The importance of the values attached to cells for a good informed consent procedure in cell donation for tissue engineering purposes

In this article the scope and contents of informed consent for cell donation in tissue engineering are discussed. We evaluate the various values donors may attach to cells and that may influence their decision to donate. Awareness of the various meanings of the value of the cells is therefore essential for all involved in cell transfer. We discuss four types of value: biological, relational, material and informational value and discuss their relevance for collection, for the relationships that are established between donor and cell collector and for informed consent procedures. The actual setting of cell donation and the contents of informed consent can either maintain or disrupt these relationships. While one can exclude donors from any further say in the destination of their cells and from any financial return, one cannot exclude them from a persistent interest in the genetic information of the cells.     

TOWARD A GENDER-SENSITIVE ASSISTED REPRODUCTION POLICY

The recent case of the UK woman who lost her legal struggle to be impregnated with her own frozen embryos, raises critical issues about the meaning of reproductive autonomy and the scope of regulatory practices. I revisit this case within the context of contemporary debate about the moral and legal dimensions of assisted reproduction. I argue that the gender neutral context that frames discussion of regulatory practices is unjust unless it gives appropriate consideration to the different positions women and men occupy in relation to reproductive processes and their options for autonomous choice. First, I consider relevant legal rulings, media debate, and scholarly commentary. Then I discuss the concept of reproductive autonomy imbedded in this debate. I argue that this concept conflates informed consent and reproductive autonomy, thereby providing an excessively narrow reading of autonomy that fails to give due regard to relations among individuals or the social, political and economic environment that shapes their options. I contrast this notion of autonomy with feminist formulations that seek to preserve respect for the agency of individuals without severing them from the conditions of their embodiment, their surrounding social relationships, or the political contexts that shape their options. Taking these considerations into account I weigh the advantages of regulation over the commercial market arrangement that prevails in some countries and suggest general guidelines for a regulatory policy that would more equitably resolve conflicting claims to reproductive autonomy.     

DONATING FRESH VERSUS FROZEN EMBRYOS TO STEM CELL RESEARCH: IN WHOSE INTERESTS?

Some stem cell researchers believe that it is easier to derive human embryonic stem cells from fresh rather than frozen embryos and they have had in vitro fertilization (IVF) clinicians invite their infertility patients to donate their fresh embryos for research use. These embryos include those that are deemed 'suitable for transfer' (i.e. to the woman's uterus) and those deemed unsuitable in this regard. This paper focuses on fresh embryos deemed suitable for transfer - hereafter 'fresh embryos'- which IVF patients have good reason not to donate. We explain why donating them to research is not in the self-interests specifically of female IVF patients. Next, we consider the other-regarding interests of these patients and conclude that while fresh embryo donation may serve those interests, it does so at unnecessary cost to patients' self-interests. Lastly, we review some of the potential barriers to the autonomous donation of fresh embryos to research and highlight the risk that female IVF patients invited to donate these embryos will misunderstand key aspects of the donation decision, be coerced to donate, or be exploited in the consent process. On the basis of our analysis, we conclude that patients should not be asked to donate their fresh embryos to stem cell research.     

How to address the ethics of reproductive travel to developing countries: a comparison of national self-sufficiency and regulated market approaches

One of the areas of concern raised by cross-border reproductive travel regards the treatment of women who are solicited to provide their ova or surrogacy services to foreign consumers. This is particularly troublesome in the context of developing countries where endemic poverty and low standards for both medical care and informed consent may place these women at risk of exploitation and harm. We explore two contrasting proposals for policy development regarding the industry, both of which seek to promote ethical outcomes and social justice: While one proposal advocates efforts to minimize cross-border demand for female reproductive resources through the pursuit of national self-sufficiency, the other defends cross-border trade as a means for meeting the needs of vulnerable groups. Despite the conflicting objectives of the proposed strategies, the paper identifies common values and points of agreement between the two, including the importance of regulations to safeguard those providing ova or surrogacy services.     

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.     

The Consequences of Vagueness in Consent to Organ Donation

In this article I argue that vagueness concerning consent to post‐mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as ‘overrules’ under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.     

Elective, non-therapeutic ventilation: a reply to Browne et al., "The ethics of elective (non-therapeutic) ventilation

Browne, Gillett and Tweeddale propose that the use of non-therapeutic elective ventilation (EV) to secure transplantable organs is ethically indefensible. Their argument centres around several propositions: that explicit patient consent for EV is essential, but since it is not included in the consent process for donation from the patient, using it constitutes assault; that inferring consent for EV from the consent to donate itself is ethically and logically indefensible; and that explicit consent from next-of-kin should neither be sought nor honoured in view of the stress EV may cause to staff and families. This article examines their reasoning and suggests that it is fatally flawed. It argues further that in most cases of donation, not using EV may itself be unethical.     

How infectious diseases got left out--and what this omission might have meant for bioethics

In this article, we first document the virtually complete absence of infectious disease examples and concerns at the time bioethics emerged as a field. We then argue that this oversight was not benign by considering two central issues in the field, informed consent and distributive justice, and showing how they might have been framed differently had infectiousness been at the forefront of concern. The solution to this omission might be to apply standard approaches in liberal bioethics, such as autonomy and the harm principle, to infectious examples. We argue that this is insufficient, however. Taking infectious disease into account requires understanding the patient as victim and as vector. Infectiousness reminds us that as autonomous agents we are both embodied and vulnerable in our relationships with others. We conclude by applying this reunderstanding of agency to the examples of informed consent and distributive justice in health care.     

Parental attitudes toward pediatric organ donation: a survey.

We conducted a telephone survey of parents in the National Capital Region to assess their intention to donate their child''s organs and to provide physicians with information that could help alleviate their concerns about approaching parents for consent. Of 339 parents who agreed to answer questions after being given details of their child''s "death" 288 (85%) said that they would be willing to donate their child''s organs. The degree of willingness was associated with the certainty of death, altruism and empathy toward children in need of an organ, previous discussion of organ donation with a family member and knowledge of an adolescent or adult child''s attitude toward donation. Factors that inhibited the intention to donate included uncertainty of death, insufficient information from medical professionals and fear of multilation. The child''s age was not significantly associated with intention to donate. Concordance between the results and actual donation rates in Canada and the United States supports the generalizability of the survey findings.     

Should consent be required for organ procurement?

Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement.     

Consenting to donation: an examination of current practices in informed consent for tissue donation in the US

Informed consent is the primary moral principle guiding the donation of human tissue for transplant purposes. When patients’ donation wishes are not known, family members making the decision about tissue donation should be provided with requisite information needed to make informed donation decisions. Using a unique dataset of 1,016 audiotaped requests for tissue obtained from 15 US tissue banking organizations, we examined whether the information provided to families considering tissue donation met current standards for informed consent. The results indicated that many elements of informed consent were missing from the donation discussions, including the timeframe for procurement, autopsy issues, the involvement of both for-profit and nonprofit organizations, and the processing, storage and distribution of donated tissue. A multiple linear regression analysis also revealed that nonwhites and family members of increased age received less information regarding tissue donation than did younger, white decision makers. Recommendations for improving the practice of obtaining consent to tissue donation are provided.     

Racial classification regarding semen donor selection in Brazil

Brazil has not yet approved legislation on assisted reproduction. For this reason, clinics, hospitals and semen banks active in the area follow Resolution 1358/92 of the Conselho Federal de Medicina, dated 30 September 1992. In respect to semen donation, the object of this article, the Resolution sets out that gamete donation shall be anonymous, that is, that the donor and recipients (and the children who might subsequently be born) shall not be informed of each other's identity. Thus, since recipients are unaware of the donor's identity, semen banks and the medical teams involved in assisted reproduction become the intermediaries in the process. The objective of this article is to show that, in practice, this represents disrespect for the ethical principles of autonomy, privacy and equality. The article also stresses that the problem is compounded by the racial question. In a country like Brazil, where racial classification is so flexible and goes side by side with racist attitudes, the intermediary role played by semen banks and medical teams is conditioned by their own criteria of racial classification, which are not always the same as those of donors and semen recipients. The data presented in this paper were taken from two semen banks located in the city of São Paulo (Brazil). At the time of my research, they were the only semen banks in the state of São Paulo and supplied semen to the capital (São Paulo city), the state of São Paulo, and to cities in other Brazilian states where semen banks were not available.     

Families’ reflections on the process of brain donation following coronial autopsy

This study aims to explore families’ reflections on their decision to donate brain tissue to the NSW Tissue Resource Centre (NSW TRC), Australia. Specifically, the study aims to investigate respondents’ initial reactions to the request for donation, primary reasons for their decision, and subsequent satisfaction levels. Participants were next-of-kin (NOK) contacted between May 2002 and May 2008, on the day of their relative’s autopsy, who agreed to donate brain tissue to the NSW TRC for medical research. All 111 NOK were invited to participate, and those who agreed completed an anonymous questionnaire. Fifty completed questionnaires were received. Results showed that 74% of respondents were not upset by the donation call and 98% were satisfied with their decision to donate. Of the 22% who reported having been upset, many indicated that their distress was partly related to their circumstances. When asked the main reason for their donation, 66% had wanted to help others, or help research, while 24% stated their primary reason as a belief that they were respecting the wishes of their deceased relative. These findings show that NOK are not further distressed by being asked to donate brain tissue, give altruistic reasons for consent and are satisfied with the decision they made. In both this study and previous literature, the importance of discussion about organ donation amongst relatives is a recurring theme. Knowledge about a relative’s wishes is likely to help facilitate decision-making, overcoming at least one crucial barrier to lifting rates of organ donation for transplantation and research.     

The Individualist Model of Autonomy and the Challenge of Disability

In recent decades, the intertwining ideas of self-determination and well-being have received tremendous support in bioethics. Discussions regarding self-determination, or autonomy, often focus on two dimensions—the capacity of the patient and the freedom from external coercion. The practice of obtaining informed consent, for example, has become a standard procedure in therapeutic and research medicine. On the surface, it appears that patients now have more opportunities to exercise their self-determination than ever. Nonetheless, discussions of patient autonomy in the bioethics literature, which focus on individual patients making particular decisions, neglect the social structure within which health-care decisions are made. Looking through the lens of disability and informed by the feminist conception of relational autonomy, this essay argues that the issue of autonomy is much more complex than the individualist model suggests. The social system and the ableist ideology impose various forms of pressure or oppressive power that can affect people’s ability to choose according to their value system. Even if such powers are not directly coercive, they influence potential parents’ decisions indirectly—they structure their alternatives in such a way that certain options are never considered as viable and other decisions must be made. This paper argues that, instead of only focusing on the individual act of decision-making, we need to pay attention to the social structure that frames people’s decision.     

Research, Informed Consent, and the Limits of Disclosure

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.     

RESPECTING AUTONOMY WITHOUT DISCLOSING INFORMATION

There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient's or research participant's autonomy. In this article I set out to challenge this claim by considering in detail each of the three most prominent ways in which ‘autonomy’ has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose.     

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.     

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.     

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness

Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification.     

Solidarity and justice as guiding principles in genomic research

In genomic research the ideal standard of free, informed, prior and explicit consent is sometimes difficult to apply. This has raised concern that important genomic research will be restricted. Different consent procedures have therefore been proposed. This paper explicitly examines the question how, in genomic research, the principles of solidarity and justice can be used to justify forms of diminished individual control over personal data and bio-samples. After a discussion of the notions of solidarity and justice and how they can be related to health care and genomic research, we examine how and in which situations these notions can form a strong moral basis for demanding certain financial sacrifices. Then we examine when these principles can justify consent procedures which diverge from the ideal standard. Because much genomic research is not expected to lead to immediate (clinical) benefits we also discuss the question of whether we can be obliged to make any sacrifices for future (not yet existing) patients. We conclude with the formulation of a number of conditions that have to be met before autonomy sacrifices can be reasonably demanded in genomic research.