Earthquakes, which can cause widespread territorial and socio-economic destruction, are life-threatening, unexpected, unpredictable and uncontrollable events caused by the shaking of the surface of the earth. The psychological consequences, such as PTSD, anxiety, depression, and suicidal ideation, are well-known to clinicians and researchers. This study was conducted with the aim of evaluating the use of the Eye Movement Desensitization and Reprocessing (EMDR) Integrative Group Treatment Protocol (IGTP) on a sample of adolescents, after the earthquake in Central Italy on (...) 24 August 2016. The objective of the EMDR intervention was to reduce PTSD symptoms. Before and after EMDR, specific assessment to find changes in PTSD symptoms was made using the IES-R (Impact of Event Scale Revised) and through the analyses of the Subjective Units of Disturbance (SUD). The EMDR treatment was given in three sessions (T1, T2, T3), each lasting 90 minutes, and the results at follow-up phase (T4) were also monitored. The results are very encouraging, showing significantly reduced PTSD symptoms in the majority of the subjects. The clinical implications and limitations will be discussed. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Chair’s Perspective on the Work of the Advisory Committee on Human Radiation ExperimentsRuth Faden (bio)On January 15, 1994, President Clinton created the Advisory Committee on Human Radiation Experiments in response to his concern about the increasing number of reports describing alleged unethical conduct of the U.S. Government, and institutions funded by the government, in the use of, or exposure to, ionizing radiation in human beings at the (...) height of the Cold War. He directed the Committee: (1) to uncover the history of human radiation experiments and intentional environmental releases of radiation; (2) to identify the ethical and scientific standards for evaluating these events; and (3) to make recommendations to ensure that whatever wrongdoing may have occurred in the past will not be repeated.The Committee was composed of 14 members: a citizen representative and 13 experts in bioethics, radiation oncology and biology, epidemiology and statistics, public health, history of science and medicine, nuclear medicine, and law. We reported to a cabinet-level group (the Human Radiation Interagency Working Group) convened by the president, which includes the secretaries of defense, energy, health and human services, and veterans affairs; the attorney general; the administrator of the National Aeronautics and Space Administration; the director of the Central Intelligence Agency; and the director of the Office of Management and Budget.On April 21, 1994, at the end of the first day of our first meeting, President Clinton invited us to the White House to personally communicate his commitment to the process we were about to undertake. He urged us to be fair, thorough, and unafraid to shine the light of truth on this hidden and poorly understood aspect of our nation’s past. Our most important task, he said, was to tell the full story to the American public. [End Page 215] At the same time, we were to examine the present, to determine how the conduct of human research today compares with that of the past, and to assess whether, in light of this inquiry, changes need to be made in the policies of the federal government. Eighteen months later, the Committee’s attempt to tell the story of the past and to report on our inquiry into the present was delivered to the president in a 900-page Final Report (ACHRE 1995) and several supplemental volumes.The Committee’s charge was enormous. We were asked to conduct a massive investigation into events that occurred as much as 50 years ago and that involved the highest reaches of the defense establishment and the medical community. This investigation necessitated an examination of the conduct and policies of six federal agencies and countless agents in the private sector, as well as the location and interpretation of hundreds of thousands of documents, many of which were buried in obscure locations or were still classified.In addition, the Committee was instructed to establish standards for judging, in moral terms, the events that it uncovered. This charge necessitated the confrontation of contentious debates in moral thought and theory about history, relativism, and the significance of context in moral judgment. But our purpose was not to engage in these debates in the abstract. Although the Committee was not expressly charged with considering issues relating to remedies, including financial compensation, we felt obliged to address the type of remedies that we believed the government, as an ethical matter, should provide to subjects of experiments where the circumstances warranted such a response. Thus our deliberations about relativism and moral judgment were tied to concrete recommendations for public policy and were conducted in a public context that included participants from numerous adversarial legal proceedings.In tandem with our reconstruction of the past, we undertook three projects to examine the current state of human radiation experiments. First, we studied how each federal agency that currently conducts or funds research involving human subjects regulates and oversees its research activity. Second, from among the very large number of federally-supported research projects involving human subjects, we randomly selected 125 projects for closer scrutiny. We reviewed all available relevant documentation for each project in order to assess how well it appeared to protect the rights and interests of the participating subjects. Third... (shrink)

ObjectiveTo investigate the characteristics of response inhibition of overweight/obese people, using behavior experiments combine with neural electrophysiological technology and discussing the difference in impulse level between obesity/overweight and normal-weight people through EEG data, questionnaire, and behavior experiment.Method All participants completed the Go/Nogo task; meanwhile, behavior data and 64 channel EEG data were recorded. Participants completed the Stop-Signal task and behavior date was recorded.Results During Go/Nogo task, no significant differences were found in reaction time, omission errors of the Go task between (...) the two groups, while commission errors of the Nogo task of the control group were significantly greater than the overweight/obesity group. About SSRT during the Stop-Signal Task, the interaction of stimulus type and group was significant. No significant differences were found between the two groups in amplitude and latency of N2. About the amplitude of P3, the interaction of task type, electrode point, and groups were significant, the control group P3 amplitude was significantly greater than overweight/obesity group during the Nogo task. Regarding about latency of P3, the interaction of group and electrode point were not significant, but the main effect of task type was significant.Conclusion In terms of behavioral outcomes, overweight–obese subjects had lower dominant response inhibition and response cessation compared to normal-weight subjects. In terms of EEG results, overweight–obese subjects showed no difference in processing speed and level of conflict monitoring for early inhibitory processing compared to normal-weight subjects, but there was a deficit in behavioral control for late inhibitory processing. (shrink)

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics (...) Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, (...) and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (shrink)

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a (...) four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants. (shrink)

The ERN-Ne of the event-related potential indicates error monitoring. Even though enlarged ERN-Ne amplitudes have often been related to higher anxiety scores, a recent meta-analysis provided very small effect sizes for the association of trait-anxiety with the ERN-Ne. Conditions modulating this association were investigated in the present study: The generality of the trait-anxiety factor, gender, and experimental conditions, i.e., worry induction and error aversiveness. Participants completed a flanker task. Worries were induced before the task by giving participants (...) a bogus feedback claiming their responses were slower than the average responses of participants, whereas other participants got the feedback that they responded as fast as other participants. Aversiveness of errors was varied by playing sinus tones after too slow responses in one part of the task and aversive screams after too slow responses in another part. Increased ERN-Ne amplitudes of response time errors occurred for individuals higher on trait-anxiety in the condition with induced worries and screams. A multiple group model for women and men indicated that women are more sensitive to conditions altering the association of trait-anxiety with the ERN-Ne. (shrink)

The Medication Event Monitoring System (MEMS) is a relatively new device designed to overcome some of the disadvantages of traditional adherence-measuring techniques. MEMS has also been found useful in tracking adherence behaviour without the need to visit patients frequently. In this study each patient was given a pre-filled, labelled MEMS bottle and cap. Patients were monitored for 24 weeks. For patients specifically studied, there were periods when drug levels may have been low and some exhibited erratic medication-taking (...) behaviour. It is concluded that MEMS can measure adherence behaviour objectively, and so might be used to improve prescribing decisions, identify drug wastage and improve carer support. Further research is needed before the routine use of electronic medication monitoring can be recommended. (shrink)

In December of last year, a few clowns appeared on the grand and spectacular stage of the Great Proletarian Cultural Revolution. These clowns were the reincarnated ghosts from the Capital Red Guard West City, East City, and Haidian Districts Pickets. They viciously attacked Chairman Mao's revolutionary line, engaged in slander on the Central Cultural Revolution Group, called dear Comrade Jiang Qing names, and sabotaged the organizations under the proletarian dictatorship. They provoked violence, created chaos, searched and confiscated the possessions (...) of revolutionary organizations, and spread reactionary declarations. The crimes they committed are simply too numerous to mention. These clowns were none other than the "Capital Red Guards United Action Committee.". (shrink)

Self-monitoring theory explains the individual differences in using interpersonal adjustment techniques like self-control, self-regulation, and self-presentation. Self-monitoring plays a key role for understanding the social life. Therefore, it has been one of most popular research topics in social psychology. The aim of this study is to find out if there is a meaningful relationship between religious orientation and self-monitoring, and to determine the direction of the relationship if it exists. Besides, examining the effect of religious (...) class='Hi'>group membership on self-monitoring is another aim of this study. In accordance with this purpose, Religious Orientation Scale and Revised Self-Monitoring Scale are applied to sample group which consists of 437 female and 369 male participants aged16 to 65+ living in Bursa. The results has revealed that there is a meaningful positive correlation between intrinsic religious orientation and self-monitoring. In addition, no meaningful relationship between religious group membership and self-monitoring has been confirmed.Summary: The adaptation process of the human being as a social creature starts in a mother's womb and becomes more complicated in consequence of coming into the world which is full of stimulus. In the beginning, this process has only a physical aspect, but with the inclusion of emotional, cognitive, and social factors over time turns into developmental tasks that people will struggle throughout their lives. The social development involves the process of becoming of the individual as an organic part of the society. As the individual realizes the existence of the other, he/she develops similar patterns of behavior that can be approved by the other. Because the meaningful relationships that form the backbone of social development constitute an important part of the self. Belonging is one of the main needs, that the individual shapes his emotions, actions, and decisions more or less in line with this need in order not to encounter the possibility of social exclusion. While belonging is a universal need for every healthy individual, there are differences between individuals in terms of directing the course of the relationship, role sharing, and using situational clues. Individual differences in how people construct interpersonal processes led Mark Snyder to systematize and theorize the concept of self-monitoring. Self-monitoring is a concept that expresses individuals' control of self-presentation, expressive behavior, and non-verbal emotional expression and their regulation. Accordingly, individuals with a high tendency to shape their behavior according to the context are classified as high self-monitors and those with low tendency are classified as low self-monitors. It can be said that adherence to religion, which is one of the determinants of social behavior, is related to self-monitoring. In this context, the main subject of this study is the relationship between self-monitoring and religiosity. The study aims to examine the effect of intrinsic-extrinsic religiosity on individuals' self-monitoring levels. Besides, as a form of religiosity, to reveal whether religious group religiosity affects self-monitoring, the study examines also self-monitoring levels of individuals belonging to the religious group and those who are not.The sample of the study was selected by a simple random sampling method and it consists of 806 participants aged 16 to 65+ living in Bursa in 2017. 437 (54.2%) of the participants in the research are women and 369 (45.8%) are men. In this study, a relational screening model was used for determining the presence, direction, and degree of the relationship between the variables. The questionnaire technique was preferred as the method of gathering information. The questionnaire was arranged in a way that does not require asking the participant any other questions apart from the questions on the form. The questionnaire form used in this research consists of 43 items. At the beginning of the questionnaire, there is a 9-item personal information form that includes demographic items consisting of age, gender, educational status, marital status, occupation, place of residence, socio-economic status, levels of subjective religious involvement, and religious group membership. For the measurement of self-monitoring, a 12-item "Self-Monitoring Scale", which was developed by Mark Snyder, revised by Richard Lennox and Raymond Wolfe and adapted by İlknur Özalp Türetgen and Sevim Cesur to Turkish (α =.80) was used. For the measurement of religious orientation, a 22-item “Religious Orientation Scale” developed by Gordon Allport and Michael Ross and adapted to Turkish by Fatma Gül Cirhinlioğlu was used (α =.90). Data collected through scales were processed by One Way Variance Analysis (ANOVA), t-Test, Pearson Correlation Analysis, and Simple Linear Regression Analysis and turned into research findings.According to the results of the simple linear correlation analysis conducted to reveal whether there is a relationship between the self-monitoring scores of the participants and the intrinsic religious orientation scores, there is a positive and significant relationship between the variables (r = 0.102, p = 0.004 0.05). The result of the correlation analysis between self-monitoring and the level of subjective religious involvement shows that no significant relationship is found (r = 0.051, p = 0.146> 0.05).This research expected that there was a negative relationship between self-monitoring and intrinsic religious orientation. However, the analyses has not reported anticipated results as addressed in the previous research. Therefore, this study opens the door for asking new questions about the subject. Religious groups, by their very nature, can refer the individual to self-presentation control, obedience, to act as deemed appropriate by the group, to adapt to the group, to change behavior without attitude change, and therefore, to attitude-behavior inconsistency. It can be argued that not only religious groups but, by their nature, all social groups create harmony-oriented pressure on the individual. Therefore, it can be predicted that belonging to a group, in general, may have a significant effect on the level of self-monitoring. The high self-monitoring scores of the participants, whether religious or non-religious group members of this study may have reduced the observability of the difference between the two groups. Therefore, repeating the study on a different sample may produce different results. (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to be (...) white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in (...) the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (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)

It is understandable that Ewen Whitaker developed an interest in the history of mapping and naming the moon. As a participant in the Apollo missions and a member of the Task Group of Lunar Nomenclature of the International Astronomical Union, he was himself directly involved in conflicts between representatives of different countries over naming newly discovered lunar features. In an effort to understand the passions surrounding current controversies more completely, his book examines their origin and development from the seventeenth (...) century to the present.Whitaker's account, written without footnotes for the general reader, proceeds in a strictly chronological fashion. As he makes clear, the key event in the history of lunar mapping and nomenclature was the discovery and application of the telescope to increasing knowledge of the moon's features. Mapping and naming thus became important issues in the wake of Galileo's observations. Accordingly, the first part of Whitaker's study, which deals with the period from prehistory to 1651, is the longest and most important of its four sections. By 1651, with the publication of Francesco Grimaldi's map and the application of Giovanni Riccioli's nomenclature, a fairly detailed and accurate picture of the moon's surface features had become available.The second part of Whitaker's account carries the story to the beginning of the Victorian period and features the creation of a new lunar map based on the work of Johann Mädler and Wilhelm Beer. In Parts 3 and 4, which together are shorter than either of the first two sections, Whitaker focuses on such key developments as the emergence of photography and the creation of international organizations to settle disputes over nomenclature. By 1935, a committee of the International Astronomical Union had reached agreement on a map and the naming of surface features. However, the further explorations of the space age dramatically increased the work of mappers by providing the first photographs of the far side of the moon and revealing new features on the near side.The most compelling facet of Whitaker's study are the 112 reproductions of drawings and photographs of the moon from the seventeenth century to the present, which, taken together, constitute a rich visual history of efforts to portray lunar features for the public and for scientists. In addition, detailed appendixes, arranged in chronological order, provide lists of new names of lunar features as assigned by the most influential mappers of the lunar surface from Michiel Van Langren to the NASA Catalogue of Lunar Nomenclature.While Whitaker limits himself strictly to matters of mapping and nomenclature, his study has already been useful to other historians of lunar exploration, including Scott Montgomery and William Sheehan and Thomas Dobbins . Montgomery seeks to explain how political and aesthetic factors shaped the portrayal of lunar features and thus the drawing of maps and the naming of surface features up to 1651, while Sheehan and Dobbins move beyond mapping and nomenclature to consider controversies over the possible existence of life on the moon and the conflict surrounding the origin of lunar craters by volcanic activity or meteor impact. Whitaker's study, however, provides a unique record of the development of our image of the moon's surface over a period of more than three centuries. (shrink)

The Report of the Ad Hoc Adivisory Group on the Operation of NHS Research Ethics Committees has resulted in a strange mixture of the timid, the revolutionary, and the bizarre.The Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees is a curious document.1 The remit of the review was focused on the workings and effectiveness of NHS research ethics committees and the multicentre committees ). The Group was primarily set up in (...) response to a series of complaints from medical researchers about the new research governance regime in the UK as a result of the Clinical Trials Directive2 and the Governance Arrangements for NHS Research Ethics Committees.3 The opportunity was also taken to consider the role of research ethics committees in a wider context, and take account of recent developments in relation to the ethics review of social care research,4 student projects,5 as well as recent legislation such as the Human Tissue Act,6 and the Mental Capacity Act.7 However, the resulting report is a strange mixture of the timid, the revolutionary, and the bizarre.A good example of the report’s timidity is its reluctance to propose fundamental change to the process of review or seriously limit the type of research that requires REC review. To its credit AHAG does suggest that some research ‘especially surveys and many studies on NHS staff, could normally be conducted safely without a requirement for REC review’ .1 This is, of course, to be welcomed. However, the report ultimately seems dismissive of the general complaint from researchers that the current process is inappropriately uniform. For example, in section 3.2, it is argued that the ‘common perception that the NHS REC system is dominated …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:IRBs Under the MicroscopeJonathan D. Moreno (bio)The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will (...) continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services’s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.Underlying these proximate causes for the IRB blitz is a growing realization that the already considerable clinical trial enterprise will expand significantly over the next few years. Congress is talking about giving the politically popular NIH half again the budget it currently receives, which in turn will stimulate more commercially supported research. The director of the National Cancer Institute is considering a five-fold increase in the number of subjects enrolled in oncology studies over the next several years. Phase I cancer studies are among the most ethically sensitive, so IRBs will have more work cut out for them if this goal is reached. Adding to the rush of interest in IRBs are the government’s recent apology to the survivors of the syphilis study in Tuskegee, continuing congressional dissatisfaction with the way the Pentagon handled its vaccine distribution during the Gulf War, and the controversy about AZT trials in developing countries.On the HillCongressman Christopher Shays, the moderate Connecticut Republican who has developed an interest in human research issues, convened hearings on human [End Page 329] subjects research and the IRB system on 11 June 1998. Shays chairs the House Government Reform/Human Resources Subcommittee. The committee’s ranking minority member is Edolphus Towns of Brooklyn, NY, who shares Shays’s interest in this area.The immediate rationale for the hearings was the release that day of the DHHS-IG report, Institutional Review Boards: A Time for Reform. The subtitle was changed from A System in Jeopardy apparently after some people in DHHS expressed reservations about its seemingly alarmist tone, but the IG staffers who testified before Shays’s subcommittee insisted that they stood behind the message that the IRB system is in trouble if considerable reforms are not undertaken. Among the factors in the research environment cited as support for the bleak forecast: managed care, commercialization, multi-site trials, high IRB workloads, minimal IRB oversight of approved studies, conflicts of interest, insufficient training of IRB members and investigators, and lack of IRB self-studies (DHHS-IG 1998).As is normally the case for congressional oversight hearings, the first panel of witnesses consisted of executive branch officials, including Eric Meslin, Executive Director of the National Bioethics Advisory Commission, and Gary Ellis, Director of the Office for Protection from Research Risks (OPRR). Shays pressed Ellis on the extent to which OPRR conducts on-site investigations of complaints about abuse of human subjects. Admitting that on-site investigations are rare, Ellis suggested that the agency is inadequately staffed to follow up on complaints as quickly as it might wish. The members of Congress who were present at the hearings generally expressed concern about the DHHS-IG’s findings.The second panel that day, which Shays was unable to attend, set a different tone. Four of the panelists—Paul Appelbaum of the University of Massachusetts at Worcester, Robert Levine of Yale University, Angela Bowen of the Western IRB (a private clinical trials review firm), and I—were invited as authorities on the current condition of the IRB system. Bert Spilker... (shrink)

The present study examined whether individuals with full-blown memories of highly implausible events are prone to commit source monitoring errors. Participants reporting previous-life memories and those without such memories completed a false fame task. This task provides an index of source monitoring errors . Participants with previous-life memories had a greater tendency to judge the names of previously presented non-famous people as famous than control participants. The two groups did not differ in terms of correct recognition of (...) new non-famous names and famous names. Although dissociation, cognitive failures, sleep-related experiences, depressive symptoms, and signs of psychological distress were all significantly higher in participants with previous-life memories than in controls, these variables did not predict the false fame illusion. (shrink)

This study examines how the CSR committee and CSR-linked executive compensation jointly affect CSR performance as governance mechanisms. Prior studies provided mixed results on the CSR committee’s effect on CSR performance. We posit that a CSR committee has both a direct and an indirect positive effect on CSR performance, with CSR-linked compensation playing the role of mediator in the relationship. We base our analysis on a sample of 164 Canadian firms covering the period 2012–2018, for a (...) total of 952 firm-year observations. We propose a regression-based approach for our mediation research design. Our findings reveal that CSR-linked compensation mediates the CSR committee’s positive effect on performance, but the type of mediation depends on whether the performance is social or environmental. We provide evidence of both direct and indirect effects on environmental performance but only a positive indirect effect on social performance. These results suggest that demands from the firm’s internal and external stakeholders are treated differently, with the former receiving priority. (shrink)

Biology is seen not merely as a privileged oppressor of women but as a co-victim of masculinist social assumptions. We see feminist critique as one of the normative controls that any scientist must perform whenever analyzing data, and we seek to demonstrate what has happened when this control has not been utilized. Narratives of fertilization and sex determination traditionally have been modeled on the cultural patterns of male/female interaction, leading to gender associations being placed on cells and their components. We (...) also find that when gender biases are controlled, new perceptions of these intracellular and extracellular relationships emerge. (shrink)

Purpose: The primary objective of this study was to determine the role of church in state and public affairs during the Kibaki Era, 2002-2013Methodology: The methodology employed in this study was qualitative in nature. The study relied mainly on the analysis of an existing dataset from secondary sources. The data was gathered from technical reports, scholarly journals, reference books, past sermons, church publications, official and unofficial doctrine, theologies and from the Kenya National Archives in Nairobi. Other sources (...) of data collection for the study included official statistics collected by government and the various agencies, bureaus and departments. The target population for this study was the mainland churches in Kenya and the role these churches played in state and public affairs in Kenya between 2002 and 2007.Results: The Kibaki era has been characterized by many an events that have attracted by far and wide the attention of the clergy. In 2005, the most significant development of the 2005 constitutional referendum is not the defeat of the draft, but the emergence of strains and tensions not just between Christians and Muslims, but also between church and state. Another significant development was the fact that the mainline clergy were increasingly viewed as partisan and divided along ethnic lines and serving narrow political interest depending on the ethnic group to which its leaders belonged. The prophetic role and voice of the church to act as the conscience of society was lost, and the church did nothing to evaluate its own role even after the people voted to soundly reject the draft constitution.Unique contribution to Theory, Practice and Policy: The study recommended that the government should put in place laws that would involve the church in government matters. This can be done by introducing motions into parliament that advocate for the direct involvement of the church. This would involve laws which ensure that a portion of all members sitting in any committee represents the church. This can also be done by the introduction of electoral posts for church representatives just as there are positions for women representatives. The study also recommends that amendments be made to the constitution to make a legal requirement that one of the nominated MPs must be from the church. (shrink)

The ability of bilingual individuals to manage two competing languages is assumed to rely on both domain-specific language control and domain-general control mechanisms. However, previous studies have reported mixed findings about the extent and nature of cross-domain generality. The present study examined the role of language dominance, along with bilingual language experience, in the relationship between word recognition and domain-general cognitive control. Two single-language lexical decision tasks and a domain-general flanker task were administered to bilinguals who live in the (...) sociolinguistic context of a minority and a majority language, namely, Uyghur and Chinese, respectively. The results showed a diversity in language dominance patterns with better performance in L2 than L1 in the recognition modality, even for participants who self-identified as globally being dominant in L1. This finding reflected all bilinguals’ self-evaluation that their preferred language for reading was L2, suggesting that language dominance is dynamic, depending on what language modality is measured. Furthermore, it was found that an earlier onset age of L2 acquisition and a higher across-modality dominance in L2 were related to faster L2 word recognition. When self-reported language dominance was operationalised as a grouping variable, it was further found that both across-modality L1- and L2-dominant bilingual participants demonstrated a significant relationship between L2 word recognition and domain-general monitoring control, while only L1-dominant bilinguals additionally tapped into inhibitory control, indexed by the flanker effect during L2 word recognition. These findings suggest that language dominance has an impact on the extent and nature of the overlap in control mechanisms across specific linguistic and domain-general cognitive domains and add evidence to a domain-general monitoring account of bilingual word recognition. (shrink)

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including (...) interventional and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

On 17-18 June of this year [1974] a discussion of the journal Voprosy filosofii in the past few years took place at the Academy of Social Sciences of the CPSU Central Committee at a session of the Special Scientific Council on Philosophical Sciences and readers of the journal. This event attracted considerable attention from philosophers working in the Academy of Social Sciences of the CPSU Central Committee as well as in other institutions, for example, the Higher Party (...) School, the Institute of Social Sciences of the CPSU Central Committee, the institutes of the USSR Academy of Sciences, and a number of higher educational establishments in the capital. (shrink)

Randomized and double-blind clinical trials are widely regarded as the most reliable way of studying the effects of medical interventions. According to received wisdom, if a new drug or treatment is to be accepted in clinical practice, its safety and efficacy must first be demonstrated in such trials. For ethical and scientific reasons, it is generally considered necessary to monitor a trial in various ways as it proceeds and to analyze data as they accumulate. Monitoring and interim analyses are (...) often conducted by a so-called data monitoring committee (DMC), a group of experts independent of both sponsors and investigators. On the basis of DMC recommendations, sponsors sometimes decide to discontinue trials .. (shrink)

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring (...) broad representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one (...) hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Institute of MedicineRuth Ellen Bulger (bio)IN 1863 the National Academy of Sciences (NAS) was established by federal charter to advise the government on scientific matters. Almost 100 years later, in 1971, the Academy created the Institute of Medicine within the NAS to focus on health-related problems and issues. Today the IOM has a program budget of about $13 million, which includes both private and government funds, and is (...) regarded as a leading center for health policy research.After briefly explaining the structure and general goals of IOM, this article describes several new or anticipated projects as well as some recently completed reports that have a strong ethical component.The IOMThe IOM's distinguished membership is made up of health care professionals of all sorts, scientists working in health-related disciplines, and lawyers, economists, and others knowledgeable in and involved with policies and activities associated with health issues. It is organized around eight working groups or divisions: Health Sciences Policy; Health Care Services; Health Promotion and Disease Prevention, including AIDS activities; International Health; Biobehavioral Sciences and Mental Disorders; the Food and Nutrition Board; the Medical Follow-up Agency; and the Health Policy Fellowship Programs. Each of these divisions is assisted by an oversight board that provides advice on its activities.It is important to know at the outset that IOM has decided that each of the divisions will include consideration of human values and ethical issues in their activities. Therefore, no separate locus was established within the IOM to deal with these matters. I am director of the Division of Health Sciences Policy, which is the only division that has made ethics a priority in its work, and it is the focus of this article.We have addressed questions of ethics, human values, social values, decision making, and priority setting in many of the division's reports. In fact, most of our reports at least raise ethical questions. In addition, a portion of the interest from endowment funds given to IOM by the Howard Hughes Medical Institute has been devoted to work in this area. [End Page 73]The division's advisory board, headed by Claude Bennett, chairman of the Department of Medicine, University of Alabama at Birmingham School of Medicine, has decided on two major priorities for the division: (1) foster an environment conducive to productive research, and (2) anticipate the impact of scientific—especially biomedical—advances on society, monitoring and considering the social and ethical factors that accompany basic scientific and technological progress. These two priorities are interdependent because the fostering of a good environment for research presupposes that the results of this research will produce beneficial effects for the society that supports the research.Upcoming StudiesSociety has been unable to establish a mechanism for discussing in a meaningful way—and possibly resolving—a number of pressing national issues with social, ethical, legal, and scientific ramifications. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research considered several such issues and produced important reports about them. However, the commission was funded only until 1983. The Congressional Biomedical Ethics Advisory Committee was authorized in 1985 to address these contentious issues, but it was caught in the crossfire of congressional abortion politics and subsequently died. A new model is needed to attempt to develop national consensus on these complex, contentious issues.The Board on Health Sciences Policy has wrestled with this idea. Recently, it approved a proposal to establish a study committee charged with developing effective alternative methodologies for anticipating and addressing the social, legal, and ethical issues that may accompany rapid advances in biomedical science and technology. This multidisciplinary committee will be given a series of tasks: (1) to explore past experiences with some of these varying methodologies (i.e., town meetings, consensus conferences, forums, commissions, etc.); (2) to develop an agenda of issues likely to arise in the future; (3) to define and test a variety of alternative methodological approaches to these questions; (4) to evaluate strengths, weaknesses, and impact of the various approaches; and (5) to make recommendations on the process and structure by which this fact-finding, analytical, and decision-making function could be... (shrink)

Background Many indigenous people have died or been harmed because of inadequately monitored research. Strong regulations in Human Research Ethics (HRE) are required to address these injustices and to ensure that peoples’ participation in health research is safe. Indigenous peoples advocate that research that respects indigenous principles can contribute to addressing their health inequities. This scoping literature review aims to analyze existing peer reviewed and grey literature to explore how indigenous values and principles from countries of Oceania are incorporated into (...) HRE and the governance of research involving human participants. Methods A scoping literature review framework was used for this study. A search for peer reviewed and grey literature from Google, bibliographies, and electronic databases such as SCOPUS, SPRINGER, Medline (Ovid) and JBI Database of Systematic Reviews was conducted, limited to the years 2002–2020. Sixty (60) documents that focused on indigenous knowledge from Oceania region and HRE were included, from which key findings and themes were synthesized. Results Charting the data showed that more than half the eligible documents were peer-reviewed journal articles (54%). Other sources included: International Declarations on Human Research (8%); book chapters (8%); government documents (8%); HRE Guidelines or protocols (13%); news articles (7%) and PhD thesis (2%). The literature was from Australia, Cook Islands, Guam, New Zealand, Fiji, Samoa, Tonga and Vanuatu, some of which focused specifically on HREs in the Pacific Region. Issues emerging from the literature were grouped into five themes (i) indigenous and cultural principles of HRE; (ii) informed consent in indigenous settings in Oceania; (iii) vulnerability and minority status of indigenous populations exploited for research; (iv) research ethics governance for Oceania indigenous peoples; and (v) research ethics committees in Oceania. Respect, relationship building, and trust were priority indigenous HRE principles that encompass the principles of partnership, capacity building, reciprocity, and equality. Relationship building and trust imply the equal distribution of benefits for indigenous population and researchers. Conclusion Indigenous principles of HRE identified were interconnected and interdependent. Recommendations were to incorporate indigenous principles of research in HRE regulations and processes of all countries with indigenous populations. This is especially pertinent for emerging national research committees in LMIC countries, including Fiji and Tonga. Relationship building among researchers and indigenous populations is key to successful research with indigenous populations. HRE principles important for relationship building include respect that is reciprocal among researchers and indigenous people. Elements of the principle of respect highlighted are empathy, collaboration, sharing of benefits, reciprocity, appreciation, empowerment, protection, safety and awareness of culture and languages. Indigenous ontology from the Oceania region involves spirituality, connectedness to land, religious beliefs and a participatory approach to HRE and should be respected in research. An ethical governance mechanism of HRE is one that incorporates indigenous principles and applications for the purpose of maximizing the protection of the dignity and rights of indigenous peoples of Oceania. (shrink)

Background Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies (...) including interventional and observational studies. WHO-ERC reviews WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. Conclusions To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively.

This project is based on the unique ‘Shared ethical debate’ between NHS RECs in the UK in which one research application is reviewed by several research ethics committees. This programme is now in its 6th cycle. In the fifth cycle a prison- based research project was reviewed by each of three NHS RECs that are ‘ flagged’ for such research and their debate and discussions were observed directly by one researcher who recorded the committee processes and the issues raised (...) in committee. Subsequently a focus group of REC members from all three committees was constituted to consider the ethical importance of these issues. The three RECs were consistent in both process and identifying ethical issues. The focus group formulated a basic framework that will further contribute to ensuring a consistent and balanced approach to ethical review within this area of research. (shrink)

Background: Funding organisations and research ethics committees should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union , funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs.Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: Do existing procedures promote representation of women and gender expertise in the (...) class='Hi'>committee? How are sex and gender issues dealt with in protocol evaluation?Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents .Results: All countries have rules to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools.Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Martin Heidegger and OntologyEmmanuel Levinas (bio)The prestige of Martin Heidegger 1 and the influence of his thought on German philosophy marks both a new phase and one of the high points of the phenomenological movement. Caught unawares, the traditional establishment is obliged to clarify its position on this new teaching which casts a spell over youth and which, overstepping the bounds of permissibility, is already in vogue. For once, (...) Fame has picked one who deserves it and, for that matter, one who is still living. Anyone who has studied philosophy cannot, when confronted by Heidegger’s work, fail to recognize how the originality and force of his achievements, stemming from genius, are combined with an attentive, painstaking, and close working-out of the argument—with that craftsmanship of the patient artisan in which phenomenologists take such pride. In this study, it is important for us to understand, above all, the true intentions of our author, to illuminate what he thinks really needs to be said, and to surmise what is most critical for him.To get to the heart of Heidegger’s system, it seems fitting to begin with a problem that is generally familiar. We choose the problem of knowledge, a deeper understanding of which takes us to the very threshold of Heidegger’s thought. For this problem, central to modern philosophy, is one of the main obstacles of modern philosophy that Heidegger wishes to surmount. Neo-Kantianism, which takes knowledge as the philosophical problem of the first rank, is the movement against which Heidegger rebels with all his strength. We have, thus, every chance of gaining access to his thought by the main door, so to speak. Once inside the system we will try to trace its outlines, 2 reserving, for a second part of our work, the determination of Heidegger’s place in the history of ideas, especially in the phenomenological movement, as well as of his relations with the philosopher to whom he owes so much—Edmund Husserl. 31In its most general form, the problem of the theory of knowledge has a critical significance. It consists in delineating a domain where knowledge can be certain and in determining the criteria for the legitimate scope of knowledge. But this problem, as normal and as simple as it may appear, has deeper roots. That knowledge should need a criterion at all presupposes that truth is not identical to all that is known and that the course [End Page 11] of things can fail to correspond with the course of thought. “How does knowledge correspond to being?” is a more profound formulation of the problem of knowledge.But we are not going to touch anymore on the primordial phenomenon that generates the problem. The problem of correspondence between thing and thought presupposes a free activity of thought and its isolation in relation to the object. It is precisely this presupposition which renders their harmony and even their contact problematic. “How does the subject take leave of itself to attain the object?” is what the problem of knowledge, in the last analysis, boils down to. Its true source is thus the concept of “subject” as elaborated by modern philosophy. The cogito presided over the subject’s birth. The cogito was the affirmation of the privileged nature of the subject’s immanent sphere, of its unique place in existence; hence, the cogito was the specificity of the subject’s connection to the rest of reality, the sui generis nature which opens up the passage from immanence to transcendence, the passage from ideas contained in the thinking substance to 4 their “formal existence.”The concept of the subject, understood as a substance having a specific position in the entire domain of being, presents us with difficulties of two kinds. First, how do we understand this leave-taking from the self which the thinking substance brings about and which displays an entirely original aspect? Indeed, we could say that thought, in reaching out toward objects, does not actually take leave of itself, since its objects—considered as ideas and contents of thought—are, in a certain sense, already within it. In order to make sense of this paradox, Descartes... (shrink)

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)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. (...) This update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

The tendency of customers’ preference to their local brands over the foreign ones is known as the consumer ethnocentrism, and it is one of the important issues in international marketing. This study aims at identifying the behavioral and neural correlates of Consumer Ethnocentrism in the field of brand preference by using Event-Related Potential (ERP). We sampled subjects from two ethnic groups, the Chinese ethnic group and the sub-Sahara black Africans group from the Zhejiang University. The subjects (...) faced two sequential stimuli, S1 followed by S2. The S1 consisted of 40 pictures of 20 Chinese and 20 Africans black peoples wearing traditional clothes, and S2 consisted of 40 fake brand-logos which were divided randomly into two groups of 20 each. The subjects were informed that the people in the S1 purchased and recommended the products with the brand-logos presented in S2, and the subjects were asked to rate their preference degree toward these logos. The brand-logos were called the “in-group recommended logos” if the recommender in S1 were the same race as the subjects, otherwise, the “out-group recommended logos”.The results revealed that the race of the brand-logo recommender highly impacted the Chinese subjects’ preference for the brand-logos. The N200 component elicited by in-group recommended logos were significantly lower than those elicited by out-group recommended logos. Besides, there was evidence that being familiar with foreign cultures reduces consumer ethnocentrism. The African subjects were familiar with Chinese people and adopted Chinese culture, as a result, they did not differ in showing preferences between in-group and out-group recommended logos. (shrink)

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were based. (...) Multiple information events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported. (shrink)

ABSTRACT In our current moment, there is considerable interest in networks, in how people and things are connected. This essay outlines one approach that brings together insights from actor-network theory, social network analysis, and digital history to interpret past scientific activity. Multispecies network analysis (MNA) is a means of understanding the historical interactions among scientists, institutions, and preferred experimental animals. A reexamination of studies of sexual behavior funded by the Committee for Research in Problems of Sex between the 1920s (...) and the 1940s demonstrates the applicability of MNA to clarifying the relations that sustained this area of psychology. The measures of weighted degree and betweenness can highlight which nodes (whether organisms or institutions) were particularly “central” to this network. Rats featured as the animals most widely studied during this period, but the analysis also reveals distinct institutional and disciplinary cultures where different species were favored as either surrogates for humans or representatives of more general biological groups. (shrink)

The new class of anti-inflammatory drugs, the COX-2 inhibitors, have been commercially successful to the point of market dominance within a short time of their launch. They attract a price premium on the basis that they are associated with fewer adverse gastric events than traditional anti-inflammatory drugs. This marketing continues even though a pivotal safety study with one of the COX-2 inhibitors, rofecoxib, showed a significant increase in myocardial infarction with rofecoxib use compared with a traditional anti-inflammatory drug. This (...) finding has led to a series of publications containing pooled analyses of existing data that both support and refute the possibility of increased cardiovascular risk with COX-2 inhibitors.These medical journal publications have served to obfuscate rather than provide guidance for medical practitioners. Consideration of a research ethics committee approach to this issue suggests that it would deal with the controversy in a straightforward manner—namely, it would simply inform research participants of the trial results with rofecoxib. The certainty of this research ethics committee approach raises the issue of whether it should be applied in normal medical practice outside of the research environment. A consideration of the legal tests for disclosure of information suggests that therapeutic medical practice should mirror that within the research environment, in this case. (shrink)

BackgroundThe phenomenon of ‘moral distress’ has continued to be a popular topic for nursing research. However, much of the scholarship has lacked conceptual clarity, and there is debate about what it means to experience moral distress. Moral distress remains an obscure concept to many clinical nurses, especially those outside of North America, and there is a lack of empirical research regarding its impact on nurses in the United Kingdom and its relevance to clinical practice.Research aimTo explore the concept of moral (...) distress in nursing both empirically and conceptually.MethodologyFeminist interpretive phenomenology was used to explore and analyse the experiences of critical care nurses at two acute care trauma hospitals in the United Kingdom. Empirical data were analysed using Van Manen’s six steps for data analysis.Ethical considerationsThe study was approved locally by the university ethics review committee and nationally by the Health Research Authority in the United Kingdom.FindingsThe empirical findings suggest that psychological distress can occur in response to a variety of moral events. The moral events identified as causing psychological distress in the participants’ narratives were moral tension, moral uncertainty, moral constraint, moral conflict and moral dilemmas.DiscussionWe suggest a new definition of moral distress which captures this broader range of moral events as legitimate causes of distress. We also suggest that moral distress can be sub-categroised according to the source of distress, for example, ‘moral-uncertainty distress’. We argue that this could aid in the development of interventions which attempt to address and mitigate moral distress.ConclusionThe empirical findings support the notion that narrow conceptions of moral distress fail to capture the real-life experiences of this group of critical care nurses. If these experiences resonate with other nurses and healthcare professionals, then it is likely that the definition needs to be broadened to recognise these experiences as ‘moral distress’. (shrink)

The program committee of the North American Nietzsche Society recently elected to suspend their long-standing practice of holding group sessions in conjunction with divisional meetings of the American Philosophical Association, and to organize bi-annual conferences instead. This journal will continue to bring its readers select presentations from those events. In the meantime, the seven articles in this issue represent the last of the complete Proceedings and Addresses of the North American Nietzsche Society.The first two articles, on the affirmation (...) and the denial of life, by Guy Elgat and Daniel I. Harris, were selected by the program committee... (shrink)

In response to the proposal by Walter Jaeschke contained in the preceding paper, the Nineteenth Century Theology Group of the American Academy of Religion discussed plans, at the annual meeting of the Academy on 15–17 November 1979, to complete a new English study edition of Hegel’s Lectures on the Philosophy of Religion, and has agreed to sponsor its publication by Scholars Press in the AAR Texts & Translations Series. An Editorial Committee has been formed with the following (...) membership: Robert F. Brown, Richard Crouter, James O. Duke, Francis S. Fiorenza, Joseph Fitzer, Peter C. Hodgson, Walter Jaeschke, Darrell Jodock, O. Kem Luther, Dale M. Schlitt, John C. Shelley, James Yerkes. Many of these persons will be involved in the editing and translating process. (shrink)

Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a (...) descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ 2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

Most donated organs in the United States come from brain dead donors, while a small percentage come from patients who die in “controlled,” or expected, circumstances, typically after the family or surrogate makes a decision to withdraw life support. The number of organs available for transplant could be substantially if donations were permitted in “uncontrolled” circumstances–that is, from people who die unexpectedly, often outside the hospital. According to projections from the Institute of Medicine, establishing programs permitting “uncontrolled donation after circulatory (...) determination of death,” or uDCDD, throughout the United States has the potential to provide 22,000 more donation opportunities annually. In contrast, U.S. controlled donation after circulatory determination of death, or cDCDD, cases have increased progressively over the past decade from 87 to 848 donors, but currently account for only 10.6 percent of all deceased donors. Following the IOM recommendations, several projects exploring the feasibility of uDCDD were funded by the federal government, including a grant from the Health Resources and Services Administration that supported a pilot project in New York City in which the authors of this article participated.A key feature of our protocol, and indeed of many uDCDD protocols, is the initiation of preservation methods such as chest compressions and extracorporeal membrane oxygenation shortly after death in order to perfuse and preserve the donor's organs. Critics of uDCDD argue that the means of determining death deviates from generally ascribed principles. They assert that reinstituting circulation in order to preserve organs has the effect of “undoing” the prior determination of death. The result is that cDCDD is widely accepted and practiced routinely even though it only marginally increases the number of organs available for transplantation, and uDCDD is widely considered unacceptable despite being ethically embraced and proven to significantly increase organ donation opportunities in other countries. This article explores the evolution of this counterintuitive state of affairs and calls for a policy that, in line with the IOM report, allows for both cDCDD and uDCDD protocols. (shrink)

We present an empirical investigation on how multiple stakeholders can influence and contribute to a standard development process. Based on the analysis of comments submitted by stakeholders developing ISO 26000 standard for social responsibility, we found no significant differences between the ratio of accepted and non-accepted comments among various stakeholder groups; however, we conclude that industry is the most influential stakeholder due to the volume of the comments. We also present a set of processes that stakeholders follow to influence and (...) contribute to standards development, namely to (1) eliminate issues that are controversial and undesirable; (2) link and integrate the standard into a network of other documents and ISO standards; (3) seek consensus by highlighting areas for further dialogue or by addressing their exclusion from the standards development, (4) reinforce issues that are important; and (5) improve the content of the new standard. In conclusion, we provide a set of propositions about multi-stakeholder standards development and compare multi-stakeholder involvement in standards developed through a new committee established in existing standards setting organization [i.e., Committees within the International Organization for Standardization (ISO)] and through new standards setting organizations established for one specific task (i.e., Forest Stewardship Council). We envisage that our study will be a useful platform to monitor and evaluate future developments of ISO 26000 and other multi-stakeholder standards. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to determine the (...) social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

News media as both a site and a process of social interaction and ideological construction (van Dijk 1993) play a unique role and carry a signifying power in structuring social thinking and disseminating social knowledge on issues related to national or international agendas, and in representing events in particular ways (Fairclough 1995). Through a comparative analysis of 30 articles from four newspapers on the events of May 31, 2010 Gaza-bound aid flotilla raid and their aftermath, the present study examined (...) the discursive properties of the articles in the process of construction of the events and representation of their participants through in and out-group identity. Using van Dijk’s (1991) approach to news analysis and drawing on the analytical framework of transitivity and lexical cohesion proposed in Halliday (1994), the study investigated the representation of the events and social actors. The results revealed the links between choices of certain discourse strategies realized in certain linguistic forms and the role of ideologies and power relations underlying such forms and strategies. (shrink)

Cigarette smoking and other addictive behaviors are among the main preventable risk factors for several severe and potentially fatal diseases. It has been argued that addictive behavior is controlled by an automatic-implicit cognitive system and by a reflective-explicit cognitive system, that operate in parallel to jointly drive human behavior. The present study addresses the formation of implicit attitudes towards smoking in both smokers and non-smokers, using a Go/NoGo association task, and behavioral and electroencephalographic measures. The GNAT assesses, via quantifying (...) participants’ reaction times, the strength of association between a target category and either pole of an evaluative dimension. EEG analysis is performed to determine the temporal course of the event-related potential components underlying Go/NoGo decisions and implicit attitude formation. Both smokers and non-smokers showed prolonged reaction times to smoking-related pictures when the pictures were coupled with positive evaluative words. This indicates negative implicit attitudes towards smoking in both groups alike at the time point of the behavioral response. However, only the non-smokers, not the smokers, were found to show a delay of the N200 component in the incongruent condition. This is interpreted as reflecting ambivalent or even positive implicit attitudes towards smoking in the smoker group at the time point of the N200. Our study thus provides evidence for the hypothesis that implicit attitudes are subject to changes within several hundred milliseconds after stimulus presentation, and can be altered in the course of their formation. (shrink)