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The emergence of an institutional discourse of ethical research is traced and questions are raised about its effects in constituting what ethical research is taken to be and how ethical researchers are configured. It is proposed that conceptualizing such a regulation of research ethics opens up the possibility for asserting counterdiscourses that make relational ethics important for moral decision making in research.

This article discusses the process for obtaining genuine informed consent for the participation of human subjects in research in developing countries. We discuss the consent process in the light of recently published guidelines, the experience of nutrition and health research projects, and the ethics review process of the Instituto de Investigacion Nutricional with peri-urban and rural populations in Peru. We discuss the cultural context in relation to (i) who should be involved in the decision for participation, especially for research in children and in community settings; (ii) when to use written or verbal consent; (iii) the format and presentation of the consent form to ensure understanding by the target population; and (iv) the process of how and by whom information is given and consent is obtained. Common concerns of participants with regard to their involvement in research studies are presented, as well as aspects that participants find difficult to understand. Some specific concerns of conducting research with Indigenous Peoples are discussed. We recommend future research to further understand and implement informed consent processes to assure genuine and voluntary consent in different developing country contexts. KEY WORDS: * ethics * developing countries * consent process * children * indigenous peoples

The problem for Institutional Review Boards (IRBs) of balancing access to participation in research with protection of research subjects has always been a difficult one. IRBs, charged with applying the 'Common Rule,' as well as the Belmont Principles, in their review of clinical research, are given little guidance on approaching this problem. This article argues that the third Belmont Principle, the Justice Principle, may provide a useful framework for considering this balance. The changing research environment is discussed in an historical context, and the Justice Principle is considered both in the context of individual rights, as well as the potential benefit to classes of people. The author further suggests that application of the Justice Principle be driven by findings derived from an analysis of the first 2 principles. This feedback model will enable a more formal application of the Justice Principle and less ambiguous, more transparent, decisions regarding the equitable selection of subjects. The author calls for more systematic attention to the Justice Principle by IRBs, and proposes a model that includes incorporating the deliberation of the other Belmont Principles into the Justice Principle. KEY WORDS: * IRB * human subjects * Belmont Principles

Institutional review board (IRB) reviews offer the benefit of perspective afforded by the board's distance from the research and the research subjects. At the same time, distance from research subjects that is geographic, socioeconomic, cognitive, linguistic, and cultural can undermine the positive role of perspective. In addition, distance between IRB and investigators, largely a result of attitudes and communication, can prolong the review process and can obscure its message. The tension that often characterizes IRB-investigator relationships is due, in part, to variability in the application of federal regulations by IRBs across institutions and, on the part of investigators, inexperience, communication problems, and difficulties in anticipating the needs of their subjects. Contributing to the variability are the demographics and the culture of the IRB, attitudes that influence IRB-investigator relationships, and the adequacy of support from the institution. The effects of these factors on review decisions and on the performance of the human subjects protection system are largely unstudied. The movement for IRB accreditation is causing institutions to examine their overall research protection system and promises a more collaborative approach, where IRB and investigators accept their common charge to meet the needs of subjects and to improve the quality of research. KEY WORDS: * IRB * human subjects * research protection

While many European countries are entering unknown legal terrain where the embryo in vitro is concerned, France can already look back on a long tradition of public discussion and legal codification of ways of dealing with in vitro embryos. In its comprehensive law of 1994. France had still rejected embryo research; however, due to the promising perspectives of stem cell research, the new law now pending implies a clear liberalization of the 1994 provisions. Both the French lawmakers and the National Ethics Commission have repeatedly argued that possible utilization of embryos for research purposes may seem legitimate from the moment that there is no more 'parental project.' De facto, this concept implies that an embryo can be transformed into an object from the moment that the parents cease to desire it and that the value of protection is solely dependent on the will of third persons. At the same time. France is still speaking of guaranteeing respect for the 'dignity of the embryo,' which would mean that an embryo must not be reduced to a thing and treated for purposes which are not his own. Therefore, the French solution is not a consistent and honest solution, and in its new legal provisions, France has involved herself in manifold contradictions. France has rejected the conception of pre-embryo, but is de facto following Britain's model without making it explicit. Keywords: embryo, moral status, stem cell research, therapeutic cloning, France

As elsewhere, the ethical debate on embryonic stem cell research in Central Europe, especially Germany and Switzerland, involves controversy over the status of the human embryo. There is a distinctive Kantian flavor to the standard arguments however, and we show how they often embody a set of misunderstandings and argumentative shortcuts we term 'embryological Kantianism.' We also undertake a broader analysis of three arguments typically presented in this debate, especially in official position papers, namely the identity, continuity, and potentiality arguments. It turns out that these arguments do not support the strong, quasi-personal status accorded to the embryos in these official opinions. Keywords: embryo, European bioethics, Kantianism, ontology, person

This article aims to show how the traditions of ethical reasoning and policy-making shape stem cell research in Britain. To do so I give a detailed account of the earlier developments of regulations on embryo research and the specific scientific advances made in Britain. The subsequent regulation of stem cell research was largely predetermined by those structures and the different and partly opposing orientations of a utilitarian approach to policies on biomedicine. The setting up of the first stem cell bank and the directing of public funding into not only bioethical but also sociological guidance of the development of the new science field are aspects of the particular British way of supporting stem cell research. However, there is also an ongoing philosophical and juridical debate on the possible erosion of fundamental values caused by incremental regulatory weakening. Although I am highly sympathetic to the critical position that there is a need for a metaphysical anchor to secure individual human rights, one has to admit that the British mode of handling the inevitable ethical problems we face with biomedical progress is rather successful in terms of securing some of the basic needs and values of a modern democratic society. Keywords: stem cell research in the UK, science policies, utilitarianism versus intrinsicalism, cultures of ethical reasoning, HFEA

In this article I rebut conservative objections to five phases of embryonic stern cell research. I argue that researchers using existing embryonic stem cell lines are not complicit in the past destruction of embryos because beneficiaries of immoral acts are not necessary morally tainted. Second, such researchers do not encourage the destruction of additional embryos because fertility clinics presently destroy more spare embryos than researchers need. Third, actually harvesting stem cells from slated-to-be-discarded embryos is not wrong. The embryos are not sacrificed for the good of others because they would have been destroyed anyway. Fourth, harvesting stem cells from embryos that are not doomed is morally acceptable, because preserving frozen embryos is futile therapy. Finally, creating embryos solely for the sake of harvesting stem cells from them is morally acceptable because the assumption that embryos have the right to life has very counterintuitive implications. Keywords: cloning, complicity, embryo, stem cell

Germany since 1990 has one of the strictest human embryo protection laws, yet according to the Stem Cell Act of 2002 allows, under strict conditions, the import and use of human embryonic stem cells (hESC) for high priority research goals. The author tries to show how this is taken to be coherent by the parliamentary majority (though not necessarily by the general public) in Germany. In doing so, he firstly looks into the chronicle of the debate in Germany showing its different stages since 1999 , then dwells upon the relation between the law and the role of ethics in this issue, and thirdly presents the two fundamentally different positions of the German debate, that is, that the human embryo created for IVF purposes is a human being and stands from its very beginnings under the constitutional principles of respect for, and protection of, human life versus the position that before being implanted the human embryo may become a human being and therefore belongs to the human species only potentially, so that its right to life protection may be assessable over against other high priority goals, such as research aiming at possible help for patients with life-endangering diseases. In spite of the Stem Cell Act of 2002, the debate of the German general public goes on, especially due to the recent EU 6th Research Framework Program which plans to also fund hESC research. Keywords: central ethics commission for stem cell research, freedom of Research, high priority research, human embryonic stem cell research, legal and ethical status of the early human embryo

There has been substantial recent activity addressed at the challenge of protecting the rights and welfare of vulnerable human participants in various kinds of research protocols, on one hand, without unduly impeding the conduct of research that promises findings that may substantially improve health and quality of life for many beneficiaries of research, on the other. Many of the emerging recommendations for improved participant protection are relevant to, and in some cases explicitly targeted at, vulnerable older persons, including long-term, chronically dependent nursing home and home health patients, who may be approached by investigators. Thus far, virtually all of the discussion and recommendations regarding research participant protection pertain to possible legal and policy changes at the federal level. Yet, both current federal law and emerging policy recommendations defer, either expressly or by default through their silence, on some very important matters about research participation, especially regarding informed consent, determinations of decisional capacity, and surrogate decision-making authority, to the laws of individual states. This article analyzes and interweaves recommendations regarding the role of state law and public policy in protecting older persons who are or may become participants in long-term care research projects. KEYWORDS. Research, ethics, law, long-term care, regulation

Despite the ethical codes guiding bereavement research, few studies have been conducted to evaluate the perceived stress experienced by the bereaved, and to explore which methodologies cause least distress. This article investigates how bereaved and traumatised populations experience research participation, and they voice their recommendations for future research. The data are from a nationwide three-phase study in Norway among parents who had lost their child by suicide, SIDS, and accidents between July 1, 1997 and December 31, 1998. Whereas the first phase reported quantitative results of perceived psychosocial health and focused on offered and ideal support (N = 262), the second phase investigated the same issues through in-depth interviews of a sub sample (N = 69). Phase three, reported here, included the responses of 64 parents to a short questionnaire evaluating research participation in the two previous phases. The results show that 100% of the parents experienced participation as 'positive'/'very positive', and none regretted participating. They linked the positive experiences to being allowed to tell their complete story, the format of the interview, and a hope that they might help others. Apparently, processes of meaning reconstruction and increased awareness of the bereavement process were facilitated by the interviews. However, three-quarters of the interviewees reported that it was to a greater or lesser degree painful to talk about the traumatic loss. Regression analysis showed that being a woman and high levels of psychic distress were the most important predictors of a painful interview experience. In order to protect bereaved and vulnerable populations from harm, already existing ethical codes must be strictly applied, and the researchers must listen respectfully to recommendations from bereaved parents. Keywords: Research participation; Research ethics; Parents; Bereavement; Family; Norway

There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub-Committee on Medical Research Ethics in 1999. The Co-operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub-Committee on Medical Research Ethics acts as a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power' to their opinions and statements. The commissions work in close collaboration with each other having regular meetings. They arrange seminars and conferences, and share information with each other: The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi-professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years.

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.

Purpose: This study addressed key concerns that gave rise to the question of whether special guidelines were needed to monitor research at the end of life. Design and Methods: Summary of established ethical and legal guidelines that govern the conduct of research with human subjects, with discussion of issues relevant to populations at life's end. Discussion of whether special guidelines are indicated focuses on four questions concerning: (a) time periods; (b) methods and approaches; (c) informed consent; and (d) obligations of researchers. Results: Although research involving patients at end of life does present important ethical and moral challenges to researchers and should be scrutinized carefully by institutional review boards (IRBs), special guidelines are not required. Implications: Closer examination of the dimensions discussed will enhance the research endeavor and model the qualities for which end-of-life research should become known. Key Words: Institutional review boards, Ethical guidelines, Vulnerable patients

Scientific research efforts and the technological innovations that follow from them are among the hallmarks of our age. Indeed, in large measure, progress in scientific knowledge and technology is exactly [...], This Essay explores a fundamental problem that scientific research poses for environmental ethics. Scientific research has brought great gains to our knowledge of the environment, but the motivations for scientific research tend systematically to run counter to environmental protection. While research scientists may have many different individual motivations for their work, economic actors are most likely to pay attention to and fund scientific research agendas that can lead to economically valuable information, which means that the research results must be capable of belonging to some entity. However, environmental harms and benefits are generally not experienced as belonging to anyone, because their diffuseness makes them difficult to reduce to property. The result is a pattern in which scientific research veers first towards products that can be 'propertized,' and only later, if at all, towards the environmental consequences of such new products. Environmental ethics need to address this research gap. This Essay explores some ways in which publicly funded research and regulatory programs might do so. It concludes that, in spite of ethical doubts that have been raised about market-based environmental regulation, such programs deserve closet attention; they may have ethical value that can offset ethical qualms, because they can motivate economic actors to channel research toward the environment, and thus help to narrow the research gap as between 'propertized' goods and environmental goods.

Stories and anecdotes can be used in the chemistry classroom, or science classroom of any sort, to inspire students to want to know about related substance. Students often remember facts when they are tied to a story, something about the history of science, a long-ago scientist's life. Students can better understand the present if they can related it to the past, and better understand blunders and ethics if they have stories to relate to. Lives of Basil Valentine, Einstein, Cavendish, Priestley, Scheele, and Lavoisier are discussed. Techniques are suggested.

Pope John Paul II's 1979 encyclical 'Redemptor hominis' encourages Catholic Christians to evaluate the moral and ethical aspects of the human body. This comment on doctrine also urges its readers to consider married men and women gifts to each other, whose sexuality produces children as collaboration with God's creativity.

From the perspective of an economist in a private basic and applied research firm, this article examines the evolving structure of social science research firms that contribute to the social science theoretical and empirical literature on measuring the nation's well-being. A distinction is made between the terms consultant and research firm in the context of historical and contemporary research practices. Visible examples and possible implications of new structural arrangements within the research industry are provided, including ethical standards. It is argued that social science research - no longer conducted in the monastic tradition - is dynamic and competitive, yielding significant contributions to our knowledge about basic and applied research techniques.

This article examines the political and ethical factors involved in the Human Genome Diversity Project (HGDP). The author argues that there is a rhetoric of research justification utilized to overshadow the political and ethical issues, and maintains the rhetoric is often very difficult to detect and needs close analysis to keep all implications of research accounted for.

An outline of goals and strategies for conducting ethical environmental research is presented. Those listed include conservation issues such as animal welfare and biodiversity, transparency concerns such as responsibility and access to information, and the rights of indigenous peoples such as culturally significant landscapes and self determination.

Increased environmental awareness is driving the development of improved research techniques that take into account non-human ethical concerns. New methodologies incorporate ecological processes and the needs of other species, and weigh these against the potential human benefits derived from manipulative experimentation. This has required a readjustment of priorities, which have traditionally favored humans exclusively.

New models are needed for ethically sound environmental research. These models should balance priorities between the need for knowledge and the need for care in environmentally vulnerable areas. They can include oversight committees to review research applications, and more inclusive ecological categories with which to weigh benefits against detriments.

Two reliable methods for evaluating ethical issues of environmental research are the harm constraint and the dilution of natural value. The harm constraint addresses the balance between human need and its impact on the environment and non-human species. The dilution of natural value addresses the inherent worth of ecosystems separate from human need.

Self and intelligence, being interconnected, play a significant role in the pursuit of knowledge. Because intelligence is a human and personal concept, cannot be completely separated from the self and its attendant ethics and values. Scientific research, as an intellectual undertaking, is therefore an inherently moral and subjective process., Introduction: The Concept of Mind and Human Dignity Our deepest intuition about human nature is that all people should respect each other's dignity. The goal of humanitarian science should be [...]

KEY WORDS: advocacy, ideology, judgment, methodology, politics, values INTRODUCTION The claim that a social scientist is 'biased' is rarely a neutral observation. In our culture, it can be a scathing [...]

The Presidential Advisory Committee on Human Radiation Experiments was established in 1994, amidst charges that the experiments had been undertaken in secret. The committee aimed to open the reports to the public, and it was found that few of the studies had been conducted secretly. Experiments reviewed in the report included plutonium injections and total body irradiation.

There is intense public debate about science and ethics, particularly following the revelations about Cold War radiation experiments on human subjects. The current Federal Common Rule governs research on humans, with regulations based on the Belmont Report. As a result of increased attention to ethical issues, the protection of subjects' rights has improved since the Cold War. However there are still ethical problems, mainly the distinction between harms and wrongs.

The federal government's Advisory Committee on Human Radiation Experiments was charged with exploring ethical and scientific standards for evaluating human radiation experiments. This involved considering the historical relatively of ethical standards. Some basic ethical principles were felt to transcend vicissitudes of time, place or culture, but that the interpretation of such principles would evolve over time.

Research on indigenous knowledge has resulted in innumerable benefits to the Outsider(s). Indigenous peoples should be compensated in return. This article argues for integrating compensation and empowerment into the heart of the research process itself rather than viewing them as post-project undertakings. 'Rights to the Benefits of Research' (RBR) is proposed as a unifying term to coalesce ideas of compensation for benefits to the Outsider(s) obtained from a noncommercial research process. In contrast, compensation of indigenous peoples via 'Intellectual Property Rights' (IPR) is seen as predicated primarily upon commercial benefits. A strategy to implement RBR based on ethical guidelines and indigenous peoples' empowerment is suggested. A participatory ethnobotanical research project conducted in Ecuador serves to illustrate benefits for which compensation would fall under RBR but not IPR. The project involved the local communities in documenting their oral knowledge of medicinal plants in a written form, primarily for themselves. It is assessed along extractive, compensatory, and empowering tendencies through post-project self-reflection. The article posits that the conservation of indigenous knowledge for and by the local peoples could have positive implications for protecting their intellectual property from predations by the Outsider(s). Key words: intellectual property rights, compensation, indigenous knowledge, ethics of research, ethnobotany; Ecuador

Ethicists argue that deception is unacceptable, whereas researchers regard it as a necessary part of (certain kinds of) research. This impasse could be resolved by establishing the specific conditions under which deception in medical and behavioral research can be tolerated. An approach based on a consideration of the 'Ethical Principles of Psychologists and Code of Conduct,' one of the few writings on this topic. would satisfy the needs of both parties. It takes the form of a requirement that subjects be informed of the use of deception before enrolling in a deceptive study. This 'second order consent' approach to acceptable deception represents our best chance for reconciling respect for subjects with the occasional scientific need for deceptive research.

Clinton's Advisory Committee on Human Radiation Experiments, was appointed in 1993. The committee investigated the Vanderbilt University project that exposed 815 pregnant women to radiation during the Cold War. Many human research patients are confused about whether they are receiving medical treatment. The Committee suggested implementation of stronger ethical standards for research. The Committee is also against exposing citizens to radiation not considered to be part of standard medical treatment. The President offered apology to Emma Craft, a Vanderbilt University victim.

Scientists regard fetuses as objects to be worked on, whereas anti-abortion activists in the US point to the connection between pregnant women and disembodied fetal work objects and assert the humanity of fetuses and fetal parts. Prevailing scientific notions that perceive human and non-human as distinct do not hold good, and a concept having the scope for varied identities should be evolved to focus on the human, the non-human and the spaces in-between.