Bauer, Taub, and Parsi's review of an international sample of standards on informed consent, confidentiality, commercialization, and quality of research in tissue banking reveals that no clear national or international consensus exists for these issues. The authors' response to the lack of uniformity in the meaning, scope, and ethical significance of the policies they examined is to call for the creation of uniform ethical guidelines. This raises questions about whether harmonization should consist of voluntary international standards or international regulations that (...) include an official oversight mechanism and sanctions for noncompliance, and about who should participate in the harmonization process. Moreover, the normative assumptions and political dynamics that shape global policymaking need to be addressed. This commentary explores the policy implications and normative questions raised by the idea of international ethical guidelines for the use of biotechnologies and biotechnological resources such as stored samples of human tissue. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)

Drawing on two years of ethnographic fieldwork in Egypt focused on organ transplantation, this paper examines the ways in which the “scientific” criteria of determining death in terms of brain function are contested by Egyptian doctors. Whereas in North American medical practice, the death of the “person” is associated with the cessation of brain function, in Egypt, any sign of biological life is evidence of the persistence, even if fleeting, of the soul. I argue that this difference does not exemplify (...) an irresolvable culture clash but points to an unsettling aspect of cadaveric organ procurement that has emerged wherever organ transplantation is practiced. Further, I argue that a misdiagnosis of the problem, as one about “religious extremism” or a “civilizational clash,” has obfuscated unresolved concerns about fairness, access, and justice within Egyptian medical spheres. This misdiagnosis has led to the suspension of a cadaveric procurement program for over 30 years, despite Egypt’s pioneering efforts in kidney transplantation. (shrink)

Based on a general review of international, representative tissue banking policies that were described in the medical, ethics, and legal literature, this paper reviews the range of standards, both conceptually and in existing regulations, relevant to four main factors:(1) commercialization, (2) confidentiality, (3) informed consent, and (4) quality of research. These four factors were selected as reflective of some of the major ethical considerations that arise in the conduct of tissue banking research. The authors emphasize that any policy or ethical (...) guidelines designed to regulate tissue bank research should address all four factors. Whenever this sort of research is conducted between several institutions or several countries, the paper suggests that the relevant entities work collaboratively to harmonize their standards. (shrink)

Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.1 Doctor-patient and researcher-participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.2 However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.3Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research confidentiality have not been (...) explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research.Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality.In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations.We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified. (shrink)

Objective To determine the attitudes of Egyptian patients regarding their participation in research and with the collection, storage and future use of blood samples for research purposes. Design Cross-sectional survey. Study population Adult Egyptian patients (n=600) at rural and urban hospitals and clinics. Results Less than half of the study population (44.3%) felt that informed consent forms should provide research participants the option to have their blood samples stored for future research. Of these participants, 39.9% thought that consent forms should (...) include the option that future research be restricted to the illness being studied. A slight majority (66.2%) would donate their samples for future genetic research. Respondents were more favourable towards having their blood samples exported to other Arab countries (62.0%) compared with countries in Europe (41.8%, p<0.001) and to the USA (37.2%, p<0.001). Conclusions This study shows that many individuals do not favour the donation of a blood sample for future research. Of those who do approve of such future research, many favour a consent model that includes an option restricting the future research to the illness being studied. Also, many Egyptians were hesitant to have their blood samples donated for genetic research or exported out of the Arab region to the USA and European countries. Further qualitative research should be performed to determine the underlying reasons for many of our results. (shrink)

Medical research must involve the participation of human subjects. Knowledge of patients' perspectives and concerns with their involvement in research would enhance recruitment efforts, improve the informed consent process, and enhance the overall trust between patients and investigators. Several studies have examined the views of patients from Western countries. There is limited empirical research involving the perspectives of individuals from developing countries. The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research. Such information would (...) help clarify the type and extent of concerns regarding research participation of individuals from cultural, economic, and political backgrounds that differ from those in developed countries. (shrink)

Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries were collected as part of a European Research Project examining human and non-human biobanking. A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and (...) interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised. Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project. (shrink)

ABSTRACT Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so (...) as to enable research subjects to claim a share of the benefits to be negotiated on a case‐by‐case basis. Our conclusion on this question is: ‘No, the CBD should not be expanded to include human genetic resources.’ There are essential differences between human and non‐human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as ‘window dressing’. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization’s Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)

Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity, adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as to (...) enable research subjects to claim a share of the benefits to be negotiated on a case-by-case basis. Our conclusion on this question is: 'No, the CBD should not be expanded to include human genetic resources.' There are essential differences between human and non-human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity. When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as 'window dressing'. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization's Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)