Conducting clinical research in Polish conditions

This paper comments on Polish legal guarantees for diseased persons with reference to the hazards that accompany experimental treatment. While acknowledging that participation in a clinical research program provides patients with additional opportunities for advanced treatment, the paper also points out that systems for monitoring patients participating in experimental treatment require improvement. This 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.     

The clinical concept of analytic process: A conceptual investigation1

The authors discuss the term ‘analytic process’, confi rming the variability of the meanings ascribed to it. Although all the psychoanalysts of this and previous times acknowledge the existence of something called analytic process, as well as its importance, it has not been possible up to now to establish a consensual defi nition of it. The defi nitions are not only numberless, they also contradict one another. The possible advantages to analytic theory and practice proceeding from a uniform concept are incontrovertible. A review of the subject in the psychoanalytic literature has been performed. A conceptual study concerning the term, carried out among members of a psychoanalytic society affi liated to the IPA is presented, no consensual conceptualization for the term analytic process having been found. The subjects referred to the term as deriving from a variety of elements, some in common, but there was no agreement regarding the elements themselves. There was consensus regarding the role of the analytical relationship in the process, considered fundamental, as well as that of the extent to which the individual life experiences in that relationship defi ne the unique character acquired by the process within it.     

临床均势原则辨析——对临床科研方法的伦理思考

随机对照试验作为一种评价新疗法的可靠设计方法,开始逐渐被世界范围内的临床医生所广泛接受和采用,成为目前最重要的试验方法之一。RCT的运用应该遵循一定的伦理准则,即临床均势原则。围绕临床均势原则这一主题,对随机对照试验的方法论进行较为深入的伦理学思考。并对临床均势的内涵、伦理意义,以及这一伦理要求在实践中所引发的各种伦理争论加以探讨。     

Principles of good clinical practice (GCP) in clinical research

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained. 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.     

Ethical decision-making in research: Identifying all competing interests

Ethical dilemmas are the result of conflicts between potential benefits or harms for two or more competing interests. Therefore, ethical decision-making implies a responsibility to identify those interests, harms, and benefits. For this purpose, researchers have responsibilities to the research, the subjects of research, other researchers, the institution, society, the environment, and self.     

The co-constructed therapy alliance and the technical and tactical quality of the therapist interventions in psychotherapy

This study sought to describe a brief review of studies conducted on the therapeutic alliance, taking into consideration therapeutic process and outcomes. We seek to reflect about the need to encourage the communities who engage in and conduct research on clinical practice not only to implement surveys of empirically validated measures of therapeutic outcomes, but also make them a regular practice among all clinical mental health psychotherapists. We therefore suggest the following paradigm – the Practice Based on Evidence of Results (PBER) – as a way to improve the quality of technical and tactical interventions of psychotherapists     

Adapting Strauss and Corbin's grounded theory in clinical case study research in the field of counselling

Case study can be adopted when aiming to understand an individual's lived experience. Such experience produces rich and complex qualitative data for analysis, conducive to counselling and psychotherapy research. Furthermore, grounded theory (GT) can be adopted to produce a theory from qualitative data, fitting well with case study research that explores complex experiences regarding social, psychological and phenomenological processes. This paper aims to guide the counselling researcher to incorporate Strauss and Corbin's model into the main arena of qualitative counselling research. In addition, this paper draws on a multiple case study that adopted Strauss and Corbin's method and identified various phases in the GT process. The aim is to inform the reader how to put the iterative process and pragmatic theoretical sampling into practice to produce a robust theory from clinical case study data.     

The Evaluation of Psychoanalytical Practice in Stockholm

The authors discuss several surveys that cover the practices of psychoanalysts and psychotherapists in the Stockholm region. They compare these practices with other psychiatrists in both the private and the public sector. In addition, they discuss the results from an attempt towards continuous evaluation of psychoanalytical practices and their treatment standards including an evaluation of the development of individual psychoanalytical processes.     

Beyond conflict of interest: the responsible conduct of research

This paper reports data and scholarly opinion that support the perception of systemic flaws in the management of scientific professions and the research enterprise; explores the responsibility that professional status places on the scientific professions, and elaborates the concept of the responsible conduct of research (RCR). Data are presented on research misconduct, availability of research guidelines, and perceived research quality. 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, 5–6 April, 2002. The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency.     

The practice research network: Research into practice,practice into research

The purpose of the broader project on which this report is based was to utilize a Practice Research Network, an alternative to traditional clinical studies to 1) identify demographically one practice group, namely professional counselors in the United States, 2) describe their practice patterns, and 3) identify their client population and the efficacy of their clinical work through client outcomes based on actual client reports. This article describes the development of one such nation‐wide Practice Research Network (PRN) and provides some preliminary findings for each phase of the project. Use of the PRN model can help overcome the traditional “research to practice” gap and provide research results into community practice thus integrating outcomes measures into the daily practice of mental health professionals. During the early phases of this project, a software program was developed upon which the participating practitioners could identify the data elements within the parameters of the focus on their agreed‐upon research interests, enter data following client visits over time, and by comparing their own composite profiles and effectiveness with those of other participating practitioners who had clients presenting with similar diagnoses, could alter their own service delivery patterns, therapeutic interventions, or approaches while working with the clients and thereby improve the efficacy of their service. By participating, the practitioners benefited by access to downloadable and printable reports on profiles of 1) their specific clients, 2) their service delivery patterns, and 3) the outcomes or efficacy by their clients’ direct feedback. They were also able to compare these results with the composite data from other practitioners.     

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 role of scientific associations in promoting research integrity and deterring research misconduct

The nature of scientific societies’ relationships with their members limits their ability to promote research integrity. They must therefore leverage their strengths as professional organizations to integrate ethical considerations into their ongoing support of their academic disciplines. This paper suggests five strategies for doing so.     

Competing interests: The need to control conflict of interests in biomedical research

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. This paper is adapted from a lecture presented to a Symposium on Scientific Integrity, Warsaw, Poland, 23 November 1995. Daniel Steiner was Vice-President and General Counsel of Harvard University (1972–92) and in that capacity became familiar with conflict of interest issues. He is currently Counsel to the Boston law firm. Ropes and Gray, and is Adjunct Lecturer in Public Policy at the John F. Kennedy School of Government. Harvard University.     

Pluralistic approaches to the study of process and outcome in psychoanalysis. The LAC depression study: a case in point

Approaching process and outcome in psychoanalysis is a topic that touches on ambitious and complex epistemological and methodological issues. As discussed in the first part of the paper, in keeping with challenging epistemic considerations, it would seem appropriate to describe the specificity of psychoanalysis as a specific scientific discipline of the unconscious (spezifische Wissenschaft des Unbewussten, see LIT). Psychoanalysis, over its more than 100-year history, evolved a range of highly advanced research methods for investigating the specific object of its research, namely unconscious conflicts and fantasies. Hence, like many other scientific disciplines, contemporary psychoanalysis comprises a plurality of theories, methods of clinical treatments as well as a plurality of research topics. This position is discussed with reference to a model illustrating different forms of clinical and extra-clinical research in psychoanalysis. A major, ongoing comparative study of outcomes of psychoanalytical and cognitive behavioural, long-term treatments of chronically depressed patients, the so-called LAC-study, serves to illustrate the richness of contemporary research in psychoanalysis.     

Managing financial conflicts of interest in clinical research

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. 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.     

Mentors, advisors and supervisors: Their role in teaching responsible research conduct

Although the terms mentor and thesis advisor (or research supervisor) are often used interchangeably, the responsibilities associated with these roles are distinct, even when they overlap. Neither are role models necessarily mentors, though mentors are role models: good examples are necessary but not sufficient. Mentorship is both a personal and a professional relationship. It has the potential for raising a number of ethical concerns, including issues of accuracy and reliability of the information conveyed, access, stereotyping and tracking of advisees, and the abuse of power. Nevertheless, mentors can be critically important for professional success and are one of a number of elements that affect the responsible conduct of research. In addition, the community as a whole has a responsibility to mentor junior members. An earlier version of this paper was presented at a conference sponsored by the National Science Foundation on Mentoring and Research Values: Students as Vital Human Resources, Chicago, USA, March 1995.