心灵观念的祛魅

通过一项疫苗临床试验国际合作项目的实施,讨论了如何在科学研究中贯彻落实GCP。结果表明,ICH提出的13项GCP指导原则在疫苗临床试验中得到了充分的实施。GCP不仅是临床试验的管理和指导原则,同时也保护研究对象的权利、保证资料的可信和自觉遵守标准操作程序（SOP）的意识。     

Towards international comparative research on the professionalisation of Religious Education

This article calls for international comparative research on the professionalisation of Religious Education (RE). To this end, it provides a rationale for focusing upon the concept of professionalisation and a theoretical justification for international comparative research, particularly identifying its significance in terms of the development of RE in England and Germany. The article outlines a methodology for exploring the concepts of professional knowledge, professional self-organisation and politics and professional development. The proposed methodology involves a systematic analysis of primary documentary sources including: (1) academic and professional journal articles and textbooks; (2) the archives of relevant institutions and organisations; and (3) external evidence, such as inspection and research reports. An analytical case study of two leading journals in each national context, Religion in Education in England and Der Evangelische Erzieher in Germany, in the immediate post-war era is appended to illustrate the benefits of implementing such a methodology across national boundaries.     

The concept of quality in clinical research

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000. An earlier version of the paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

谈谈中国临床试验研究中受试者权益保障问题

随着国家《药品临床试验管理规范》的颁布与实施,我国新药临床试验研究水平有相当的提高,但也存在着一些问题。其中包括保护受试者权益问题。国家GCP有关章节中明确指出要保护受试者权益。并有具体规定,但在执行中尚有出入,如试验方案未经伦理委员会批准,未向受试者告知试验内容。或告知的不够充分,甚至在未签署知情同意书时就开始试验等。为此,我国采取了相应的措施,如设立药品临床研究培训中心;定期对临床试验基地的研究者以及相关人员如与试验有关的医师,药师及申办者进行GCP培训,基地审核制度,以法律手段来保证受试者权益等。     

A response Consistency statistic for the millon clinical multiaxial inventory (MCMI)

Response style in objective psychological testing is an important issue in the reliability and validity of tests as well as in the interpretation of test results. The MCMI provides two response-style indices, the validity scale and the weight factor. The present work presents an additional statistic to assess random response in subjects. The Consistency Coefficient is the correlation between the subjects' endorsement of even and odd items across the 20 MCMI scales. The distributions of 500 patient and 500 randomly generated profiles were compared. Good separation between these distributions was found. The subject data were extremely negatively skewed, whereas the randomly generated data were normally distributed. Data are presented that display positive and negative predictive values, as well as sensitivity and specificity across ranges of prevalence and cut score. These data facilitate the identification of subjects who respond to the MCMI in a random manner so that their scores can be interpreted accordingly.     

Medicine and pharmacy — facts and myths about the development of an innovative pharmaceutical industry in Poland

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US$ 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP). An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

Sociology and psychology within the scope of scientific dishonesty

A survey is undertaken based on qualitative analyses of the cases of scientific misconduct from the Danish Committee on Scientific Dishonesty’s first five years of collecting data, with additional information from selected international sources, in which underlying psychological motivations can be judged. An carlier version of this paper was presented at a symposium, Scientific Misconduct. An International Perspective, organised by The Medical University of Warsay, 16 November, 1998.     

‘My language thing … is like a big shadow always behind me’: International counselling trainees' challenges in beginning clinical practice

Background: While counsellor education becomes increasingly culturally diverse, little is known about international trainees' experiences of training. Objective: The present study explores one aspect of training, namely clinical practice from the perspective of international, non‐native speaking trainees. In particular, this paper focuses on the challenges this group encounters when practicing in a second language. Methodology: Semi‐structured interviews with four non‐native English‐speaking trainees were conducted and analysed following the principles of interpretative phenomenological analysis (IPA). Results: Findings suggest that participants encounter practical difficulties related to their non‐native/foreign identity in practice, such as problems with articulate self‐expression and understanding the client's speech. These difficulties generate anxiety and impact on the trainees' confidence. Conclusions and implications for counsellor training: This study elucidates language as a fundamental aspect of culture, and identifies second language use as a significant source of difference in counselling practice. This paper highlights the need for attention to linguistic diversity and for appropriate support during counsellor education. This will improve international trainees' experiences of training, but also enhance all trainees' understanding of difference, resulting in better service provision for the community.     

Does imagery contribute to metaphoric quality?

With metaphoric quality divided into an appropriateness and novelty component, college-student subjects rated 75 metaphoric sentences on those components and on imageability. Different subjects were assigned to each of the three rating conditions (n=45 in each). Correlations based on mean ratings of the metaphors indicated that imageability was negatively related to novelty and positively related to appropriateness. A composite of the novelty and appropriateness ratings (deemed to reflect metaphoric quality) proved to be independent of imageability. Examination of metaphors with the highest and lowest imagery ratings suggested that imagery was facilitated by perceptual-configural linkages and inhibited by remote conceptual linkages between topic and vehicle. This configural-conceptual distinction appears to be of greater importance than quality in influencing the extent to which a metaphor is imaged.An earlier version of this paper was presented by the first author at the Annual Meeting of the Eastern Psychological Association, New York City, April 1981. This research was funded in part by a doctoral fellowship from the Social Sciences and Humanities Research Council of Canada to the first author, who is now affiliated with the University of Illinois.     

On more powerful tests of judge agreement with a known standard

To establish the existence of his abilities, a judge is given the task of classifying each ofN=rs subjects into one ofr known categories, each containings of the subjects. An incomplete design is proposed whereby the judge is presented withb groups, each one containingn=rs/b<r subjects. Then different categories corresponding to members of the group are known. Using the total number of correct classifications, this method of grouping is compared to that in which the group size is equal to the number of categories. The incomplete grouping is shown to yield a more powerful test for discriminating between the null hypothesis that the judge is guessing the classifications and the alternative hypothesis that he has some definite abilities. The incomplete design is found to be most effective (powerful) when the number of subjects in a group is limited to two or three.The author is grateful for the suggestions of the referees and the editor, which greatly improved the paper.     

Systems use to objectify program evaluation,clinical, and management decisions

The utility of the observational assessment systems at different levels — from local clinical to systemwide management — is outlined. An overview is provided of TSBC information applied to individualized problem identification and programming/monitoring, discharge and competency determinations, and both absolute and comparative program evaluation. The utility of SRIC information for prgoramming/monitoring and for staff training and evaluation is outlined in addition to the applied uses of the information of the assessment systems in combination. Once implemented, the continuous data from the systems allow for empirically based self-corrective improvements in the quality of mental health services while automatically providing a basis for legal documentation and accurate cost/effectiveness comparisons of mental health programs.Preparation of this article and the research and development on which the article is based were supported, in part, by Public Health Service Grants MH-15553 and MH-25464 from the National Institute of Mental Health, and by grants from The Joyce Foundation and the Illinois Department of Mental Health and Developmental Disabilities.Presented at the 87th Annual Meetings of the American Psychological Association, New York City, September 1979, as part of a symposium on New assessment systems for residential treatment, management, research, and evaluation.     

Understanding,respecting and integrating difference in therapeutic practice

The purpose of this paper is to promote thought and discussion around how and why we treat patients in chosen ways. In the present climate practitioners are required to treat patients following NICE guidelines in which cognitive behavioural therapy (CBT) is the treatment of choice in the majority of diagnoses. This paper raises concerns that this may lead to an homogenization of treatment, loss of invaluable skills and understanding from other treatment approaches, and loss to the patient who may be best cared for by a combination of treatments and approaches, most notably patients presenting with complex pathology. This paper aims to present this as a general principle, and by way of example, will focus on coupling two specific treatment orientations, cognitive behavioural therapy with psychodynamic psychotherapy, with the specific diagnosis of obsessive compulsive disorder (OCD).

Methods: Clinical material is drawn from case studies from practice in secondary adult mental health care services within the NHS. All patients were referred to the psychological services for treatment for OCD and provided with 1:1 therapy with UKCP‐registered therapists. Details have been anonymized by describing fictitious cases re‐constructed from clinical material. A theoretical understanding is included which provides both an overview for integrating treatment for the specific example of OCD and is intended by extension to other diagnoses.

Results: Working with the commonalities of therapeutic approaches, and integrating specific skills of CBT and psychodynamic psychotherapy, appears to offer a viable mode of treatment for cases resistant to single‐orientation therapies.

Conclusions: Coupling the skills of different therapies can be effective in treating complex patients that are referred to the secondary mental health services. Conversely, restricting practice to single orientation therapies can lead to an impoverished care for patients and diminution of invaluable therapeutic skills which may become underused, undervalued and lost in the practice of mental health care within the NHS. Acknowledgement of the skills of others, valuing these and learning from each other can help to avoid the defensive reactions of practitioners, where each may defensively retreat to their corners of specialism. Respecting and sharing skills from different orientations, and acknowledging this in the NICE guidelines, is good for both mental health services and patient care and addresses the concerns raised by practitioners exemplified by Bateman (2000 Bateman, A. 2000. Integration in psychotherapy: An evolving reality in personality disorder.. British Journal of Psychotherapy, 17(2): 147–156.  [Google Scholar], p. 147) that ‘psychotherapy continues to be bedeviled by ideological schisms with practitioners apparently ignoring alternative conceptualizations and potentially superior interventions’.     

Ethical considerations and proposed guidelines for the use of radio frequency identification: Especially concerning its use for promoting public safety and national security

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy. An earlier version of this paper was presented at the 2005 conference, Ethics and Social Responsibility in Engineering and Technology, Linking Workplace Ethics and Education, co-hosted by Gonzaga University and Loyola Marymount University, Los Angeles, CA, USA, 9–10 June 2005.     

Rethinking Diakonia and Transforming Our World

This article analyzes how ecumenical diakonia contributes to a critical view of the power dimension of the Sustainable Development Goals (SDGs). At the same time, it presents both the opportunities and the challenges the SDGs provide in rethinking diakonia and diaconal praxis. The commitment of the global community to the SDGs signifies a new context for diaconal praxis at local and international levels. In this article, power relations and the priority of the marginalized are presented as key concerns for rethinking diakonia in the current context. A model for diaconal reflection, based on perspectives from development studies and theology, is suggested as a tool for an interdisciplinary rethinking of diakonia aiming at renewed praxis in the context of the SDGs.     

Conflicts of interest in science in Armenia

The author describes problems facing Armenia in reorganization of the structure of science in the post-socialist era with the aim of utilizing limited state resources more efficiently by reducing the number of separate scientific institutes, concentrating on essential core subjects required by the nation and encouraging all other projects to compete in the international arena for grant sponsorship. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

The CIOMS view on the use of placebo in clinical trials

Based on worldwide consultations with experts in science and ethics the revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects provide guidance on when the use of placebo as a comparator in clinical research is ethically acceptable. The article reviews the main points of the CIOMS Guidelines and commentaries including the use of placebo in situations where the best current method is available and the relation of placebo to established effective intervention. It discusses the use of placebo in externally sponsored research in low-resource countries and requirements for informed consent related to placebo studies. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Is there an association between severity of illness and psychiatric symptoms in patients with chronic renal failure?

Chronic renal failure (CRF) is a frequent condition in elderly subjects, and it is associated with psychiatric comorbidity, especially depressive symptoms. Purpose of the present research was to compare patients with different severity of chronic kidney disease (CKD) in terms of psychiatric symptoms. One hundred CKD subjects were randomly selected among those attending the Department of Nephrology, University of Milan. The patients were evaluated through the following rating scales: Mini-Mental State Examination (MMSE), Beck Depression Inventory (BDI), Symptom Checklist (SCL-90), Kidney Disease Quality of Life- Short Form (KDQOL-SF) and Cumulative Illness Rating Scale (CIRS). A multivariable linear regression analysis was performed considering eGFR as continuous-dependent variable and rating scale scores as independent variables. A worse eGFR significantly correlated with the score about the effects of kidney disease on daily life (r = 0.25, p = 0.01) and the burden of kidney disease (r = 0.18, p = 0.05). Statistical significance of kidney disease on daily life persisted also in the final multivariate model (t = 2.04, p = 0.04). Severity of renal dysfunction seems to influence few psychiatric outcomes, particularly those related to quality of life and daily functioning. This result might depend on the over-worrying derived from the necessity to start a renal replacement therapy in the near future.     

Responding to allegations of scientific misconduct

Institutions in France are not yet well prepared to respond to allegations of scientific misconduct. Following a serious allegation in late 1997. INSERM,* the primary organization for medical and health-related research in France, began to reflect on this subject, aided by scientists and jurists. The conclusions have resulted in establishing a procedure to be followed in cases of alleged misconduct, and also in reinforcing the application of good laboratory practices within each laboratory. Guidelines for authorship practices and scientific assessment must also be considered. Even though each institution must remain responsible for responding to allegations of scientific misconduct within its doors, INSERM would like to see national, European, and international co-ordination about the methods of such response. Institut National de la Santé et de la Recherche Médicale (eng. French National Medical Research Institute) is known as INSERM. An earlier version of this paper was presented at a symposium, Scientific Misconduct: An International Perspective, organised by The Medical University of Warsaw, 16 November, 1998.     

Education for all: The Good Inclusion Game

The term “education for all” in the context of inclusive schooling describes the aim that children with identified special/additional needs are fully included in education together with their typically developing peers. However, this is easier said than done as there are few easy‐to‐use methods that teachers can use while at the same time teaching the approbate curriculum to children with a full range of different abilities. The Good Inclusion Game (GIG) is a group contingency‐based tool to create inclusive classrooms that utilizes principles of the applied branch of the science of behavior analysis (applied behavior analysis) and can be used across settings and academic subjects. The GIG was evaluated across nine classrooms including 93 boys and girls aged between 9 and 15 years of age, including 20 children with identified special educational needs. Findings show that the GIG reliably led to a significant increase of inclusive curriculum‐focused activities with the collateral effect of decreasing disruptive behaviors for all children. Findings are discussed in the context of inclusive schooling and evidence‐based education.