Carlo Petrini

Informed consent in experimentation involving mentally impaired persons: ethical issues

The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

Theoretical Models and Operational Frameworks in Public Health Ethics

The article is divided into three sections: (i) an overview of the main ethical models in public health (theoretical foundations); (ii) a summary of several published frameworks for public health ethics (practical frameworks); and (iii) a few general remarks. Rather than maintaining the superiority of one position over the others, the main aim of the article is to summarize the basic approaches proposed thus far concerning the development of public health ethics by describing and comparing the various ideas in the literature. With this in mind, an extensive list of references is provided.

Umbilical cord blood banking: from personal donation to international public registries to global bioeconomy

The procedures for collecting voluntarily and freely donated umbilical cord blood (UCB) units and processing them for use in transplants are extremely costly, and the capital flows thus generated form part of an increasingly pervasive global bioeconomy. To place the issue in perspective, this article first examines the different types of UCB biobank, the organization of international registries of public UCB biobanks, the optimal size of national inventories, and the possibility of obtaining commercial products from donated units. The fees generally applied for the acquisition of UCB units for transplantation are then discussed, and some considerations are proposed regarding the social and ethical implications raised by the international network for the importation and exportation of UCB, with a particular emphasis on the globalized bioeconomy of UCB and its commerciality or lack thereof.

Ethical issues in umbilical cord blood banking: a comparative analysis of documents from national and international institutions

The issues of collection, storage, and use of cord blood (CB) stem cells have been addressed extensively in national and international guidelines, policies, and regulations. Many of these documents are not binding, but are nonetheless accorded considerable respect on account of the authority of the issuing organizations. Most discussion has to date focused on two topics: informed consent for collection, banking, and use and the debate between those who favor public storage for altruistic purposes and those who advocate private storage for autologous use. There is generally agreement or consensus in the guidelines that public storage for allogeneic transplants is preferable and that private storage should be discouraged. Given the consensus in national and international guidance on these two issues, it is time for other ethical issues to be examined in greater detail. These include additional uses of CB samples, for example, for research or for the production of blood‐derived drugs, and the economic implications arising from the extensive international network for the exchange of CB for transplantation.

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.

Tumor necrosis factor α and interferon γ production by human peripheral blood mononuclear cells exposed in vitro to sinusoidal 50 Hz magnetic fields

Abstract The eventuality of adverse effects due to exposure to extremely low frequency (ELF) magnetic field under discussion among both researchers and proctectionists. It is important to understand if some functions of the immune system may be affected by the exposure to ELF magnetic fields. We have studied the tumor necrosis factor α (TNF α) and interferon γ (IFN γ) production by human peripheral blood mononuclear cells (PBMC) exposed in vitro to sinusoidal 50 Hz magnetic fields after stimulation by means of different inducers. Employing an enzyme-linked immunosorbent assay (ELISA), we have not found effects on IFN γ production, while a decrease in TNF α production by exposed cells is observed in different experimental conditions.

International statements and definitions of the precautionary principle

4 IEEE Technology and Society Magazine, Winter 2002/2003 0278-0079/02/

Ethical Issues in Translational Research

17.00©2002IEEE he precautionary principle (PP), according to one of its definitions, says that lack of certainty, given the current scientific and technological knowledge, shall not delay effective and proportionate actions to prevent hazards, taking into account cost-benefit considerations. Rather than being a single principle, a variety of statements of the PP are found in international treaties and other documents. Apart from any specific legal force of the documents, countries (e.g., France [1]) have used these statements as a starting point for their own guidance documents and regulations for addressing specific environmental and health issues, for example regulation of genetically modified organisms (GMOs) [2]). Thus, any discussion of the “Precautionary Principle” must address a complex legal and regulatory situation. As a resource to our readers, we briefly review different statements of the PP and important commentary, largely from the European Union. We provide references to the original source documents (many of which are found in English on the World Wide Web).

ETHICAL MODELS UNDERPINNING RESPONSES TO THREATS TO PUBLIC HEALTH: A COMPARISON OF APPROACHES TO COMMUNICABLE DISEASE CONTROL IN EUROPE

The translation of biomedical research knowledge to effective clinical treatment is essential to the public good and is a main focus of current health policy. However, recent health policy initiatives intended to foster the translation of basic science into clinical and public health advances must also consider the unique bioethical issues raised by the increased focus on translational research. Safety of study participants and balancing of risk due to treatment with the potential benefits of the research is tantamount. This article synthesizes theory from clinical ethics, operational design, and philosophy to provide a bioethical framework for the health policy of translational research.

European regulations on cord blood banking: an overview

Increases in international travel and migratory flows have enabled infectious diseases to emerge and spread more rapidly than ever before. Hence, it is increasingly easy for local infectious diseases to become global infectious diseases (GIDs). National governments must be able to react quickly and effectively to GIDs, whether naturally occurring or intentionally instigated by bioterrorism. According to the World Health Organisation, global partnerships are necessary to gather the most up-to-date information and to mobilize resources to tackle GIDs when necessary. Communicable disease control also depends upon national public health laws and policies. The containment of an infectious disease typically involves detection, notification, quarantine and isolation of actual or suspected cases; the protection and monitoring of those not infected; and possibly even treatment. Some measures are clearly contentious and raise conflicts between individual and societal interests. In Europe national policies against infectious diseases are very heterogeneous. Some countries have a more communitarian approach to public health ethics, in which the interests of individual and society are more closely intertwined and interdependent, while others take a more liberal approach and give priority to individual freedoms in communicable disease control. This paper provides an overview of the different policies around communicable disease control that exist across a select number of countries across Europe. It then proposes ethical arguments to be considered in the making of public health laws, mostly concerning their effectiveness for public health protection.