Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

Transition to comfort-focused care: Moral agency of acute care nurses

Background: Moving into the last phase of life comprises a developmental transition with specific needs and risks. Facilitating transitions is an important component of the work of nurses. When curative interventions are no longer helpful, nurses enact key roles in caring for patients and families. Aim: The aim of this study was to examine the experiences of registered nurses in acute care settings as they worked with patients and families to facilitate transition to comfort-focused care. Research design: Sampling, data collection, and data analysis were guided by constructivist grounded theory, chosen because of its strength in identifying and explicating social processes. Participants and context: A purposeful sample of 26 registered nurses working in acute care hospitals in one community in the northeastern United States participated in this study through semi-structured interviews. Ethical considerations: The study received approval from the university’s Institutional Review Board for the Protection of Human Subjects. Participants provided informed consent. Findings: Nurses facilitated transition to comfort-focused care by enacting their moral commitments to patients and families. They focused on building relationships, honoring patient self-determination, and maintaining respect for personhood. In this context, they discerned a need for transition, opened a discussion, and used diverse strategies to facilitate achieving consensus on the part of patients, family members, and care providers. Regardless of how the process unfolded, nurses offered support throughout. Discussion: Achievement of consensus by all stakeholders is critical in the transition to comfort-focused care. This study deepens our understanding of how nurses as moral agents utilize specific strategies to assist progress toward consensus. It also offers an example of recognizing the moral agency of nurses through listening to their voices. Conclusion: Increased understanding of effective nursing strategies for facilitating transition to comfort-focused care is essential for developing needed evidence for excellent care and strengthening end-of-life nursing education.

Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

Facebook Recruitment and the Protection of Human Subjects

Social and behavioral scientists increasingly use Facebook to recruit research participants. Given the everchanging social media landscape, it is important to consider the ethical principles of using such a strategy. The aims of this methodological article are to (a) examine Facebook recruitment in light of the ethical principles of the Belmont Report (respect for persons, beneficence, and justice), (b) describe ethical challenges that may be faced in Facebook recruitment, and (c) provide recommendations for researchers interested in adopting this recruitment method. Ethical challenges inherent in Facebook recruitment include selecting subjects fairly, privacy, and data security. Overall, Facebook is a beneficial resource for recruiting participants into research; however, researchers need to be aware of their responsibility in protecting human subjects.

Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018

In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking.

Research Ethics

In this chapter, students are presented with the many ethical dilemmas that can potentially confront social science researchers. Research ethics centers of two fundamental principles: 1) the protection of human subjects and 2) maintaining the integrity of the research process. Both of these principles are discussed in the context of popular culture and past transgressions of researchers, specifically the film Ghostbusters, the Tuskegee experiments, and Milgram experiments.

Adolescents and Teachers as Partners in a School-Based Research Project to Increase Physical Activity Opportunities in a Rural Community

Schools are an important resource in combating the physical inactivity and obesity epidemics in rural economically depressed areas. Through a University-community partnership, teachers and adolescents in a rural West Virginia county with one of the highest obesity rates in the state developed a school-based research intervention to increase physical activity opportunities. The intervention included walking routes, educational sessions, and pedometers. A survey about barriers to physical activity revealed that “lack of willpower” was a barrier of concern among program participants (mostly school employees) and had a statistically significant (p = .0033) pre to post mean score decrease during the year two offering. Focus groups with the adolescent researchers revealed that pedometers may facilitate maintenance of physical activity and a broader community impact. Focus group dialogue combined with teacher-researcher perspectives suggested that the adolescents changed their weight control paradigm from “dieting” to include the critical role of energy expenditure. Approval to conduct this research was provided by the West Virginia University Institutional Review Board for the Protection of Human Subjects Protocols No. 16041 and 15632. A poster based on this paper was presented at the 135th Annual Meeting & Exposition of the American Public Health Association, Washington, DC, November, 2007. The authors are very appreciative of the HSTA students for their continued efforts in addressing important public health problems in their community. The project described was supported by funds from the Centers for Disease Control and Prevention (CDC) Grant Award No. H75CCH322130-02 through the West Virginia University Prevention Research Center and by Grant Number 2R25RR12329-04 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC, NCRR, or NIH.