The Ethical Standard of Care

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research—social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.     

Early stopping of clinical trials: charting the ethical terrain

The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.     

Control groups in psychosocial intervention research: ethical and methodological issues

This article summarizes a National Institute of Mental Health (NIMH) workshop that was convened to address the ethical and methodological issues that arise when conducting controlled psychosocial interventions research and introduces 6 thoughtful and inspiring papers presented by workshop participants. These papers, on topics ranging from informed consent to ethnic minority issues, reflect the depth and breadth of expertise represented by the multidisciplinary group of scientists and ethicists present at the meeting. More extensive follow-up, particularly from federal research applications and publications, of how investigators balance the need for strong research design with ethical considerations may help advance the science of psychosocial intervention research.     

Collaborative healthcare research: Some ethical considerations

This article reviews some of the ethical aspects of collaborative research. Scientific collaboration has known potential benefits but it’s a challenging task to successfully accomplish a collaborative venture on ethically sound grounds. Current trends in international healthcare research collaboration reflect limited benefits for the majority of world population. Research collaboration between scientists of academia and industry usually has financial considerations. Successful cross-cultural and international collaborations have to overcome many regional and global barriers. Despite these difficulties, many scientific collaborations usually begin with an informal meeting or contact. With advancement in global communications, scientists have greater responsibility towards the world community while considering the impact of their collaborative partnerships. I review the basic factors that are required for forging a collaborative partnership and responsible attitudes to sustain the relationship. Finally I conclude that scientists in healthcare research can play important roles beyond collaborations and contribute to bringing harmony, resolving differences across the nations and countries in today’s troubled world.     

Toward a hermeneutic model of ethical decision making in clinical practice

Documented ethical violations and empirical research have demonstrated that, despite professional standards and formal training in ethical principles, some psychotherapists engage in unethical behaviors that compromise the welfare of clients. It appears that competing values and interests that emerge in the therapeutic endeavor can interfere with therapists' considerations of ethical standards and their willingness to act ethically. Expanding current models of ethical decision making, this article offers a hermeneutic model that recognizes that in addition to moral reasoning, the context of the therapeutic relationship and the therapist's subjective responses are fundamental considerations in the interpretation and application of ethical interventions. Implications for understanding and training of ethics in psychotherapy in this broader context are explored.     

Towards ethical decision-making in counselling research

This paper explores the process of ethical decision-making in counselling research and asks the question: after following ethical guidelines, reviewing ethical principles and consulting codes of practice, to what extent is our decision-making based on intuitive thinking? The paper begins by examining Kitchener's model of ethical justification and the ethical principles upon which it rests. Bond's approach to ethical problem-solving is also considered. The second part of the paper explores the sequential decision-making process suggested by Gellatt, upon which both the Kitchener and Bond models seem to rest, and compares this with Gellatt's later revision of his model. The process by which we arrive at an ethical decision is then explored in relation to these. The final part of the paper argues that we reach ethical decisions through intuition, informed by ethical principles, codes of practice and reference to the laws of society. In order to safeguard the well-being of our clients and/or research participants, we need to be aware of this and offer up our decision-making process to the scrutiny of peers and the public at large. Although much of the paper explores this process at a general level, research undertaken into children's perception of stress will be used as an example.     

Neuroimaging of emotion and personality: scientific evidence and ethical considerations

Affective neuroscience has seen an explosion of research efforts using modern neuroimaging approaches to uncover the neural basis of emotion and personality. The first section of this paper reviews studies from the domains of affective and forensic neuroimaging. These studies illustrate some of the topics likely to be the subject of future ethical debates. The second section relates limitations of the neuroimaging approach to ethical considerations in predicting future psychopathology on the basis of brain state analysis.     

Reporting and referring research participants: ethical challenges for investigators studying children and youth

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research-derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsiblity. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care.     

Scientific rewards and conflicts of ethical choices in human subjects research.

The primary responsibility of the American Psychological Association's (APA) Committee on Standards in Research (CSR) is to advise the APA on issues and standards related to the protection of human participants in psychological research. A related goal is to enhance the use of good ethical practices by APA members. The purpose of this article is to foster the view of research ethics not as an affront to the integrity of sound research, but as opportunities for scientific rewards, including increased understanding of the meaning of data, enhanced recruitment, and the inclusion of more representative samples. Three ethical practices are discussed as examples of this general premise: respect for confidentiality, use of debriefing, and assurance that participants are noncoerced volunteers. The Committee's intent is to promote consideration of these issues, not to promulgate specific guidelines or procedures.     

Health Research in Complex Emergencies: A Humanitarian Imperative

Health researchers, research trainees, and ethics reviewers should be prepared for the special application of research ethics within complex humanitarian emergencies. This paper argues that as a precursor to published ethical guidelines for conducting research in complex emergencies, researchers and research ethics committees should observe the following primary ethical considerations: (1) the research is not at the expense of humanitarian action; (2) the research is justified in that it is needs-driven and relevant to the affected populations; and (3) the research does not compromise the humanitarian principles of neutrality, impartiality and independence. These primary considerations are in harmony with the humanitarian goals of saving lives, alleviating suffering, and témoignage. Furthermore, there is an important role for research in supporting humanitarian action, and the extreme vulnerability of research participants in complex emergencies demands intense research ethics scrutiny. It is important to discern which ethical considerations are essential, and which are merely desirable, as excessive research ethics requirements may impede life-saving research.     

Some ethical dilemmas in sensitivity training, encounter groups and related activities

Some ethical dilemmas in connection with sensitivity training, encounter groups and related activities are discussed. We distinguished between pre-group, in-group and post-group dilemmas. Pre-group dilemmas consisted of competence of leader, screening of participants, contract, voluntary participation, conflicting roles, organization of group work and conducting of research. In-group dilemmas were optimum level of awareness, leadership style and personality, image of man, issue of "casualties", confidentiality and freedom to make errors. Post-group dilemmas included "re-entry" difficulties, repression of changing individuals and follow-up procedures. Conclusions were as follows: ( a ) There exist indeed a series of ethical dilemmas in conducting growth groups. ( b ) The good group leader must learn to live with this seemingly chronic ethical dissonance. ( c ) The one most significant ethical guideline is to establish the optimum level of awareness in the group. ( d ) There is a pressing need for more adequate research on such ethical dilemmas.     

Sham surgery: An ethical analysis

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.     

Sham surgery: an ethical analysis

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.     

Parental consent for psychological evaluations: Legal,ethical and practical considerations

This article explores the legal, ethical, and practical considerations underlying the requirement for acquiring parental consent prior to a psychological assessment of children in school settings. Publ. L. 94-142 now mandates that parents for all children potentially labeled as handicapped give permission for a preplacement evaluation. This article reviews in detail specific aspects of that mandate, argues that this procedure be generalized to all situations where psychologists propose to evaluate children by reviewing both current ethical codes and standards for practice and public policy which favors such an undertaking. Finally, the authors indicate methods for implementing the mandate by discussing such issues as who should obtain consent and what information parents should receive prior to giving consent.     

The ethical practice of Web C ounseling

The emergence of on-line counselling services for addressing problems ranging from poor self-esteem, stressful relationships and addictions raises serious ethical concerns in this new electronic venue. A number of ethical considerations are discussed. The evolution of the National Board of Certified Counselors' Standards for the Ethical Practice of WebCounseling is described.     

Reporting ethical practices in journal articles

Little attention has focused on the reporting of ethical research practices in journal articles. In Study 1, published articles in 2 psychopathology journals were reviewed to ascertain the types of ethical research information that were reported. In Study 2, a survey was sent to authors in Study 1 to determine which ethical practices they engaged in, if they reported this information, and reasons for not including this information in their article. In general, there is a great variability regarding the types of ethical research practices reported in journal articles. Commonly cited reasons for not including ethical research practice information in the articles included the need for brevity, belief that it was common practice, and lack of relevance for the project. These results suggest that there is no standard practice for reporting research practices in journal articles and great variability in the implementation of procedures that are generally considered standard.     

Universal ethical principles in a diverse universe: a commentary on Monshi and Zieglmayer's case study

Monshi and Zieglmayer's case study presents Sri Lankan participants as having views on the privacy of health information that differ radically from those commonly found in Western nations. This article explores 2 questions that their case study raises for the ethical review of research in international settings: First, are allegedly universal ethical principles--of the sort promulgated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978)--useful in international settings?, and second, how should research oversight bodies address the challenges that arise in international behavioral and social science research?     

A review of the concurrent-chains arrangement to assess intervention choice: 2018–2023

The purpose of this review is to summarize recent literature on the use of concurrent-chains arrangements in the assessment of preference for interventions (or intervention components) in the applied literature. The types of interventions and participants are described briefly, and procedural variations, ethical considerations, and recommendations for future research are discussed.