Dual consent? Donors' and recipients' views about involvement in decision-making on the use of embryos created by gamete donation in research.

BACKGROUND: Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. METHODS: From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. RESULTS: The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors' consent (26.4% vs. 11.4% among recipients). CONCLUSIONS: Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.

Anonymous sperm donors' attitude towards donation and the release of identifying information.

INTRODUCTION: Belgian legislation allows only strictly anonymous gamete donation and known donation (donation to a recipient known by the donor). Recently, an amendment of the legislation was proposed to grant donor offspring, as of 18 years old, the right to claim identifying information about their donor. PURPOSE: The aim is to explore the attitude of actual sperm donors towards donation and the release of identifying information and to investigate which donors would be willing to donate when anonymity would be prohibited by law. METHODS: All men who were accepted as sperm donors (n = 242) by AZ Jan Palfijn Hospital (Ghent, Belgium) were invited to complete an anonymous online survey. The response rate was 65.5%. RESULTS: One in five (20.1%; n = 30) would continue sperm donation upon a legislation change towards identifiable donation. Three in four donors (75.2%) would agree to provide basic non-identifiable information about themselves and one in three (32.9%) would provide extra non-identifiable information such as a baby photo or a personal letter. Almost half of the donors (45.6%) would agree to donate in a system where the hospital can trace the donor at the child's request and contact the donor, leaving it to the donor to decide whether or not to have contact with the requesting donor child. CONCLUSION: These findings show that only one in five current donors would continue to donate when identifiable. The study also demonstrates that current donors think more positive about alternative options and that nearly half of them are willing to be contacted by the hospital at the donor child's request, providing the donor can decide at that time whether or not to release his identity.

Family Communication About the Donor Conception: A Multi-Perspective Qualitative Study With Lesbian Parents and Their Children.

In literature, disclosure of donor conception in lesbian families has been considered an obvious and straightforward event. However, little is known about the ways in which donor conception is discussed in planned lesbian co-mother families. This study focuses on the process of parent-child communication about the donor conception on a within-family level. Six families, including 7 children and 12 parents, were interviewed about their family communication with regard to donor conception. A dyadic interview analysis revealed that family members managed the space taken up by the topic of donor conception in their daily conversations. Within these conversations, they also took care of each other and of their family relationships. In addition, children had an active position in the co-construction of the donor conception narrative. Linking these findings to the concepts of relational management and functionality of donor conception narratives, this study informs practitioners in the field of medically assisted reproduction.

Lesbian couples' views about and experiences of not being able to choose their sperm donor.

In this qualitative study, we explore how lesbian recipients view and experience the selection of their anonymous sperm donor. The study was conducted in Belgium, where fertility centres follow a legal protocol that severely restricts personal choice in donor selection. While previous studies have shown that recipients want greater control and input in the selection of their sperm donor, this was not a main concern for most women in the present study. They generally acknowledged their lack of control on the selection outcome and accepted this as part and parcel of an anonymous donation policy that provides an opportunity to have a child. They actively and passively downplayed initial concerns about the donor selection procedure and felt they did not have or need a right to further control over the donor selection. In adopting this 'subordinate' position, they felt they should trust the hospital, which they hoped would fulfil rather high screening standards. Those who did want more choice were nuanced and careful about their motivations: they focused on selecting traits that would facilitate normal child development or increase family coherence. The findings shed light on how these patients perceive their position in this third-party reproduction setting.

Beyond sperm cells: a qualitative study on constructed meanings of the sperm donor in lesbian families.

STUDY QUESTION: What meanings do lesbian couples construct regarding their sperm donor? SUMMARY ANSWER: For some parents, the donor was increasingly presented as a person, whereas for other parents, the donor was seen as an instrument from the moment they received the sperm donation. WHAT IS KNOWN ALREADY: Few studies specifically focus on how lesbian couples deal with the issue of third-party anonymous gamete donation. It is often assumed that they have fewer difficulties than heterosexual couples with the involvement of a male procreator, since their status as a donor conception family is 'socially visible' and there is no social father who fears exclusion. STUDY DESIGN, SIZE, DURATION: Semi-structured interviews were conducted with 10 lesbian couples (20 participants), recruited via the Ghent University Hospital. All couples had at least one child, conceived through anonymous donor insemination, between 7 and 10 years old. PARTICIPANTS/MATERIALS, SETTING, METHODS: Within the data corpus, a particular data set was analyzed where couples referred to their donor and his position in their family. Step-by-step inductive thematic analysis was performed resulting in themes that are grounded in the data. All phases of the analysis were followed by team discussion. MAIN RESULTS AND THE ROLE OF CHANCE: This study reveals different donor constructs, indicating different ways of dealing with the third-party involvement in the family. Some parents diminish the role of the donor throughout family life and continue to present him as an instrument: something they needed in order to become parents. Others show an increasing interest in the donor as the children mature, which results in a more personalized account of the donor. LIMITATIONS, REASONS FOR CAUTION: In our qualitative cross-sectional study, we collected retrospectively constructed stories. Longitudinal qualitative and quantitative research is required to allow for an extrapolation of the conclusions made. WIDER IMPLICATIONS OF THE FINDINGS: This study shows how the concept of the donor is constructed within lesbian families and how it is challenged by the child's developing personality and features. When counseling prospective parents, it could therefore be useful to discuss the concept of the anonymous donor beyond the conception phase. STUDY FUNDING/COMPETING INTEREST(S): The project was funded by the Research Fund of Ghent University, Belgium. There are no competing interests.

ESHRE Task Force on Ethics and Law 21: genetic screening of gamete donors: ethical issues.

This Task Force document explores the ethical issues involved in the debate about the scope of genetic screening of gamete donors. Calls for expanded donor screening arise against the background of both occasional findings of serious but rare genetic conditions in donors or donor offspring that were not detected through present screening procedures and the advent of new genomic technologies promising affordable testing of donors for a wide range of conditions. Ethical principles require that all stakeholders' interests are taken into account, including those of candidate donors. The message of the profession should be that avoiding all risks is impossible and that testing should remain proportional.

ESHRE Task Force on Ethics and Law 23: medically assisted reproduction in singles, lesbian and gay couples, and transsexual people†.

This Task Force document discusses ethical issues arising with requests for medically assisted reproduction from people in what may be called 'non-standard' situations and relationships. The document stresses that categorically denying access to any of these groups cannot be reconciled with a human rights perspective. If there are concerns about the implications of assisted reproduction on the wellbeing of any of the persons involved, including the future child, a surrogate mother or the applicants themselves, these concerns have to be considered in the light of the available scientific evidence. When doing so it is important to avoid the use of double standards. More research is needed into the psychosocial implications of raising children in non-standard situations, especially with regard to single women, male homosexual couples and transsexual people.

ESHRE task force on ethics and Law22: preimplantation genetic diagnosis.

This Task Force document discusses some relatively unexplored ethical issues involved in preimplantation genetic diagnosis (PGD). The document starts from the wide consensus that PGD is ethically acceptable if aimed at helping at-risk couples to avoid having a child with a serious disorder. However, if understood as a limit to acceptable indications for PGD, this 'medical model' may turn out too restrictive. The document discusses a range of possible requests for PGD that for different reasons fall outwith the accepted model and argues that instead of rejecting those requests out of hand, they need to be independently assessed in the light of ethical criteria. Whereas, for instance, there is no good reason for rejecting PGD in order to avoid health problems in a third generation (where the second generation would be healthy but faced with burdensome reproductive choices if wanting to have children), using PGD to make sure that one's child will have the same disorder or handicap as its parents, is ethically unacceptable.

The representation of medical risks and incentives concerning egg donation: an analysis of the websites of fertility clinics of Belgium, Spain and the UK.

Considering the growing demand for egg donation (ED) and the scarcity of women coming forward as donors to meet this demand, scholars have expressed concerns that clinics may (initially) misrepresent risks to recruit more donors. Additionally, (non-)monetary incentives might be used to try to influence potential donors, which may pressure these women or cause them to dismiss their concerns. Since the internet is often the first source of information and first impressions influence individuals' choices, we examined the websites of fertility clinics to explore how they present medical risks, incentives and emotional appeals. Content Analysis and Frame Analysis were used to analyze a sample of Belgian, Spanish and UK clinic websites. The data show that the websites mainly focus on extreme and dangerous risks and side effects (e.g. severe OHSS) even though it is highly relevant for donors to be informed about less severe but more frequently occurring risks and side effects (e.g. bloating), since those influence donors' daily functioning. The altruistic narrative of ED in Europe was dominant in the data, although some (hidden) financial incentives were found on Spanish and UK websites. Nonetheless, all information about financial incentives still were presented subtly or in combination with altruistic incentives.

The Vagueness of Integrating the Empirical and the Normative: Researchers' Views on Doing Empirical Bioethics.

The integration of normative analysis with empirical data often remains unclear despite the availability of many empirical bioethics methodologies. This paper sought bioethics scholars' experiences and reflections of doing empirical bioethics research to feed these practical insights into the debate on methods. We interviewed twenty-six participants who revealed their process of integrating the normative and the empirical. From the analysis of the data, we first used the themes to identify the methodological content. That is, we show participants' use of familiar methods explained as "back-and-forth" methods (reflective equilibrium), followed by dialogical methods where collaboration was seen as a better way of doing integration. Thereafter, we highlight methods that were deemed as inherent integration approaches, where the normative and the empirical were intertwined from the start of the research project. Second, we used the themes to express not only how we interpreted what was said but also how things were said. In this, we describe an air of uncertainty and overall vagueness that surrounded the above methods. We conclude that the indeterminacy of integration methods is a double-edged sword. It allows for flexibility but also risks obscuring a lack of understanding of the theoretical-methodological underpinnings of empirical bioethics research methods.

Trends in embryo disposition decisions: patients' responses to a 15-year mailing program.

BACKGROUND: This study examined the responses of patients of a Belgian fertility center to mailed requests to make or renew an embryo disposition decision (EDD), over a period of 15 years, to investigate trends in the decisions. METHODS: A retrospective analysis was performed on a mailing program from 1992 to 2006, for patients, of the Department of Reproductive Medicine, Ghent University Hospital (Belgium), from whom embryos had been cryopreserved at least 2 years. RESULTS: In 15 years, 3840 EDD forms were prepared for 2334 couples or female patients. The number of forms increased from 21 in 1992 to 558 in 2006. Each year, around a third of the forms were not returned. In general, a quarter of patients who received more than one form never answered. Donation to others for reproduction was overall the least popular option and decreased over the years. The rising trend in decisions to discard reversed into a negative trend from the introduction of donation for science (1997). Since then, donation for science has been the most popular option and its popularity increased with time. In 15 years, 2504 embryos were donated for science. More than a quarter of the patients who chose more than one final EDD in different years did not select the same EDD the second time. CONCLUSIONS: This study showed a positive trend in donation for science and a negative trend in donation to others and discarding. A substantial number of individual patients chose different types of EDDs in consecutive mailings, which shows that advance EDD directives should be used with caution.

To continue or discontinue storage of cryopreserved embryos? Patients' decisions in view of their child wish.

OBJECTIVE Cryopreservation of supernumerary embryos resulting from IVF treatment offers extra chances to conceive. The objective of this study is to describe patients' decisions to continue or discontinue storage of their embryos after a minimum storage period of 2 years. METHODS Female patients who had embryos stored at the Infertility Centre of the Ghent University Hospital (Belgium) were sent a mail questionnaire to be completed anonymously. RESULTS The questionnaire had a response rate of 79% (326/412). After an embryo storage period of at least 2 years, 40% of the couples who were still together wished to continue storage of their embryos. Half of these had no concrete plans for a transfer and wanted to postpone the decision or keep all options open. For those who decided to discontinue storage (60%), the main reason was the completion of their families. Despite the fact that the patients' child wish was the main factor in their storage decision, two groups of patients with distinct profiles made decisions that were inconsistent with their child wish: those who wanted to continue storage while not wanting a(nother) child (7% of those with no child wish), and those who wanted a(nother) child but decided to discontinue storage (25% of those with a child wish). Overall, these patients more often expressed emotional difficulties regarding this decision. CONCLUSIONS This study demonstrates the importance of gaining more insight into patients' embryo storage decisions (along with their embryo disposition decisions) and into the emotional factors playing a role in patients' decision-making.

Patients' conceptualization of cryopreserved embryos used in their fertility treatment.

BACKGROUND: Although IVF treatments using cryopreserved embryos are offered by most infertility centres, little is known about patients' opinions regarding treatment using these embryos. The objective of this study is to describe how patients think about (treatment with) cryopreserved embryos. METHODS: In-depth interviews based on the method of interpretative phenomenological analysis were conducted with patients undergoing IVF/ICSI treatment at the Department of Reproductive Medicine of the Ghent University Hospital between May and July 2006. Seven couples (one couple considered as one participant) and 11 female patients who attended the clinic without their partner were interviewed. RESULTS: Most participants knew little about medical-technical procedures involved in treatment with cryopreserved embryos. This was compensated by a high confidence in the medical team. However, seven of the eighteen participants thought the quality of cryopreserved embryos diminished during the storage period. A lack of knowledge about medical-technical procedures was compensated by metaphors related to other domains of experience, especially kitchen metaphors: this might add to the belief that frozen embryos have an expiry date. However, none of the patients who considered treatment with cryopreserved embryos as less effective ever thought of refusing this type of treatment or discussed this with medical staff. In addition, patients rarely discussed the moral status of their cryopreserved embryos. CONCLUSIONS: The beliefs of infertile patients about (the effectiveness of treatment with) cryopreserved embryos encompass misconceptions, and doubts and fears which may influence their decision-making but which are seldom discussed with the medical staff.

Reflections by patients who undergo IVF on the use of their supernumerary embryos for science.

Interviews were conducted with patients undergoing treatment at the department for reproductive medicine at the University Hospital of Ghent, Belgium to describe how patients think about the use of embryos for science and how patients' views are related to their decision whether or not to donate their supernumerary embryos for science. Most participants knew little about the use of embryos for science. The perception of science and scientists, rather than the perception of the embryo, played an important role in the disposition decision making. The feeling of not having control over what would happen to their embryo and the fear that scientists would allow their embryo to develop into children were the main arguments against donation. This showed the importance of information about scientific research with embryos, such as the 14-day limit to keep embryos alive. Half of the participants pictured the medical team as the requesting party for their embryos and those who were not willing to donate indicated that they could be persuaded when asked directly by their caregivers. In conclusion, this study suggests that the perception of science, rather than the perception of the embryo, plays an important role in the decision to donate for science.

Infertility patients' beliefs about their embryos and their disposition preferences.

BACKGROUND: Little research has been done on how beliefs of infertility patients about their embryos are related to their disposition decisions. The objective of this study was to describe how patients speak about their embryos, in moral (e.g. status) and non-moral terms, and to investigate how patients' narratives are related to their disposition preferences. METHODS: In-depth interviews based on the method of interpretative phenomenological analysis were conducted with patients undergoing IVF/ICSI treatment between May and July 2006. RESULTS: Seven couples and 11 female patients were interviewed. Six major themes emerged from the narratives of the participants when they spoke about their embryos: (i) a medical-technical perspective; (ii) feelings; (iii) genetic link to oneself and/or one's partner; (iv) symbolic meaning of the relationship between the infertile partners; (v) moral status and (vi) instrumental value. All but two participants spontaneously considered the embryo disposition options as a two-stage decision sequence. In the first step, they considered donation to another couple for reproductive purposes. At this stage, the presence of the themes 'genetic link' and 'symbol of the relationship' was linked with a clear reluctance to donate. In the second step of the decision-making process, the option of donation for research and discarding were considered. At this stage, participants' confidence in medical science and the instrumental value they attached to the embryo were related to their decisions. CONCLUSIONS: Patients' conceptualization of their embryos plays an important role in embryo disposition decisions. Our research showed that patients deal with these decisions in a two-stage decision sequence.

[Medical end-of-life decisions in neonates and infants in Flanders, Belgium; 1999/2000]. / Medische beslissingen rond het levenseinde bij pasgeborenen en zuigelingen in Vlaanderen; 1991/'00.

OBJECTIVE: To determine the number of medical end-of-life decisions in critically ill neonates and infants in Flanders, Belgium. DESIGN: Retrospective. METHOD: A death certificate study on all deaths of neonates and infants in the whole of Flanders was carried out over a i2-month period (August 1999-July 2000). An anonymous questionnaire was sent by mail to the attending physician of each of the 292 children who died under the age of 1 year. All physicians who had attended at least one death during the study period were included in an attitude study. RESULTS: A total of 253 (87%) of the 292 questionnaires were returned and 121 (69%) of the 175 physicians involved completed the questions on attitude. An end-of-life decision had been possible in 194 (77%; 95% CI: 70.4-82.4) of the 253 deaths for which questionnaires were returned, and such a decision was actually made in 143 cases (57%; 95% CI: 48.9-64.0). Lethal drugs were administered in 15 of 117 early neonatal deaths and in 2 of 77 later deaths (13% versus 3%; p = 0.018). The attitude study showed that 69 (58%; 95% CI: 48.1-66.5) of the 120 physicians supported a change in the law making life-termination possible in some well-defined cases. CONCLUSION: The death of neonates and infants was commonly preceded by an end-of-life decision in Flanders. The type of decision varied substantially according to the age of the child. The majority of physicians involved, favoured legalization of the use of lethal drugs in some well-defined cases.

Two mothers and a donor: exploration of children's family concepts in lesbian households.

BACKGROUND: Although children from lesbian families appear to make a distinction between a residential father and a donor, defining these two concepts seems to be a challenge. They need to appeal to more familiar concepts such as the hetero-normative concept of 'mother' to give a definition of the unfamiliar concepts they are confronted with. METHODS: The study is based on qualitative in-depth interviews with 6 children (9-10 years old) from lesbian families, all of which have been conceived using anonymous sperm donation. Semi-structured interviews were conducted. RESULTS: Two findings stand out. First, in defining the concepts of biological and non-biological mother, both mothers were described as equal parents. No difference was attached by the children to the mothers' position as a parent. Second, the concepts 'non-biological mother' and 'donor' were defined by looking at the hetero-normative concepts of 'mummy' and 'daddy'. To define the non-biological mother, both a 'mummy' and a 'daddy' were used as a reference. To define the donor concept, often references were made to a daddy. This comparison with a 'daddy' turned out to be complex due to the conflict between the role as a progenitor and the lack of a social relationship. The lack of language surrounding this concept turned out to be difficult. WIDER IMPLICATIONS OF THE FINDINGS: This study illustrates the complexity and ambiguity of children's experiences and perceptions when dealing with issues related to genetic and social parenthood.

Donor-conceived children looking for their sperm donor: what do they want to know?

OBJECTIVE: This paper aims to gain in-depth understanding of why some donor-conceived offspring want to know the identity of their sperm donor. METHODS: Step-by-step inductive thematic analysis was performed on first-hand quotes from donor-conceived offspring selected from a wide range of sources (including empirical studies and donor conception networks, registries and support groups). RESULTS: We found that at least 7 different objectives can underlie the wish to know one's donor: to avoid medical risks and consanguineous relationships; to connect with one's roots; to complete one's life (hi-)story; to understand where one's traits come from; to discover or assess one's defining characteristics and capabilities; to rectify a wrong-doing, and to map out one's ancestral history. CONCLUSION: The analysis shows that there is great variance among identity-seekers in the weight they attribute to wanting to know their donor. It is also clear that they have very different assumptions about the role and importance of genetics in terms of establishing 'who they are' or 'can become', including deterministic misconceptions. Rather than treat all donor-conceived offspring's needs as of equal concern, this analysis should help distinguish between and assess the relevance of the various motivations.

Decisions on embryo disposition in cross-border reproductive care: differences between Belgian and Dutch patients at a Belgian fertility center.

Empirical research into cross-border reproductive care is scarce and many facets of the phenomenon are unexplored. The objective of this study was to compare Belgian and Dutch patients regarding the way they perceived the treatment they received and regarding the embryo disposition decisions (EDDs) they made. A questionnaire was sent to patients for whom embryos were cryopreserved at the Ghent University Hospital, Belgium. The response rate was 79%. Of those who replied the questionnaire, 70.9% was Belgian (n = 231) and 29.1% was from The Netherlands (n = 95). Dutch patients were on average three years older (38.22 years) than Belgian patients (35.30 years). Belgian patients more often considered their last treatment both physically and emotionally burdensome compared to Dutch patients (36.0% versus 25.5%). Half of the Dutch patients wanted to continue the storage of their embryos compared to a third of the Belgian patients. Dutch patients less often considered the EDD difficult to make compared to the local patients and they less often experienced stress or tension regarding the decision. In conclusion, Dutch cross-border patients had more positive experiences regarding to the treatment and the EDD compared to -Belgian patients. However, they wanted to hold on longer to their cryopreserved embryos.

A special case on the use of ultrasonography for evaluation of the spinal canal and its contents in adults.

In this article we present a 70-year-old man with a history of severe trauma in the upper thoracic spine. This patient presented at our emergency department with a leaking wound in the lower neck after removal of osteosynthetic material. He had undergone a laminectomy of the third thoracic vertebra in the past. As an incidental finding, while examining the region of the lower neck by transcutaneous ultrasonography, we diagnosed a post-traumatic syrinx of the spinal medulla at this level.