ABSTRACT
Scientists in earlier times considered personal research participation an essential component of their work.Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies.Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research.But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as a study subject, investigators and other research professionals can obtain valuable information about their work.
Subject(s)
Autoexperimentation/ethics , Human Experimentation/ethics , Autoexperimentation/history , Education, Medical/methods , Ethics, Research , Health Knowledge, Attitudes, Practice , History, 19th Century , History, 20th Century , Humans , Moral ObligationsABSTRACT
Many people assume that invasive research on animals is justified because of its supposed benefits and because of the supposed mental inferiority of animals. However probably most people would be unwilling to sign a living will which consigns themselves to live biomedical experimentation if they ever, through misfortune, end up with a mental capacity equivalent to a laboratory animal. The benefits would be greater by far for medical science if living will signatories were to be used, and also the mental superiority boast would no longer apply. Ultimately, it is argued that invasive biomedical experiments would be unacceptable in a democratic society whose members are philosophically self-consistent.
Subject(s)
Animal Experimentation/ethics , Animal Rights , Animal Use Alternatives/ethics , Autoexperimentation/ethics , Cognition , Ethical Analysis , Ethical Theory , Living Wills/ethics , Species Specificity , Animals , Animals, Laboratory/psychology , Behavior, Animal , Disease Models, Animal , Human Experimentation/ethics , Humans , Living Wills/classification , Mammals , Mental Competency , Public Opinion , Stress, PsychologicalABSTRACT
It is particularly within the past three decades that increased attention has been focused on human experimentation, both in regard to the scientific design that ensures the greatest chance of success and to conformity to ethical principles that are most likely to receive public approbation. The story of man's experimentation on man dates back to prehistoric times. In the past two centuries, these investigations have been carried out at an increasing level of sophistication. In this saga, the narratives of the auto-experimenters define a special group of investigators, to many of whom the term "heroic" can be applied. When investigators involve themselves as subjects of their research, a situation of informed consent is often assumed to exist. Discussions concerning voluntarism and ethical propriety have been much less voluminous when the investigators have themselves been subjects that when this is not so. It is within the past half century that physiologists particularly have often been auto-experimenters, and Dr. Earl Wood belongs to the best of this illustrious group.
Subject(s)
Autoexperimentation , Clinical Competence , Human Experimentation , Nontherapeutic Human Experimentation , Physiology/history , Research Personnel , Research Subjects , Volition , Cardiac Catheterization/history , Ethical Review , Ethics , Ethics, Medical/history , History , History, 20th Century , Humans , Motivation , Mythology , Patient Selection , Risk , Risk Assessment , United States , VolunteersABSTRACT
Ackerman reviews three recent books on moral issues in human research: Who Goes First? The Story of Self-Experimentation in Medicine, by Lawrence K. Altman (Random House; 1987); The Patient as Partner: A Theory of Human-Experimentation Ethics, by Robert M. Veatch (Indiana University Press; 1987); and Ethics and Regulation of Clinical Research, 2d ed., by Robert J. Levine (Urban & Schwarzenberg; 1986).
Subject(s)
Human Experimentation , Altruism , Autoexperimentation , Beneficence , Deception , Ethics , Freedom , Humans , Informed Consent , Moral Obligations , Nontherapeutic Human Experimentation , Patient Selection , Patients , Personal Autonomy , Research Personnel , Research Subjects , Researcher-Subject Relations , Social Justice , Social Responsibility , VolunteersABSTRACT
Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.
Subject(s)
Healthy Volunteers , Nontherapeutic Human Experimentation/ethics , Nontherapeutic Human Experimentation/legislation & jurisprudence , Autoexperimentation/ethics , Autoexperimentation/legislation & jurisprudence , Comprehension , Ethics Committees, Research , Government Regulation , Healthy Volunteers/legislation & jurisprudence , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence , Humans , Informed Consent , Paternalism , Research Subjects , Risk Assessment , United StatesSubject(s)
Aflatoxin B1/pharmacokinetics , Aflatoxin M1/pharmacokinetics , Autoexperimentation , Human Experimentation , Risk Assessment , Aflatoxin B1/adverse effects , Aflatoxin M1/adverse effects , Animals , Biomarkers, Tumor/urine , Ethics Committees, Research , Ethics, Medical , Humans , Liver Neoplasms, Experimental/chemically induced , Liver Neoplasms, Experimental/urine , Patient Selection , Research SubjectsSubject(s)
Human Experimentation , Patients , Persons , Risk Assessment , Risk , Vulnerable Populations , Altruism , Autoexperimentation , Beneficence , Child , Chronic Disease , Dementia , Disclosure , Emergency Medical Services , Federal Government , Government , Government Regulation , Humans , Informed Consent , Institutionalization , Mental Competency , Mentally Ill Persons , Neoplasms , Nontherapeutic Human Experimentation , Patient Selection , Persons with Mental Disabilities , Pharmaceutical Preparations , Placebos , Research , Research Design , Research Subjects , Social Control, Formal , Social Justice , Terminally Ill , Therapeutic Human Experimentation , United StatesSubject(s)
Chimera , Embryo Research , Research , Stem Cells , Animals , Autoexperimentation , Cloning, Organism , Embryo, Mammalian , Human Experimentation , Humans , Industry , Research Embryo Creation , Research PersonnelSubject(s)
Autoexperimentation , Human Experimentation , Nontherapeutic Human Experimentation , Physicians , Research Personnel , Research Subjects , Volunteers , Anemia , Humans , Motivation , Risk , Risk Assessment , VitaminsABSTRACT
Apresentar um tratamento homeo-pático de úlcera de córnea por ceratoconjuntivite primaveril, considerando-o bioeticamente. MÉTODOS: foram usados nove casos, encami-nhados por insucesso terapêutico convencional. Escolheram-se os medicamentos de acordo com características singularizantes dos pacientes que incluíram o psiquismo. Levantaram-se os custos medicamentosos consultando-se três farmácias homeopáticas e três não-homeopáticas de Belo Horizonte. O tratamento convencional foi estimado a partir da medicação usada pelos enfermos antes do início dos cuidados homeopáticos. RESULTADOS: as cicatrizações ocorreram entre quinze e cento e oitenta dias, com custo medicamentoso médio de oito dólares, cerca de treze vezes menor do que a estimativa de custo direto de um mês da abordagem convencional. O manejo terapêutico da similitude pode minimizar preocupações bioéticas relativas à atenção à saúde de crianças com ceratoconjuntivite primaveril. CONCLUSÕES: a homeopatia pode colaborar para o tratamento desta enfermidade, aprimorando-o bioeticamente...
Present a homeopathic treatment of corneal ulcers for vernal keratoconjunctivitis and its bioethical implications. METHODS: nine cases were studied, after having been referred following the failure of conventional treatments. Medications were chosen according to the specific characteristics of the patients, including psychiatric disorders. The medication costs were gathered by consulting three homeopathic and three non-homeopathic pharmacies in Belo Horizonte. The estimate for conventional treatment cost was based on the medication prescribed for the patient prior to the commencement of homeopathic care. RESULTS: scarring occurred between fifteen and one-hundred eighty days, with an average medication cost of eight dollars, roughly one-thirteenth of the estimated direct cost of one month of conventional treatment. The similarity of therapeutic approaches should minimize bioethical concerns regarding the medical care of children with vernal keratoconjunctivitis. CONCLUSIONS: homeopathy can contribute to both the medical and bioethical aspects of treatment of this disease...
Subject(s)
Humans , Male , Child , Conjunctivitis, Allergic/therapy , Homeopathy , Mechanisms of Action of Homeopathic Remedies , Corneal Ulcer/therapy , Bioethics , Human Experimentation , Experiment of Substances , Principle of SimilarityABSTRACT
Ciertamente, un medicamento debe ser administrado en un cuerpo sano sin ninguna sustancia extraña; cuando el olor y el sabor hayan sido examinados debe tomarse una pequeña dosis y llevar un registro de cada uno de los cambios que se pudieran presentar, tanto en el pulso, la temperatura, la respiración y las secreciones.Una vez analizados los síntomas encontrados en una persona se puede entonces proceder a probarse en el cuerpo de una persona enferma.
Certainly, a drug must be administered in a healthy body without any foreign substance; when the smell and taste have been examined must take a small dose and keep a record of each of the changes that may arise, both the pulse, temperature, breathing and secreciones.Una after analyzing the symptoms found in a person can then proceed to try on in the body of a sick person.
Subject(s)
Experiment of Substances/methods , Homeopathy , Homeopathic Pathogenesy , Controlled Clinical Trials as Topic/methods , Clinical Trials as Topic/methods , Human Experimentation , Materia Medica, PureABSTRACT
Ciertamente, un medicamento debe ser administrado en un cuerpo sano sin ninguna sustancia extraña; cuando el olor y el sabor hayan sido examinados debe tomarse una pequeña dosis y llevar un registro de cada uno de los cambios que se pudieran presentar, tanto en el pulso, la temperatura, la respiración y las secreciones.Una vez analizados los síntomas encontrados en una persona se puede entonces proceder a probarse en el cuerpo de una persona enferma. (AU)
Certainly, a drug must be administered in a healthy body without any foreign substance; when the smell and taste have been examined must take a small dose and keep a record of each of the changes that may arise, both the pulse, temperature, breathing and secreciones.Una after analyzing the symptoms found in a person can then proceed to try on in the body of a sick person. (AU)
Subject(s)
Homeopathy , Experiment of Substances/methods , Homeopathic Pathogenesy , Human Experimentation , Controlled Clinical Trials as Topic/methods , Materia Medica, Pure , Clinical Trials as Topic/methodsABSTRACT
De una manera clara, directa y muy didáctica, los autores de este trabajo realizan un recorrido por los principios que configuran la estructura de la filosofía homeopática, rescatando muchos de los conceptos inscritos en algunas de las obras literarias del célebre Higinio G. Pérez, fundador de la Escuela Libre de Homeopatía, y del fisiólogo norteamericano Walter Bradford Cannon, los cuales, por supuesto, son coincidentes con muchos de los preceptos hipocráticos y hahnemaniannos. Para complementar su análisis, los investigadores refieren las opiniones de algunos otros científicos (fisiólogos y biólogos) y citan de manera textual diversos parágrafos del doctor Samuel Hahnemann, al tiempo que expresan su opinión sobre la vigencia de dichas premisas en la época moderna. (AU)
In a clear direct and very didactic manner the authors of this paper perform a journey by the principles that configure the philosophical structure of homeopathy, recovering many of the concepts written in various of the literary works of the notorious physician Higinio G. Pérez, founder of the Homeopathic Free Scholl and from the north American physiologist Walter Bradford Cannon, which of course, are coincidental with most of the Hippocratic an Hanemanniann precepts. In order to complete their analysis, these researchers refer the opinions of some other scientists (Physiologist and Biologists) and quoted verbatim various paragraphs of Dr. Samuel Hahnemann, at the same time, that they state their personal opinion on the validity of these assumptions in modern times. (AU)
Subject(s)
Homeopathy , Homeopathic Philosophy/history , Human Experimentation , Medicamentous Diagnosis , Small DosesABSTRACT
De una manera clara, directa y muy didáctica, los autores de este trabajo realizan un recorrido por los principios que configuran la estructura de la filosofía homeopática, rescatando muchos de los conceptos inscritos en algunas de las obras literarias del célebre Higinio G. Pérez, fundador de la Escuela Libre de Homeopatía, y del fisiólogo norteamericano Walter Bradford Cannon, los cuales, por supuesto, son coincidentes con muchos de los preceptos hipocráticos y hahnemaniannos. Para complementar su análisis, los investigadores refieren las opiniones de algunos otros científicos (fisiólogos y biólogos) y citan de manera textual diversos parágrafos del doctor Samuel Hahnemann, al tiempo que expresan su opinión sobre la vigencia de dichas premisas en la época moderna...
In a clear direct and very didactic manner the authors of this paper perform a journey by the principles that configure the philosophical structure of homeopathy, recovering many of the concepts written in various of the literary works of the notorious physician Higinio G. Pérez, founder of the Homeopathic Free Scholl and from the north American physiologist Walter Bradford Cannon, which of course, are coincidental with most of the Hippocratic an Hanemanniann precepts. In order to complete their analysis, these researchers refer the opinions of some other scientists (Physiologist and Biologists) and quoted verbatim various paragraphs of Dr. Samuel Hahnemann, at the same time, that they state their personal opinion on the validity of these assumptions in modern times...
Subject(s)
Humans , Homeopathic Philosophy/history , Homeopathy , Human Experimentation , Medicamentous Diagnosis , Small DosesABSTRACT
An extensive research project is described, during which resentment and hostility were aroused due to the data gathering methods. Those effects disturbed the smooth running of the project and led to subjects withdrawing from some experiments. Although the entire project had many positive features, those that are reported here detracted from its complete success. The negative features should be heeded by others who wish to improve the quality of their experimental work with human beings, otherwise the unintended stress of experimentation might restrict subject participation and disrupt data collection.
Subject(s)
Acclimatization , Expeditions , Human Experimentation , Interpersonal Relations , Adult , Antarctic Regions , Autoexperimentation , Humans , Internationality , Middle Aged , Patient Selection , Research Subjects , Risk AssessmentABSTRACT
The Nuremberg Code is a foundational document in the ethics of medical research and human experimentation; the principle its authors espoused in 1946 have provided the framework for modern codes that address the same issues, and have received little challenge and only slight modification in decades since. By analyzing the Code's tragic genesis and its normative implications, it is possible to understand some of the essence of modern experimental ethics, as well as certain outstanding controversies that still plague medical science.
Subject(s)
Codes of Ethics , Ethics, Research , Evaluation Studies as Topic , Human Experimentation , Autoexperimentation , Humans , Informed Consent , National Socialism , Nontherapeutic Human Experimentation , Risk Assessment , Therapeutic Human ExperimentationABSTRACT
The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules.