Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial

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.     

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.     

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.     

Perceived Risks and Benefits in a Text Message Study of Substance Abuse and Sexual Behavior

To inform ethical procedures for human subjects research using mobile health (mHealth), we examined perceived risks and benefits of study participation among emerging adults (N = 54) with drug use who completed text message assessments of substance use and sexual behaviors. Most participants reported comfort with participation and some reported perceived benefits, such as improved relationships. Perceived risks were infrequently reported, including negative emotions and legal or financial concerns. In conclusion, participants from a vulnerable population reported few perceived harms of participation in longitudinal mHealth assessments of sensitive behaviors. Researchers should continue characterizing participants’ perspectives on ethical aspects of mHealth research.     

Human Rights,Cultural Pluralism,and International Health Research

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry.     

For the Good of the Group? Balancing Individual and Collective Risks and Benefits in Community Psychology Research

Balancing risks and benefits is a necessary ethical task for social science researchers. Community psychologists must often consider risks and benefits not just for individual participants, but also for the group, system, or society that those individuals inhabit. Little ethical guidance currently exists for how to navigate this ethical challenge across these multiple levels. In this article, we use a case example of social network research incorporating multiple levels of analysis to identify common risks and benefits and understand their relationship to each other. We conclude by discussing distinctive ethical considerations revealed by this case example.     

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.     

Statistical Power,the Belmont Report,and the Ethics of Clinical Trials

Achieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense—it is ethically required in experiments when participants are at risk of harm. This paper argues that doing a power analysis effectively contributes to ensuring that a trial design is good. The ethical importance of good trial design has long been recognized for trials in which there is risk of serious harm to participants. However, whether the quality of a trial design, when the risk to participants is only minimal, is an ethical issue is rarely discussed. This paper argues that even in cases when the risk is minimal, the quality of the trial design is an ethical issue, and that this is reflected in the emphasis the Belmont Report places on the importance of the benefit of knowledge gained by society. The paper also argues that good trial design is required for true informed consent.     

Ethical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits

Previous research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood disorders. This article examines the ecological validity of ketamine trials, measures to protect patients, informed consent procedures, financial inducements to participants and conflict of interest of researchers, therapeutic misconception, concealment, and deception. Further recommendations are purposed to improve ethical standard of clinical research involving ketamine.     

Child abuse: is there a mandate for researchers to report?

During the past 20 years, states have increasingly expanded the lists of individuals who are obligated to report their suspicions of child abuse and neglect. These legal requirements are juxtaposed with ethical considerations in research and professional practice. The ethical issues include the obligation to maintain both confidentiality of information provided by human participants and the safety and protection of these participants. This article reviews the types of state child abuse reporting statutes and outlines the categories of mandated reporters. I develop a model of how individual researchers should approach deciding whether they are mandated reporters of child abuse and neglect.     

Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. In each case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants.     

The “Ethical” Professor and the Undergraduate Student: Current Perceptions of Moral Behavior among Business School Faculty

A survey of 830 faculty members at 89 AASCB-accredited business schools throughout the United States was conducted in Fall 2002 to develop a snapshot of perceptions of ethical and unethical conduct with regard to undergraduate business instruction across a wide range of business disciplines. These behaviors fell into such categories as course content, evaluation of students, educational environment, disrespectful behavior, research and publication issues, financial and material transactions, social relationships with students, and sexual relationships with students and other faculty. Of the 55 behaviors, two were almost universally perceived to be unethical. Eight behaviors were controversial in that there was wide variance on whether the behavior was perceived to be unethical. In addition, females' ethical perceptions differed significantly from males on three behaviors; older participants differed from younger participants on seven behaviors; participants at research-oriented institutions differed from participants at teaching-oriented institutions on one behavior; and tenured, untenured tenure-track, and untenured non-tenure-track participants differed on three behaviors. The findings of this study and the detailed comments of the respondents provide a starting point for discussing more systematic means to consider ethical issues within collegiate schools of business.     

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.     

Masked ball: Ethics,laws and financial contradictions in hungarian health care

Corruption is a major problem in the societies of the post-communist Central European countries. Corruption in health care has some unique characteristics undermining the efficacy of and respect for Hungarian health care. One of the forms of corruption is tipping. This highly contested phenomenon is present in most of the patient/health professional’s interactions in a sophisticated manner, raising serious ethical and legal dilemmas. The present paper analyzes tipping and other corruption-related factors, such as financial conflict of interest between industry and health care and argues that since ethical and legal considerations are often ignored in the country, patient care and clinical research are affected by these controversial issues to a great extent.     

Evaluating the therapeutic misconception

The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.     

Confidentiality issues in psychological research

There has been increased attention in recent years to the importance of individual privacy and professional confidentiality both in Australia and overseas. At the same time, psychologists' growing research interests in areas such as AIDS, child sexual abuse, and domestic violence have led to new ethical dilemmas over the contract of confidentiality between researchers and their research participants. The present paper discusses a number of issues regarding the ethics of confidentiality in psychological research. Following Bok (1989), the issues are highlighted within the context of four ethical principles that underlie researchers' obligations to preserve confidentiality. These principles are derived from considerations of privacy, loyalty, the pledge of silence, and professional codes of ethical standards. Each of these principles is illustrated with examples taken from recent research. We devote special attention to instances that appear to provide a clash between moral principles.     

Dating and Sexual Violence Research in the Schools: Balancing Protection of Confidentiality with Supporting the Welfare of Survivors

Rigorous research and program evaluation are needed to understand the experience of dating and sexual violence among youth and the impact of prevention and intervention efforts. Our dilemma in doing this work occurred when youth disclosed dating and sexual violence on a research survey. What responsibility do researchers have to protect survivors’ confidentiality as a research participant versus taking steps to ensure the student has the opportunity to access help? In our evaluation of a pilot dating violence prevention program, our protocols employed widely used procedures for providing resources to participants upon their completion of the survey and de‐identifying survey data. Upon reviewing preliminary survey results, we became concerned that these established procedures were not sufficient to support research participants who were adolescent survivors of dating and sexual violence. We followed a structured ethical decision‐making process to examine legal and ethical considerations, consult with colleagues, consider impacts and alternative solutions, and ultimately find a solution. Through this process, we developed procedures that balance participant confidentiality and the desire to support the welfare of survivors, which other researchers may want to employ when conducting youth sexual and dating violence research in school and community settings.     

Fight,Flight, or Remain Silent? Juggling Multiple Accountabilities throughout the Formative Stage of a Neighborhood Revitalization Initiative

This paper describes the experiences of a research team as they navigated uncertain ethical and political terrain throughout the formative stage of a public housing redevelopment project. Specifically, we discuss the challenges related to balancing multiple accountabilities and the tensions among the various roles and responsibilities that emanated from different accountabilities. Due to contractual obligations to our funding source, established relations with community partners, and an ethical imperative to align with those holding the least power, we grappled with embodying multiple and often conflicting roles. Without oversight provided by our university institutional review board or a clear ethical framework for community psychology research and action, our team was left to negotiate the challenges that emerged through critical reflection and financial considerations. Throughout the case example presented in this paper, we highlight our difficulty in ethical decision‐making with respect to the principles of obligation, disclosure, consent, commitment, and professionalism. Community psychologists often straddle the realms of academia, community partnerships, and conscious engagement with little guidance in navigating often conflicting roles and value systems. We present our narrative to highlight the complexity of scholar‐activism in the context of community psychology and the necessity for developing ethical standards and guidelines tailored to meet the unique needs of community psychologists.