Prisoners as Living Organ Donors

This chapter considers the special case in which a prisoner seeks to serve as a living donor and what lessons can be learned from human subjects protections for research participants given that both activities are done with the primary goal to benefit third parties. In the federal regulations that codify human subjects protections in the US (45 CFR 46), there are additional protections enumerated for research on prisoners. Current Department of Justice Federal Bureau of Prisons policy allows prisoners to serve as living donors but only for first-degree relatives. This chapter describes what special considerations should be assessed for prisoners to ethically serve as potential living donors using a vulnerabilities approach adapted from the human research subjects protection literature. The donor transplant team (living donor advocacy team) needs both a living donor advocate and a prisoner liaison to ensure that the potential prisoner-donor satisfactorily addresses the vulnerabilities faced by prisoners.

OBSTETRIC AND PSYCHOLOGICAL CARE FOR PREGNANT WOMAN WITH HYPEREMESIS GRAVIDARUM WITH MODERATE ANXIETY

Physical and psychological changes experienced by pregnant women, especially hormonal changes, cause symptoms of nausea and vomiting in early pregnancy. Excessive nausea and vomiting in early pregnancy and persist throughout pregnancy will cause physical and psychological complications. The existence of psychological problems in pregnant women can predispose to nausea and vomiting which then worsens. Emotional problems are also associated with the incidence of nausea and vomiting becoming more severe. Methods: the authors conducted extensive searches by scientific journals through trusted and frequently used databases, namely PubMed, Springer, and Science Direct. The keywords used were "hyperemesis" AND "psychological" with journal publication filters, the last 4 years, randomized clinical trials, systematic reviews, meta-analysis, human research subjects. Conclusion: care that focuses on mothers by applying the principles of holistic care, where patients not only receive midwifery care physically and biologically but include psychological, social, spiritual and cultural by involving their husbands in midwifery care is proven to accelerate the physical and psychological recovery of hyperemesis sufferers.

Care-full research ethics in multispecies relations on dairy farms

Although ethical questions are at the core of more-than-human geographies, more attention needs to be paid on researchers’ ethical responsibilities to more-than-human research subjects in social scientific research. In this paper I critically analyze my empirical work on Finnish dairy farms from the perspective of multispecies research ethics. I suggest that the concept of care is useful in understanding more-than-human research ethics. Attending to the needs of others can work as a starting point for making difficult ethical decisions in the field. However, in contested moments, different needs are often in conflict. Here, situated ethical responses might be needed in relation to the practices of fieldwork, for example to avoid causing harm to research subjects. Importantly, researchers have to care for their research subjects also through their analysis; addressing the questions related to research ethics also in terms of knowledge politics. When the ethics of care is complemented with the notion of ethics of exclusion, it has potential to tease out broader responsibilities both in interactions and knowledge about other animals and more-than-human research settings.

Compensation of subjects for participation in biomedical research in resource – limited settings: a discussion of practices in Malawi

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research.

Conflicts of Interest in Human Subject Research: The Insufficiency of U.S. and International Standards

Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It finds current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

The Shifting Aesthetics of Expertise in the Sharing Economy of Scientific Medicine

ArgumentThe deficit model of science communication assumes that the creation and dissemination of knowledge is limited to researchers with formal credentials. Recent challenges to this model have emerged among “e-patients” who develop extensive online activist communities, demand access to their own health data, conduct crowd-sourced experiments, and “hack” health problems that traditional medical experts have failed to solve. This article explores the aesthetics of medical media that enact the transition from a deficit model to a patient-driven model of visual representation and health communication. I present a framework for understanding the role of film and video in patient movements by analyzing the historical transition from researchers filming patients as nameless, voiceless human research subjects to patients recording their own health narratives through activist cinematography. By comparing several approaches to patient-centered video, I argue that imperfect production aesthetics play a critically important role in establishing the credibility of health communications.

Research coordinator networks and support models among academic health centers in the CTSA consortium

IntroductionResearch coordinators (RCs) are vital to the clinical research enterprise, ensuring research is conducted ethically, results are scientifically sound and human research subjects are protected. Given the absence of a prior systematic inquiry, we sought to understand the ways in which Clinical & Translational Science Award-funded academic health centers support RCs.MethodsOur survey asked questions about existing coordinator networks and where none existed, collected data on the characterization of resources and services provided to support RCs (outside of salary).ResultsFindings show 4 mechanisms support RCs: identification of the workforce, professionalization of the position, dissemination of information, and offering of services.ConclusionAn academic health center that wishes to deliver research training and services to their RC workforce will need identification and communication structures in place before supportive activities can be effectively implemented.

Neurosurgical Patients as Human Research Subjects: Ethical Considerations in Intracranial Electrophysiology Research

Intracranial electrical recordings and stimulation of neurosurgical patients have been central to the advancement of human neuroscience. The use of these methods has rapidly expanded over the last decade due to theoretical and technical advances, as well as the growing number of neurosurgical patients undergoing functional procedures for indications such as epilepsy, tumor resection, and movement disorders. These methods pose the potential for ethical conflict, as they involve basic neuroscientific research utilizing invasive procedures in human patients undergoing treatment for neurological illnesses. This review addresses technical aspects, clinical contexts, and issues of ethical concern, utilizing a framework that is informed by, but also departs from, existing bioethical literature on matters in clinical research. We conclude with proposals for improving informed consent processes to address potential problems specific to intracranial electrophysiology research, a general schema for scrutinizing research-related risk associated with different methods, and a call for the development of consensus to ensure continuing scientific progress alongside crucial patient protections in this promising area of human neuroscience.