donor's ovum. The two pronuclei from the donor-father combination are removed and then replaced by two pronuclei formed by the mother-father combination.

Copyright, March 2017

THE “ART” OF MAKING BABIES USING IN VITRO FERTILIZATION ASSISTED REPRODUCTION TECHNOLOGIES (ARTs) IN THE UNITED ARAB EMIRATES

Shirin Karsan MBE Objectives: To explore: • Influence of religion and Emirati culture on using ARTs • Patient’s level of understanding of ARTs • If IVF / ARTs in the UAE are overused since cost is not usually a factor • Emirati attitudes towards “treatment shopping” • Shari’a (Islamic law) and ARTs in the UAE

• 23 % of the world’s 6.8 billion population is Muslim • 87-90 % are Sunni Muslims; 10-13 % are Shia Muslims • more than 1/5 of Muslims (300 million) live in countries where Islam is not the major religion • 1% (3 million people) of the US population is Muslim •

Ethical Issues: The lack of regulation of the infertility treatment process in the United Arab Emirates, combined with a high demand of IVF clinics, religious permissibility, and sociocultural stigma, raises ethical concerns about the overuse of In Vitro Fertilization treatment in the UAE

• Desire to have children is powerful and widespread • Tough plight and not easily fulfilled • “Treatment shopping” is common and frequent • Cost is not a factor (in the UAE) and IVF is heavily relied on even for multiple attempts • Lack of awareness of risks and benefits of ARTs • Lack of infertility counseling • Lack of national registries to monitor ART usage • Autonomy is based on family and society values • Infertility patients derive great guidance and comfort from references in The Holy Quran • ART usage must comply with the Shari’a • Lineage is very important in Islam • Deep concern about human error • ARTs are unnatural and unacceptable in society • No barriers because of religion • Culture is not a barrier for research What difference does it make?

Method/Strategy: This was a six month qualitative study with seventy-two participants (from all seven Emirates), based at private and government clinics (with permission and private interview spaces) in Dubai, Al Ain and Abu Dhabi. Semistructured interviews (in English and Arabic) were utilized. including closed- and openended questions. Interviews were audio-recorded, with permission.

Approval was obtained from the local Ethics Committee. SPSS was used for analysis.

Implications/Discussion/Conclusions:

Future Plans/Recommendations: 1. Provide Counseling and support services to couples in ART centers: •At time of diagnosis of infertility •During infertility treatment, and at every subsequent attempt for IVF •If and when ARTs fail 2. Community education on infertility procedures, risks and benefits 3. Expedite clarifications on contemporary bioethical issues 4. Create a national registry to maintain all ART records for pregnancy rates; outcomes; live births; child development; side effects 5. Further research based as a follow up process Copyright, March 2017

This program to support Emirati nationals has inadvertently created a commensurate need for support to manage the physiological and psychological impacts on those who are overusing such technologies like IVF. The threat of polygyny creates an especially fraught dynamic for Emirati women. Support systems are undermined by the overarching social stigma around infertility, and resources have not been created to keep pace with the growth of local IVF clinics.

HUMAN GAMETES AND UTERUSES AS AGRICULTURAL SURPLUS? Hana Konečná

University of South Bohemia, Czech Republic Situation

Czech Republic (CR) is currently a great power in the field of assisted reproduction (ART) with 43 centers for ten million residents. The needs of Czech patients would be nicely saturated even with half of the centers, the reason for such a high number is the demand of foreign patients. They look for the treatment in CR for its high quality, low prices and accessibility of third-party reproduction techniques.

Czech ART in numbers Chart 1. Types of ART cycles by woman age in 2014

Chart 2.Home country of patients – egg donation recipients

Reference: ÚZIS/NRAR. Asistovaná reprodukce v České republice 2014. http://www.uzis.cz/category/tematicke-rady/zdravotnicka-statistika/asistovana-reprodukce

Objective

The long-term goal of our work is psychosocial and ethical analysis of the situation. We are afraid of multiplying of the number of foreign patients, if the state assumes responsibility also for ART for single and homosexual individuals and for surrogate motherhood.

Probably we will become the exporter not only of oocytes and sperm, but also uteruses, and we will also become a “world incubator”.

Impact of our work

However, our analyses and activities do not get positive feedback. We claim that the third-party reproduction is almost exclusively connected to non-standard requests but the response is: the right to be parent, the rights of women and minorities and absence of studies demonstrating that children from non-standard families would show any problems in psychosocial development.

The EU Directive 2011/24/EU on free patient mobility, which CR is bounded by, is being used as a counterargument when pointing out the high number of foreign recipients of donated oocytes.

Not even the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation, which establishes the possibility to use donated body parts only in cases where there are no alternative solutions, and forbidding the trade with body parts, is not considered a relevant ethical problem. The propagators of unrestricted access to ART claim that it is necessary to respect the donor's autonomy and that third-party reproduction doesn't exactly fall under this Convention, because the donors give something they have suprlus of and wouldn't use anyway.

Piquant and paradoxically advantageous for our efforts is that a significant portion of Czech ART "market" is owned by current Czech finance minister, a billionaire Andrej Babiš, which did slightly turn the interest of both experts and the public towards the ethical side of ART. Unfortunately not towards the fundamental questions of ART, but only towards the conflict of interest of aforementioned government official.

Conclusion

The arguments used to defend all ART techniques and unacceptability of any restrictions are currently part of the predominant world discourse and hence our voice resembles the voice of the One crying in the desert. We can do nothing without a global change.

But perhaps we are not right, and human gametes, uteruses and pregnancy time really are something like a surplus carrots being

sold at the market…

Supported by GACR 17-07753S

The Impact of Reproductive Technologies on the Deaf and Hard-of-Hearing Community Exploring Evidence-Informed Guidelines for Healthcare Professionals Abirami Kirubarajan1, Shannon Leung1, Sama Anvari1, Chantal Graveline PhD2 McMaster University, Hamilton, Ontario, Canada1; Canadian Hearing Society, Toronto, Ontario, Canada2

Background

Results

The ethics regarding reproductive technology have historically been controversial within the deaf and hard-of-hearing (D/HH) population. Genetic screening for prenatal deafness and preimplantation genetic diagnosis have recently been criticized within deaf studies literature, as several policies regarding in-vitro fertilization do not allow healthcare providers to implant viable deaf embryos. For deaf patients who consider deafness and American Sign Language to be a significant part of their family’s identity and culture, this has been reported to violate parental consent as well as contribute to the marginalization of those living with a disability. In addition, due to the welldocumented healthcare and communication barriers that exist for the D/HH population, it can be difficult to assess the ethical implications of these reproductive technologies from the perspective of those living with disability.

D/HH persons possess different views of reproductive technologies than hearing persons, in addition to having different concerns regarding their use. Reported concerns include erasure of Deaf identity and culture, stigmatization of disability, and bodily autonomy. According to the social model of disability, deafness may not need to be screened or treated medically. Advancements such as the cochlear implant and genetic screening can prevent Deaf culture from being passed from generation to generation, a concern that is brought by both hearing and D/HH parents.

Objective This research project, conducted with the support of The Canadian Hearing Society, will elucidate the impact of reproductive technologies on D/HH person (namely genetic screening, in-vitro fertilization, and selective fertilization), as well as establish evidence-informed guidelines for healthcare professionals.

Methodology A Medline review was conducted of existing literature concerning reproductive technologies and D/HH patients, in addition to supplemental research on existing health policy and guidelines for healthcare professionals. Review articles and underpowered studies were excluded according to predefined guidelines, Over 214 pieces of relevant literature were initially identified from Medline as of January 2017, with hand-search yielding 38 relevant studies.

214 pieces of relevant literature initially identified from OVID MEDLINE (R)

38 relevant literature obtained after hand-search and applying inclusion and exclusion criteria,

LexisNexis was searched for news articles, limiting searches to CAN/US/UK. Health Systems Evidence was searched for health policy and guidelines.

Figure 1: Flow chart of data collection process

Search Terms Reproductive technology, D/HH, perception, social model of disability, in-vitro fertilization, physician, disability, accessibility

Discussion & Guidelines Figure 2: Classification of Participants in Perceptions-Based Studies (n=20)

Representation General D/HH Hearing Children of D/HH Parents Parents Healthcare Professionals

While the views regarding genetic testing by the D/HH community are heterogeneous, they demand greater health literacy and education regarding reproductive technologies in specific to disability. In order to provide ethical and patient-centered care, healthcare providers should be educated regarding these unique views to reproductive technologies in specific to disability.

Figure 3: Description of key included observational studies

Study Brunger et al.

(2000)

Study Design Crosssectional study

Sample Size 96 hearing parents with one or more deaf children

Results 96% reported a positive attitude for genetic testing for deafness; all respondents had a poor understanding of genetics

Crosssectional study

28 pediatric otolaryngologists

Moeller, White, and Shisler (2006)

Crosssectional study

1,968 primary 81.6% of physicians care physicians reported a high level of support for universal hearing screening at birth

Prospective, 256 longitudinal participants study affiliated with the hearing, deaf, or both communities

Communication

Social Modelling

Conclusion Ultimately, there are several ethical components to the use of reproductive technologies in screening or preventing deafness, which are highly complicated by health inequalities faced by the D/HH population as well as historical biomedical models of disability. Healthcare professionals should be trained in cultural competency to navigate bioethics with sensitivity and care.

Acknowledgements

Robin, Dietz, Arnold, and Smith (2001)

Boudreault et al. (2010)

Recent studies have found that healthcare professionals and medical students often lack cultural competency regarding deaf patients. Furthermore, our results have shown that reproductive centres and women’s centres lack healthcare providers that have proficiency in American Sign Language, disability sensitivity training, or even access to effective interpreting services. D/HH patients significantly rely on family for interpreting services, which can undermine the patient’s confidentiality, especially in sensitive situations regarding reproduction and fertility.

71% offered genetic testing in all situations

Strong interest in genetic testing for why one is deaf; little interest in testing for decisions related to having children

We would like to thank Gary Malkowski and Kelly Smith from CHS-SCO for their invaluable support and guidance.

Key References Brunger JW, Murray GS, O’Riordan M, Matthews AL, Smith RJ, Robin NH. Parental attitudes toward genetic testing for pediatric deafness. The American Journal of Human Genetics. 2000 Dec 31;67(6):1621-5.

Moeller MP, White KR, Shisler L. Primary care physicians' knowledge, attitudes, and practices related to newborn hearing screening. Pediatrics.

2006 Oct 1;118(4):1357-70.

Brunger JW, Murray GS, O’Riordan M, Matthews AL, Smith RJ, Robin NH. Parental attitudes toward genetic testing for pediatric deafness. The American Journal of Human Genetics. 2000 Dec 31;67(6):1621-5.

Robin NH, Dietz C, Arnold JE, Smith RJ. Pediatric otolaryngologists' knowledge and understanding of genetic testing for deafness. Archives of Otolaryngology–Head & Neck Surgery. 2001 Aug 1;127(8):937-40.

Anastasiou D, Kauffman JM. The social model of disability: Dichotomy between impairment and disability. Journal of Medicine and Philosophy.

2013 Aug 1;38(4):441-59.

Full list of references not shown in poster – available upon request.

Reproduc*ve Autonomy and Decision-making Regarding Non-invasive Prenatal Tes*ng: Pregnant Women and Couples’ Perspec*ves from Lebanon and Quebec Hazar Haidar, PhD candidate and Vardit Ravitsky, PhD University of Montreal

BACKGROUND Non-Invasive Prenatal Tes*ng (NIPT) based on the detec:on of cell-free fetal DNA in maternal blood: • Non-invasive • High specificity and sensi:vity • Early detec:on of abnormali:es

METHODS ª Qualita*ve study: 30 semi-structured interviews, 15 in each country, of pregnant women and couples

ª Data analysis: Thema:c analysis

ª Qualita:ve Descrip:ve methodology

Source: Global Market 2016

Currently commercially available worldwide

RESEARCH QUESTION AND OBJECTIVE How is the framework of reproduc:ve autonomy opera:onalised in a Western v. non-Western cultural context?

Case studies: Compara:ve study of Quebec, Canada and Beirut, Lebanon.

Objec*ve: explore ethical considera:ons related to reproduc:ve autonomy that influence NIPT decision-making

Role of the partner and HCP

FINDINGS

Features of

NIPT

NIPT

decision making

Cost & Coverage

Copyright, March 2017

ETHICAL IMPLICATIONS & DISCUSSION ­ Counseling approach Quebec -> Non-direc:ve: emphasis on pa:ent choice Vs. Lebanon -> Guidance: Healthcare professional’s recommenda:on

­ Involvement/opinion of the partner

Quebec -> Secondary to the woman’s preference Lebanon -> Influen:al factor in decision making

­ NIPT cost and coverage, in both contexts

Abor:on/ pregnancy management

Absence of coverage -> Inequity of access to NIPT Coverage –> Implicit recommenda:on to accept tes:ng

CONCLUSION & FUTURE RESEARCH

THE CASE

FINDINGS

METHODS

The case concerns two couples, who began at the same time an in vitro fertilization and embryo transfer program at the fertility center of Pertini Hospital, in Rome, Italy. The embryos were implanted in the uteruses of the two women. During this operation, a painful mistake occurred: the two women received the embryos formed from the gene of the wrong couple. The procedure was successful for only one of the couples, which resulted in a twin pregnancy. The terrible mistake was immediately discovered, at the beginning of the pregnancy. After that, the gestational couple decided to keep the babies and expressed the will to assume the legal parenthood of the twins. The other genetic couple, on the other hand, claimed the right to be recognized as effective parents of the unborn children, initiating legal proceedings.

This exceptional event resulted in the problem of identifying which is the applicable law. Who are the real parents of the embryos? The genetic couple or the gestational ones? Or, maybe, should the couples be separated? That is to say that the mother should be the woman who carried out the pregnancy and the father should be the “genetic man”, the man who is biologically linked to the children.

The Italian case-study has had the following results summarized below

Analysis and interpretation of the traditional legal categories Our reflection is focused on the rules for granting legal parenthood and their rationality concerning the current case. The analysis also focuses on the study of medically assisted procreation legislation, attempting to classify this case-study in the field of heterologous fertilization or surrogacy (actually, the case-study does not fall into either of the two hypotheses, see Main Implications).

Review of the evaluations carried out by the National Bioethics Committee (Italy).

According to the National Bioethics Committee: - The moral complexity of the case makes it impossible to declare it clearly a bias of 'bioethics' - The relevant parental figures must be two, however it is not considered appropriate to exclude one of the couples from the life of the babies - Each competing logic should be set aside, and the two involved couples should be able to cooperate in ethic responsibility and solidarity in the interests of the children.

- Ethically, there may be different solutions, especially with regard to the paternity (only one of two men has a genetic link with the children, and it is not the husband of the woman who gave them birth).

Examination of the judgments and identifying decision criteria used by the courts According to the Italian legal system, there have been various rulings. To date the matter has already been adjudicated.

1) the Court of Rome, 08/08/2014 2) the European Court of Human Rights (ECHR), X e Y v. Italy, 10/10/2014 3) the Court of Rome, 04/22/2015 - 3a) the Court of Rome, 10/02/2015 4) the Court of Rome, 05/02/2016

All court decisions have rejected the request of the genetic parents and chose to bestow the legal parenthood to the pregnant couple.

The rulings, while presenting in part different arguments, converge on some points: 1) the inability of legislation to recognize the genetic couple as the parental couple (art. 269, paragraph 3, and art. 231 of the Italian Civil Code); 2) the child’s best interest rather than others: the need for two parental figures and a peaceful family environment in which to grow; 3) enhancement, according to the scientific data, of the symbiotic bond between expectant mother and the children; 4) consequently, paternity was attributed to the husband of the woman in labor.

Critical reflections: was it the only possible solution?

The decision of the Italian case appears to be the only possibility within the Italian context, especially with regard to the mother. A different option would have led to recognizing legally the possibility of forcing the pregnant woman to carry the pregnancy to term and then handing over to another couple the children once they born, as if she were a surrogate mother. This hypothesis is not provided in Italy and, in any case, would need the consent of the couples.

Nevertheless, we believe that the decision was too one-sided. It has not provided balanced measures regarding the positions (and rights) in the conflict: the court issued a fairly rigid solution, excluding any need for contact between the children and the genetic couple.

Moreover, the principle of childbirth as a criterion for allocation of motherhood may still be the only decisive factor for the systematic coherent ruling? The possibilities offered by technology have disrupted the ideals of the traditional family. Those who turn to assisted reproduction techniques cannot become a parent without the other and, therefore, mother, regardless of the birth.

In the Italian case, those embryos were produced for a real, personal –and irreplaceable- parenting plan. In fact, ART has created a far too discontinuous pattern to be read in the same way as traditional conceptual categories. Especially in homologous insemination, assisted reproduction simply aims to be the replacement version on a technical level, of what cannot be obtained (which nevertheless continues to be intensely desired) through the natural means of sexual intercourse. Not forgetting it is a wholly emotional process for the couple, characterized by profiles perhaps even more intense than involuntary and natural varieties from the situation of the couple in which the woman whom the embryos were implanted by mistake.

Survey on the evolution of the concept of family in Europe The scientific and technological progress provides the possibility to create a family even to those who, following “natural” methods (however, is there an unique dimension of what is considered natural today?), may not be able to be realize. In this way, we are witnessing the establishment of a new relational schema, in which the element of voluntary acquisition is gaining greater importance in the definition of family relationships. (ECHR, Mennesson v. France, 2014; Labasse v.

France, 2014; Paradise-Campanelli v. Italy, 2015; others quoted above).

Comparative analysis of similar cases:

LEGAL BACKGROUND

While it is understood that no cases are alike, it is possible to identify some other particular pertinent cases. They have resulted in different solutions to the Italian case, due to different legislations present in those countries. In particular, we would recall the following cases: - Robert B. v. Susan B., 135 Cal. RPTR. 2d 785 (Cal. Ct. App. 2003): medical personnel implanted by mistake, into Susan Buchwaitz’s uterus, the embryo destined for another couple. The error was discovered only after the baby was born. A legal battle ended with a remarkable decision. The Court, in fact, in addition to providing compensation of a million dollars in favor of the pregnant mother, Susan, decreed 'joint custody' of the child, awarding custody of the newborn both to the pregnant mother and the natural father, and definitively rejecting every parental claim from the wife of the natural father, whom cannot claim any biological-social ties to the child. The natural mother was, in this case, a donor. The couple, in fact, had resorted to the techniques of heterologous assisted reproductive technologies (ART), using the gametes of the husband and addressing a donor for the female.

- D. Perry-Rogers et al. v. A. Fasano, Supreme Court, 2000, Appellate Division, New York, 2000: Donna Fasano, after undergoing, together with her husband Robert, assisted reproduction techniques, gave birth to twins, one of whom is unexpectedly of color. After the outcome of clinical tests, the child was discovered to correspond genetically to another couple, who had also started medically assisted procreation procedures at the same structure. In this case, the error of the medical staff emerged shortly after the execution of the implant. However it was only as a result of childbirth, they could shed light on the natural paternity and motherhood of each of the twins. The "genetic" couple, from the beginning, turned to the courts, resulting, ultimately, in foster care (or should we say the return?) of the colored baby. The verdict resulted in the child's separation from the "pregnancy" family, as well as the "twin", and decreed the disappearance of all visiting rights to the latter. In this case, contrary to the Italian one, the genetic truth prevailed over the legal one. The Court, in fact, decided that it could correct the error of the clinic, entrusting the child to its biological parents, believing that the child had not yet established an emotional attachment (bond) with the expectant mother.

Italian Law no. 40/2004 The case is part of the implementation of assisted reproduction procedures, which are governed in Italy by Legislation no. 40/2004. This legal provision has been completely rewritten through several Italian Constitutional Court (ICC) and the European Court of Human Rights (ECHR) judgments over time. Originally the law was characterized as a particular rigid application, a cause of discrimination. The Constitutional Court has modified the legislation, deleting: (1) the obligation to produce strictly necessary embryos for a contemporary and unique implant (ICC No 151/2009), (2) the prohibition of heterologous insemination (ICC no. 162/2014) and the prohibition of access to in vitro fertilization with pre-implantation genetic diagnosis for couples suffering from particularly severe genetically transmissible diseases (ICC no. 96/2015). The prohibitions on surrogacy and embryo donation, even if no longer implantable, for the purpose of scientific research, still remain. Although regarding this last point, there could be openings. (ICC no . 84/2016).

The Italian Civil Code The Italian Civil Code provides among its normative pillars "she who gives birth is the mother" (Art. 269, paragraph 3). Moreover, it declares that "it is presumed that the father is the husband of the woman in labor" (art. 231). Motherhood is anchored to the fact that childbirth and fatherhood emerges automatically as a result of a nuptial bond. In addition, under Article 243-bis the action of denial of paternity can only be exercised by the legal father. Hence, it excludes that any natural father can exercise the same action, in the end being recognized as having legal paternity of the child.

MAIN IMPLICATIONS Case uniqueness The Italian case does not fall into the case of heterologous fertilization, and even that of surrogacy. On one hand, there was not the consent of the couples with regard to the use of gametes outside of the couple or the use of a uterus from a third woman; on the other side the Italian legal system does not allow this last form of surrogacy. Consequently, there is inapplicability of the relevant regulation and the need for the judge to fulfill a legal vacuum. This case is an important test to understand what is the role of the judge. Not only in the absence of legislation, but even if a law exists and it is considered unjust. The judge is alone facing this human drama. He understands the problem and cannot turn away. Charles Baron (emeritus Professor of Constitutional Law, Law School, Boston College) uses correctly a military metaphor to provide the distinction between a B52 (as the legislator) and a foot soldier (as the judge), when he distinguishes the role between judge and legislator with reference to the "tragic choices of bioethics".

Unlikelihood of a legal agreement In light of current Italian legislation, not only there is no specific provision applicable to this case, not even an agreement between the couples, concerning the "return" of those born to the genetic parents, could be valid and enforced.

Absence of specific rules for the assumption of error The Italian legal system does not provide any rules governing the case of involuntary embryo change, that establishes who are the legal parents, as in this case-study.

Situation of vagueness and the problematic attribution of parenthood: who is the mother and who is the father?

FUTURE PLANS Increased safety in assisted reproductive technology: - Amending implementation protocols to ensure safety procedures in an increasingly technological dimension of life.

- If an error occurs, the information must be communicated to couples adopting particular caution: everything must be communicated in a clear and timely manner, involving the referral Ethic Committee.

Urgent need for legislative action (in the Italian case) The study has brought to light, the necessary intervention of the Italian legislator intended to regulate cases of errors that could occur with the use of reproductive techniques. In particular, it appears necessary to introduce a specific discipline in the involuntary change of embryos, in the knowledge that it is the human error and, albeit a scary fact, a possible variable of procreative events.

With ART parenthood becomes a divisible quality.

Regarding maternity: the concept of mother, always indisputable, can be broken down into a variety of figures that are not easy to place on a hierarchical scale. The axiom "Mater semper certa est" suffers a rupture that seems irreparable: on the one hand, the genetic mother; on the other, the expectant mother who eventually becomes 'legally' the main actor of this project maternity, only if we consider what art. 269, paragraph 3, of the Italian Civil Code, states (a mother is "the person who brought the child to term.”). In other countries that provide surrogacy the breakdown of the mother figure can concern three different subjects: a mother "social" (the one who wants the child), a pregnant mother, a genetic mother (the one that provides the ovum, which often coincides with the social). Therefore, different actors are in play the same role, from different perspectives; thereby it is difficult to say exactly who is to prevail and who should be recognized legally as "the parent.”

Regarding paternity: Even for paternity a breakdown of the concept occurs: on one hand, the genetic father, on the other, the ‘social’ father. Within Italian law, in the presence of a nuptial bond, the attribution of paternity is a consequence of the recognition of motherhood. It is assumed that the father is the husband of the woman in labor. This assumption forms an image of the traditional family as might be expected: the institution of marriage is relevant key in the definition of family bond. If the couple were not married, would the judicial decision have been the same?The possibility of bringing an action for paternity denial only to the legal father, confirms a rather traditional setting that in time does not upset the established family balance.

Other implications - Genetic ties and family ties: affirmation of new family models disconnected from the genetic data. The biological link is replaced by an element of will and parental responsibility.

- New family dynamics, made possible by innovative procreation techniques, determine the uncertainty of the status of the child.

- It remains steadfast the personal identity rights of a minor (ICC n. 278/2013): the knowledge of biological origins is an essential component of the personal identity of a minor. Regardless of the conferment of legal parenthood, it should be guaranteed that children have the means to learn about their true genetic ancestry.

* Full Professor of Constitutional Law and Biolaw, Director of University Center for Bioethics – antonio.daloia@unipr.it

** PhD Student of Constitutional Law and Biolaw – mariachiara.errigo@studenti.unipr.it

AN ETHICAL ANALYSIS OF OVASCIENCE – A PUBLICLY TRADED FERTILITY COMPANY AND ITS LEAD PRODUCT AUGMENT Katarina Lee, JD, MA Baylor College of Medicine’s Center for Medical Ethics and Health Policy

Ethical ImplicaGons of AUGMENT AND IVF: Ethical concerns include (A) the ability to acquire appropriate informed consent of both the intended parent(s) and from the embryo(s); (B) conducLng ferLlity treatments without an adequate clinical trial; (C) concerns about increasing length of ferLlity and obligaLons to children and (D) whether AUGMENT increases commodificaLon.

Paper Background: There are five parts to this paper: Part I will outline what OvaScience is and the four proposed technologies they seek to develop; Part II will examine the history of mitochondrial manipulaLon; Part III will examine the laws in the countries that currently permit the pracLce and why the FDA has prohibited OvaScience from using AUGMENT in the United States; Part IV will examine the ethical concerns of these technologies; and Part V will discuss the ethical issues surrounding OvaScience as a publicly traded company.

Ethical ImplicaGons of Publicly Traded FerGlity Companies: The most ethically concerning aspect about allowing ferLlity companies (and for that maSer all medically related companies) to be publicly traded is that the company will be driven by profit and the desire to increase revenue. As a result, the main intenLon is not simply to provide ferLlity treatments to individuals who are struggling with inferLlity, but to create a profit. This pressure causes inappropriate incenLves to cut corners and speed up implementaLon of potenLally unsafe treatments and products.

Conclusion: While OvaScience’s technology has had some success, countries should not be permiWng (1) the public trading of ferLlity companies and (2) the private use of new arLficial reproducLve technologies without previous clinical trials.

Copyright, March 2017

Fer$lity Preserva$on for Young Girls or Preserva$on of Social Inequali$es?

A Mul$centric Study: Canada, France and Morocco Aliya O. Affdal1 PhD(c); Michael Grynberg2 M.D, PhD; Laila Hessissen3 M.D, PhD; Vardit Ravitsky1 PhD 1University of Montreal, Canada / 2Assistance publique-Hôpitaux de Paris, France / 3Oncology Center Rabat, Morocco

BACKGROUND

AIM & METHOD

While chemotherapy and radiotherapy have increased cancer pa$ents’ life expectancy, they may cause premature ovarian failure and irreversible loss of ferSlity, which may impact future reproduc$ve autonomy.

To preserve the future fer$lity of prepubescent girls suffering from cancer, the only technique currently available is an experimental Ovarian Tissue Cryopreserva$on (OTC).

Technique Surgical procedure that may be performed by minimally invasive laparoscopy.

• Aim: To explore current knowledge, prac$ce, and aXtudes regarding ferSlity preservaSon by Ovarian Tissue CryopreservaSon (OTC) • Quan$ta$ve method: Online survey Par$cipants: Pediatric oncologists from Canada, France and Morocco

FINDINGS

ETHICAL CONSIDERATIONS / DISCUSSION • Cost and equity $ 5,000-$ 30,000 = barrier to access for many young girls.

JusSce and equity issues can be alleviated by public funding

• 1 Do you offer OTC to prepubescents girls?

• 2 Why are you not offering OTC for prepubescent girls?

• Vulnerability Stress caused by unequal access to ferSlity preservaSon may exacerbate the vulnerability of the girl and her parents at a Sme when she is coping with a life-threatening diagnosis and an impending cancer treatment.

• 3 Coverage of OTC by the local health system

In June 2015, in Belgium the first child was born following the use of this technique!

oulaya.affdal@umontreal.ca

• Future reproduc$ve autonomy Barriers to ferSlity preservaSon possibly limiSng their future capacity to have geneScally-related children.

Meaning of inferSlity based on cultural context: e.g., great importance of geneSc relatedness in Morocco.

• Morocco: yes! 100% Should OTC be • Canada: yes! 97% supported • Covered by the French health system by the health system?

• Equity • Quality of life of the survivor • Only possibility for fertility preservation Why? • Direct results of the cancer treatment

• Consent All paSents should be offered OTC and allowed to make informed decisions without financial consideraSons.

FUTURE DIRECTIONS • In-depth interviews to explore the needs and concerns of young girls, families as well as those of health professionals.

• Cost-effec$veness analysis to inform policy decisions about public funding of OTC which can promote “Just Health Care” • Ethical analysis to consider the implicaSons of this revoluSonary technology for reproduc$ve rights and autonomy.

Copyright, March 2017

(Daniels, 1985).

ASSISTED REPRODUCTIVE TECHNOLOGIES: A LOOK FROM BIOLAW THROUGH THE CINEMA Diana Rocío Bernal Camargo, PhD Universidad del Rosario

Aims/Objec;ve

To analyze different bioethical dilemmas about ART that are approached through the cinema

Method/Strategy

As a methodological strategy, the discourse analysis was used from the approach in specific cinematographic films.

Students (2) from medicine and law school parTcipated through a hotbed of research

Findings

The films shows dilemmas about the use ART by single women, women who postponed their maternity, samesex couples, couples seeking children without hereditary geneTc diseases

Implica;ons/Discussion/ Conclusions The pedagogical strategy through the cinema can be visualized in a creaTve way and the problem in our legislaTon

Future Plans/Follow Up To make a contrast between the cases of the films and judicial cases in Colombia

Deciphering Case Law on Human Embryo Disposal Disputes: Defining the Embryo, Weighing Interest, and the Appearance of Linguistic Turns Nathanael Stanley B.S., M.A. Department of Global Health, University of South Florida; H. Lee Moffitt Cancer Center and Research Institute

Background

• Cryopreservation of human embryos first used in the 1980’s, for use with assisted reproductive technology (ART) • Many legal disputes on the fate of unused, or surplus embryos • Ability to decide what an embryo is, and how to treat an embryo in a legal dispute, left to the court systems • Court justices must make a verdict that affects an individual’s right to privacy

Methods

• Critical Discourse Analysis (CDA) • Structural features of the case report • Quantitative analysis of specific terms • Identify uses of “power” within the case discourse • Linguistic Turns: Identify reversal of court decision: • What changed?

• Why it happened?

Trial Appeals Supreme (state) Davis v Davis Davis v Davis Davis v Davis '89 Ratio '90 Ratio '92 Ratio

Term/Frequency Parent/Parentage/ Parenthood/Parental 15 0.0013 Property 17 0.0015 Person(s)/Personhood 22 0.0019 Human(s)/Humanity 109 0.0095 Consent/Agreement/ Contract 2 0.0002 Intent 9 0.0008 Interest/Interests 16 0.0014 Right/Rights 7 0.0006 Control 4 0.0003 Power 4 0.0003 Davis vs Davis

Human life LexisNexis CDA on Case Law Identify existing state legislation

• Case law discourse is the construction of ideologies on reproductive autonomy held by the State • Justices express concern that the State is involved in a personal reproductive decision • Science of ART evolving faster than law and ethics • Intertextuality necessary because of the lack of legislation • Consent forms are necessary, but they can be invalidated

• States with published case law: 15 • State with unpublished case law: 8 • 26 published case reports • 18 published cases (some had multiple hearings) • Divorce: 12 • Clinical Negligence: 4 • Ownership Dispute: 1 • Procreation Dispute: 1

Systematic Review WestlawNext

Conclusions

Findings

1 0 4 3

2 0 2 6 5 1

Who has control over fate

0.0007 0.0000 0.0028 0.0021

0.0014 0.0000 0.0014 0.0041 0.0034 0.0007

54 15 33 26

41 1 58 83 10 7

Overall

0.0055 0.0031 0.0015 0.001 0.0034 0.0026 0.0027 0.006

0.0042 0.002 0.0001 0.000 0.0059 0.0033 0.0085 0.004 0.0010 0.001 0.0007 0.001

Control determined by interests

• Case language reflects foci of the court • Greatest interest determines fate of embryo • Court Justices use: • Fate of embryo determines • State of the science whose right to privacy is • Expert opinion protected • Existing legislation • Existing, related case law Copyright, March 2017

The effect that public opinion has on individual autonomy to make a reproductive decision is immense when it comes to embryo disposal disputes

Discussion

• These cases are creating the foundation for future legislation specific to embryo disposal disputes • Personhood statements will affect reproductive autonomy in embryo th disposal dispute cases, based on the 14 Amendment to the U.S. Constitution 14th Amendment to the U.S. Constitution

Harvard Medical School Annual Bioethics Conference

The Ethics of "Making Babies" Poster Abstracts Friday, April 7, 2017 bioethics.hms.harvard.edu

@HMSBioethics #HarvardBioethics

This conference is co-sponsored by the Hastings Center, the Petrie-Flom Center at Harvard Law School, and the Harvard Medical School Center for Bioethics with support from the Oswald DeN. Cammann Fund.

Shared Decision Making and Ethical Challenges in Fertility Preservation in Youth at Risk for Infertility 1 PhD ,

2 MD

Gwendolyn P. Quinn, Leena Nahata, 1 Moffitt Cancer Center, 2 Nationwide Children’s Hospital The Harvard Annual Bioethics Conference: The Ethics of “Making Babies”

Purpose The purpose of this presentation is to present a series of cases of youth at risk for impaired fertility due to gonadotoxic treatment or genetic conditions and examine the ethical issues of shared decision making (SDM).

Case 1 Case 2 • 14 yo transgender male beginning gender affirming • 16 yo with Klinefelter syndrome hormones • Has low IQ and behavioral problems • Fertility preservation offered, but declined • Pt interested in getting testing and trying to bank • Parents want it, but the pt does not want to sperm but parents not interested, state “he will not consider “right now” and wants to start treatment be able to care for a child”

Shared Decision Making is a collaborative process that allows patients and providers to make healthcare decisions together. It takes into account the best clinical evidence available, as well as the patient’s values and preferences.

Case 3 • 22 yo male GBM cancer pt with poor prognosis • MD reluctant to discuss/make arrangements for fertility preservation • Feels patient has < 3 months to live

Approach 4 cases examine the: • Evidence of SDM • Parental decision challenges • Clinician challenges Using the Thompson and Thompson bioethical decision-making model (TBDM) Thompson and Thompson Bioethical Decision Making Model

• • • • • •

Case 4 • 3 yo with Turner syndrome • Pt is likely to experience POI- opportunity for ovarian tissue cryopreservation • Single mother unsure if child should have invasive procedure

Significance In each case, there is high risk of permanent infertility Options exist to preserve fertility through standard and experimental assisted reproductive technologies (ART) Decisions ideally require input from the parents/caregivers, clinicians and the patient through shared decision making Current evidence contradictory on teen’s ability to make decisions about future reproductive goals Decision making in general can be compromised in an emergency situation In the case of ART there may be little empirical evidence on which to base decisions

Implications • The field of ART is rapidly developing and offering options for fertility preservation, yet its growth is occurring at a greater speed than empirical evidence can be gathered or guidelines can be established • Each of the cases reviewed presents a learning opportunity for those involved in reproductive decision making • Future directions include developing tools and strategies for shared decision making in the context of fertility and preservation are essential to assist patients, parents and providers in reducing decisional regret and improving communication

Copyright, March 2017

How Subterranean Regulation Hinders Innovation in Assisted Reproductive Technology Myrisha S. Lewis Visiting Assistant Professor, IIT Chicago-Kent College of Law Background

Findings

Implications/Discussion/Conclusions

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This Article reveals why that belief is wrong.

The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (“advanced assisted reproductive technologies” or “AARTs”) through regulatory actions that receive little public, media, or scholarly attention.

I term this method of regulation “subterranean regulation.”

• It is likely that the FDA lacks jurisdiction over AARTs under applicable statutes, namely the Food, Drug and Cosmetic Act and the Public Health Service Act. • FDA regulation has hindered the use of cytoplasmic transfer and mitochondrial transfer in the United States.

• A hidden, ad hoc regulatory practice is exactly the wrong kind of process to use when it comes to scientific innovations in fraught ethical areas, which includes not only assisted reproductive technology but also other DNA-modifying technologies (including CRISPR-Cas9).

TIMELINE OF THE INCREASING FEDERAL REGULATION OF ADVANCED ASSISTED REPRODUCTIVE TECHNOLOGIES

BASIC DIAGRAM OF A CELL

References

Method/Strategy • The Article examines agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past 15 years to reveal an overlooked regulatory program.

• In addition to using the FDA’s website, Federal Register website, legal search engines, and media accounts, I obtained primary source documents through Freedom of Information Act requests.

• The primary source documents examined in this Article included FDA Advisory Committee Meeting Transcripts, Congressional testimony, and FDA communications with researchers.

Future Plans/Follow Up • The full Article is forthcoming and will be available at http://ssrn.com/author=1639733.

• In the future, I will conduct a legal analysis of the FDA’s expanding subterranean jurisdiction over the human body, with an emphasis on the designation of modified human reproductive tissues and transplanted fecal matter as “drugs.”

Copyright, March 2017

1. See Charlotte Pritchard, The Girl with Three Biological Parents, BBC News, Magazine, Sept. 1, 2014.

2. It is estimated that the “popular use” of artificial insemination in the United States began in the 1940s.

See Gaia Bernstein, The Socio-Legal Acceptance of New Technologies: A Close Look at Artificial Insemination, 77 WASH. L. REV. 1035, 1060-1072 (2002).

3. See National Bioethics Advisory Committee, Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Committee, at 5(noting that in 1981, the first baby was born in the United States as a result of in vitro fertilization).

4. See U.S. Food and Drug Administration, Proposed Approach to Regulation of Cellular and Tissue-Based Products; Availability and Public Meeting, 62 Fed. Reg. 9721, Mar. 4, 1997.

5. See U.S. Food and Drug Administration, Human Tissue Intended for Transplantation, 58 Fed. Reg. 65514, July 29, 1997.

Biological Ties and Right to Parenthood in the Medically Assisted Reproduction: Ethical and Juridical Implications among Lesbian Couples GULINO Matteo PhD*1, IORIO Silvia PhD2, MARINOZZI Silvia Researcher2 and GAZZANIGA Valentina Full Professor1 1 Department

Annual Bioethics Conference - April 6-7, 2017

of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome – 2 Department of Molecular Medicine, Unit of History of Medicine and Bioethics, Sapienza University of Rome

Background, Ethical Problem

The act of procreating is an essential part of private life, allowing people to achieve and live specific role in the society. Every one, including homosexuals and single individuals, may have, at some stage of their life, the desire to form a family with children.

Adoption and foster care are not always considered by couples as good alternatives. While homosexual couples tend to use ARTs to overtake the ontological inability to procreate, heterosexual people are used to access to these technologies to cure a sterility/infertility status or other types of pathologies. By providing a broad technologic portfolio, medical science is able to support homosexuals in the achieving of their needs [Figure 1]. When a lesbian couple decides to have a baby, one of the partners may be obliged to have with the baby only a social relationship. The choice of who will be biologically linked to the baby is a pivotal moment. In this situation, the need to take part to the procreation process may cause concerns.

Because some Western Countries (such as Italy, France and Germany) do not allow homosexuals to access to ARTs, it is very common that they leave their country towards more open-minded places in order to circumvent domestic prohibitions. This phenomenon, called as “Reproductive Tourism”, may cause problems of Public Order and International Family Law, given that couples want to come back to their own country and to be recognized as parents in accordance with the local laws. The aim of this research is to provide, by a practical approach, an International overview of ethical and juridical implications that may derive from the transnational application of assisted reproduction technologies (ARTs) among lesbian couples, taking into account the best child’s interest.

GESTATIONAL SURROGACY

o r



1 GENETIC MOTHER (the woman who gives her egg)



1 GESTATIONAL (AND/OR BIOLOGICAL) MOTHER (the third woman who gives birth the baby)



1 SOCIAL MOTHER (the genetic mother’s partner)

Only one of the partners will be biologically linked to the baby, the other partner will be considered as the social parent and will be subject to the local Family laws (!?)

TRADITIONAL SURROGACY 

1 GENETIC AND GESTATIONAL (AND/OR BIOLOGICAL) MOTHER (the third woman who gives her egg and gives birth the baby)



2 SOCIAL MOTHERS (the women who hired the third woman to

None of the partners will be biologically linked to the baby. Both of them will be considered as the social parents and will be subject to the local Family laws (!?)

bear a baby)

PARTIAL SHARED MOTHERHOOD 

1 GENETIC AND/OR BIOLOGICAL MOTHER (the woman who gives her egg and gives birth the baby)



1 SOCIAL MOTHER (the genetic mother’s partner)

Only one of the partners will be biologically linked to the baby, the other partner will be considered as the social parent and will be subject to the local Family laws (!?)

WHOLE SHARED MOTHERHOOD (RECEPTION OF OOCYTES FROM PARTNER) 

1 GENETIC AND/OR BIOLOGICAL MOTHER (the woman who gives her egg)



Materials and Methods

Local and EU legal sources (laws, judgments, orders of Institutions and national scientific publications) have been examined, using official web-sites and electronics databases of national authorities and institutional bodies, with the aim to define the law context about the use of ARTs. A critical analysis of the conceptual distinction between cases in which both the partners are biologically linked to the baby and cases in which one of the partners only maintains a social relationship with the baby has been made. An international bibliography research pertaining to the use of ARTs was performed using the “PubMed” database. The Eurispes 2016 survey about surrogate motherhood, adoption and marriage by LGBT were analyzed, in order to determine the perception of Italian public opinion regarding the right to homosexual parenthood [Figure 3].

Figure 1 – Technologic Portfolio (ARTs)

ASSISTED REPRODUCTION TECHNOLOGIES

Intra Uterine Insemination - (IUI)

In Vitro Fertilization – (IVF)

Gamete Intrafallopian Transfer – (GIFT)

Zygote Intrafallopian transfer – (ZIFT)

Surrogacy

*Figure 1 shows part of the ARTs technologic portfolio provided by the medical sciences that may be applied by lesbian couples.

   

  

Findings

Discussion

Figure 2 - List of some cases of parental project that may derive by the application of ARTs

The will of homosexual couples to be recognized as parents of babies born abroad through ARTs is subject to the local regulations on legal parentage.

The fact that certain types of ARTs are prohibited under the laws of the countries may be relevant in the assessment of the legal parentage.

At International level, the right to use ARTs by homosexuals is debatable and contentious.

The analysis of the EU cases law shows i) a trend in favour of the recognition of foreign birth certificates, formed abroad in accordance with the lex loci, when there is a biological link at least with one of the partners of the couple and ii) the importance to protect the fundamental right of child to personal identity.

Italian regulation on medically assisted reproduction (Law no. 40/2004) allows ARTs access only for different-sex couples, married or cohabitant, and potentially childbearing.

Surrogate motherhood is strictly forbidden.

From 2016, Italy has a law governing the civil unions among homosexual couples (Law no.

76/2016). The law confirm the ban of civil marriage and does not include the step child adoption.

In the last years, stepchild adoption has been provided by Italian Courts and Tribunals in more than one occasion, regardless of the sex and sexual orientation of the intended parents.

1 BIOLOGICAL MOTHER (the woman who gives birth the baby)

Both partners are biologically linked to the baby and thus considered as the biological parents (?!)

Figure 2 shows a synthetic list of some situations that may derive by the application of ARTs among lesbian couples. The presence of biological ties is highlighted. *The term biological mother is used to refer both the case of the woman who gives her egg and the case of the woman who gives birth the baby.

ROPA – Italian Supreme Court of Cassation Case no. 19599/2016

A lesbian couple, an Italian and a Spanish girls, contracted a civil marriage in Spain with the aim to grow in Italy a family with children. Due to the strictness of the Italian regulation on ART, the women decided to have a baby in Spain where the law regulating reproduction health technology are more homosexuals friendly. The couple decided to use the ROPA treatment (reception of oocytes from partner). One of the partners decided to be the genetic mother by giving her oocyte that will be inseminated with anonymous donor sperm while the other agreed to be the gestational mother by carrying on the pregnancy. The baby was regularly declared Spanish citizen and the couple were recorded as parents. As the women’s aim was to extend their parental project also in Italy, they asked to the official register of the city of Turin to record the Spanish birth certificate. The registrar refused their request for reason of Public Order and because the Italian law does not permit neither ARTs for homosexual couples nor surrogate motherhood.

After years of legal battles, the case was settled by the highest Italian Court of Appeal that recognized the lesbian couple’s right to parenthood (30 September 2016). The Court addressed important guidelines that may be useful in the assessment of a combination of cases [Figure 2]. The limit of Public Order has to be interpreted as far as possible in accordance with the moral and political values of the International community. In the assessment of the validity of a foreign birth certificate, it should be verified not so much whether the act requires a law complying with the local laws, but rather whether the act is contrary to the requirements of the human rights protection. It is unfair to assume that the recognition of the foreign birth certificate contrasts with the Public order solely because Italian law does not allow or forbid similar situation. The governance model for the reproduction health technology represents an ethical sensitive matter, where legislative choices are not constitutionally obligated. The treatment chosen by the couple should not be considered as a practice of surrogate motherhood. ROPA presents similarities and dissimilarities with the practice of heterologous insemination: it is similar because the couple follows a mutual parental project, but it is different because both partners are biologically linked to the baby. The Italian order does not exclude a priori the right for same-sex couples to welcome children in family. Family with children represents the direct expression of the fundamental right to selfdetermination. Both the parents were biologically linked and the baby was the result of a mutual parental project. The refusal of the legal recognition of parenthood would make the child in an uncertainty of legal status that would affect his/her right to personal identity.

Figure 3 – Eurispes 2015 and 2016 Survey: What do Italians think about surrogate motherhood, adoption and marriage for homosexuals?

Surrogacy

Juridical Protection De Facto Couples

Adoption by LGBT

Marriage for LGBT)

2016 (M+F)

38.5

2016 (M+F)

67.6

2016 (M+F)

29.0

2016 (M+F)

47.8

2015 (M+F)

49.8

2015 (M+F)

64.4

2015 (M+F)

27.8

2016 (M+F)

40.8

* Figure 3 shows the results of the Eurispes survey about the public Italian opinion towards surrogate motherhood, adoption and marriage for homosexuals.

Survey does not focus specifically on the matter of homosexual couples.

Copyright, March 2017

The right to use ARTs by homosexuals depends on the governance model stated for the medically assisted reproduction framework. At International level, the matter is differently regulated due to the associated ethical and social implications on the moral acceptability of ARTs for non medical reasons. Legal feasibilities about the application of these technologies among same-sex couples are debatable and contentious. Like to some EU countries (such as France and German), Italy does not allow homosexual couples to access to ARTs. Law no. 40/2004 allows the use of ARTs, including heterologous insemination (Italian Constitutional Court no. 162/2014) and PGD (Italian Constitutional Court cases no. 96/2015 and no. 229/2015), only to different-sex couples, married or cohabitant, and potentially childbearing that suffer from irreversible sterility/infertility, certified by a physician, and/or from genetic diseases (Italian Constitutional Court no. 96/2015). Surrogacy is strictly forbidden. Because medical advances goes fast, doctors and public opinion are increasingly faced with ethical issues about the beginning of life. As for Italy, the Eurispes data for 2016 have revealed a decrease of the Italian acceptance towards the practice of surrogate motherhood (38,5 Vs 49.8 in the 2015), while an increasing trend towards the moral acceptability of adoption (29.0 Vs 27.8 in the 2015) and marriage (47.8 Vs 40.8 in the 2015) for homosexuals [Figure 3].

From a practical point of view, the transnational application of ARTs among homosexual couples may cause problems of a) International Family Law as for the recognition of paternity/maternity, b) Public Order because it may violate obligations and duties stated by local laws and c) cultural adjustment due to the impact that certain situations may have on the public opinion. ARTs are certainty considered as a matter for domestic law and every State has a certain margin of discretion in the resolution of cases involving the beginning of life. At European level, the European Court of Human Rights (ECHR) has been many times involved in cases regarding the recognition of legal parentage both in same-sex and different-sex families. In cases Labassee and Mennesson v. France 2014 (case no. 65192/2011 and case no. 65941/11) – two cases focusing on French couples who decided to use traditional surrogacy in the United States – the ECHR accepted to record the foreign birth certificates. Because a familiar relationship was grown between the couples and the babies, the judgments’ decision was made on the basis on article 8 of the European Convention of Human Rights ruling the right to respect for private and family life. On 2015, the ECHR settled the request of an Italian couple who decided to use in Russia gestational surrogacy with egg and sperm donation, ruling the same conclusion. In this occasion, the Court’s decision focused also on the removal of the baby. Although the intended parents did not have any biological relationship with the baby, the ground that couple had lived with him for six months was able to qualify the case as a sort of “de facto family” and, hence, protectable under article 8 (Paradiso and Campanelli v. Italy, case no. 25358/2012). However only two years later, the Grand Chamber of ECHR reformed the precedent given in the Paradiso and Campanelli case (24 January 2017). According to the Court of last resort, the absence of any biological ties between the child and the intended parents, the short duration of the relationship with the child and the uncertainty of the ties from a legal perspective prevent to regulate the case under the article 8. As for homosexual people, in cases Foulon and Bouvet v. France 2014 (cases no. 9063/14 and no. 10410/14) – two cases focusing on a single man and a couple of men who decided to have a baby through traditional surrogacy in India, respectively – the ECHR recognized the legal parenthood of the applicants on the basis of article 8 of the European Convention of Human Rights. In both cases, applicants were genetically related to the baby. The analysis of the EU cases law, shows that in the European juridical framework there is a trend towards the recognition of foreign birth certificates in cases where at least one of the partners is biologically linked with the baby.

The recognition of legal parentage in lesbian families requires a complex assessment in order to strike a balance between private and public interests, taking into account the child’s best interest. In this respect, biological bonds may have a pivotal impact on the final decision. When biological bonds are lacking, an extensive evaluation of other elements shall be performed to determine whether the couple has established a relationship with a baby in a familiar environment.

Like to other EU cases law, the Italian Court stressed the importance of the biological bonds of the intended parents and wellevaluated the suitability of the familiar environment in which the baby was born.

As for the International Family Law, the case is perfectly complying with the EU trend and the Public Interest. From an ethical point of view, the case does not seem to meet severe criticisms. In literature, Marina et al. described that ROPA meets all the main principles of Bioethics: 1) “Beneficence” because to bring a child to the world is a positive fact; 2) “Non-Maleficence” because to form a same-sex families does not harm anyone and 3) “Autonomy” because ROPA requires a mutual and informed consent. ROPA presents many interesting similarities and dissimilarities with the other ARTs (heterologous and homologous insemination, surrogate motherhood, etc.). Italian case adds new hot topics to the international bioethical debate over the moral acceptability of ARTs among homosexual couples.

Conclusions and Follow-up

The widespread of ARTs among homosexuals increased the number of non-standard situations that do not fit with the traditional model of family=BIOLOGICAL MOTHER, FATHER and CHILDREN [Figure 2] The traditional model of family is changed as the needs of people is changed in the years. Medical advance in the field of reproduction health technology may enlarge the spectrum of civil rights. Domestic bans about some types of ARTs and difficulties in meeting treatment-eligibility criteria place same-sex families in a situation of legal uncertainty and cause disparities and inequalities, destabilizing the harmony and the balance of the family along with the child’s best interest. In the absence of the law, the resolution of cases is made at the discretion of the Courts, taking into account the child’s best interest.

Which is the real value of biological ties?

Should the biological ties be necessary to achieve the right to parenthood?

References

1.Marina S, Marina D, Marina F, et al. Sharing motherhood: biological lesbian co-mothers, a new IVF indication. Hum Reprod 2010;25(4):938-41.

2.Vermeulen VA. Developments in European law and European Union policy on same-sex couples: an overview of judicial, legislative and policy developments in the recognition of same-sex couples in Europe. Codex 2008;2008: 1-27.

3.Pennings G. Evaluating the welfare of the child in same-sex families. Hum Reprod 2011;26(7):1609-615.

4.Di Nucci E. IVF, same-sex couples and the value of biological ties. J Med Ethics 2016;42(12):784-87.

5.Eurispes. Rapporto Italia 2016. Available at external link (Accessed on 11 March 2017): http://eurispes.eu/content/rapporto-italia-2016-la-sindrome-del-palio.

6.Zeiler K, Malmquist A. Lesbian shared biological motherhood: the ethics of IVF with reception of oocytes from partner. Med Health Care Philos 2014;17(3):347-55.

7.Yeshua A, Lee JA, Witkin G, et al. Female Couples Undergoing IVF with Partner Eggs (Co-IVF): Pathways to Parenthood. LGBT Health 2015;2(2):135-39.

8.Pennings G. Evaluating the welfare of the child in same-sex families. Hum Reprod 2011 Jul;26(7):1609-15 9.Judith A. Burnett. Use of Assisted Reproductive Technology and Gay and Lesbian Couples. Journal of LGBT Issues in Counseling 2006;1(1):115-125 10.Präg P. and C. Mills M. Assisted Reproductive Technology in Europe: Usage and Regulation in the Context of Cross-Border Reproductive Care 2017. In: Kreyenfeld M. and Konietzka D. (Eds), Childlessness in Europe: Contexts, Causes, and Consequences. Springer, pp. 289-309.

WOMEN’S REPRODUCTIVE AUTONOMY AND THE ETHICS OF BABY MAKING: THE NIGERIAN CASE STUDY

Chitu Womehoma Princewill Institute for Biomedical Ethics, University of Basel, Switzerland

Background: The Patriarchal Ikwerre society of Rivers State, Nigeria and the culture of absolute respect for men have turned the average Ikwerre wife into baby making factory. Not just any baby but a male child. Hence a wife who is unable to produce children, especially male children for her husband is regarded as a worthless woman.

She is either expected to marry a wife who will bear children for her husband or her husband marries another wife who will bear children for him. The implication for this is that the wife which her husband will marry will be her mate and the first wife will not have control over her.

But if she marries a wife for her husband, she will be able to control the new wife.

Aim: To examine the ethical implications of using women as a baby making ‘factory’

Findings: • Poverty and patriarchy were observed to be the major factors responsible for the use of women for making babies.

• Lack of education was also another reason women succumb to be used for baby production.

• Pressure from the family and the society on the wife to have male children is also a factor that make women allow themselves to be used as baby making factories.

Methods: Using qualitative exploratory research design, 34 Indepth interviews (IDIs) and six focus group discussions (FGDs) were conducted with married women of various educational status, in either monogamous or polygynous marriages, aged 22-60 years.

Questions such as educational status, type of marriage, age, religion, reason for marriage, and decision when to have children were asked. When necessary, prompts were asked to elicit further details to understand implicit meaning in the responses of the participants. Data were analyzed thematically with the aid of content and narrative analysis . Coding was done by using MAXQDA version 11 software.

Implications/Discussion: The use of a woman solely for the purposes of making babies does not only reduce her to a sex object but also harms her bodily integrity and psychology. Her self identification and personal identity are undermined. Also, her autonomy is greatly diminished because she is controlled and manipulated by her user.

Conclusion: The patriarchal Ikwerre society and the culture of absolute respect for men need to be addressed. Policies that protect women have to be implemented.

Future Plans/Follow Up • Legal framework and code of practice for proper surrogacy is needed.

•

Copyright, March 2017

Cultural practices that exploit women should be addressed.

Savior Siblings: Ethical Conundrums and Regulatory Void Zachary E. Shapiro, JD, MSc Presidential Scholar of Law The Hastings Center, Garrison, NY BACKGROUND • Savior sibling: a sibling created for the purpose of providing biological material that can help treat or cure an existing terminally ill child • They are conceived through the sequential use of two reproductive technologies developed for other purposes: pre-implantation genetic diagnosis (PGD) and in-vitro fertilization (IVF).

• PGD is used to screen embryos prior to implantation in the uterus, in order to determine whether the embryo will be a tissue “match” to a sick child.

• Roughly 1% of PGD in the United States is used to create children that are tissue matches for their siblings

AIM To consider the regulatory and ethical frameworks concerning savior siblings

METHODS Considered the position of savior siblings, from an ethical and bioethical dimension • Examined stories, interviews, and case studies with actual families and savior siblings, to try and distill the landscape • Examined legislation and regulation concerning IVF, PGD, and specifically about savior siblings, both in the United States and the United Kingdom • Reached out and discussed savior siblings with several IVF clinics in the US and UK

FINDINGS REGULATION United States:

• No governmental regulation or specific legal guidance • Uses of PGD, including creation of a savior sibling, left to the discretion of providers and patients • Sole governmental action/ “regulation” is the ban on federal funding for embryo-related research

United Kingdom:

• The Human Fertilization and Embryology Act (HFEA) of 1990 regulates PGD • PGD can be performed in order to • Test for severe genetic diseases • Perform tissue type matching for savior siblings under strict criteria • Clinics must obtain licenses before they can perform the procedures that create a savior sibling • UK has fertility regulators in specialized courts • 2004 RULING: HFEA allows parents to use modern reproductive techniques to create a savior sibling • HFEA provides for enforcement: Required clinics to apply for NEW license for EACH GENETIC DISEASE they would like for test for in an embryo

• PGD: Pre-implantation genetic diagnosis • The genetic profiling of embryos • IVF: In-Vitro Fertilization: • A procedure in which eggs (ova) from a woman's ovary are removed and fertilized with sperm in a laboratory procedure, and then the fertilized egg (embryo) is returned to the uterus The author has nothing to disclose.

Parental Motives: • Ultimate arbiter of medical and family planning decisions for their individual family unit • Process unlikely to be undertaken by parents who don’t care for their children • Acceptable motives for family planning are complex • Create heir, continue legacy, provide playmate, strengthen/save marriage • Pandora’s Box: Questioning whether society/gov’t should have role in which birth motives are acceptable • Newer but not necessarily worse reason than traditionally selfish motives

CONCLUSIONS Need Monitoring and IN/FORMAL Regulation:

Potential Harms:

Ethics

• If the child believes that they were not wanted for themselves • If a child conceived for this reason enjoys a less close and loving relationship with parents • Could lead to feelings of depression and a lack of self-worth (malaise), as the child may not feel special in their own right, but rather that they are forever tied to their sibling • Is the savior sibling afforded the same level of autonomy that a normal individual is given when deciding to consent to a transplant of biological material?

• Will savior siblings face undue pressure from their family unit?

• Slippery Slope Arguments: • Today: savior children save sick siblings. Tomorrow: create a child to save a parent, elderly family member, or even someone outside the family unit • IVF and PGD could be used to usher in a new age of eugenics, if parents can select certain traits/ characteristics

In Support: • While some contend that the savior sibling is being used a means, it is not merely a means to an end. In fact,

DEFINITIONS

Ethics Continued

savior siblings serve a more complicated role: that of a savior, a family member, and an individual person.

• Anecdotal interview data report high level of satisfaction for the savior sibling • Many siblings report high levels of personal pride • Unique feeling of connection with their sick, older siblings • Clear therapeutic benefits for • The existing sick child, who gets to continue living • The family unit *as a whole, who now does not have to bury a child, and shares in the happiness of two (hopefully healthy) children

Given the absence of the above: • Gathering of data regarding the prevalence of savior siblings is restricted • Harm to savior children may go unreported • No system exists for follow-up with savior families • Limited data on long term emotional and physical health is collected • Clinics performing PGD make their own decisions on moral and ethical issues • Similarly situated individuals in different locations may have vastly different options

FUTURE DIRECTIONS US can learn from the UK regulatory framework: Efforts to advance a discussion are currently hampered by the lack of robust data

Cord Banking:

As a method to reduce the need for a living donor

New Technological Advances:

As medicine and medical technology advances, the hope is that living donors will become less important

The Role of Egg Dona.on Agencies in Defining the Moral Status of Eggs 1 2 Divya Yerramilli, MD/MBE , Alexandra Charrow, MD/MBE

Harvard Radia=on Oncology, Harvard Dermatology

Introduc.on

• As long as there have been reproduc=ve complica=ons, there has been a demand for assisted reproduc=ve strategies, including egg dona=on.

• While infer=lity is a medical diagnosis, services for egg dona=on are provided through private agencies.

• Egg dona=on agencies use both market-­‐based approaches and a language of altruism, which results in morally ambiguous language.

• This ambiguity may poten=ate widening discrepancies regarding the moral status of an oocyte, as biological =ssue, as poten=al life, or as an economic good.

• Clarifying these defini=ons is at the heart of most ethical issues regarding egg dona=on.

Findings

• In the aTempt of egg dona=on agencies to simultaneously defend the exchange of egg dona=on with language of altruism while promo=ng compensa.on using economic arguments, egg dona=on agencies help frame the exchange in such a way that contributes to moral ambigui.es regarding the status of eggs.

Transac=on of Egg Dona=on Market-­‐Based

Altruism

What is an egg?

Economic Good

Biological =ssue Minimal Risk

Commercial iPad $

Human Life

“Dona=on” “GiQ”

Compensa=on for Time/Inconvenience

Exchange of Money

Price based on market forces

Medical Risk

Drug/Device Sta=n $

Blood

Kidney

Ø

Ø

Adop=on Ø

Sex-­‐Work $

Aims of Research

• The objec=ves are to beTer describe the role of egg dona=on agencies as brokers of moral value for human oocytes and for the process of egg dona=on itself.

Method/Strategy

• Mixed methodologies, including media and content analysis, were used to explore the language used by egg dona=on agencies.

• The transi=on of egg dona=on from a medicine to the market is explored.

• Two differing views on the exchange of ova for money are examined: (1) the altruis=c dona=on, rewarded with a monetary giQ (2) a commercialized, market-­‐based transac=on of a good for money.

Conclusions

• Whether or not egg dona=on is framed as a transac.on for services or as altruis.c dona.on of biologic .ssue may ul=mately influence future decisions regarding parental rights, compensa.on limits, the use of eggs for medical research, and other emerging ethical issues regarding the moral status of a human oocyte.

Copyright, March 2017

A"tudes of Pediatric Cancer Pa2ents Regarding Fer2lity Preserva2on Op2ons 1 2 Divya Yerramilli, MD, MBE, Clarisa Gracia, MD, MSCE

1Harvard Radia:on Oncology Program, 2Obstetrics and Gynecology at the Hospital of the University of Pennsylvania

Introduc2on

• Pa:ents of reproduc:ve age or with reproduc:ve poten:al who receive treatment for cancer may be at risk for infer:lity.

• It is standard of care to discuss fer:lity preserva:on with all cancer pa:ents if infer:lity is a risk of treatment, regardless of pa:ent age, as it is part of their total cancer care.1 • Cancer pa:ents face many barriers to accessing fer:lity preserva:on, which include awareness of fer:lity preserva:on op:ons.2-­‐4 • Pediatric pa:ents may face addi:onal barriers for many reasons, including: awareness of op:ons, willingness of physicians to discuss these op:ons, and priori:zing cure over survivorship.

• However, given the high rates of care and survivorship in pediatric pa:ents, infer:lity must be discussed prior to ini:a:ng therapy.

• Studies have shown that youth diagnosed with cancer in fact desire future fer:lity at the :me of cancer diagnosis.5

Aims of Research

• The study aimed to describe the differences in knowledge of fer:lity preserva:on op:ons between adult and pediatric female pa:ents.

Method/Strategy

• A survey-­‐based study was administered to female cancer pa:ents referred to the Reproduc:ve, Endocrinology, and Infer:lity Department at the University of Pennsylvania.

• The survey was designed to prospec:vely collect health, exposure, and demographic informa:on of female pa:ents as it related to ovarian reserve.

• 101 adult and 23 pediatric pa:ents were asked if they had thought about various op:ons for fer:lity preserva:on, and then asked if they had pursued any of these op:ons.

• These survey results were then analyzed to characterize differences between pediatric and adult pa:ents.

Fer2lity Preserva2on Op2ons Pre-­‐Puberty Ovarian Tissue Banking

Ovarian Tissue Transposi:on

GnRH Agonist

Post-­‐puberty Embryo Oocyte Oocyte Cryopreserva:on Cryopreserva:on Cryopreserva:on

Findings

• 101 adult pa:ents and 23 pediatric pa:ents were surveyed.

• 74% of adult vs. 30% of pediatric pa:ents thought about fer:lity op:ons (p=0.0001).

• Adults thought about embryo cryopreserva:on more oZen than pediatric pa:ents (34% vs. 4%, p=0.004).

• Pediatric pa:ents thought more frequently of not using any method for fer:lity preserva:on (61% versus 24%, p=0.008).

• More adults pursued fer:lity preserva:on, with 28% versus 0% (p=0.007) pursuing oocyte cryopreserva:on (17% versus 0%, p=0.0403).

Adults (n=101) Age Mean Age of Consent Mean Age at Diagnosis Mean Age at Treatment Race Caucasian African Asian Other Cancer Subtype CNS Head & Neck Breast Lymphoma Leukemia Sarcoma Lung GI Gyn Other Highest Level of Education 1-8 yrs (Grade School) 9-12 yrs (Some High School) Completed High School Some College College Graduate Post-Graduate Level Unknown Thought about fertility?

No method GnRH Agonist Embryo Cryopreservation Oocyte Cryopreservation Ovarian Tissue Banking Ovarian Tissue Transposition Other

Method Pursued?

No method GnRH Agonist Embryo Cryopreservation Oocyte Cryopreservation Ovarian Tissue Banking Ovarian Tissue Transposition Other Question Not Asked

Children (n=23)

p-value

29.433 (±5.77) 28.66 (±5.74) 28.57 (±5.31)

16.212 (±1.38) 15.93 (±1.44) 15.70 (±1.64)

<0.0001 <0.0001 <0.0001 0.014

77% (78) 11% (11) 6% (6) 6% (6)

74% (17) 4% (1) 0% (0) 2% (5)

1% (1) 3% (3) 46% (46) 26% (26) 9% (9) 3% (3) 1% (1) 2% (2) 5% (5) 4% (4)

0% (0) 0% (0) 0% (0) 52% (12) 4% (1) 30% (7) 0% (0) 4% (1) 4% (1) 4% (1)

0% (0) 2% (2) 6% (6) 18% (18) 40% (40) 25% (25) 10% (10)

26% (6) 65% (15)

74% (75) 24% (24) 12% (12) 41% (41) 35% (35) 12% (12) 4% (4) 15% (15)

30% (7) 61% (14) 0% (0) 0% (0) 4% (1) 22% (5) 0% (0) 0% (0)

0.0001 0.0008 0.1206 <0.0001 0.0040 0.3095 1.0000 0.0711

71% (72) 7% (7) 23% (23) 17% (17) 5% (5) 2% (2) 5% (5) 3% (3)

82% (19) 0% (0) 0% (0) 0% (0) 9% (2) 0% (0) 0% (0) 13% (3)

0.3095 0.3465 0.0070 0.0403 0.6128 1.0000 0.5829 0.0769

Copyright, March 2017

• Pediatric cancer pa:ents do not think about fer:lity op:ons frequently.

• This may be due to age and reproduc:ve goals at diagnosis.

• The difference in knowledge between adult and pediatric pa:ents highlights the need for greater dissemina:on of informa:on and referral for fer:lity preserva:on to all pediatric cancer pa:ents.

Strategies To Improve Referral for Fer2lity Preserva2on Physician Knowledge

Mul2-­‐disciplinary Care

Bias regarding delay in care Pa2ent Comprehension

<0.001

Consent/Assent

Parent Comprehension

Insurance Coverage

Financial Barriers

<0.001

References

9% (2)

Other/ Not Asked

Conclusions

1. Fer:lity/Endocrine Considera:ons. The Na:onal Comprehensive Cancer Network Guidelines: Adolescent and Young Adult Oncology. Version 2.2017. hbps://www.nccn.org/professionals/physician_gls/pdf/aya.pdf 2. Quinn, G.P. , Vadaparampil, S.T., Bell-­‐Ellison, B.A., Gwede, C.K., and Albrecht, T.L. (2008). Pa:ent-­‐physician communica:on barriers regarding fer:lity preserva:on among newly diagnosed cancer pa:ents. Soc. Sci. Med. 66:784-­‐789.

3. Goodwin, T., Oosterhuis, B. E., Kiernan, M., Hudson, M. M., & Dahl, G. V. (2006). Aitudes and prac:ces of pediatric oncology providers regarding fer:lity issues. Pediatric Blood & Cancer, 48, 80–85.

4. Schover, L.R., Brey, K., Lich:n, A. Lipshulz, L. I., and Jeha, S. (2002).

Oncologists’ Aitudes and Prac:ces Regarding Sperm Before Cancer Treatment. J. Clin. Onc. 20(7):1890-­‐7.

5. Geue, K., Richter, D., Schmidt, R., Sender, A., Siedentopf, F., Brähler, E., and Stöbel-­‐ Richeter, Y. (2014) The Desire for Children and Fer:lity Issues Among Young German Cancer Survivors. J. Adol. Health, 1-­‐9.

Harvard Medical School Annual Bioethics Conference

The Ethics of "Making Babies" Poster Abstracts Friday, April 7, 2017 bioethics.hms.harvard.edu

@HMSBioethics #HarvardBioethics

This conference is co-sponsored by the Hastings Center, the Petrie-Flom Center at Harvard Law School, and the Harvard Medical School Center for Bioethics with support from the Oswald DeN. Cammann Fund.

Shared Decision Making and Ethical Challenges in Fertility Preservation in Youth at Risk for Infertility 1 PhD ,

2 MD

Gwendolyn P. Quinn, Leena Nahata, 1 Moffitt Cancer Center, 2 Nationwide Children’s Hospital The Harvard Annual Bioethics Conference: The Ethics of “Making Babies”

Purpose The purpose of this presentation is to present a series of cases of youth at risk for impaired fertility due to gonadotoxic treatment or genetic conditions and examine the ethical issues of shared decision making (SDM).

Case 1 Case 2 • 14 yo transgender male beginning gender affirming • 16 yo with Klinefelter syndrome hormones • Has low IQ and behavioral problems • Fertility preservation offered, but declined • Pt interested in getting testing and trying to bank • Parents want it, but the pt does not want to sperm but parents not interested, state “he will not consider “right now” and wants to start treatment be able to care for a child”

Shared Decision Making is a collaborative process that allows patients and providers to make healthcare decisions together. It takes into account the best clinical evidence available, as well as the patient’s values and preferences.

Case 3 • 22 yo male GBM cancer pt with poor prognosis • MD reluctant to discuss/make arrangements for fertility preservation • Feels patient has < 3 months to live

Approach 4 cases examine the: • Evidence of SDM • Parental decision challenges • Clinician challenges Using the Thompson and Thompson bioethical decision-making model (TBDM) Thompson and Thompson Bioethical Decision Making Model

• • • • • •

Case 4 • 3 yo with Turner syndrome • Pt is likely to experience POI- opportunity for ovarian tissue cryopreservation • Single mother unsure if child should have invasive procedure

Significance In each case, there is high risk of permanent infertility Options exist to preserve fertility through standard and experimental assisted reproductive technologies (ART) Decisions ideally require input from the parents/caregivers, clinicians and the patient through shared decision making Current evidence contradictory on teen’s ability to make decisions about future reproductive goals Decision making in general can be compromised in an emergency situation In the case of ART there may be little empirical evidence on which to base decisions

Implications • The field of ART is rapidly developing and offering options for fertility preservation, yet its growth is occurring at a greater speed than empirical evidence can be gathered or guidelines can be established • Each of the cases reviewed presents a learning opportunity for those involved in reproductive decision making • Future directions include developing tools and strategies for shared decision making in the context of fertility and preservation are essential to assist patients, parents and providers in reducing decisional regret and improving communication

Copyright, March 2017

How Subterranean Regulation Hinders Innovation in Assisted Reproductive Technology Myrisha S. Lewis Visiting Assistant Professor, IIT Chicago-Kent College of Law Background

Findings

Implications/Discussion/Conclusions

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This Article reveals why that belief is wrong.

The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (“advanced assisted reproductive technologies” or “AARTs”) through regulatory actions that receive little public, media, or scholarly attention.

I term this method of regulation “subterranean regulation.”

• It is likely that the FDA lacks jurisdiction over AARTs under applicable statutes, namely the Food, Drug and Cosmetic Act and the Public Health Service Act. • FDA regulation has hindered the use of cytoplasmic transfer and mitochondrial transfer in the United States.

• A hidden, ad hoc regulatory practice is exactly the wrong kind of process to use when it comes to scientific innovations in fraught ethical areas, which includes not only assisted reproductive technology but also other DNA-modifying technologies (including CRISPR-Cas9).

TIMELINE OF THE INCREASING FEDERAL REGULATION OF ADVANCED ASSISTED REPRODUCTIVE TECHNOLOGIES

BASIC DIAGRAM OF A CELL

References

Method/Strategy • The Article examines agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past 15 years to reveal an overlooked regulatory program.

• In addition to using the FDA’s website, Federal Register website, legal search engines, and media accounts, I obtained primary source documents through Freedom of Information Act requests.

• The primary source documents examined in this Article included FDA Advisory Committee Meeting Transcripts, Congressional testimony, and FDA communications with researchers.

Future Plans/Follow Up • The full Article is forthcoming and will be available at http://ssrn.com/author=1639733.

• In the future, I will conduct a legal analysis of the FDA’s expanding subterranean jurisdiction over the human body, with an emphasis on the designation of modified human reproductive tissues and transplanted fecal matter as “drugs.”

Copyright, March 2017

1. See Charlotte Pritchard, The Girl with Three Biological Parents, BBC News, Magazine, Sept. 1, 2014.

2. It is estimated that the “popular use” of artificial insemination in the United States began in the 1940s.

See Gaia Bernstein, The Socio-Legal Acceptance of New Technologies: A Close Look at Artificial Insemination, 77 WASH. L. REV. 1035, 1060-1072 (2002).

3. See National Bioethics Advisory Committee, Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Committee, at 5(noting that in 1981, the first baby was born in the United States as a result of in vitro fertilization).

4. See U.S. Food and Drug Administration, Proposed Approach to Regulation of Cellular and Tissue-Based Products; Availability and Public Meeting, 62 Fed. Reg. 9721, Mar. 4, 1997.

5. See U.S. Food and Drug Administration, Human Tissue Intended for Transplantation, 58 Fed. Reg. 65514, July 29, 1997.

Biological Ties and Right to Parenthood in the Medically Assisted Reproduction: Ethical and Juridical Implications among Lesbian Couples GULINO Matteo PhD*1, IORIO Silvia PhD2, MARINOZZI Silvia Researcher2 and GAZZANIGA Valentina Full Professor1 1 Department

Annual Bioethics Conference - April 6-7, 2017

of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome – 2 Department of Molecular Medicine, Unit of History of Medicine and Bioethics, Sapienza University of Rome

Background, Ethical Problem

The act of procreating is an essential part of private life, allowing people to achieve and live specific role in the society. Every one, including homosexuals and single individuals, may have, at some stage of their life, the desire to form a family with children.

Adoption and foster care are not always considered by couples as good alternatives. While homosexual couples tend to use ARTs to overtake the ontological inability to procreate, heterosexual people are used to access to these technologies to cure a sterility/infertility status or other types of pathologies. By providing a broad technologic portfolio, medical science is able to support homosexuals in the achieving of their needs [Figure 1]. When a lesbian couple decides to have a baby, one of the partners may be obliged to have with the baby only a social relationship. The choice of who will be biologically linked to the baby is a pivotal moment. In this situation, the need to take part to the procreation process may cause concerns.

Because some Western Countries (such as Italy, France and Germany) do not allow homosexuals to access to ARTs, it is very common that they leave their country towards more open-minded places in order to circumvent domestic prohibitions. This phenomenon, called as “Reproductive Tourism”, may cause problems of Public Order and International Family Law, given that couples want to come back to their own country and to be recognized as parents in accordance with the local laws. The aim of this research is to provide, by a practical approach, an International overview of ethical and juridical implications that may derive from the transnational application of assisted reproduction technologies (ARTs) among lesbian couples, taking into account the best child’s interest.

GESTATIONAL SURROGACY

o r



1 GENETIC MOTHER (the woman who gives her egg)



1 GESTATIONAL (AND/OR BIOLOGICAL) MOTHER (the third woman who gives birth the baby)



1 SOCIAL MOTHER (the genetic mother’s partner)

Only one of the partners will be biologically linked to the baby, the other partner will be considered as the social parent and will be subject to the local Family laws (!?)

TRADITIONAL SURROGACY 

1 GENETIC AND GESTATIONAL (AND/OR BIOLOGICAL) MOTHER (the third woman who gives her egg and gives birth the baby)



2 SOCIAL MOTHERS (the women who hired the third woman to

None of the partners will be biologically linked to the baby. Both of them will be considered as the social parents and will be subject to the local Family laws (!?)

bear a baby)

PARTIAL SHARED MOTHERHOOD 

1 GENETIC AND/OR BIOLOGICAL MOTHER (the woman who gives her egg and gives birth the baby)



1 SOCIAL MOTHER (the genetic mother’s partner)

Only one of the partners will be biologically linked to the baby, the other partner will be considered as the social parent and will be subject to the local Family laws (!?)

WHOLE SHARED MOTHERHOOD (RECEPTION OF OOCYTES FROM PARTNER) 

1 GENETIC AND/OR BIOLOGICAL MOTHER (the woman who gives her egg)



Materials and Methods

Local and EU legal sources (laws, judgments, orders of Institutions and national scientific publications) have been examined, using official web-sites and electronics databases of national authorities and institutional bodies, with the aim to define the law context about the use of ARTs. A critical analysis of the conceptual distinction between cases in which both the partners are biologically linked to the baby and cases in which one of the partners only maintains a social relationship with the baby has been made. An international bibliography research pertaining to the use of ARTs was performed using the “PubMed” database. The Eurispes 2016 survey about surrogate motherhood, adoption and marriage by LGBT were analyzed, in order to determine the perception of Italian public opinion regarding the right to homosexual parenthood [Figure 3].

Figure 1 – Technologic Portfolio (ARTs)

ASSISTED REPRODUCTION TECHNOLOGIES

Intra Uterine Insemination - (IUI)

In Vitro Fertilization – (IVF)

Gamete Intrafallopian Transfer – (GIFT)

Zygote Intrafallopian transfer – (ZIFT)

Surrogacy

*Figure 1 shows part of the ARTs technologic portfolio provided by the medical sciences that may be applied by lesbian couples.

   

  

Findings

Discussion

Figure 2 - List of some cases of parental project that may derive by the application of ARTs

The will of homosexual couples to be recognized as parents of babies born abroad through ARTs is subject to the local regulations on legal parentage.

The fact that certain types of ARTs are prohibited under the laws of the countries may be relevant in the assessment of the legal parentage.

At International level, the right to use ARTs by homosexuals is debatable and contentious.

The analysis of the EU cases law shows i) a trend in favour of the recognition of foreign birth certificates, formed abroad in accordance with the lex loci, when there is a biological link at least with one of the partners of the couple and ii) the importance to protect the fundamental right of child to personal identity.

Italian regulation on medically assisted reproduction (Law no. 40/2004) allows ARTs access only for different-sex couples, married or cohabitant, and potentially childbearing.

Surrogate motherhood is strictly forbidden.

From 2016, Italy has a law governing the civil unions among homosexual couples (Law no.

76/2016). The law confirm the ban of civil marriage and does not include the step child adoption.

In the last years, stepchild adoption has been provided by Italian Courts and Tribunals in more than one occasion, regardless of the sex and sexual orientation of the intended parents.

1 BIOLOGICAL MOTHER (the woman who gives birth the baby)

Both partners are biologically linked to the baby and thus considered as the biological parents (?!)

Figure 2 shows a synthetic list of some situations that may derive by the application of ARTs among lesbian couples. The presence of biological ties is highlighted. *The term biological mother is used to refer both the case of the woman who gives her egg and the case of the woman who gives birth the baby.

ROPA – Italian Supreme Court of Cassation Case no. 19599/2016

A lesbian couple, an Italian and a Spanish girls, contracted a civil marriage in Spain with the aim to grow in Italy a family with children. Due to the strictness of the Italian regulation on ART, the women decided to have a baby in Spain where the law regulating reproduction health technology are more homosexuals friendly. The couple decided to use the ROPA treatment (reception of oocytes from partner). One of the partners decided to be the genetic mother by giving her oocyte that will be inseminated with anonymous donor sperm while the other agreed to be the gestational mother by carrying on the pregnancy. The baby was regularly declared Spanish citizen and the couple were recorded as parents. As the women’s aim was to extend their parental project also in Italy, they asked to the official register of the city of Turin to record the Spanish birth certificate. The registrar refused their request for reason of Public Order and because the Italian law does not permit neither ARTs for homosexual couples nor surrogate motherhood.

After years of legal battles, the case was settled by the highest Italian Court of Appeal that recognized the lesbian couple’s right to parenthood (30 September 2016). The Court addressed important guidelines that may be useful in the assessment of a combination of cases [Figure 2]. The limit of Public Order has to be interpreted as far as possible in accordance with the moral and political values of the International community. In the assessment of the validity of a foreign birth certificate, it should be verified not so much whether the act requires a law complying with the local laws, but rather whether the act is contrary to the requirements of the human rights protection. It is unfair to assume that the recognition of the foreign birth certificate contrasts with the Public order solely because Italian law does not allow or forbid similar situation. The governance model for the reproduction health technology represents an ethical sensitive matter, where legislative choices are not constitutionally obligated. The treatment chosen by the couple should not be considered as a practice of surrogate motherhood. ROPA presents similarities and dissimilarities with the practice of heterologous insemination: it is similar because the couple follows a mutual parental project, but it is different because both partners are biologically linked to the baby. The Italian order does not exclude a priori the right for same-sex couples to welcome children in family. Family with children represents the direct expression of the fundamental right to selfdetermination. Both the parents were biologically linked and the baby was the result of a mutual parental project. The refusal of the legal recognition of parenthood would make the child in an uncertainty of legal status that would affect his/her right to personal identity.

Figure 3 – Eurispes 2015 and 2016 Survey: What do Italians think about surrogate motherhood, adoption and marriage for homosexuals?

Surrogacy

Juridical Protection De Facto Couples

Adoption by LGBT

Marriage for LGBT)

2016 (M+F)

38.5

2016 (M+F)

67.6

2016 (M+F)

29.0

2016 (M+F)

47.8

2015 (M+F)

49.8

2015 (M+F)

64.4

2015 (M+F)

27.8

2016 (M+F)

40.8

* Figure 3 shows the results of the Eurispes survey about the public Italian opinion towards surrogate motherhood, adoption and marriage for homosexuals.

Survey does not focus specifically on the matter of homosexual couples.

Copyright, March 2017

The right to use ARTs by homosexuals depends on the governance model stated for the medically assisted reproduction framework. At International level, the matter is differently regulated due to the associated ethical and social implications on the moral acceptability of ARTs for non medical reasons. Legal feasibilities about the application of these technologies among same-sex couples are debatable and contentious. Like to some EU countries (such as France and German), Italy does not allow homosexual couples to access to ARTs. Law no. 40/2004 allows the use of ARTs, including heterologous insemination (Italian Constitutional Court no. 162/2014) and PGD (Italian Constitutional Court cases no. 96/2015 and no. 229/2015), only to different-sex couples, married or cohabitant, and potentially childbearing that suffer from irreversible sterility/infertility, certified by a physician, and/or from genetic diseases (Italian Constitutional Court no. 96/2015). Surrogacy is strictly forbidden. Because medical advances goes fast, doctors and public opinion are increasingly faced with ethical issues about the beginning of life. As for Italy, the Eurispes data for 2016 have revealed a decrease of the Italian acceptance towards the practice of surrogate motherhood (38,5 Vs 49.8 in the 2015), while an increasing trend towards the moral acceptability of adoption (29.0 Vs 27.8 in the 2015) and marriage (47.8 Vs 40.8 in the 2015) for homosexuals [Figure 3].

From a practical point of view, the transnational application of ARTs among homosexual couples may cause problems of a) International Family Law as for the recognition of paternity/maternity, b) Public Order because it may violate obligations and duties stated by local laws and c) cultural adjustment due to the impact that certain situations may have on the public opinion. ARTs are certainty considered as a matter for domestic law and every State has a certain margin of discretion in the resolution of cases involving the beginning of life. At European level, the European Court of Human Rights (ECHR) has been many times involved in cases regarding the recognition of legal parentage both in same-sex and different-sex families. In cases Labassee and Mennesson v. France 2014 (case no. 65192/2011 and case no. 65941/11) – two cases focusing on French couples who decided to use traditional surrogacy in the United States – the ECHR accepted to record the foreign birth certificates. Because a familiar relationship was grown between the couples and the babies, the judgments’ decision was made on the basis on article 8 of the European Convention of Human Rights ruling the right to respect for private and family life. On 2015, the ECHR settled the request of an Italian couple who decided to use in Russia gestational surrogacy with egg and sperm donation, ruling the same conclusion. In this occasion, the Court’s decision focused also on the removal of the baby. Although the intended parents did not have any biological relationship with the baby, the ground that couple had lived with him for six months was able to qualify the case as a sort of “de facto family” and, hence, protectable under article 8 (Paradiso and Campanelli v. Italy, case no. 25358/2012). However only two years later, the Grand Chamber of ECHR reformed the precedent given in the Paradiso and Campanelli case (24 January 2017). According to the Court of last resort, the absence of any biological ties between the child and the intended parents, the short duration of the relationship with the child and the uncertainty of the ties from a legal perspective prevent to regulate the case under the article 8. As for homosexual people, in cases Foulon and Bouvet v. France 2014 (cases no. 9063/14 and no. 10410/14) – two cases focusing on a single man and a couple of men who decided to have a baby through traditional surrogacy in India, respectively – the ECHR recognized the legal parenthood of the applicants on the basis of article 8 of the European Convention of Human Rights. In both cases, applicants were genetically related to the baby. The analysis of the EU cases law, shows that in the European juridical framework there is a trend towards the recognition of foreign birth certificates in cases where at least one of the partners is biologically linked with the baby.

The recognition of legal parentage in lesbian families requires a complex assessment in order to strike a balance between private and public interests, taking into account the child’s best interest. In this respect, biological bonds may have a pivotal impact on the final decision. When biological bonds are lacking, an extensive evaluation of other elements shall be performed to determine whether the couple has established a relationship with a baby in a familiar environment.

Like to other EU cases law, the Italian Court stressed the importance of the biological bonds of the intended parents and wellevaluated the suitability of the familiar environment in which the baby was born.

As for the International Family Law, the case is perfectly complying with the EU trend and the Public Interest. From an ethical point of view, the case does not seem to meet severe criticisms. In literature, Marina et al. described that ROPA meets all the main principles of Bioethics: 1) “Beneficence” because to bring a child to the world is a positive fact; 2) “Non-Maleficence” because to form a same-sex families does not harm anyone and 3) “Autonomy” because ROPA requires a mutual and informed consent. ROPA presents many interesting similarities and dissimilarities with the other ARTs (heterologous and homologous insemination, surrogate motherhood, etc.). Italian case adds new hot topics to the international bioethical debate over the moral acceptability of ARTs among homosexual couples.

Conclusions and Follow-up

The widespread of ARTs among homosexuals increased the number of non-standard situations that do not fit with the traditional model of family=BIOLOGICAL MOTHER, FATHER and CHILDREN [Figure 2] The traditional model of family is changed as the needs of people is changed in the years. Medical advance in the field of reproduction health technology may enlarge the spectrum of civil rights. Domestic bans about some types of ARTs and difficulties in meeting treatment-eligibility criteria place same-sex families in a situation of legal uncertainty and cause disparities and inequalities, destabilizing the harmony and the balance of the family along with the child’s best interest. In the absence of the law, the resolution of cases is made at the discretion of the Courts, taking into account the child’s best interest.

Which is the real value of biological ties?

Should the biological ties be necessary to achieve the right to parenthood?

References

1.Marina S, Marina D, Marina F, et al. Sharing motherhood: biological lesbian co-mothers, a new IVF indication. Hum Reprod 2010;25(4):938-41.

2.Vermeulen VA. Developments in European law and European Union policy on same-sex couples: an overview of judicial, legislative and policy developments in the recognition of same-sex couples in Europe. Codex 2008;2008: 1-27.

3.Pennings G. Evaluating the welfare of the child in same-sex families. Hum Reprod 2011;26(7):1609-615.

4.Di Nucci E. IVF, same-sex couples and the value of biological ties. J Med Ethics 2016;42(12):784-87.

5.Eurispes. Rapporto Italia 2016. Available at external link (Accessed on 11 March 2017): http://eurispes.eu/content/rapporto-italia-2016-la-sindrome-del-palio.

6.Zeiler K, Malmquist A. Lesbian shared biological motherhood: the ethics of IVF with reception of oocytes from partner. Med Health Care Philos 2014;17(3):347-55.

7.Yeshua A, Lee JA, Witkin G, et al. Female Couples Undergoing IVF with Partner Eggs (Co-IVF): Pathways to Parenthood. LGBT Health 2015;2(2):135-39.

8.Pennings G. Evaluating the welfare of the child in same-sex families. Hum Reprod 2011 Jul;26(7):1609-15 9.Judith A. Burnett. Use of Assisted Reproductive Technology and Gay and Lesbian Couples. Journal of LGBT Issues in Counseling 2006;1(1):115-125 10.Präg P. and C. Mills M. Assisted Reproductive Technology in Europe: Usage and Regulation in the Context of Cross-Border Reproductive Care 2017. In: Kreyenfeld M. and Konietzka D. (Eds), Childlessness in Europe: Contexts, Causes, and Consequences. Springer, pp. 289-309.

WOMEN’S REPRODUCTIVE AUTONOMY AND THE ETHICS OF BABY MAKING: THE NIGERIAN CASE STUDY

Chitu Womehoma Princewill Institute for Biomedical Ethics, University of Basel, Switzerland

Background: The Patriarchal Ikwerre society of Rivers State, Nigeria and the culture of absolute respect for men have turned the average Ikwerre wife into baby making factory. Not just any baby but a male child. Hence a wife who is unable to produce children, especially male children for her husband is regarded as a worthless woman.

She is either expected to marry a wife who will bear children for her husband or her husband marries another wife who will bear children for him. The implication for this is that the wife which her husband will marry will be her mate and the first wife will not have control over her.

But if she marries a wife for her husband, she will be able to control the new wife.

Aim: To examine the ethical implications of using women as a baby making ‘factory’

Findings: • Poverty and patriarchy were observed to be the major factors responsible for the use of women for making babies.

• Lack of education was also another reason women succumb to be used for baby production.

• Pressure from the family and the society on the wife to have male children is also a factor that make women allow themselves to be used as baby making factories.

Methods: Using qualitative exploratory research design, 34 Indepth interviews (IDIs) and six focus group discussions (FGDs) were conducted with married women of various educational status, in either monogamous or polygynous marriages, aged 22-60 years.

Questions such as educational status, type of marriage, age, religion, reason for marriage, and decision when to have children were asked. When necessary, prompts were asked to elicit further details to understand implicit meaning in the responses of the participants. Data were analyzed thematically with the aid of content and narrative analysis . Coding was done by using MAXQDA version 11 software.

Implications/Discussion: The use of a woman solely for the purposes of making babies does not only reduce her to a sex object but also harms her bodily integrity and psychology. Her self identification and personal identity are undermined. Also, her autonomy is greatly diminished because she is controlled and manipulated by her user.

Conclusion: The patriarchal Ikwerre society and the culture of absolute respect for men need to be addressed. Policies that protect women have to be implemented.

Future Plans/Follow Up • Legal framework and code of practice for proper surrogacy is needed.

•

Copyright, March 2017

Cultural practices that exploit women should be addressed.

Savior Siblings: Ethical Conundrums and Regulatory Void Zachary E. Shapiro, JD, MSc Presidential Scholar of Law The Hastings Center, Garrison, NY BACKGROUND • Savior sibling: a sibling created for the purpose of providing biological material that can help treat or cure an existing terminally ill child • They are conceived through the sequential use of two reproductive technologies developed for other purposes: pre-implantation genetic diagnosis (PGD) and in-vitro fertilization (IVF).

• PGD is used to screen embryos prior to implantation in the uterus, in order to determine whether the embryo will be a tissue “match” to a sick child.

• Roughly 1% of PGD in the United States is used to create children that are tissue matches for their siblings

AIM To consider the regulatory and ethical frameworks concerning savior siblings

METHODS Considered the position of savior siblings, from an ethical and bioethical dimension • Examined stories, interviews, and case studies with actual families and savior siblings, to try and distill the landscape • Examined legislation and regulation concerning IVF, PGD, and specifically about savior siblings, both in the United States and the United Kingdom • Reached out and discussed savior siblings with several IVF clinics in the US and UK

FINDINGS REGULATION United States: • No governmental regulation or specific legal guidance • Uses of PGD, including creation of a savior sibling, left to the discretion of providers and patients • Sole governmental action/ “regulation” is the ban on federal funding for embryo-related research

United Kingdom: • The Human Fertilization and Embryology Act (HFEA) of 1990 regulates PGD • PGD can be performed in order to • Test for severe genetic diseases • Perform tissue type matching for savior siblings under strict criteria • Clinics must obtain licenses before they can perform the procedures that create a savior sibling • UK has fertility regulators in specialized courts • 2004 RULING: HFEA allows parents to use modern reproductive techniques to create a savior sibling • HFEA provides for enforcement: Required clinics to apply for NEW license for EACH GENETIC DISEASE they would like for test for in an embryo

• PGD: Pre-implantation genetic diagnosis • The genetic profiling of embryos • IVF: In-Vitro Fertilization: • A procedure in which eggs (ova) from a woman's ovary are removed and fertilized with sperm in a laboratory procedure, and then the fertilized egg (embryo) is returned to the uterus The author has nothing to disclose.

Parental Motives: • Ultimate arbiter of medical and family planning decisions for their individual family unit • Process unlikely to be undertaken by parents who don’t care for their children • Acceptable motives for family planning are complex • Create heir, continue legacy, provide playmate, strengthen/save marriage • Pandora’s Box: Questioning whether society/gov’t should have role in which birth motives are acceptable • Newer but not necessarily worse reason than traditionally selfish motives

CONCLUSIONS Need Monitoring and IN/FORMAL Regulation:

Potential Harms:

Ethics

• If the child believes that they were not wanted for themselves • If a child conceived for this reason enjoys a less close and loving relationship with parents • Could lead to feelings of depression and a lack of self-worth (malaise), as the child may not feel special in their own right, but rather that they are forever tied to their sibling • Is the savior sibling afforded the same level of autonomy that a normal individual is given when deciding to consent to a transplant of biological material?

• Will savior siblings face undue pressure from their family unit?

• Slippery Slope Arguments: • Today: savior children save sick siblings. Tomorrow: create a child to save a parent, elderly family member, or even someone outside the family unit • IVF and PGD could be used to usher in a new age of eugenics, if parents can select certain traits/ characteristics

In Support: • While some contend that the savior sibling is being used a means, it is not merely a means to an end. In fact,

DEFINITIONS

Ethics Continued

savior siblings serve a more complicated role: that of a savior, a family member, and an individual person.

• Anecdotal interview data report high level of satisfaction for the savior sibling • Many siblings report high levels of personal pride • Unique feeling of connection with their sick, older siblings • Clear therapeutic benefits for • The existing sick child, who gets to continue living • The family unit *as a whole, who now does not have to bury a child, and shares in the happiness of two (hopefully healthy) children

Given the absence of the above: • Gathering of data regarding the prevalence of savior siblings is restricted • Harm to savior children may go unreported • No system exists for follow-up with savior families • Limited data on long term emotional and physical health is collected • Clinics performing PGD make their own decisions on moral and ethical issues • Similarly situated individuals in different locations may have vastly different options

FUTURE DIRECTIONS US can learn from the UK regulatory framework: Efforts to advance a discussion are currently hampered by the lack of robust data

Cord Banking: As a method to reduce the need for a living donor

New Technological Advances: As medicine and medical technology advances, the hope is that living donors will become less important

The Role of Egg Dona.on Agencies in Defining the Moral Status of Eggs 1 2 Divya Yerramilli, MD/MBE , Alexandra Charrow, MD/MBE

Harvard Radia=on Oncology, Harvard Dermatology

Introduc.on

• As long as there have been reproduc=ve complica=ons, there has been a demand for assisted reproduc=ve strategies, including egg dona=on.

• While infer=lity is a medical diagnosis, services for egg dona=on are provided through private agencies.

• Egg dona=on agencies use both market-­‐based approaches and a language of altruism, which results in morally ambiguous language.

• This ambiguity may poten=ate widening discrepancies regarding the moral status of an oocyte, as biological =ssue, as poten=al life, or as an economic good.

• Clarifying these defini=ons is at the heart of most ethical issues regarding egg dona=on.

Findings

• In the aTempt of egg dona=on agencies to simultaneously defend the exchange of egg dona=on with language of altruism while promo=ng compensa.on using economic arguments, egg dona=on agencies help frame the exchange in such a way that contributes to moral ambigui.es regarding the status of eggs.

Transac=on of Egg Dona=on Market-­‐Based

Altruism

What is an egg?

Economic Good

Biological =ssue Minimal Risk

Commercial iPad $

Human Life

“Dona=on” “GiQ”

Compensa=on for Time/Inconvenience

Exchange of Money

Price based on market forces

Medical Risk

Drug/Device Sta=n $

Blood

Kidney

Ø

Ø

Adop=on Ø

Sex-­‐Work $

Aims of Research

• The objec=ves are to beTer describe the role of egg dona=on agencies as brokers of moral value for human oocytes and for the process of egg dona=on itself.

Method/Strategy

• Mixed methodologies, including media and content analysis, were used to explore the language used by egg dona=on agencies.

• The transi=on of egg dona=on from a medicine to the market is explored.

• Two differing views on the exchange of ova for money are examined: (1) the altruis=c dona=on, rewarded with a monetary giQ (2) a commercialized, market-­‐based transac=on of a good for money.

Conclusions

• Whether or not egg dona=on is framed as a transac.on for services or as altruis.c dona.on of biologic .ssue may ul=mately influence future decisions regarding parental rights, compensa.on limits, the use of eggs for medical research, and other emerging ethical issues regarding the moral status of a human oocyte.

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A"tudes of Pediatric Cancer Pa2ents Regarding Fer2lity Preserva2on Op2ons 1 2 Divya Yerramilli, MD, MBE, Clarisa Gracia, MD, MSCE

1Harvard Radia:on Oncology Program, 2Obstetrics and Gynecology at the Hospital of the University of Pennsylvania

Introduc2on

• Pa:ents of reproduc:ve age or with reproduc:ve poten:al who receive treatment for cancer may be at risk for infer:lity.

• It is standard of care to discuss fer:lity preserva:on with all cancer pa:ents if infer:lity is a risk of treatment, regardless of pa:ent age, as it is part of their total cancer care.1 • Cancer pa:ents face many barriers to accessing fer:lity preserva:on, which include awareness of fer:lity preserva:on op:ons.2-­‐4 • Pediatric pa:ents may face addi:onal barriers for many reasons, including: awareness of op:ons, willingness of physicians to discuss these op:ons, and priori:zing cure over survivorship.

• However, given the high rates of care and survivorship in pediatric pa:ents, infer:lity must be discussed prior to ini:a:ng therapy.

• Studies have shown that youth diagnosed with cancer in fact desire future fer:lity at the :me of cancer diagnosis.5

Aims of Research

• The study aimed to describe the differences in knowledge of fer:lity preserva:on op:ons between adult and pediatric female pa:ents.

Method/Strategy

• A survey-­‐based study was administered to female cancer pa:ents referred to the Reproduc:ve, Endocrinology, and Infer:lity Department at the University of Pennsylvania.

• The survey was designed to prospec:vely collect health, exposure, and demographic informa:on of female pa:ents as it related to ovarian reserve.

• 101 adult and 23 pediatric pa:ents were asked if they had thought about various op:ons for fer:lity preserva:on, and then asked if they had pursued any of these op:ons.

• These survey results were then analyzed to characterize differences between pediatric and adult pa:ents.

Fer2lity Preserva2on Op2ons Pre-­‐Puberty Ovarian Tissue Banking

Ovarian Tissue Transposi:on

GnRH Agonist

Post-­‐puberty Embryo Oocyte Oocyte Cryopreserva:on Cryopreserva:on Cryopreserva:on

Findings

• 101 adult pa:ents and 23 pediatric pa:ents were surveyed.

• 74% of adult vs. 30% of pediatric pa:ents thought about fer:lity op:ons (p=0.0001).

• Adults thought about embryo cryopreserva:on more oZen than pediatric pa:ents (34% vs. 4%, p=0.004).

• Pediatric pa:ents thought more frequently of not using any method for fer:lity preserva:on (61% versus 24%, p=0.008).

• More adults pursued fer:lity preserva:on, with 28% versus 0% (p=0.007) pursuing oocyte cryopreserva:on (17% versus 0%, p=0.0403).

Adults (n=101) Age Mean Age of Consent Mean Age at Diagnosis Mean Age at Treatment Race Caucasian African Asian Other Cancer Subtype CNS Head & Neck Breast Lymphoma Leukemia Sarcoma Lung GI Gyn Other Highest Level of Education 1-8 yrs (Grade School) 9-12 yrs (Some High School) Completed High School Some College College Graduate Post-Graduate Level Unknown Thought about fertility?

No method GnRH Agonist Embryo Cryopreservation Oocyte Cryopreservation Ovarian Tissue Banking Ovarian Tissue Transposition Other

Method Pursued?

No method GnRH Agonist Embryo Cryopreservation Oocyte Cryopreservation Ovarian Tissue Banking Ovarian Tissue Transposition Other Question Not Asked

Children (n=23)

29.433 (±5.77) 28.66 (±5.74) 28.57 (±5.31)

16.212 (±1.38) 15.93 (±1.44) 15.70 (±1.64)

77% (78) 11% (11) 6% (6) 6% (6)

74% (17) 4% (1) 0% (0) 2% (5)

p-value

<0.0001 <0.0001 <0.0001 0.014

• Pediatric cancer pa:ents do not think about fer:lity op:ons frequently.

• This may be due to age and reproduc:ve goals at diagnosis.

• The difference in knowledge between adult and pediatric pa:ents highlights the need for greater dissemina:on of informa:on and referral for fer:lity preserva:on to all pediatric cancer pa:ents.

Strategies To Improve Referral for Fer2lity Preserva2on Physician Knowledge

Mul2-­‐disciplinary Care

Bias regarding delay in care Pa2ent Comprehension

<0.001 1% (1) 3% (3) 46% (46) 26% (26) 9% (9) 3% (3) 1% (1) 2% (2) 5% (5) 4% (4)

Conclusions

0% (0) 0% (0) 0% (0) 52% (12) 4% (1) 30% (7) 0% (0) 4% (1) 4% (1) 4% (1)

Consent/Assent

Parent Comprehension

Insurance Coverage

Financial Barriers

<0.001 0% (0) 2% (2) 6% (6) 18% (18) 40% (40) 25% (25) 10% (10)

26% (6) 65% (15)

74% (75) 24% (24) 12% (12) 41% (41) 35% (35) 12% (12) 4% (4) 15% (15)

30% (7) 61% (14) 0% (0) 0% (0) 4% (1) 22% (5) 0% (0) 0% (0)

0.0001 0.0008 0.1206 <0.0001 0.0040 0.3095 1.0000 0.0711

71% (72) 7% (7) 23% (23) 17% (17) 5% (5) 2% (2) 5% (5) 3% (3)

82% (19) 0% (0) 0% (0) 0% (0) 9% (2) 0% (0) 0% (0) 13% (3)

0.3095 0.3465 0.0070 0.0403 0.6128 1.0000 0.5829 0.0769

References

9% (2)

Other/ Not Asked

Copyright, March 2017

1. Fer:lity/Endocrine Considera:ons. The Na:onal Comprehensive Cancer Network Guidelines: Adolescent and Young Adult Oncology. Version 2.2017. hbps://www.nccn.org/professionals/physician_gls/pdf/aya.pdf 2. Quinn, G.P. , Vadaparampil, S.T., Bell-­‐Ellison, B.A., Gwede, C.K., and Albrecht, T.L. (2008). Pa:ent-­‐physician communica:on barriers regarding fer:lity preserva:on among newly diagnosed cancer pa:ents. Soc. Sci. Med. 66:784-­‐789.

3. Goodwin, T., Oosterhuis, B. E., Kiernan, M., Hudson, M. M., & Dahl, G. V. (2006). Aitudes and prac:ces of pediatric oncology providers regarding fer:lity issues. Pediatric Blood & Cancer, 48, 80–85.

4. Schover, L.R., Brey, K., Lich:n, A. Lipshulz, L. I., and Jeha, S. (2002).

Oncologists’ Aitudes and Prac:ces Regarding Sperm Before Cancer Treatment. J. Clin. Onc. 20(7):1890-­‐7.

5. Geue, K., Richter, D., Schmidt, R., Sender, A., Siedentopf, F., Brähler, E., and Stöbel-­‐ Richeter, Y. (2014) The Desire for Children and Fer:lity Issues Among Young German Cancer Survivors. J. Adol. Health, 1-­‐9.