Developments in stem cell research and therapeutic cloning: Islamic ethical positions, a review

Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not - in the opinion of scientists - reduce the need to continue human embryonic stem cell research. So the debate continues. Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment. In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly. The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed.     

Our flawed approach to undue inducement in medical research

Some worry that offering too much money to participate in medical research can seduce people into participating against their better judgment. These overly attractive offers that impair judgment are often referred to as ‘undue inducements’. The current approach to prevent undue inducement is to limit the size of such offers. The hope is that smaller offers will not be attractive enough to impair judgment. Even if this is true, I argue that we should reject this solution. In Section 1, I go over the problem of undue inducement, and our current approach to preventing it, in more detail. In Section 2, I argue that, like money, therapeutic benefits of medical research may also unduly induce. In Section 3, I argue that the current approach to preventing undue inducement is absurd in the case of therapeutic inducements. In Section 4, I argue that our current approach is analogously problematic in the case of monetary inducements.     

Paternalism and fairness in clinical research

In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical research and that considerations of distributive fairness justify some paternalistic protections of research subjects.     

Faith-based perspectives on the use of chimeric organisms for medical research

Efforts to advance our understanding of neurodegenerative diseases involve the creation chimeric organisms from human neural stem cells and primate embryos—known as prenatal chimeras. The existence of potential mentally complex beings with human and non-human neural apparatus raises fundamental questions as to the ethical permissibility of chimeric research and the moral status of the creatures it creates. Even as bioethicists find fewer reasons to be troubled by most types of chimeric organisms, social attitudes towards the non-human world are often influenced by religious beliefs. In this paper scholars representing eight major religious traditions provide a brief commentary on a hypothetical case concerning the development and use of prenatal human–animal chimeric primates in medical research. These commentaries reflect the plurality and complexity within and between religious discourses of our relationships with other species. Views on the moral status and permissibility of research on neural human animal chimeras vary. The authors provide an introduction to those who seek a better understanding of how faith-based perspectives might enter into biomedical ethics and public discourse towards forms of biomedical research that involves chimeric organisms.     

AGAINST RISK-BENEFIT REVIEW OF PRISONER RESEARCH

The 2006 Institute of Medicine (IOM) report, 'Ethical Considerations for Research Involving Prisoners', recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category-based to a risk-benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk-benefit constraints on prisoner research must be justified in a different way from those on pediatric research. In this paper I argue that additional risk-benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category-based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non-prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk-benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk-benefit constraints on prisoner research.     

The Italian Way to Stem Cell Research: Rethinking the Role of Catholic Religion in Shaping Italian Stem Cell Research Regulations

Stem cell research regulations are highly variable across nations, notwithstanding shared and common ethical concerns. Dominant in political debates has been the so‐called embryo question. However, the permissibility of human embryonic stem cell (hESC) research varies among national regulatory frameworks. Scholars have explained differences by resorting to notions of political culture, traditions of ethical reasoning, discursive strategies and political manoeuvring of involved actors. Explanations based on the role of religion or other cultural structural variables are also employed. This paper analyses the emerging of the Italian regulatory framework on stem cell research using an analytical framework that considers the interplay between cultural structural features, political culture, traditions of ethical reasoning, institutional settings and the discursive and political agency of the actors involved. It aims also to explain the role of Roman Catholic Church in shaping the Italian stem cell research regulation not by treating religion as an autonomous causal factor, but through the analysis of the agency of Catholic and allied actors in the Italian political culture and institutional setting.     

Why a right to life rules out infanticide: A final reply to Räsänen

Joona Räsänen has argued that pro‐life arguments against the permissibility of infanticide are not persuasive, and fail to show it to be immoral. We responded to Räsänen’s arguments, concluding that his critique of pro‐life arguments was misplaced. Räsänen has recently replied in ‘Why pro‐life arguments still are not convincing: A reply to my critics’, providing some additional arguments as to why he does not find pro‐life arguments against infanticide convincing. Here, we respond briefly to Räsänen’s critique of the substance view, and also to his most important claim: that possession of a right to life by an infant does not rule out the permissibility of infanticide. We demonstrate that this claim is unfounded, and conclude that Räsänen has not refuted pro‐life arguments against infanticide.     

IS PAYMENT A BENEFIT?

What I call ‘the standard view’ claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt ‘the incorporation view.’ The incorporation view is more consistent with the underlying soft‐paternalist justification for risk‐benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects.     

GOING FROM PRINCIPLES TO RULES IN RESEARCH ETHICS

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis‐à‐vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished. The rules I call into question are the rules requiring:

• – that studies be designed in a scientifically valid way
• – that risks to subjects be minimized
• – that subjects be afforded post‐trial access to experimental interventions
• – that inducements paid to subjects not be counted as a benefit to them
• – that inducements paid to subjects not be ‘undue’
• – that subjects must remain free to withdraw from the study at any time for any reason without penalty

Both canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries.     

Playing God and tampering with nature: popular labels for real concerns in synthetic biology

Public engagement in science with diverse cross-sections of the community is considered a critical aspect of responsible biotechnological innovation. While the research community shows willingness to engage with both ambivalent and supportive audiences about potentially disruptive technological advances, there is less enthusiasm for engaging with groups who hold deeply opposing views to such advances. ‘Playing God’ and ‘tampering with nature’ are popular examples of intrinsic objections often made in opposition to the development or use of novel genetic technologies. Historically appearing in arguments against the pursuit of genetically modified organisms in agriculture and food industries, intrinsic objections have previously been labelled by the science community as inconsistent, non-scientific, and vague. Now found in a range of innovation contexts, the domain of synthetic biology appears to attract such objections consistently. We present the findings from a large Australian study (N?=?4593) which suggests ‘playing God’ objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of open-ended responses from an online survey to show how these objections are articulated in response to selected synthetic biology applications across environmental and health domains. Our research invites a rethink of how the synthetic biology community perceives, and engages with, people who express intrinsic objections. These people may additionally hold extrinsic concerns that may be potentially addressed, or at least reasonably considered, through dialogue. We offer some concluding remarks for engaging with publics who employ these types of arguments to communicate unease with aspects of technology development and use.

     

Putting placebo‐controlled trials in developing countries to the interpersonal justifiability test

This paper considers the ethics of placebo‐controlled trials in developing countries, where a treatment already exists but is not available due to the low local standard of care. Such trials would not be permitted in more developed nations where a higher standard of care is available. I argue that there are moral intuitions against such trials, but a further intuition that if the trials were aimed at producing treatment options for the developing world, that would be more permissible than if the trials were designed with the benefit of rich world people in mind. An approach based upon GA Cohen's work on interpersonal justifiability is suggested to allow us to explain these intuitions. Cohen's framework shows that these trials are ethically problematic because the inequality in healthcare provision between developing and developed nations that allows them to take place is at least partly the pharmaceutical corporations’ fault. Following Cohen's argument, this means the trials are non‐comprehensively justified. This allows for a more complete explanation of our intuitions than to consider such trials as cases of exploitation, because intuitions on the ethicacy of research can vary even when the exploitation relation remains the same. It is then established that there is good empirical evidence to believe that pharmaceutical corporations do fail the interpersonal justifiability test. The policy implications of this judgement are then considered, and it is suggested that the framework might be equally applicable to examining the permissibility of research conducted on vulnerable people within more developed nations.     

Embryos,The Principle of Proportionality,and the Shaky Ground of Moral Respect

The debate concerning the moral permissibility of using human embryos in human embryonic stem cell (hESC) research has long centred on the question of the embryo's supposed right to life. However, in focussing only on this question, many opponents to hESC research have escaped rigorous scrutiny by making vague and unfounded appeals to the concept of moral respect in order to justify their opposition to certain hESC practices. In this paper, I offer a critical analysis of the concept of moral respect, and its use to support the intuitively appealing principle of proportionality in hESC research. I argue that if proponents of this principle are to justify its adoption by appealing to the concept of moral respect, they must explain two things concerning the nature of the moral respect owed to embryos. First, they must explain which particular aspect of the embryo is morally relevant, and why. Second, they must explain why some uses of embryos in research fail to acknowledge what is morally relevant about the embryo, and thereby involve a violation of the moral respect that they are due. I shall show that providing such explanations may be more difficult than it first appears.     

No conscientious objection without normative justification: A reply

Benjamin Zolf, in his recent paper ‘No conscientious objection without normative justification: Against conscientious objection in medicine’, attempts to establish that in order to rule out arbitrary conscientious objections, a reasonability constraint is necessary. This, he contends, requires normative justification, and the subjective beliefs that ground conscientious objections cannot easily be judged by normative criteria. Zolf shows that the alternative of using extrinsic criteria, such as requiring that unjustified harm must not be caused, are likewise grounded on normative criteria. He concludes that conscientious objection is therefore untenable. Here, I present an alternative account, based on the value we are willing to place on conscientious objection as an expression of freedom of conscience and religion. Using an extrinsic criterion such as harm, we can make a judgement of what degree of harm should be tolerated as the cost of permitting conscientious objection. A normative criterion for judging individual claims is therefore not required.     

IVF and women's interests: an analysis of feminist concerns

Feminist objections to the new reproductive technologies are examined. The author argues that although these technologies entail significant risks and costs to women, help only a small minority, and do not address the underlying social causes of infertility, women's interests do not demand the rejection of research on and use of reproductive technologies. Their potential threat to female reproductive autonomy can be counteracted by protecting individual civil rights. Warren urges that women, as well as members of various racial, ethnic, and socioeconomic groups, be represented in decisions on reproductive technologies, participate in their development and funding, and supervise their provision.     

Natura non facit saltum

The suggestion that speciation involves non-adaptive processes needs further research, not more argument.
Mr Darwin's position might, we think, have been stronger than it is if he had not embarrassed himself with the aphorism, "Natura non facit salturn", which turns up so often in his pages. We believe…that Nature does make jumps now and then and a recognition of the fact is of no small importance in disposing of many minor objections to the doctrine of transmutation (i.e. speciation).     

Public reason in justifications of conscientious objection in health care

Current mainstream approaches to conscientious objection either uphold the standards of public health care by preventing objections or protect the consciences of health‐care professionals by accommodating objections. Public justification approaches are a compromise position that accommodate conscientious objections only when objectors can publicly justify the grounds of their objections. Public justification approaches require objectors and assessors to speak a common normative language and to this end it has been suggested that objectors should be required to cast their objection in terms of public reason. We provide critical support for such a public reason condition and argue that it would be neither too demanding nor too permissive. We also respond to objections that it unfairly favours secular over religious objectors and that public reasons cannot be held with the kind of sincerity thought to characterize conscientious objections.     

Educational pelvic exams on anesthetized women: Why consent matters

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible.     

REVISITING CHILD‐BASED OBJECTIONS TO COMMERCIAL SURROGACY

Many critics of commercial surrogate motherhood argue that it violates the rights of children. In this paper, I respond to several versions of this objection. The most common version claims that surrogacy involves child‐selling. I argue that while proponents of surrogacy have generally failed to provide an adequate response to this objection, it can be overcome. After showing that the two most prominent arguments for the child‐selling objection fail, I explain how the commissioning couple can acquire parental rights by paying the surrogate only for her reproductive labor. My explanation appeals to the idea that parental rights are acquired by those who have claims over the reproductive labor that produces the child, not necessarily by those who actually perform the labor. This account clarifies how commercial surrogacy differs from commercial adoption. In the final section of the paper, I consider and reject three further child‐based objections to commercial surrogacy: that it establishes a market in children's attributes, that it requires courts to stray from the best interests standard in determining custodial rights, and that it requires the surrogate to neglect her parental responsibilities. Since each of these objections fails, children's rights probably do not pose an obstacle to the acceptability of commercial surrogacy arrangements.     

The design of a wireless-controlled intra-oral electrolarynx

Many patients who have failed to acquire esophageal speech after total laryngectomy are presently using artificial electrolarynges. Two of the principle objections to currently available devices are their bulkiness and visibility. The authors have developed and tested a wireless-controlled intra-oral electrolarynx which overcomes these main objections. In addition, it produces intelligible speech which compares favorably with other existing devices. In this paper, the design details will be presented which significantly influence the performance and the patients' acceptability of the new device.