Abstract
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.
Self-experimentation, ethics, and regulation of vaccines Guerrini, Christi J; Sherkow, Jacob S; Meyer, Michelle N ...
Science (American Association for the Advancement of Science),
09/2020, Volume:
369, Issue:
6511
Journal Article
Abstract Objectives This study aims to (1) elucidate whether the Hawthorne effect exists, (2) explore under what conditions, and (3) estimate the size of any such effect. Study Design and Setting ...This systematic review summarizes and evaluates the strength of available evidence on the Hawthorne effect. An inclusive definition of any form of research artifact on behavior using this label, and without cointerventions, was adopted. Results Nineteen purposively designed studies were included, providing quantitative data on the size of the effect in eight randomized controlled trials, five quasiexperimental studies, and six observational evaluations of reporting on one's behavior by answering questions or being directly observed and being aware of being studied. Although all but one study was undertaken within health sciences, study methods, contexts, and findings were highly heterogeneous. Most studies reported some evidence of an effect, although significant biases are judged likely because of the complexity of the evaluation object. Conclusion Consequences of research participation for behaviors being investigated do exist, although little can be securely known about the conditions under which they operate, their mechanisms of effects, or their magnitudes. New concepts are needed to guide empirical studies.
Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and ...supervised bureaucracies called "institutional review boards" (IRBs). Do -- can -- these IRBs do more harm than good? InThe Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience -- the law's learning about regulation -- and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging -- universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.
Proactive, that is, unsolicited, prosociality is a key component of our hyper-cooperation, which in turn has enabled the emergence of various uniquely human traits, including complex cognition, ...morality and cumulative culture and technology. However, the evolutionary foundation of the human prosocial sentiment remains poorly understood, largely because primate data from numerous, often incommensurable testing paradigms do not provide an adequate basis for formal tests of the various functional hypotheses. We therefore present the results of standardized prosociality experiments in 24 groups of 15 primate species, including humans. Extensive allomaternal care is by far the best predictor of interspecific variation in proactive prosociality. Proactive prosocial motivations therefore systematically arise whenever selection favours the evolution of cooperative breeding. Because the human data fit this general primate pattern, the adoption of cooperative breeding by our hominin ancestors also provides the most parsimonious explanation for the origin of human hyper-cooperation.
This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to ...scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.
Shortly after Pearl Harbor, the Japanese Imperial Army invaded the Dutch East Indies, now known as Indonesia. A deceitful campaign promoting Asian brotherhood recruited and coerced young Indonesian ...men to support the Japanese occupation with the sinister outcome that several million of them were worked to death or summarily killed as expendable slave laborers, orromusha, as they were called.
While many romusha disappeared from the record, nine hundred were known victims of a brutal and immoral medical experiment perpetuated by an increasingly desperate Imperial Japan. In anticipation of a land assault, the Japanese needed a means to protect their troops from tetanus, and they used these nine hundred men as human guinea pigs to test an insufficiently vetted vaccine. Within days, all nine hundred suffered the protracted, agonizing death of acute tetanus.
With the Allied forces poised for victory, the Japanese needed a scapegoat for this well-documented incident if they were to avoid war-crimes prosecution. They brutally tortured Achmad Mochtar, a native Indonesian and renowned scientist, along with his colleagues at the Eijkman Institute in Batavia (now Jakarta), until Mochtar signed a confession to the murders in exchange for the liberty of his fellow scientists. The Japanese beheaded Mochtar weeks before the war ended.War Crimes in Japan-Occupied Indonesiaunravels the deceit of the Japanese Army, the reasons for the mass murder of the romusha, and Mochtar's heroic role in these tragic events. The end result finds justice for Mochtar and reveals the true extent of one of the least recognized war crimes of World War II.
The dysregulation of human subjects research Fost, Norman; Levine, Robert J
JAMA : the journal of the American Medical Association,
2007-Nov-14, Volume:
298, Issue:
18
Journal Article
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