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Issues and Perspectives
edited by S.S. Connor and H.L. Fuenzalida-Puelma
PAHO Scientific Publication, No. 527
1990, xii + 238 pages [E; S from PAHO]
ISBN 92 75 315272
Sw.fr. 48.-/US $43.20; in developing countries: Sw.fr. 33.60
Order no. 1610527
A multi-authored analysis of the many sensitive ethical and moral issues created by advances in medicine and technology. The book features 25 original contributions presented in four main parts. Contributions in the first part, which is devoted to the theory of bioethics, review the historical development of modern bioethical views and discuss relationships with other spheres of inquiry, including philosophy, religion, law and technology. Topics covered range from the reasons why technology is so often abused, to religious perspectives on the artificial prolongation of life.
The practice of bioethics is explored in the second part, which considers several techniques, such as hospital ethics review committees and informed consent, that have been developed to apply the principles of bioethics to concrete moral problems. Contributions in the third part discuss the application of bioethics in four sensitive areas: organ transplantation, the act of dying, the reporting of AIDS cases and warning of third parties, and research on human subjects.
The final and most extensive part brings together a collection of articles dealing with current ethical controversies as experienced in Argentina, Brazil, Canada, Colombia, Chile, Spain, the United States, Mexico and Peru. The book also includes a round table discussion of what constitutes a just health services system and how scarce resources should be allocated. The book concludes with reprints of selected international codes of ethics, research codes of ethics, patients' bills of rights, and international texts relating to health as a human right.
Biomedical Research Ethics: Updating International Guidelines
edited by R.J. Levine and S. Gorovitz with J.
CIOMS 2000, viii + 295 pages [E]
ISBN 92 9036 073 9
Sw.fr. 30./US $27.00; in developing countries: Sw.fr. 21.
Order no. 1840023
Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials, in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV.
The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO.
The consultation centred on seven specially commissioned papers, authored by international experts, that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate.
The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation.
Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research.
Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research.
Community Genetics Services in Europe
Report on a Survey
B. Modell, A.M. Kuliev, and M. Wagner WHO
Regional Publications, European Series, No. 38
1991, x + 137 pages [E, F, G]
ISBN 92 890 1301 X
Sw.fr. 24.-/US $21.60; in developing countries: Sw.fr. 16.80
Order no. 1310038
A comprehensive account of genetic diseases in Europe and the technologies and services now available for treatment and prevention. Adopting a critical approach, the book uses the results of a European-wide survey to assess the strengths and weaknesses of existing genetics services and map out precise strategies for improvement. Details range from estimated numbers of Europeans suffering from specific genetic diseases to the average annual costs, per patient, of treatment, from advice on the safety and reliability of screening tests to a point-by-point account of deficiencies in most existing services.
The book's analysis, which is supported by over 100 references, is presented in four parts. The first summarizes and interprets current medical knowledge about the causes, mode of inheritance, prevalence, management, and possibilities for prevention of congenital malformations, chromosomal disorders, and Mendelian (single-gene) disorders. The second part evaluates the quality of Europe's existing community genetics services, focusing on the extent to which current tools for primary prevention are being effectively used.
The third part discusses the infrastructure and organization of community genetics services needed to reach the goals of relieving anxiety, increasing the proportion of healthy children born, and allowing families to live normal lives. Detailed advice on cost-benefit analysis is also provided. The final part issues 11 precise recommendations for improvements that could, if adequately implemented, reduce the annual number of births of European children with serious congenital disorders by tens of thousands.
International Organizations of Medical Sciences (CIOMS)
Current Challenges in Pharmacovigilance: Pragmatic Approaches
Report of CIOMS Working Group V
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines, consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators.
The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports, solicited reports, literature, the Internet, observational studies and secondary data bases, disease and other registries, regulatory ADR databases, and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases, incidental vs other events, patient and reporter "identifiability," seriousness criteria, expectedness criteria, case follow-up criteria, and the role and structure of case narratives); improvements and efficiencies in the format, content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports, simplification of certain PSURs, summary "bridging" reports, "addendum" reports, license renewal reports for EU and Japan, dealing with "old" products, and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).
The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world, with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process.
In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives, the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Ethics and Epidemiology: International Guidelines
Proceedings of the XXVth CIOMS Conference
edited by Z. Bankowski, J.H. Bryant and J.M.
1991, viii + 191 pages [E]
ISBN 92 9036 048 8
Sw.fr. 25.-/US $22.50; in developing countries: Sw.fr. 17.50
Order no. 1830025
Presents the first international guidelines formulated to ensure that epidemiological investigation, particularly research conducted by First World scientists in Third World countries, adheres to internationally agreed rules of ethical conduct. The guidelines, drafted by an international steering committee and extensively reviewed and revised, were formulated in response to the ethical issues raised by the application in epidemiology of information technology to large data-files, and particularly by HIV prevalence and monitoring studies, as well as clinical trials of candidate HIV vaccines and treatment drugs in Third World populations.
The guidelines are centred on four basic principles of ethics: respect for persons, beneficence, non-maleficence, and justice. Separate sections, moving from informed consent to conflict of interest, stipulate the ethical obligations of investigators themselves, their employers or sponsors, and the ethics committees that review their protocols. Examples specific to the AIDS epidemic are used to clarify these obligations, particularly concerning questions of recruitment for clinical trials, confidentiality, and the use of linked and unlinked information.
The main part of the book consists of fifteen papers presented at a conference where the draft guidelines were debated prior to their final revision and formal adoption in July 1991. These papers, which often differ markedly in their views, serve to illustrate the ethical dilemmas that are likely to arise during the formulation and review of protocols for testing candidate drugs and vaccines for HIV.
Ethics and Law in the Study of AIDS
edited by H. Fuenzalida-Puelma, A.M. Linares Parada, and
D. Serrano LaVertu
PAHO Scientific Publication, No. 530
1992, x + 273 pages [E; S from PAHO]
ISBN 92 75 11530 3
Sw.fr. 52.-; in developing countries: Sw.fr. 36.40
Order no. 1610530
A multi-authored analysis of ethical and legal issues created by the epidemic of AIDS and HIV-infection. The 25 papers assembled in the book cover a variety of issues, ranging from the management of confidentiality to the mandatory testing of immigrants, that influence the way society responds to AIDS and thus determine the success of policies aimed at prevention and control. All papers share a human rights approach that affirms the patient's right to dignity and protection against discrimination.
The book is divided into four main parts complemented by an appendix. Chapters in the first part update knowledge on the epidemiology of the disease, summarize the status of international legislation on AIDS, and provide an 80-page comparative analysis of AIDS legislation enacted in the countries of Latin America and the Caribbean. Chapters in the second part focus on ethical issues. Topics covered include confidentiality, ethics review committees, ethical research on AIDS, and the allocation of resources, particular concerning the distribution of a future vaccine against AIDS.
The third and most extensive part covers implications for public health policy. Papers report on experiences, in different countries and with different groups, that yield important lessons for the formulation of public health policies that respect the social and human dimensions of the disease. Topics include the use of the church in educational campaigns, the protection of blood and blood products, issues that arise at the workplace, and the roles of civil and criminal law in defining the rights and obligations of patients. Other papers define policy issues that arise from the needs of special groups. The final part conveys perceptions of AIDS from the viewpoint of the patient, the physician, and nursing personnel.
Ethics and Research on Human Subjects
Proceedings of the XXVIth CIOMS Conference
edited by Z. Bankowski and R.J. Levine
CIOMS 1993, ix + 291 pages [E]
ISBN 92 9036 054 2
Sw.fr. 25.-/US $22.50; in developing countries: Sw.fr. 17.50
Order no. 1830026
Records the main presentations and discussions held at an international conference organized to review an early draft of revised international ethical guidelines for biomedical research involving human subjects. Revisions reflect the need for a fundamental rethinking of several principles embodied in the previous guidelines, which were issued in 1982 by CIOMS largely as guidance on the application to developing countries of the Declaration of Helsinki.
The proceedings of the conference reflect the developments in biomedical research and bioethics that had occurred over the previous decade and which pointed to the need to revise the 1982 guidelines. Discussions consider the unique ethical issues raised by HIV infection and AIDS, by the asserted right of HIV-infected people to have access to incompletely tested new treatments, and by the prospect of field trials of candidate AIDS vaccines and drugs. New problems have been raised by studies designed to detect HIV infection and other diseases in large populations, by externally sponsored research, and by advances in the management of electronically collected and stored data, which call for a rethinking of the principles of confidentiality and informed consent. Chapters also reflect a growing perception that research involving human subjects is beneficial rather than threatening and that vulnerable groups, such as women, children, the elderly, and prisoners, should not be deprived arbitrarily of the opportunity to benefit from investigational drugs, vaccines or devices.
The guidelines, revised to reflect the consensus of the conference, are also issued as a separate publication (see International Ethical Guidelines for Biomedical Research Involving Human Subjects).
Ethics, Equity and Health for All
Proceedings of the XXIXth CIOMS Conference
edited by Z. Bankowski, J.H. Bryant and J.
CIOMS 1997, xvi + 186 pages [E]
ISBN 92 9036 066 6
Sw.fr. 20.-/US $18.00; in developing countries: Sw.fr. 14.-
Order no. 1830029
Records the main presentations of an international conference convened to identify the ethical concerns that need to be addressed as WHO renews its health for all policy for the 21st century. The meeting was attended by more than 150 experts in the fields of ethics, human rights, philosophy, medicine, and public health. Their contributions illustrate the many complex issues that need to be addressed when formulating global health policies for the future, particularly in view of striking recent changes in health care, disease patterns, market forces, and political systems.
The report opens with a description of the WHO policy framework for achieving four goals in the 21st century: attainment by all of health rights, achievement of global health equity, increase in healthy life expectancy, and access for all to essential, quality health services. Against this background, the first section traces the evolution of bioethics to its present concern with the health of populations, and identifies some of the most important inequalities that confront contemporary society. Papers in section two discuss key policy issues, including the definition of essential public health functions and their relationship to primary health care, ethical issues raised by the use of Disability-Adjusted Life Years (DALYs) to prioritize health resources, and the potential conflict between policies aimed at reaching vulnerable groups and those seeking to achieve aggregate health benefits.
Ethical issues are discussed in subsequent sections, which explore policy implications at global, regional, and national levels. The remaining sections consider the actions needed to ensure that ethical analysis plays a role in the renewal of the health for all strategy, and discuss some of the practical requirements for gaining commitment to equity as an essential public health goal for the 21st century.
Human Organ Transplantation
A Report on Developments Under the Auspices of WHO (1987-1991)
Reprinted from the International Digest of Health
Legislation, 1991, 42: 389-413
1991, 28 pages [E, F]
ISBN 92 4 169304 5
Sw.fr. 8.-/US $7.20; in developing countries: Sw.fr. 5.60
Order no. 1959101
Describes the response of WHO to some of the ethical and moral issues raised by organ transplantation. The ever-increasing demand for transplantable human organs has been accompanied by persuasive reports of "trade for profit in human organs among living human beings" - a form of trade which, in the words of WHO's supreme governing body, the World Health Assembly, is inconsistent with the most basic human values and in contravention of the Universal Declaration of Human Rights.
The first part sets forth a set of nine Guiding Principles on Human Organ Transplantation, formulated by WHO after extensive consultations. These Guiding Principles seek to provide an orderly, ethical, and acceptable framework for regulating the procurement and transplantation of human organs - preferably from the bodies of deceased persons - for transplantation purposes. Issues raised by the use of living donors are also considered.
The second part presents the results of a systematic study conducted by WHO to determine all known international responses to commerce in human organs, on the part of intergovernmental and nongovernmental bodies, as well as relevant national and subnational legislation, codes, or other measures designed to interdict this trade. Information is provided on the steps taken or, in some cases, envisaged, in more than 50 countries.
"... There have been efforts to regulate the use
of human organs for transplantation through approved guidelines. The most extensive of
these are the World Health Organization's Guiding Principles, which were endorsed by the
44th world health assembly in 1991..."
British Medical Journal
International Ethical Guidelines for Biomedical Research Involving Human Subjects
CIOMS 1993, 63 pages [E]
ISBN 92 9036 056 9
Sw.fr. 10.-/US $9.00; in developing countries: Sw.fr. 7.-
Order no. 1840016
Presents fifteen guidelines formulated to provide an international tool for the protection of human rights in biomedical research involving human subjects, particularly in developing countries. The guidelines, which were first issued in 1982 largely as guidance on the application of the Declaration of Helsinki to developing countries, have been revised and refined in line with several recent developments.
Addressed to biomedical researchers, ethical review committees, and sponsors, the guidelines are centred on three main themes: informed consent of prospective subjects, the ethical review process, and the obligations of sponsors, particularly in the case of externally sponsored research. Revisions concern informed consent, research involving subjects in underdeveloped communities, exclusion of pregnant and nursing women, confidentiality, externally sponsored research, and compensation for injury.
Nine of the guidelines address the issue of informed consent, moving from individual informed consent to the special cases of research involving children, persons incapable of giving adequately informed consent by reason of mental or behavioural disorders, prisoners, and persons in underdeveloped communities of both developed and developing countries. The selection of research subjects is addressed by two guidelines, which cover the equitable distribution of burdens and benefits, and the use of pregnant or nursing women as research subjects. The remaining guidelines set out ethical principles governing the confidentiality of data, compensation of research subjects for accidental injury, the constitution and responsibilities of ethical review committees, and the obligations of sponsoring and host countries in regard to externally sponsored research.
International Guidelines for Ethical Review of Epidemiological Studies
CIOMS 1991, 31 pages [E, F]
ISBN 92 9036 048 8
Sw.fr. 6.-/US $5.40; in developing countries: Sw.fr. 4.20
Order no. 1840013
Presents the first international guidelines formulated to ensure that epidemiological investigation, particularly research conducted by First World scientists in Third World countries, adheres to internationally agreed rules of ethical conduct. The booklet contains the guidelines in the form adopted following their extensive debate (see Ethics and Epidemiology: International Guidelines).
Poverty, Vulnerability, and the Value of Human Life
A Global Agenda for Bioethics
Highlights and Papers of the XXVIIIth CIOMS Conference, Ixtapa, Guerrero State, Mexico
edited by Z. Bankowski and J.H. Bryant
CIOMS 1994, xi + 246 pages [E]
ISBN 92 9036 060 7
Sw.fr. 25.-/US $22.50; in developing countries: Sw.fr. 17.50
Order no. 1830028
Records the papers and discussions of an international conference convened to consider how bioethics and human rights can be applied in socioeconomic development aimed at a more equitable distribution of resources and privileges. The conference, which was attended by leading experts in ethics, health legislation, and human rights, gave particular attention to poverty and vulnerability as fundamental human conditions that should become central concerns of bioethics at the global level. Throughout, bioethics is regarded as a social movement concerned with human and ethical values in the formulation of health policy as well as in the practice of medicine.
Women's Health and Human Rights
The Promotion and Protection of Women's Health through International Human Rights Law
1994, vii + 62 pages [E, F, S from PAHO]
ISBN 92 4 156166 1
Sw.fr. 14.-/US $12.60; in developing countries: Sw.fr. 9.80
Order no. 1150412
Explores the ways in which international treaties on human rights can be used as a mechanism for improving the health of women. Arguing that the inferior health status of women can be viewed as a violation of international agreements, the book aims to identify the specific rights, embodied in these treaties, that affect women's health and can thus be used as a lever to press for conditions conducive to greater equality and better health. Throughout the book, a special effort is made to point out the many new lines of action that arise when the health risks associated with women's low status are viewed as a violation of international human rights agreements.
The first chapter describes the evolution of international human rights relevant to women's health and shows how specific universal and regional international instruments can provide a framework for understanding the nature of State obligations to improve women's health. Evidence of the pervasive neglect of women's health is reviewed in the second chapter, which points to a number of health risks, present from birth through old age, that are uniquely experienced by women and closely linked to society's tendency to "devalue" their importance. Chapter three considers the key questions of how compliance with a right is determined and how breach of the right can be established. The fourth and most extensive chapter summarizes each of the main health-related rights of women embodied in the international treaties and explains how these rights can be invoked to provide relief, remedy, and preventive interventions. The remaining chapters discuss some of the judicial processes available to promote women's health and issue a call for greater initiative in the use of these mechanisms.
"... excellent ... gathers in one place all the
relevant international statements that offer guidance concerning fundamental human rights
that are related to health care for women ... a valuable resource ... a challenge and an
Journal of Law, Medicine and Ethics
"... a useful attempt to place current issues
about women's health across the world within the framework of the language and law of