To analyse legislation and medical professionals’ position concerning the doctor’s role in assisted reproduction techniques in Italy, and to discuss the implications for physicians of preimplantation genetic diagnosis (PGD).

Until recently a strict interpretation of the assisted reproduction law (40/2004) and the guidelines subsequently issued, lead to denying infertile couples affected by genetic diseases the right to resort to PGD. In October 2006 the Constitutional Court ruled regarding the question of the constitutional legitimacy of the prohibition of PGD.

The Constitutional Court declared the manifest inadmissibility of the question of the constitutional legitimacy of article 13 of law 40/2004. The debate has become very animated since the ruling. After the negative sentence of the Constitutional Court, three further sentences recognised the right of couples to obtain PGD, representing a hard blow to law 40/2004 and to the ministerial guidelines; a further confirmation of the untenability of a law that violates fundamental principles such as the right to healthcare for women and the unborn child, the right to responsible motherhood and to informed consent.

It seems that in Italy the legislative inadequacy for medically assisted procreation is reprieved by the courageous decisions of the judges, which refer to the values of the Italian Constitution, in defence of the fundamental rights of the citizens.

The aim of this article is to provide a preliminary ethical evaluation of the effect of telesurgery (long distance, remote surgery) on patient care. In order to accomplish this task we give a broad description of the state of the art in telesurgery and analyse it using Joan Tronto’s articulation of care as a structured process. This structure illuminates the significance of the patient-physician relationship as the buttress for establishing and preserving practices of care in the healthcare context, with the ultimate goal of safeguarding patient dignity. The process of care combined with the moral aim of medicine—to fulfil the good of the patient—provides the ethical foundation for assessing telesurgery. By exploring various telesurgical scenarios we may assess its potential role in augmenting or diminishing patient care within the frame of the patient-physician relationship. The significance of conducting this evaluation lies in the fact that the practice of telesurgery may very shortly become routine and an evaluation has not yet been attempted.

The Alexandra District Ambulance Service is the only volunteer-based ambulance service in Victoria, Australia. It provides an opportunity to reflect on the ethical issues surrounding the delivery of ambulance service by volunteers, and its impact on the community.

Due to the worldwide shortage of organs for transplantation, there has been an increased use of organs obtained after circulatory death alone. A protocol for this procedure has recently been approved by a major transplant consortium. This development raises serious moral and ethical concerns. Two renowned theologians of the previous generation, Paul Ramsey and Moshe Feinstein, wrote extensively on the ethical issues relating to transplantation, and their work has much relevance to current moral dilemmas. Their writings relating to definition of death, organ transplantation and the care of the terminally ill are briefly presented, and their potential application to the moral problem of organ donation after circulatory death is discussed.

This paper aims to outline the ethical concerns regarding the use of antidepressant medication in children and adolescents. Recent debates surrounding this issue have focused on the link between selective serotonin reuptake inhibitor use and an increased risk of suicidal thinking/behaviour, and weighed that against the benefit of the alleviation of depressive symptoms. It is argued here that such an approach is simplistic. There are several serious risks surrounding antidepressant use in the young that ought to be included in the equation, along with a consideration of the neuroethical concerns surrounding pharmacotherapy for affective disorders. Using the precautionary principle as a framework for analysis it is concluded that the risks are sufficiently serious and plausible that the prescribing of antidepressant medication to the young ought to be severely restricted; further it is imperative that the child and their parents are made fully aware of the risks, short-term and long-term, involved.

The traditional view that having a personality disorder, unlike other mental disorders, is not usually reason enough to consider a person incompetent to make healthcare decisions is challenged. The example of a case in which a woman was treated for a physical disorder without her consent illustrates that personality disorder can render a person incompetent to refuse essential treatment, particularly because it can affect the doctor–patient relationship within which consent is given.

Discussions about medical errors facilitate professional learning for physicians and may provide emotional support after an error, but little is known about physicians’ attitudes and practices regarding error discussions with colleagues.

Survey of faculty and resident physicians in generalist specialties in Midwest, Mid-Atlantic and Northeast regions of the US to investigate attitudes and practices regarding error discussions, likelihood of discussing hypothetical errors, experience role-modelling error discussions and demographic variables.

Responses were received from 338 participants (response rate = 74%). In all, 73% of respondents indicated they usually discuss their mistakes with colleagues, 70% believed discussing mistakes strengthens professional relationships and 89% knew at least one colleague who would be a supportive listener. Motivations for error discussions included wanting to learn whether a colleague would have made the same decision (91%), wanting colleagues to learn from the mistake (80%) and wanting to receive support (79%). Given hypothetical scenarios, most respondents indicated they would likely discuss an error resulting in no harm (77%), minor harm (87%) or major harm (94%). Fifty-seven percent of physicians had tried to serve as a role model by discussing an error and role-modelling was more likely among those who had previously observed an error discussion (OR 4.17, CI 2.34 to 7.42).

Most generalist physicians in teaching hospitals report that they usually discuss their errors with colleagues, and more than half have tried to role-model discussions. However, a significant number of these physicians report that they do not usually discuss their errors and some do not know colleagues who would be supportive listeners.

Face transplantation—or, more properly, facial allograft transplantation (FAT)—generates much public interest and academic debate. In this paper, we suggest that it is up to opponents of FAT to make the case for its impermissibility. We allow that there is a number of apparently strong arguments that might be deployed against FAT. However, all but one of these turn out not to be compelling after examination. The remaining argument is not so easily dismissed—but its central point is fairly workaday and certainly does not tell us anything about FAT in particular. Therefore, qua argument about facial transplant surgery, it fails to hit its target. Overall, we conclude that a compelling case against FAT remains to be made.

Don Marquis has put forward a non-religious argument against abortion based on what he claims is a morally relevant similarity between killing adult human beings and killing fetuses. He asserts that killing adults is wrong because it deprives them of their valuable futures. He points out that a fetus’s future includes everything that is in an adult’s future, given that fetuses naturally develop into adults. Thus, according to Marquis, killing a fetus deprives it of the same sort of valuable future that an adult is deprived of in being killed and this makes abortion seriously wrong. Commentators have raised a number of objections to Marquis’s argument, to which he has satisfactorily responded. In this paper, difficulties with Marquis’s argument that have not been considered by previous commentators are pointed out. A main thesis of this paper is that Marquis does not adequately defend his argument against several important objections that he himself has raised. These new considerations support the view that Marquis’s argument is unsuccessful.

While some people claim that the present disagreement over embryonic stem (ES) cell research cannot be resolved, others argue that developing transparency and trust are key elements that could resolve the existing disagreements over such research. This paper reveals that transparency is not necessarily a requirement for advancing ES cell research, since in Israel, for instance, there is (almost) no transparency, and research nevertheless flourishes. Moreover, trust is not independent of cultural values and religious beliefs. Because of these beliefs, the environment in Israel for ES cell research has been pragmatic and liberal. The Israeli case illustrates the key role that culture and religion can play in biomedical research; it also suggests that as far as cultural values or religious beliefs of people in Western countries strongly oppose research on embryonic tissue, it would be very difficult, if not impossible, to overcome the disagreements.

In Italy, judicial and extrajudicial requests for paternity testing have increased in recent years. A retrospective analysis of such private extrajudicial requests received by the legal medicine unit of the Department of Environmental Medicine and Public Health of Padua University was conducted to identify problem areas most helpful in determining whether to accept private parties’ requests for paternity testing. Such testing is most delicate when a presumptive father may be seeking to disown paternity and when testing is wanted without the consent of a member of the mother–child–father triangle. Tests that could establish paternity where none has been recognised are less problematic, as the child will not lose out. Legal and ethical–deontological aspects of consent, of the protection of minors and of children’s and parents’ need for follow-up interviews to deal with the outcome of such testing are carefully considered by the Padua University team when deciding whether to accept a request for testing. It is argued that because such issues are not dealt with by mail-order laboratories, the use of such services is inappropriate.

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics.

To develop an approach for seeking informed consent to examine tissues retained from a previous study of sudden infant death syndrome (SIDS) as part of a study on asthma, and to document responses and participation rate.

Pilot open-ended approach to 10 volunteer SIDS parents, followed by staged approach (newsletter, mail and telephone call) to seek consent from the target SIDS families for the asthma study.

Parents (n = 10) of SIDS infants known to SIDS and Kids Victoria and parents of SIDS infants (n = 107) from the 1991–2 SIDS in Victoria case–control study.

Qualitative responses of the piloted parents and study parents, and participation rates.

The pilot group responses were used to refine the written material to be provided. Of the 72 families for which contact details were available, 45 gave verbal consent for contact by the Victorian Institute of Forensic Medicine regarding the asthma study, three refused and 24 did not respond to two letters. Thirty-three completed consent forms, all positive for participation in the asthma study, giving a positive response rate of 73% (33/45).

The use of postmortem tissue for research is acceptable to the next of kin when an approach is sensitive to their concerns and needs and is made by experienced counsellors from a familiar organisation. Despite the painful memories evoked by the approach of the research group, the acceptance rate among those who could be contacted was high.

The present work assessed the impact of two decrees on ethics committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into line with the rest of the EC, and regulating and facilitating not-for-profit research.

Prospectively collected data from an Italian multicentre study were examined with respect to the ethics review process. Administrative and time elements of the review process were audited. Main outcome measures were time between the application submission and the ethics committee definitive opinion, type and number of application submission forms, number of ethics committees that refused fee exemption, and time between the ethics committee approval and the administrative authorisation.

A total of 134 local research ethics committees (LRECs) were approached. Application submission procedures and application forms varied greatly; paper submission was mandatory. The median time from submission to approval was 72 days. Only two LRECs refused the fee exemption. The median time from LREC approval to administrative agreement was 50 days and only 9.6% of local authorities came to a verbal agreement with the sponsor.

Italian LRECs are still not sufficiently efficient in complying with the Directive 2001/20/EC requirement (60 days). Better coordination of LRECs work is needed although the optimal level of coordination between them is still not known. In the meantime, national guidelines are needed concerning the application of Directive 2001/20/EC. The behaviour of Italian LRECs towards not-for-profit research was excellent although only the fee exemption was requested.

Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.

The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.

11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.

None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.

The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent.

The difficulties of undertaking good quality effectiveness research in palliative medicine are well documented. Much of the ethical literature in this area focuses on the vulnerability of the palliative care population. It is clear that a wider ethical approach will need to be used to justify research in the terminally ill. Some themes of ethical thought are underutilised in considering the ethics of palliative care research. Three arguments to justify the need for effectiveness research in palliative care should be highlighted: (1) there is evidence of an untapped altruism amongst the population of palliative care patients who would be keen to be involved in such research; (2) traditional Aristotelean and Thomistic virtue ethics would point to the need to gain knowledge in and of itself, but especially in palliative medicine for the benefit of patients: virtue also accrues in the acquisition of a stock of research experience which in turn makes further research feasible; (3) most compellingly, justice would dictate that palliative treatments are effective, that futile or useless treatments are avoided and that patients are not party to "n of 1" trials by default. The current state of the evidence base of effectiveness in palliative care leads us to the uncomfortable position where patients are in precisely the position of being unwitting participants in "n of 1" clinical trials by default, without their explicit consent.

The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.

To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.

Retrospective, observational study.

Online review of five major medical journals.

All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.

Statement of REB approval and informed consent.

Of 1780 articles reviewed, 1133 (63.7%) met inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research), 36 (3.2%) articles lacked a statement of REB approval, 62 (5.5%) lacked disclosure of informed consent and 15 (1.3%) articles lacked both. Articles that did not state REB approval were associated with not stating informed consent (p<0.001). There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.

Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency.