https://bic.berkeley.edu/sites/default/files/Rossi_09_TMS%20safety%20review.pdf

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research

The Study of Man. By Michael Polanyi. Price, $1.75. Pp. 102. University of Chicago Press, 5750 Ellis Ave., Chicago 37, 1959. One subtitle to Polanyi's challenging and fascinating book might be The Evolution and Natural History of Error , for Polanyi is at pains to expunge what he believes to be the false notion contained in the contemporary view of science which treats it as an object and basically impersonal discipline. According to Polanyi not only is this a radical and important error, but it is harmful to the objectives of science itself. Another subtitle could be Farewell to Detachment , for in place of cold objectivity he develops the idea that science is necessarily intensely personal. It is a human endeavor and human point of view which cannot be divorced from nor uprooted out of the human matrix from which it arises and in which it works. For a good while

Personal Knowledge: Towards a Post-Critical Philosophy

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

/pdf/what-makes-clinical-research-ethical-1aaoil4fbl.pdf

What Makes Clinical Research Ethical

The biological existence of human beings has become political in novel ways. The object, target and stake of this new 'vital' politics are human life itself. The contemporary state does not 'nationalize' the corporeality of its subjects into a body politic on which it works en masse, in relation to the body politics of other states competing in similar terms. Biopolitics addresses human existence at the molecular level: it is waged about molecules, amongst molecules, and where the molecules themselves are at stake. Human beings in contemporary Western culture are increasingly coming to understand themselves in somatic terms – corporeality has become of the most important sites for ethical judgements and techniques. Biopolitics was inextricably bound up with the rise of the life sciences, the human sciences, clinical medicine. It has given birth to techniques, technologies, experts and apparatuses for the care and administration of the life of each and all, from town planning to health services.

/pdf/the-politics-of-life-itself-4278mv6s8b.pdf

The Politics of Life Itself

BIOMEDICAL RESEARCH POLICY COMMITTEE REPORT WAS PUBLISHED AS A SUPPLEMENT TO THE AUGUSTJOURNAL OF MEDICAL EDUCATION. A REPRINT IS ENCLOSED. REQUESTS FOR ADDITIONAL COPIES SHOULD BE ADDRESSED TO THISOFFICE. -COPIES ARE BEING SENT TO MEMBERS OF CONGRESS AND THE KEY MEMBERS OF THE ADMINISTRATION. CALLING UPON-YOUR SENATORSAND CONGRESSMEN TO TELL THE STORY OF THE ROLE. OF MEDICAL SCHOOLS IN BIOMEDICAL RESEARCH AND HEALTH CARE IS IMPORTANT.I STRONGLY URGE THAT YOU MAKE AN 411 APPOINTMENT TO SEE YOUR CONGRESSIONAL REPRESENTATIVES WHILE YOU ARE IN WASHINGTON FOR THE COUNCIL MEETINGON OCTOBER 29. UPON REQUEST WE CAN SUPPLY THE NAMES OF APPOINTMENT SECRETARIES AND PHONE NUMBERS OF YOUR SENATORS AND CONGRESSMEN. APPROPRIATIONS COMMITTEE ACTED WITH EXTRAORDINARY ALACRITY THIS YEAR. THE-NIH APPROPRIATION WAS INCREASED BY 242 MILLION DOLLARSOVER 1971, REPRESENTING A 142 MILLION DOLLAR INCREASE OVER. THE ADMINISTRATION BUDGET, THE BLUE SHEET ASCRIBES APPROPRIATIONS OUTCOME TO THE EFFECTIVENESS OF THE COALITION FOR HEALTH FUNDING UNDER THE LEADERSHIP OF JOHN A. D. COOPER.

The Association of American Medical Colleges

Medical training must at some point use live patients to hone the skills of health professionals. But there is also an obligation to provide optimal treatment and to ensure patients' safety and well-being. Balancing these two needs represents a fundamental ethical tension in medical educatio

http://disciplinas.stoa.usp.br/pluginfile.php/41034/mod_folder/content/0/Simulation_Based_Medical_Education__An_Ethical.10.pdf?forcedownload=1

Simulation-Based Medical Education: An Ethical Imperative

Our growing ability to alter brain function can be used to enhance the mental processes of normal individuals as well as to treat mental dysfunction in people who are ill The prospect of neurocognitive enhancement raises many issues about what is safe, fair and otherwise morally acceptable This article resulted from a meeting on neurocognitive enhancement that was held by the authors Our goal is to review the state of the art in neurocognitive enhancement, its attendant social and ethical problems, and the ways in which society can address these problems

/pdf/neurocognitive-enhancement-what-can-we-do-and-what-should-we-4vbrhm6leh.pdf

Neurocognitive enhancement: what can we do and what should we do?

Continuous quality improvement is an accepted mandate in healthcare services. The delivery of the best, evidence based quality of care ultimately depends on the competences of practitioners as well as the system that supports their work. Medical education has been increasingly called upon to insure providers possess the skills and understanding necessary to fulfill the quality mission. Patient safety has in the past five years rapidly risen to the top of the healthcare policy agenda, and been incorporated into quality initiatives. Demand for curricula in patient safety and transfer of safety lessons learned in other risky industries have created new responsibilities for medical educators. Simulation based medical education will help fill these needs. Simulation offers ethical benefits, increased precision and relevance of training and competency assessment, and new methods of teaching error management and safety culture.Established and successful simulation methods such as standardized patients and task t...

/pdf/patient-safety-and-simulation-based-medical-education-k8646jmc95.pdf

Patient safety and simulation-based medical education.

Detection of deception and confirmation of truth telling with conventional polygraphy raised a host of technical and ethical issues. Recently, newer methods of recording electromagnetic signals from the brain show promise in permitting the detection of deception or truth telling. Some are even being promoted as more accurate than conventional polygraphy. While the new technologies raise issues of personal privacy, acceptable forensic application, and other social issues, the focus of this paper is the technical limitations of the developing technology. Those limitations include the measurement validity of the new technologies, which remains largely unknown. Another set of questions pertains to the psychological paradigms used to model or constrain the target behavior. Finally, there is little standardization in the field, and the vulnerability of the techniques to countermeasures is unknown. Premature application of these technologies outside of research settings should be resisted, and the social conversation about the appropriate parameters of its civil, forensic, and security use should begin.

/pdf/emerging-neurotechnologies-for-lie-detection-promises-and-cwz3udwj4y.pdf

Paul Root Wolpe

Papers

Simulation-Based Medical Education: An Ethical Imperative

Neurocognitive enhancement: what can we do and what should we do?

Patient safety and simulation-based medical education.

Emerging Neurotechnologies for Lie-Detection: Promises and Perils

Treatment, enhancement, and the ethics of neurotherapeutics.