Compilation of the most important documents and speeches by Pierre de Coubertin on Olympism and the Olympic Games.

The UNESCO International Bioethics Committee is an international body that sets standards in the field of bioethics. This collection represents the contributions of the IBC to global bioethics. The IBC is a body of 36 independent experts that follows progress in the life sciences and its applications in order to ensure respect for human dignity and freedom. Currently, some of the topics of the IBC contributions have been discussed in the bioethics literature, mostly journal articles. However, this (...) is a unique contribution by the scholars who developed these universal declarations and reports. The contributors have not only provided a scholarly up to date discussion of their research topics, but as members of the IBC they have also discussed specific practical challenges in the development of such international documents. This book will be suited to academics within bioethics, health care policy and international law. (shrink)

The International Olympic Committee (IOC) has always been plagued by what queer theorist Judith Butler calls gender trouble. In 2000, the IOC discontinued their practice of sex-testing because medical experts could not agree on what defined a genetic female and so an adequate medical testing measure could not be found. In response to outside pressure, the IOC adopted a policy enabling transsexual athletes to compete in the 2004 Olympic Games. This article argues that the IOC policy on sex (...) reassignment does not operate to guard against discrimination and harassment against transsexual athletes but that it operates to maintain the popular illusion that there are two, binary gender designations. While both transsexual and Olympic bodies have unique histories and vastly different experiences in the social and political realms, using psychoanalysis we contend that the need to test gendered bodies is incited by an anxiety about bodily deterioration, aging, and, ultimately, mortality. (shrink)

This article addresses the moral and legal difficulties sport governing bodies encounter as human rights promoters. The case presented here is the 2023 decision by the International Olympic Committee (IOC) to allow athletes from Russia and Belarus to compete in international sport under neutral colours, after recommending complete exclusion a year before due to the Russian invasion of Ukraine. While IOC’s change of mind was influenced by UN experts on human rights, claiming that the ban discriminated against (...) Russian athletes, the same experts fail to take into account competing human rights elements that could favour the ban. To that end, this article discusses the complexities of prioritizing human rights in an Olympic context and, deriving from that, demonstrates the existence of moral and legal support for upholding the exclusion of Russia. Finally, the analysis of how to prioritize morally and legally between competing human rights offers deliberative material to other sport governing bodies which could be used to carve out preventive measures prior to their next encounter with a similar situation. (shrink)

Over the last few decades an increasingly pressing social demand for access to assisted reproductive technologies (ART) has emerged. Alongside the use of reproductive technologies, relevant bioethical and biolegal issues arise, such as the claim of a “right” to have a child, the so-called “reproductive rights”, of the prospective parents and the rights of children. This paper explores these and further challenges, both old and new, calling for a transformation of parenthood and filiation, from the perspective of the different theories (...) of the contemporary pluralistic debate, with a descriptive and critical analysis of the recent Report on ART of the Unesco International Bioethics Committee, the first global document on these topics. (shrink)

In the past decade UNESCO has pursued a leadership role in the articulation of general principles for bioethics, as well as an extensive campaign to promulgate these principles globally.1 Since UNESCO's General Conference adopted the Universal Declaration on Bioethics and Human Rights in 2005, UNESCO's Bioethics Section has worked with member states to develop a "bioethics infrastructure." UNESCO also provides an "Ethics Teacher Training Course" to member states and disseminates a "core curriculum," primarily targeting medical students. The core curriculum orients (...) itself by the Universal Declaration on Bioethics and Human Rights and aims to articulate a set of "bioethical principles" that provide a "common global . (shrink)

Historically, the most interesting phases to me are those in which some events are treated, whether for praise or blame, reward or punishment, as dangerous revolts or as promising innovations—generally both at once.February 2, 1945, was an eventful day in the international press. In Pravda, the organ of the Central Committee of the Communist Party of the Soviet Union, journalist Boris Polevoi introduced to the world “The Factory of Death at Auschwitz” (1945). Shaken by the horrors he (...) witnessed after the Soviet liberation of the camp, he described in graphic detail the remains of an “electric conveyor belt, on which hundreds of people were simultaneously electrocuted,” and a staggering mass of inmates, “so worn .. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Our exploratory study considers whether the internal audit function is an efficient “third line of defense” for risk management and control as proposed by The Institute of Internal Auditors. To that end, we interview chief audit executives and experienced internal auditors to examine whether CAEs manage the impressions of audit committee members in the annual accountability process. We also provide an illustration of impression management techniques through a documentary case that explores a unique and exclusive dataset consisting of the (...) main guidance, framework, and accountability documents of one of these organizations. Our analysis highlights how several macro- and microimpression management techniques were used to burnish the image of internal auditors and, more importantly, the management team. Rather than monitoring managers, the CAEs team up with them. Our findings cast doubts on the conceptualization of internal audit as the independent third line of defense envisioned to be a keystone of the governance mosaic. This study supports other research that questions the effectiveness of internal auditing as a governance mechanism. It also contributes to the impression management literature by exposing impression management practices that occur through a private reporting channel—the internal audit function’s annual accountability to the audit committee. Last but not least, significant ethical concerns are raised in regard to internal audit, and research is urged in that area. (shrink)

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy‐makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise ethical dilemmas that traverse (...) national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity‐building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low‐ and middle‐income countries. (shrink)

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel (...) to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

The publication of the article “Recent Models of the African Iron Age and the Cattle-Related Evidence” by Hromnik in a journal sponsored by Unesco raises a number of serious issues which we, as members of the International Scientific Committee charged with the responsibility of preparing an up-to-date and scientific history of Africa purged of its mists of racist propaganda, unfounded assertions and misleading and dangerous misinterpretations, cannot ignore. These issues include the scientific accuracy or authenticity of the article.

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings (...) of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic. (shrink)

Today local, national and international ethics committees have become an effective means of social regulation in many European countries. Science itself is an important precondition for the development of bioethical knowledge and ethics expertise. Cultural, social, historical and religious preconditions can facilitate different forms and methods of ethics expertise in each country. Ukrainian ethics expertise has some methodological problems connected with its socio-cultural, historical, science and philosophy development particularities. In this context, clarification of some common legitimacies or methodological approaches (...) to ethics committee (EC) phenomena such as globalization, scientization and the prioritization of an ethics paradigm are very important. On the other hand, elaborate study and critical analysis of international experience by Ukraine and other Eastern European countries will provide the integration of their local and national ethics expertises into a world bioethics ethos. (shrink)

The use of remuneration committees to foster corporate accountability concerning executive remuneration decisions has attracted increasing public attention following various corporate scandals and the recent global financial crisis. This study empirically examines the link between RCs and attributions disclosures, i.e. explanation of reasons for executive remuneration decisions. Using a sample of 644 firm-year observations drawn from top 200 Australian Securities Exchange -listed firms from 2007 to 2011, we find that firms with RCs tend to voluntarily disclose attribution, and the extent (...) of disclosures increases with remuneration committee quality. While existence of attribution disclosures is related to pay-performance sensitivity, the extent of disclosures does not show incremental effect on pay-performance sensitivity. The results also show that the presence and quality of RCs are positively associated with internal attribution disclosures regarding executive remuneration decisions during the GFC, suggesting corporate responsiveness to corporate accountability demands at times of economic crisis. (shrink)

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. (shrink)

The authors examine the internal and external motivating factors behind the actions of the House Committee on Ethics members by looking at the procedural efficiency of the Committee on Ethics (or lack thereof), as a natural consequence of the committee members' implicit public policy actions.

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects.

Background Clinical Ethics Committees are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services on the continent. Methods A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data (...) were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics. All participants were familiar with Research Ethics Committees, and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines fo.

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving (...) exchange of biospecimens and data and in monitoring compliance. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of (...) two workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health (...) RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage (...) regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

Abstract Gender and Ethics Committees: Where’s the Different Voice? -/- Prominent international and national ethics commissions such as the UNESCO Bioethics Commission rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics committees because of relatively straightforward, if discriminatory, (...) demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti-female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in Eastern and Western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference. (shrink)

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates (...) at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar. (shrink)

In this paper, we investigate the link between audit committees and earnings management providing a more comprehensive simultaneous analysis of the influence of audit committee features using a sample of 485 firm-years from Singapore's publicly traded firms during the 2000 2001 calendar period. Empirical findings indicate firms with a higher proportion of independent audit committee members are more effective at constraining earnings management. Firms with audit committees that are more diligent and/or lack the presence of independent directors serving (...) simultaneously on a substantial number of boards and committees are more effective at constraining earnings management. These findings are robust to alternative income-incentives facing corporate management. Overall, our findings have implications for stakeholders, regulators, and corporate governance. For example, our findings infer policymakers may need to focus on other audit committee characteristics to strengthen the committee's ability to constrain earnings management rather than continue the present fixation with independence. (shrink)

Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until at (...) least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. (shrink)

This paper argues that the EuropeanCourt of Human Rights couldserve as a model for an international court ofhuman rights to be builtupon the United Nations Committee on HumanRights. It argues that theconcerns states might have over the surrenderof a significant portion oftheir national sovereignity might be lessenedif such an internationalcourt were to incorporate the margin ofappreciation doctrine employed bythe European Court of Human Rights. Thisdoctrine is intended to respectthe customs and traditions of sovereign statesin dealing with humanrights issues, (...) while maintaining that somerights such as the right not tobe tortured will be considered as basic andwill stand independently ofthe customs and traditions of sovereignstates. (shrink)

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to (...) 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)

Clinical ethics committees (CECs) are well established in North America where they are known as hospital or health care ethics committees. Similar groups and other kinds of clinical ethics support are now developing in Europe. This supplement to the Journal of Medical Ethics provides an overview of the issues arising from the provision of clinical ethics support services, and clinical ethics committees in particular. Its primary focus is the UK but contributors from North America and continental Europe provide an (...) class='Hi'>international perspective. Clinical ethics committees are an emerging feature of UK health care. This supplement's first paper provides an overview of the current provision of clinical ethics support in the UK and an assessment of the way in which CECs are developing. Personal perspectives from five UK CECs provide insight into some of the issues that those considering setting up a committee in their …. (shrink)