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The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.

Background: Alzheimer's disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder's causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer's disease. This raises the controversial issue of whether patients with Alzheimer's disease are competent to give their consent for research participation., Discussion: We discuss the case of subjects with Alzheimer's disease who may have impaired decision-making capacity and who could be involved in research protocols, taking into consideration aspects of the Italian normative framework, which requires a court-appointed legal representative for patients who are not able to give consent and does not recognise the legal value of advance directives. We show that this normative framework risks preventing individuals with Alzheimer's disease from taking part in research and that a new policy that favours research while promoting respect for patients' well-being and rights needs to be implemented., Summary: We believe that concerns about the difficulty of obtaining fully valid consent of patients with Alzheimer's disease should not prevent them from participating in clinical trials and benefiting from scientific progress. Therefore, we argue that the requirement for patients to have a legal representative may not be the best solution in all countries and clinical situations, and suggest promoting the role of patients' family members in the decision-making process. In addition, we outline the possible role of advance directives and ethics committees.

During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.

The Italian Data Protection Authority recently authorised a US pharmaceutical company and an Italian hospital to use the personal data of people without capacity to make their own decisions, including those with no legal representation, within the framework of a specific clinical trial although this is not legal under current Italian legislation. This action effectively acknowledged the validity of consent given by persons with family ties to patients, or those in hospitals caring for patients, in contrast with Italian legislation which regards as valid only consent that is given by a legally appointed guardian. This article considers the present state of the regulations governing trials involving incapacitated adults, the paradoxes generated by the discrepancy between the authorisation granted by the Authority and current legislation, and (possible) future developments.

One of the more frequently debated questions about the ethics of research with children is that of informed consent. This raises a twofold problem: the legally valid consent given by the person or persons exercising parental authority, and the consent of the minor when he or she has adequate decision-making capacity. Another ethically important issue is the weighing of risks and benefits. Any assessment of the benefits will embrace the controversial problem of balancing the direct benefits to the individual and the social benefits to other children in similar medical circumstances deriving from increased knowledge. The highly significant questions of risk and of the advancement of knowledge are often - perhaps too emphatically - taken together with that of consent, as though the existence of legally valid consent and, where possible, the assent of the minor were sufficient to justify exposing a child to serious or probable risks.

The different approaches of two nations to the issues surrounding informed consent by persons with no or limited capacity of understanding are compared. It is important that efforts to ensure formal compliance with consent procedures should not be allowed to distract attention from the risks of harm to individuals.

This article explores the current and proposed requirements for informed consent for research with biological samples. The establishment of biobanks and the capabilities of collecting, storing, and using cells and tissues for research purposes have noticeably grown. With new abilities come new challenges to ethical questions of consent, specifically concerning genetic information, and unanticipated usage. This paper summarizes these issues in the context of levels of informed consent, subject risk, individual vs. societal benefits, anonymity, legal consensus.

Videorecording of patients requires the utmost respect for the privacy and confidentiality of the patients. Consent should be requested from patients for all videorecording. When a mental disability or mental or physical illness prevents patients from giving their permission, agreement to recording from a legal representative or from a close relative or carer are necessary. Three documents on this subject issued in the United Kingdom, the United State of America and Italy are briefly summarized and discussed. The problem of consent for videorecording is addressed particularly in reference to persons incapable of making decisions on their own, such as persons in vegetative state. The general ethical framework is outlined and a few practical proposals are given.

This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

An important ethical issue regarding biological samples stored in biobanks is unforeseen future sample use, when no or limited subject consent is obtained. Biobanks of biological samples have significant future research potential, but may cause conflicts of interest regarding the consent obtained. Indeed, ethics, deontology, and jurisprudence generally advise that consent must be specific and circumstantiated. However, it is not possible to foresee all of the future circumstances in which the samples might be useful, nor is it possible to re-contact all subjects in order to gain consent for a new use. The main arguments for the use of "broad" consent are presented with a brief discussion of the conditions where it may be legitimate not to obtain consent. Particular attention is given to the expressed positions of national and international bioethics bodies., (Copyright 2009 Elsevier Ltd. All rights reserved.)

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.

The article contains a list of national and international documents addressing the ethical aspects of biobanking, which were drafted by national bioethics committees; national ad hoc commissions; and national and international agencies, organizations, and societies. The greater part of the documents specifically focuses on questions involving the ethics of informed consent for biobanking. The documents are grouped according to the nature of the promulgating body, and are listed alphabetically within each group according to the promulgating body. Special attention is devoted to documents issued by the European Union and the Council of Europe.

This article considers some of the ethical and legal issues relating to the ownership and use - including for commercial purposes - of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed. [ABSTRACT FROM AUTHOR]