Anonymity and informed consent in artificial procreation: a report from Denmark

The practice of informed consent in biomedicine is so widely spread that it must be considered the most important principle within bioethics, and the most universally appealed to within recent legislation. There seems to be a consensus as to its value in research on autonomous persons, but also a problem concerning its application when dealing with people having a serious mental, social or even physical disability.
Within the field of artificial procreation there are even more problems. Informed written consent is often demanded from anonymous donors of gametes in order to ensure their consent to the legal and moral consequences of their anonymity. The child resulting from the artificial procreation, on the contrary, cannot consent to, nor be informed before being conceived, of the secrecy laid on the identity of its genetic parents. Some countries resolve this problem by allowing the children, when they reach their majority, to obtain some information pertaining to the health or the identity of their genetic parents.
This presents ethical problems. It can be argued that the anonymity of the parents chiefly affects the children, so that an agreement on this point among parents, doctors and others must be regarded as invalid. The paper will argue that a law ensuring the complete anonymity of the parents is disregarding the informed consent and the interests of the children resulting from artificial procreation, and is thus doing more damage to society than good.     

Le principe de l’anonymat du donneur de gamètes à l’épreuve de son contexte. Analyse des conceptions juridiques de l’identité

This study clarifies the lively debate surrounding the anonymity of gamete donors. This principle, which has not been challenged since 1994, is currently criticized by a number of people, who were conceived through medically assisted procreation technologies with donor and who now have reached adulthood. Their testimony has a very significant impact on French public opinion. Several official reports have already suggested that the anonymity of gamete donors may well be removed under certain circumstances. To understand why public opinion has evolved so dramatically, we must revisit the legal position of gamete donors in the specific context of less visible changes in the law. Indeed, the legal concepts of parenthood and identity have been reshuffled over time, and such changes have deeply affected the legal issues relating to the anonymity of gamete donors. Formerly, the law governing the identification of individuals was shaped by political and social objectives. Now it is more concerned with the sense of identity and personal fulfilment of people. This change, based on modern western notions of egalitarianism and individuality, has dramatically affected the outcome of parenthood trials. Moreover, biological tests have made the truth available like never before. The possibility of finding out the truth has shocked the practice of many areas of family law and has created a new set of challenges, especially when the secrecy of the genetic parents has been legally established. In France, women have traditionally been able to deliver their children anonymously. A deadlock has resulted, which may now be overcome by introducing a new concept of personal origins. Now the law is evolving to permit the children to demand their biological mothers’ identity under certain circumstances, but without affecting anyone’s rights. The concept of personal origins has been quite successful on the European scene and has also charged the debate. It is now recognized under French and European laws that individuals must have privileged access to their personal origins. Can the principle of anonymity of gamete donors remain immune from such a (r)evolution ?     

La majorité des couples procréant par don de sperme envisagent d’informer l’enfant de son mode de conception, mais la plupart souhaitent le maintien de l’anonymat du donneur

Semen donation is anonymous by law since 1994 in France but has been abolished in various countries. We present the results of a study that has been conducted in 14 Cecos in 2006, including 534 couples who were waiting for the assisted procreation, were under treatment, or had already at least one child with donor semen. The results were very similar between men and women and in the various groups. Over 90% of the men and the women are in agreement with donors’ anonymity and less than 10% would like the law to be changed on this point. Approximately 25% of them would give up their parental project if the law was going to change. Almost one-third would like information on the semen donor, mainly on his health, to be transmitted to themselves and to the children. The couples who plan to become parents through semen donation make a clear distinction between donor anonymity and child disclosure on its conception circumstances.     

En France, la majorité des donneurs de spermatozoïdes souhaite le maintien de leur anonymat

So far in France, sperm donor anonymity, which was a fundamental principle and has been twice confirmed in the law in 1994 and 2004, is debated nowadays. In this context, the Cecos wanted to know the donors opinion on anonymity. In 2006, 193 semen donors recruited in 14 Cecos answered anonymously a questionnaire: 73% were in agreement with the principle of anonymity and less than 30% agreed that the future law should change to allow the children to know the donor identity. In case of anonymity disclosure, 60% would give up their sperm donation. The same proportion of donors would accept that non identifying information on them could be given on request to the parents and the child.     

Altruistic surrogacy and informed consent

A crucial premise in many recent arguments against the moral permissibility of surrogate motherhood arrangements is the claim that a woman cannot autonomously consent to gestating and relinquishing a child to another couple, because she cannot be fully informed about what her future emotional responses will be to the foetus developing within her, and to the giving up of the newborn infant to its social parents. When conjoined with some moral principle about the justifiable limits on the ways others can be expected to exercise their autonomy on our behalf, this claim is often taken to establish that various forms of surrogate motherhood arrangements are morally wrong. In this paper I want to show that there is a serious non sequitur in this kind of argument. That is, I want to show that even if women cannot in fact have this kind of information about what their future emotional responses to pregnancy and relinquishment will be, nothing follows about the wrongness or otherwise of surrogacy. For, when we consider what counts as informed consent in the context of other important ventures with uncertain consequences, it becomes clear that informed consent does not require having this kind of information about one's future emotional states. In putting these arguments, I also hope to clarify some of the connections which might be thought to hold between informed consent and autonomous decision-making generally.     

Informed consent and nudging

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure.     

Module two: informed consent

The objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.     

L’entretien psychologique systématique pour les couples optant pour l’IAD: huit ans d’expérience clinique dans une législation prévoyant la levée de l’anonymat du donneur

A law on medically assisted procreation was implemented in Switzerland in 2001. This law is subordinate to the well-being of the child and stipulates that only married couples can benefit from donor insemination (DI). Furthermore, a child who was conceived with donor sperm may obtain access to information including the identity of the donor on reaching adulthood, at age 18. The law also specifies that psychological assistance must be offered before, during, and after treatment. For the past 12 years, the Unit of Reproductive Medicine and the Center of Medically Assisted Procreation in Lausanne employ a concept of psychological assistance adjusted to each couple’s needs, called “ressource counselling”. In preparation for DI, specific questions are examined, such as “Should the child be informed about the donor insemination, should others be informed, if so, how and when?” These questions may also be discussed in a group setting specific for couples concerned with DI. Our experience shows that systematic counselling helps couples in finding their own path through the delicate subjects of secrecy, attachment, and the rights of a child to be informed of his/her genetic links.     

Could the Decision of Trial Participation Precede the Informed Consent Process? Evidence From Burkina Faso

Background

Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants’ vulnerability that limit the efficacy of the informed consent.

Methods

A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial.

Results

For most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents’ willingness to have their child included in the trial made them develop active strategies to achieve this purpose.

Discussion

In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process.     

Infants,Children, and Informed Consent

Obtaining informed consent for non-therapeutic experimentation on infants and children has ethical and legal implications that cause great controversy. There is some danger that worthy research will be inhibited if current ethical codes are interpreted too strictly, yet infants, children, and other vulnerable groups clearly must be protected from exploitation as research subjects. It is suggested that permission from parents coupled with integrity of the investigator will remain the child''s best protection, but several additional protective mechanisms are available and should be used. Some guidelines for non-therapeutic research are suggested which should not only provide adequate protection for infants and young children involved in research projects, but allow investigators reasonable freedom to prosecute worthy research vital to continued improvements in child care.     

Adaptation of children to a chronically ill or mentally handicapped sibling.

The presence of a chronically ill or mentally handicapped child in a family can be a stress for the child''s siblings, who often are ill informed about the nature and prognosis of the illness, may be uncertain what is expected of them in the caregiving role, may feel their own identities threatened, and may experience ostracism by their friends and misunderstanding at school. Although individual reactions vary widely, feelings of anger, guilt, resentment and shame are commonly reported. Excessive responsibility and concern about one''s identity may add to these feelings and culminate in psychologic problems in the sibling. The physician caring for the family must be alert for symptoms of emotional disturbance or social maladjustment among the siblings of chronically ill or mentally handicapped children and should be prepared to counsel the family or refer them to a counsellor experienced in this area. In general, the first step is to be sure that the sibling is fully informed about the condition and to encourage frank discussion between the parents and the handicapped child''s siblings.     

Voluntary Informed Consent in Paediatric Oncology Research

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research‐care context.     

Why babies look like their daddies: paternity uncertainty and the evolution of self-deception in evaluating family resemblance

It has been suggested that in a socially monogamous system where fathers invest in their mate's offspring but paternity is far from certain, it will be adaptive on the part of infants to conceal their father's identity; but the opposite claim has also been made that this is against the genetic interests of the fathers, and a high frequency of adulterine births will select instead for paternal resemblance. In this article, I present a simple theoretical model that suggests that neonatal anonymity benefits fathers, mothers, and children. Once anonymity becomes established, however, all babies start paying the cost of paternity uncertainty, that is, the reduction in paternal care due to fathers not knowing whether they have truly sired their mate's offspring. By diminishing the fitness of babies, such a cost bounces back as lowered fitness for parents as well. We should then expect the evolution of maternal strategies directed to decrease paternity uncertainty, in the form of instinctive and unsolicited comments on babies' resemblance to their putative fathers. In contradiction to the widespread belief that it would be in fathers' interest to be skeptical of these allegations, the model suggests that, under conditions of infant anonymity, fathers will actually promote their own fitness by believing their spouses. Received in revised form: 5 September 2001 Electronic Publication     

The Controversy Over Pediatric Bariatric Surgery

Despite the reported limited success of conventional treatments and growing evidence of the effectiveness of adult bariatric surgery, weight loss operations for (morbidly) obese children and adolescents are still considered to be controversial by health care professionals and lay people alike. This paper describes an explorative, qualitative study involving obesity specialists, morbidly obese adolescents, and parents and identifies attitudes and normative beliefs regarding pediatric bariatric surgery. Views on the etiology of obesity—whether it should be considered primarily a medical condition or more a psychosocial problem—seem to affect the specialists’ normative opinions concerning the acceptability of bariatric procedures as a treatment option, the parents’ feelings regarding both being able to influence their child’s health and their child being able to control their own condition, and the adolescents’ sense of competence and motivation for treatment. Moreover, parents and adolescents who saw obesity as something that they could influence themselves were more in favor of non-surgical treatment and vice versa. Conflicting attitudes and normative views—e.g., with regard to concepts of disease, personal influence on health, motivation, and the possibility of a careful informed consent procedure—play an important role in the acceptability of bariatric surgery for childhood obesity.     

Informed Consent and Genetic Information

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent.     

Medical experimentation, informed consent and using people

In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means.     

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.     

Does benefit justify research with children?

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non‐medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk.     

Cruel choices: autonomy and critical care decision-making

Although autonomy is clearly still the paradigm in bioethics, there is increasing concern over its value and feasibility. In agreeing with those concerns, I argue that autonomy is not just a status, but a skill, one that must be developed and maintained. I also argue that nearly all health-care interactions do anything but promote such decisional skills, since they rely upon assent, rather than upon genuinely autonomous consent. Thus, throughout most of their medical lives, patients are socialised to be heteronomous, rather than autonomous. Yet, at the worst possible time--critical care decision-making--when life and death consequences are attached to the choices, the paradigm shifts and real consent is sought, even demanded, thereby making an often traumatic situation even harder. I go on, though, to also reject paternalistic models of beneficence as an alternative. Rather, I conclude that the problem is so fundamental in healthcare that a genuine solution would require a radical restructuring. I recommend steps that can be taken in the interim to improve the situation and to move toward such a restructuring.