In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the (...) research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

In June 1992, a national mail survey was directed to 204 state inpatient psychiatric institutions. This study was implemented following the 1992 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirement that hospitals put in place some means with which to address ethical issues. The goals of the study were: 1. to examine state mental hospital characteristics and their response to the JCAHO requirements; 2. to describe healthcare ethics committee (HEC) composition, function, and role; 3. to study patient (...) and family access to a HEC; and 4. to discover ethical issues most frequently addressed. The survey response rate was 71%. Of the 145 responders, 62 had HECs in place, and 53 were in the process of implementing HECs. There were no differences between JCAHO accredited institutions and non-accredited facilities with regard to having HECs. Physicians accounted for 22% of HEC membership, followed by nurses (15%), and administrators (12%). Twenty-six percent of facilities systematically notified patients about existence of the HEC; 71% of facilities had no patient request for HEC services in the last year. A patient's danger to others, and resuscitation policy were issues most frequently (23%) heard by HECs. (shrink)

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent (...) of ethics committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies. (shrink)

This work has been selected by scholars as being culturally important and is part of the knowledge base of civilization as we know it. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and (...) made generally available to the public. To ensure a quality reading experience, this work has been proofread and republished using a format that seamlessly blends the original graphical elements with text in an easy-to-read typeface. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in Ethics Committees in (...) Japan. Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (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)

This article shows how the legacy of Hans Christian Ørsted (1777-1851), and his discovery of electromagnetism in 1820, was reconfigured and used by the H.C. english abstracts Ørsted Committee from 1914 before and during the centenary of 1920. Combining Somsen’s (2008) concept of olympic internationalism with uses of the past, I suggest understanding the 1920-centenary as an instance of olympic commemoration [olympisk historiebrug]. I argue that central actors from the committee, e.g. Martin Knudsen (1871-1949) and Kirstine (...) Meyer, née Bjerrum (1861-1941), used Ørsted's nationality to substantiate Denmark’s cultural and scientific achievements. By comparison to pre-twentieth century biographies, I show how the committee re-described Ørsted, i.e. from a scientist [Naturforsker] to being a Danish scientist [dansk Naturforsker]. The committee was deeply concerned with proving the big contributions by the small nation of Denmark, and I show how this relates to cultural politics of the early twentieth century Denmark. (shrink)

The Committee for Ethics in Science and Higher Education was created in Croatia as a national body appointed by the Parliament. Thus Croatia became one of a handful of countries with national means of responding to allegations of scientific misconduct. The Committee’s duties, with the help of the Ethics Code, include promotion of ethical norms and values in science and higher education. The CESHE will work on cases of possible research misconduct and alleged disregard for the (...) ethical norms associated with research. (shrink)

Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to two (...) separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. (shrink)

BackgroundCase consultation performed by clinical ethics committees (CECs) is a complex activity which should be evaluated. Several evaluation studies have reported stakeholder satisfaction in single institutions. The present study was conducted nationwide and compares clinicians’ evaluations on a range of aspects with the CEC’s own evaluation.MethodsProspective questionnaire study involving case consultations at 19 Norwegian CECs for 1 year, where consultations were evaluated by CECs and clinicians who had participated.ResultsEvaluations of 64 case consultations were received. Cases were complex with multiple ethical (...) problems intertwined. Clinicians rated the average CEC consult highly, being both satisfied with the process and perceiving it to be useful across a number of aspects. CEC evaluations corresponded well with those of clinicians in a large majority of cases. Having next of kin/patients present was experienced as predominantly positive, though practised by only half of the CECs. The educational function of the consult was evaluated more positively when the CEC used a systematic deliberation method.ConclusionsCEC case consultation was found to be a useful service. The study is also a favourable evaluation of the Norwegian CEC system, implying that it is feasible to implement well-functioning CECs on a large scale. There are good reasons to involve the stakeholders in the consultations as a main rule. (shrink)

Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two (...) sections: (1) the structure, function and activities of ethics committees, and (2) the strategies for dealing with ethical problems. Response rates were 84.4% in 1998 and 64.4% in 2003. Findings showed a significant increase of ethics committees at medical organizations between 1998 (25.6%) and 2003 (50.0%). Members were mostly male, medical doctors in clinical or basic medicine, and members of the organization. The major functions of ethics committees were ethical reviews of research protocols, policy making and ethical reviews of manuscripts submitted for journal publication. Among organizations that did not have an ethics committee, a significant decrease was found in organizations that replied that they had never experienced an ethical problem which needed further investigation (p<0.01). Findings suggested an overall rise in awareness of the importance of ethical issues and also highlighted an increase in recognition of responsibility regarding ethical problems. (shrink)

In 1992, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) passed a mandate that all its approved hospitals put in place a means for addressing ethical concerns.Although the particular process the hospital uses to address such concernsmay vary, the hospital or healthcare ethics committee (HEC) is used most often. In a companion study to that reported here, we found that in 1998 over 90% of U.S. hospitals had ethics committees, compared to just 1% in 1983, and that (...) many have some and a few have sweeping clinical powers in hospitals. (shrink)

This paper reports an initiative from the National Research Ethics Service (UK) and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.

In the 1990s, social movements against large dams in India were celebrated for crafting a powerful challenge to dominant policies of development. These grounded struggles were acclaimed for their critique of capitalist industrialization and their advocacy for an alternative model of socially just and ecologically sustainable development. Twenty years later, as large dams continue to be built, their critics have shifted the battle off the streets to new arenas – to courts and government committees, in particular – and switched to (...) a techno-managerial discourse of maintaining river health. What accounts for this change? This article traces the trajectory of cultural politics around Indian rivers within the larger imagination of the nation, the rise of economic liberalization and Hindu nationalism, and the emergence of environmental bureaucracies. It argues that, alongside being shaped by this context, current anti-dam campaigns also contend with the legacy of earlier social movements, their gains as well as losses. This political field has narrowed the potential for radical critique, large-scale collective mobilization and, ultimately, keeping rivers alive. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics Committees in HospitalsPat Milmoe McCarrick (bio)(Literature about hospital ethics committees has grown enormously since Scope Note 3 first appeared. This update provides new information about resources and documents now available while continuing to include important earlier sources.)Hospital ethics committees increasingly have taken hold in the United States since 1983, when the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research encouraged their (...) creation in its report, Deciding to Forego Life-Sustaining Treatment (III, 1983, p. 5).The President's Commission report (pp. 160-64) suggested the following roles for ethics committees: 1) review of treatment decisions made on behalf of incompetent, terminally ill patients; 2) review of medical decisions having ethical implications with the option, in cases of disagreement, to refer cases to a court with proper jurisdiction; 3) provision of social, psychological, spiritual, or other counseling for patients, family members, physicians, or other hospital staff; 4) establishing guidelines regarding treatment or other medical decisions; and 5) sponsoring or conducting educational programs to inform all concerned, including the public, about ethical problems in medicine.No exact count of these committees is available. According to estimates cited by Donald F. Phillips, managing editor of Hospital Ethics, about two-thirds to three-fourths of hospitals with more than 200 beds have ethics committees, as do about one-third of hospitals under 200 beds. He thinks that about half of the 6,000 hospitals in the United States now have working ethics committees.Several journal articles and a court decision in the late 1970s influenced their formation. A 1975 journal article by pediatrician Karen Teel (VII A) urged the use of hospital ethics committees to provide for dialogue in individual care situations as an appropriate sharing of responsibility. Another early article suggested that beyond parents and treating physicians, a "disinterested," mixed lay and medical committee could consider cases about defective newborns to improve the ethical decisionmaking process (VII A, Robertson and Fost, 1976). Three 1977 discussions in the Hastings Center Report highlighted this new concept (VII A, Levine; Shannon; Veatch).Produced at the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, Washington, DC 20057. It is supported by funds provided under grant number LM04492 from the National Library of Medicine, National Institutes of Health. Literature available through June 1992 is represented in this Scope Note. [End Page 285]The court decision was the March 31, 1976 ruling by the New Jersey Supreme Court in the Karen Quinlan case. The parents of a young woman in a persistent vegetative state had requested that she be taken off a respirator. The court designated a "prognosis" role for the hospital ethics committee and stipulated that the committee must concur that the patient will never return to a "cognitive, sapient state" before the life-support system can be withdrawn (In the Matter of Karen Quinlan, 70 N.J. 10, 355 A.2d 647, cert. denied sub nom. Garger v. New Jersey, 429 U.S. 922 (1976)). Shortly after the Quinlan decision, Massachusetts General Hospital's Clinical Care Committee created an ad hoc subcommittee (a psychiatrist, a legal counsel, an ICU nurse, an oncologist/internist, a surgeon, and a lay person who had recovered from serious cancer disease) which looked at 15 cases. Based on the subcommittee's success, establishment of a permanent committee to review treatment of the terminally ill was recommended by the critical care committee (VII A, Clinical Care Committee 1976).In its 1984 Baby Doe rules, the federal government recommended establishment of infant care review committees, which promoted the growth of hospital ethics committees (VII C, Povar 1991). In July 1987 Maryland became the first state to require by law that hospitals establish patient care advisory committees to offer advice about choices available in the care of life-threatening illnesses; this requirement was extended to nursing homes in 1990 [codified as amended at Md. Health-Gen. Code Ann. Sections 19-370 to -374 (1990)] (VII C, Hollinger 1991).Recently the role for these committees has been noted in the Accreditation Manual for Hospitals, 1992 Supplement (p. 10, Patient Rights, Section RI. 1.1.6.1) of the Joint Commission... (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The (...) key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (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)

Leading biologists and physicians in France have been considering bioethical problems for several decades. In 1983 an important new forum for bioethical discussion in France was created, with the establishment of the Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé. This committee has produced numerous important opinions and reports on such topics as research involving human subjects, fetal tissue research, and the new reproductive technologies. At the local level the discussion of bioethical (...) questions is carried on by ethics committees, which are charged with the responsibility of reviewing research protocols. Keywords: commissions, ethics committees, codes of ethics, physicians, human experimentation, reproductive technologies CiteULike Connotea Del.icio.us What's this? (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics (...) class='Hi'>Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.Objective: To assess training needs for biomedical research ethics evaluation among targeted countries.Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing (...) the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different (...) levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (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)

The purpose of this article is to provide a short overview of the condition of clinical ethics committees (CECs) and other forms of the so-called "ethics support" infrastructure. This includes but is not limited to CECs because some countries also have ethics consultation services that function independently from the CECs. It seems that properly structured CECs and other types of ethics support have a potential to act as facilitators of ethically sensitive healthcare decision-making. This goal can be achieved if the (...) ethics support infrastructure becomes an integral part of the healthcare institution where the majority of ethical dilemmas and the need for ethical debate arise. At the same time, CECs can become a useful tool for implementing bioethical standards developed at both national and international levels, including those established by the Council of Europe instruments. This is the main reason why the issue of developing clinical ethics support services might be very important for the Steering Committee on Bioethics (CDBI) of the Council of Europe. More specifically, the question is what special role ethics support services can play in the context of the follow up to the Council of Europe Symposium in the decision-making process regarding medical treatment in end-of-life situations (Strasbourg, 30 November-1 December). Very often, cases to be considered by the CECs and ethics consultants deal with the difficult end-of-life treatment choices. (shrink)

Gandhi’s notion of passive-resistance is critical in two ways and defines swaraj and swadeshi, leading to his assertion that India alone is the land of redemption for the world afflicted with modern civilization, “the sheet-anchor of our hope”. “Sound at the foundation”, “India remains as it was before”, while the world speeds on, “usurp[ing] the function of Godhead” and indulg[ing] in novel experiments”. This paper aims at elaborating Gandhi’s definition of nature in terms of the scalar, speed, as (...) found in Hind Swaraj and other writings in order to demonstrate that India as hind swaraj is critical nation. (shrink)

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion at a European (...) level.Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)

Violence, as a concept, has shaped most of human history and discourse. Over the centuries, the concept has gone through dynamic evolutions and should be understood in relation to diverse agents such as nation, nostalgia, and culture. Modern society’s tendency to impede and constrain overt forms of violence has paved the way for covert forms to exist in socio-cultural spheres. Cultural violence is one such realization where aggression gets exercised covertly through heterogenous mediums such as language, regulations, mass media, and (...) most importantly cultural practices. Its topological structures can be traced in national imagination and a sense of cultural nostalgia originating out of it, that ultimately formulates cultural “otherness.” In Gandhian philosophy, the absence of physical aggression is insignificant, if not complemented with the eradication of violence from the cultural and intellectual strata. Gandhi’s critique of exclusive nationalism and narrowness is reflective of a distinct kind of cultural topology that generates structural violence and with the due course of history it gets legitimacy to exert power over the cultural binary it constructed. The fundamental questions of the paper are associated with assessing the role of national imagination and cultural imperatives in germinating the structures of violence in culture, exclusive nationalism, and Gandhian reconsideration of peace in the context of covert violence in the material and intellectual realms. (shrink)

Background: The research on nursing professionals in Clinical Ethics Committees and Nursing Ethics Commissions occurs in different parts of the world; however, little information on this subject is found in the literature. Objective: This study analyzed national and international publications in relation to the participation of nursing professionals in Clinical Ethics Committees. Research design: This was an integrative review of articles published in national and international journals between 1994 and 2016 which described the participation of nursing professionals in (...) ethics commissions. Participants and research context: A total of 35 articles were selected. Discussion and conclusion for this article: The thematic categories were the need for time to discuss ethical issues; ethics committee to reduce the moral suffering of professionals; competencies required for participation; and barriers/difficulties and facilitators for implementation/ performance. It was concluded that professionals recognize the need for ethics committees to foster discussions. However, barriers hamper operation and fundamental competencies for participation. Communication of committee activities to professionals and educational activities may be major allies to improve the functioning of these committees. (shrink)

As has become tradition, executive directors of United States’ presidential bioethics committees offer reflections about their experience shortly after the orderly shutdown of the commission staff. After the records are filed according to government records regulations; after all the staff members, who are hired into temporary positions that must be renewed every two years, have secured permanent employment; after preparations are made to ensure that the next commission staff (should there be one) has a budget and standard operating procedures in (...) order to begin its work in a timely manner; after the lights are turned out for the last time, the executive director makes the final climb up the stairs into the sunlight and reflects on the whirlwind. There is much about my work with the Presidential Commission for the Study of Bioethical Issues that deserves comment, but one aspect of the commission that has been especially valuable to me is its work to educate the nation on bioethical issues. This is, moreover, a contribution in which the commission staff was central, and it is one that, as an ethics educator myself, I will cherish deeply. (shrink)

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics Committees oversee (...) most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (shrink)

The drives of white nationalism in the US and Hindu nationalism in India are found to be significantly similar in aim and methods. Witnessed in two large nations that are alike too in diversity and in constitutions, the two drives violate statutory norms as also the norms of democracy and equality acknowledged by the world. Contrasting these drives with Gandhi’s vision of partnership and mutual respect among communities and races is illuminating. It may be seen, in addition, that both (...) white nationalism and Hindu nationalism rest on a falsification of history. Stirring up and employing a sentiment of majority victimhood, and another sentiment of dislike for the minority “other,” the two drives present a challenge to all who regard humanity as one and human beings as equal. (shrink)

In India culture and religion play important roles in the workforce's perception of work, social ethics, moral discipline, and human relations. Some of these values originate from the teachings of Mahatma Gandhi. This article presents selections of Gandhi's teachings and philosophy that are germane to modern- day business management, especially for multinational corporations operating in India. It serves to help foreign managers understand India's culture and work values, as well as offer guidelines for successful total quality management. Three (...) of India's national-level quality awards are used to present the essential concepts of total quality. (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)

Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership (...) composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)

BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting an end of (...) study declaration to the Hampshire A research ethics committee between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.ResultsOut of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 of the published studies.ConclusionsThis study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research. (shrink)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...) synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

Medical ethics committees are increasingly called on to assist doctors, patients, and families in resolving difficult ethics issues. Although committees are becoming more sophisticated in the substance of medical ethics, little attention has been given to the processes these committees use to facilitate decision-making. In 1990, the National Institute for Dispute Resolution in Washington, D.C., provided a planning grant from its Innovation Fund to the Institute of Public Law of the University of New Mexico School of Law to look (...) at what ethics committees can learn from facilitation and mediation techniques. The study's thesis was that, if adapted for use by medical ethics committees, facilitation and mediation techniques can be helpful to those bodies in case review consultations and in other internal committee processes. This article reports on that project. (shrink)

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national (...) guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues. (shrink)

Aims and background: The present work assessed the impact of two decrees on ethics committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into line with the rest of the EC, and regulating and facilitating not-for-profit research.Material and methods: Prospectively collected data from an Italian multicentre study were examined with respect to the ethics review process. Administrative and time elements of the review process were audited. Main outcome measures were time between the application (...) submission and the ethics committee definitive opinion, type and number of application submission forms, number of ethics committees that refused fee exemption, and time between the ethics committee approval and the administrative authorisation.Results: A total of 134 local research ethics committees were approached. Application submission procedures and application forms varied greatly; paper submission was mandatory. The median time from submission to approval was 72 days. Only two LRECs refused the fee exemption. The median time from LREC approval to administrative agreement was 50 days and only 9.6% of local authorities came to a verbal agreement with the sponsor.Conclusions: Italian LRECs are still not sufficiently efficient in complying with the Directive 2001/20/EC requirement . Better coordination of LRECs work is needed although the optimal level of coordination between them is still not known. In the meantime, national guidelines are needed concerning the application of Directive 2001/20/EC. The behaviour of Italian LRECs towards not-for-profit research was excellent although only the fee exemption was requested. (shrink)

: Calls for ethics education for members of hospital ethics committees presume that the effects and benefits of such education are well-established. This is not the case. A review of the literature reveals that studies consistently have failed to uncover any significant effect of ethics education on the moral reasoning, moral competency, and/or moral development of medical professionals. The present paper discusses this negative result and describes the author's national study of the value priorities of members of hospital ethics (...) committees. This study discovered correlations between moral decision making and factors like age and type of institution where the committee operates. The results of this study also resemble those of previous studies in finding no correlation between ethics education and moral decision making. The author concludes that there is a need for more research on the effects of nonmoral personal, societal, and institutional factors on the moral reasoning of members of hospital ethics committees. Further, in the absence of any firm empirical basis, calls for ethics education for medical professionals and ethics committee members should be rethought. (shrink)

ABSTRACT There is growing concern about the reuse and exportation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing (...) country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re‐use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels. (shrink)

To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999).1 In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) 2 are in conflict with an important stream of industrial sociological (...) research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a ‘good news story’ guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences. (shrink)

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee, was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health (...) research ethics committees.Objective. To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC.Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country.Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor.Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them. (shrink)

The doctorate forms the basis for academic careers and the regeneration of academia, and has increasingly become important for other sectors of society. The latter is reflected in efforts on institutional, national as well as supranational levels to change and adapt the doctoral degree to new expectations. As doctoral education is embedded in research, changes in governance and funding of research further affect the doctorate. The evaluation of the doctoral thesis appears, however, to have remained true to the academic (...) tradition: an examination committee exercising their gatekeeping in a ceremonial setting. This study sets out to explore doctoral examination committees’ evaluation practices. Insights were gained through six focus group interviews with experienced examination committee members at three large research-intensive universities in Sweden. Of particular interest is how the object of evaluation is formed, the nature of the boundary-work conducted, and variations in examination practices related to different and changing conditions for research and doctoral education. Our results show how the object of evaluation emerges through a gradual interpretation of the thesis and defence, becoming more complex and nuanced as the process of evaluation progresses from its initial stages to the final closed discussions of the committee. The finalised object of evaluation, only fully present at the conclusion of the closed meeting and hence transient in nature, encompasses the research contribution, educational achievement, and academic competence of the candidate. Furthermore, the boundary-work conducted in this process often transcends the object of evaluation to include also supervision and the local context for doctoral education and research, and hence contributes to upholding, and potential changing, norms in research fields, educational contexts, and academia at large. This extended boundary-work intensified as problems and inconsistencies were discovered during the evaluation process. The ceremonial staging underscored the gravity of the decision and the extended boundary-work. Despite changing conditions for the doctorate, our findings highlight the importance of the practice of evaluation committees, and the disciplinary communities to which they belong, for upholding and negotiating norms in academia. (shrink)