Risk Assessment and Management for Medically Complex Potential Living Kidney Donors: A Few Deontological Criteria and Ethical Values

A sound evaluation of every bioethical problem should be predicated on a careful analysis of at least two basic elements: (i) reliable scientific information and (ii) the ethical principles and values at stake. A thorough evaluation of both elements also calls for a careful examination of statements by authoritative institutions. Unfortunately, in the case of medically complex living donors neither element gives clear-cut answers to the ethical problems raised. Likewise, institutionary documents frequently offer only general criteria, which are not very helpful when making practical choices. This paper first introduces a brief overview of scientific information, ethical values, and institutionary documents; the notions of “acceptable risk” and “minimal risk” are then briefly examined, with reference to the problem of medically complex living donors. The so-called precautionary principle and the value of solidarity are then discussed as offering a possible approach to the ethical problem of medically complex living donors

In defence of bioethicists of the third kind

n/

After the Italian Constitutional Court’s ruling on the absence of criminal liability for assisted suicide: the role of ethics committees and clinical ethics

The Constitutional Court handed down a judgment on 25 September 2019 following on from that Court’s Order No 207 of 24 October 2018. The issue of constitutionality of Article 580 of the Criminal Code, in the part about the punishment of the aid to suicide, was raised by the Court of Milan. According to the Court “under certain conditions, a person who facilitates the execution of the suicide intention, autonomously and freely formed, of a patient kept alive by life support treatments and affected by a irreversible pathology, source of physical or psychological suffering that he considers intolerable but fully capable of making free and conscious decisions”.According to the Court, a local ethics committee must provide an opinion in all cases involving a request for medically-assisted suicide

Organ donor families should be free to meet their recipients under controlled conditions if both sides wish, Italian National Committee for Bioethics says

n 27 September 2018 the Italian Committee for Bioethics (ICB) adopted an opinion regarding the possibility of an exception to the anonymity obligation when both parties agree and have signed an appropriate informed consent form. According to the IBC any contact between the donor’s family and recipient must be managed by a third-party body pertaining to the National Health Service, established to guarantee strict control over the expression of consent in order to avoid any risk of inappropriate behaviour. The paper traces how Reg  and Maggie Green, on holiday from California, donated the organs of their seven-year old son, Nicholas, to seven Italians after he had been shot in a carjacking on the Salerno-Reggio Calabria autostrada in 1994. Reluctant as a foreigner to propose a change in Italian law that effectively prevents the two sides from contacting each other, Reg Green held back for 22 years until, at age 87, he began a public campaign to voice his concern that the law was hurting transplant families rather than helping them

Ethics committees and research in Italy: seeking new regulatory frameworks (with a look at the past)

The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this article provides a brief review of the history of ethic committees in Italy. We then discuss certain considerations about the current situation and formulate some proposals in terms of the regulatory choices that must be made. There is a vital need for rules that promote efficiency, to guarantee that Italy’s position remains competitive and attractive within the European Union

Procedures for the ethical review of public health surveillance protocols

The present commentary is based on the following considerations:1) for the purposes of authorisation, a distinction is drawn between “research” and “intervention”. The procedures for authorising the former are more complex, the relevant controls are stricter and approval has to be granted by a Research Ethics Committee (REC);2) although the debate is still open, it is barely credible to claim that public health surveillance is not a form of research. It should, therefore, be subject to rigorous ethical assessment;3) when addressing specifically the issue of surveillance, it would be appropriate to shift the focus of attention from the type of procedure (research/intervention) to the risk implied in that procedure;4) much emphasis has hitherto been placed on the risks that public health surveillance may imply for the protection of personal data;5) the emphasis on the protection of personal data is frequently excessive and the risks should be examined in a broader context. 

Some comments on the new regulations governing Ethics Committees in Italy

Italy has recently introduced regulations that profoundly change the arrangement of ethics committees. Specifically, their numbers have been reduced from more than 200 to a few dozen.The decree defining the criteria for their composition and functioning includes regulations intended to improve efficiency and efficacy. The present article provides a brief overview of the new provisions and identifies some critical aspects

Insurance Policies for Clinical Trials in the United States and in some European Countries

In clinical research there are important moral arguments supporting the need to offer a compensation to the injured research participants. Bene fi cence justi fi es compensation at least for the expenses of "reparative" health care, while justice requires that the risks of research do not fall exclusively on the research participants. Although the ethical arguments for compensating injured participants are generally acknowledged, the practical details are complicated — particularly the determination of the extent and duration of coverage and the assignment of responsibility for paying compensation.In this paper we analyze how several national legislations, in the United States and Europe deal with the following problems: the voluntary or compulsory requirement to draw up an insurance for the research participants; the kind of compensable injuries including death, serious harm, pain, suffering and economic losses; the compensability of harms which are inevitable in a trial and of health problems which can depend on a subject's noncompliance or on the natural progression of the subject's disease; the importance of the informed consent document and the details to be given to the research participants; the rules for compensation in phase 1 and phase 2 trials and in phase 3 and phase 4 trials, or the distinction among trials involving different levels of risk; the possibility to provide a no-fault compensation to the injured research participants when negligence cannot be established; the rules on insurance and compensation in public and private research; the actors responsible to provide compensation to the injured subjects (the State, private insurances, or both); the availability of temporal indications for the compensation of research participants.The comparative analysis highlights the strengths and weaknesses of the analyzed legislations and proposes a model for the insurance and compensation of the injured research participants, which hopefully promotes the principles of bene fi cence, autonomy and justice in research

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview

For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an over-view of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination

From bench to bedside and to health policies (and back): ethics in translational research

AbstractIntroduction. The medical aim of translational research is to smooth the transition of discoveries made through basic esearch from the laboratory bench to their diagnostic or therapeutic pplications for patients. These applications may be extended to current clinical practice and to health policies.Aim. The converse is also important: health policies should provide a point of departure when identifying research priorities. Translational research poses the same ethical problems as trials with human subjects – albeit in different ways. One of the more significant problems is the risk for participants in trials: it is thus necessary to ensure that the risks to which these subjects are exposed are not out of proportion to the expected benefits.Discussion. Translational research does not require new ethical principles, but existing biomedical principles need to be adjusted to the specific context. The well-being of participants should always be the primary objective; these persons should never be considered as means for the advancement of knowledge or for the improvement of applications