A Qualitative Investigation of Provers' Experiences of Participation in Homeopathic Pathogenetic Trials.

BACKGROUND: Information on homeopathic medicines is derived from "provings" or homeopathic pathogenetic trials (HPTs), in which people (often homeopaths and homeopathy students) are invited to take an unnamed and often untested highly diluted and serially succussed substance, and record in detail their experiences and perceived effects. HPTs are assumed to have an "excellent safety record", but there has been no academic research to date into provers' experiences of participating in an HPT. AIMS: This qualitative study aimed to explore the lived experience of participation in an HPT. It is hoped that the results from this study will inform the future conduct of HPTs. METHODS: Semi-structured interviews were conducted in person, by phone or via Skype, according to the interviewees' preferences. Thematic analysis was used for the generation of themes. RESULTS: Eight former provers were interviewed from across the European Union (EU) and Australia. Of these, seven were practicing homeopaths and one was not a practitioner. Overarching themes were identified as: (1) the ethical conduct of HPTs, and (2) the impact of participation in HPTs. CONCLUSION: Former provers who participated in this study reported enthusiasm for, and trust in, the proving process. However, some also reported adverse events, which varied in intensity and duration. The process of gaining fully informed consent for participation in an HPT is complex and there were examples of both failure and inadequacy in terms of informed consent and support mechanisms. RECOMMENDATIONS: The researchers recommend that HPTs are subject to ethical approval processes and that consent is fully informed and ongoing. It is also recommended that appropriate and robust support mechanisms be developed.

[Informed consent analysis and its role in modern medicine]. / Analýza informovaného konsenzu a jeho role v moderní medicíne.

"Informed consent" is a term adopted by the contemporary medicine in all its fields. There may seem that it is a plain rendering of information to the patient followed by her/his decision about further procedures but the facts are different. Actually this relationship between patient and doctor has an intricate nature. It guarantees an ethical frame and structure of any treatment afforded to the patient and it covers all the possible dilemmas as conflicts of any two principles taken from any contemporary medical code while it allows no simple resolution. Individual steps require a compromise based on continuous discussion between both sides. In this process means controlled by the doctor and patients goals must be conscientiously distinguished since a goal or meaning of live is not an expertise of the doctor and the doctor is obliged solely to revere them whereas to develop means or tools (organon) in all its manners is on the other side her/his main task.

[Placebo and the relationship between doctors and patients. Overview]. / Placeboaspekte der Arzt-Patienten-Beziehung. Übersicht.

In medicine, placebos are used both in scientific studies and for practical therapeutic purposes. In evidence-based medicine, the efficacy of treatment may be determined as the difference between the effects of the verum (the active study drug) and the placebo, the latter being a substance lacking specific action on the disease under consideration. However, the improvements in patients' conditions under placebo treatment may be substantial and comparable to those with verum. Genuine placebos predominate in clinical studies, while pseudoplacebos prevail in practical therapy. The term pseudoplacebo can also be applied to many procedures in complementary medicine, including homeopathic medicine (Büchel et al., Placebo in der Medizin, 2011). The comprehensive definition of placebo, as used in a report by the German Medical Association (Büchel et al., Placebo in der Medizin, 2011), states that a placebo effect may occur even when treating with verum. The placebo effect is modulated by the context of the treatment, by the expectations of the patients and the doctors, and by the success of the relationship between doctors and patients. A number of unspecific effects, e.g., spontaneous alleviation, statistical effects, variance with time, methodological errors, in addition to the placebo effect make up the total response that is called"placebo reaction." A complete list of the effectiveness of placebo for all important diseases is still lacking. Further, it is not possible to predict which patients will respond to placebo. Which characteristics of doctors are important (competence, empathy, communicative ability and partnership, trust) in order to achieve a placebo effect, particularly in addition to the verum effect measures of evidence-based medicine? Are there doctors who are better in this than others? Could the nocebo effect weaken the efficacy of treatment in evidence-based medicine? Since a placebo effect may occur in almost any standard therapy, information about placebos should be provided during medical education and continuing medical education (CME). The use of placebo in clinical studies is ethically justified and lawful in consenting patients if there is no other effective treatment available with which the test substance could be compared. For daily practical therapeutic purposes, placebos may be ethically acceptable and lawful if there is no effective therapy available, if the complaints are minor, if the patient expressly wishes treatment, and if there is a reasonable likelihood of success. However, an explanation of the expected benefits and risks must be provided to the patients. At present, there are two explanatory theories for the mechanism of action of placebo, namely, the associative and the mentalistic explanation (Büchel et al., Placebo in der Medizin, 2011). Interestingly, effects of placebo and of verum can be localized in the brain by physiological and anatomical techniques. With many open questions remaining, research on placebo is currently very active. These aspect and neurobiological findings in particular may facilitate for "scientifically" educated doctors to accept that ineffective materials, i.e., placebos, are in fact effective.

Self-experimentation.

Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior investigators participate as research subjects.

Research with human subjects.

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).

[Special therapeutic processes from the viewpoint of the lawyer]. / Besondere Therapierichtungen aus der Sicht des Juristen.

The particular schools of therapy never have been exactly defined--neither by law nor by judicature. Despite being in contrast to the scientifically based classical medicine, its application is basically accepted by the judicature within the general scope of the therapeutic autonomy of the physician. There are however, special limitations to be observed by the naturopath in order to protect the patient. Thus, disciples of alternative schools of therapy must always consider carefully whether or not methods of the classical medicine should be preferred for the sake of the patient's health. In addition, they must inform the patient about all therapeutic alternatives. Special problems may arise if parents reject proven measures of the classical medicine to be applied to their minor children. In such a case the child's benefit has priority to the parent's rights.

Implications of the 'placebo effect' for CAM research.

The 'placebo effect' concept is intrinsic to the architecture of the double blind placebo randomised controlled trial (RCT), the oft quoted 'gold standard' method of clinical research whose findings are supposed to inform our understanding of the interventions used in clinical practice. The 'placebo effect' concept is often used in discussions of both clinical practice and clinical research, particularly when discussing why patients report improvements with complementary and alternative medicines (CAMs). Despite its frequent use, 'placebo effect' is a non-sequitur, thus confusion abounds. In routine healthcare patients are not told that they might receive placebo. However, in clinical trials the opposite is true. Telling people that they might receive a placebo really complicates things. The uncertainty invoked by information that a placebo may be given can impact trial recruitment, the delivery of the intervention, and the reporting of outcomes, as can the 'meaning responses' invoked by other types of information provided to patients in standard RCT designs. Future CAM research should consider alternative RCT designs that help ensure that participants' experiences are uncontaminated by 'meaning responses' to information that they may receive fake treatments, i.e. placebos.

La ficha clínica mirada desde la legislación chilena actual / Clinical record looked at from the current Chilean legislation / A ficha clínica vista a partir da legislação chilena atual

Resumen: La historia o ficha clínica ha servido de instrumento de registro de las actividades sanitarias desde el inicio de las profesiones de salud, otorgándosele diversas utilidades y valoraciones, según su objetivo, un valor docente, en investigación, judicial, entre otros. Ante las diferentes interpretaciones de las normas vigentes en Chile se ha debido legislar en su uso, pertenencia, contenido y otros aspectos, aclarando algunas situaciones pero restringiendo su acceso en otros aspectos. Dado las distintas leyes y normativas a las que se asocia su uso, se hizo necesario elaborar un documento que incluya sus aspectos más importantes. Aún quedan elementos asociados a las costumbres, creencias, especialidades en salud, entre otras, que no han sido abordados por las leyes, además de la labor docente de este instrumento.

Abstract: The history or clinical record has served as an element of registration of health activities since the beginning of the health professions, granting him other utilities and valuations according to their objective, as a teaching value, in research, judicial, among others. Given the different interpretations of the norms in force in Chile, it has had to legislate in its use, membership, content and other aspects of the clinical file, clarifying some situations, but restricting their access in other aspects. Given the different laws and regulations associated with its use, it became necessary to produce a document that collects its most important aspects. There are still aspects associated with customs, beliefs, specialties in health, among others, that have not been addressed by the Laws, in addition to the teaching work of this instrument.

Resumo: A história ou ficha clínica tem servido como instrumento de registro das atividades sanitárias desde o início das profissões de saúde, concedendo-se a elas vários utilitários e valorações de acordo com sua finalidade: ensino, pesquisa, valor jurídico, entre outros. Para as diferentes interpretações das normas vigentes no Chile havia de legislar em seu uso, composição, conteúdo e outros aspectos da ficha clínica, esclarecendo algumas situações, mas restringindo seu acesso em outros aspectos. Tendo em conta as diferentes leis e regulamentos aos quais o seu uso está associado, tornou-se necessário apresentar um documento que reúne os aspectos mais importantes. Existem ainda os aspectos associados a costumes, crenças, especialidades em saúde, entre outros, que não foram abordadas pelas leis, além do ensino deste instrumento.

Limits on risks for healthy volunteers in biomedical research.

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.

Consentimento informado: estratégia para mitigar a vulnerabilidade na assistência hospitalar / Informed consent: a strategy to mitigate vulnerability in hospital care / Consentimiento informado: estrategia para mitigar la vulnerabilidad en la asistencia hospitalaria

Resumo Este texto trata de identificar vulnerabilidade como característica inerente ao ser humano e apresentar o consentimento informado como estratégia para minimizá-la no contexto da assistência hospitalar. Sujeitos que vivenciam internação hospitalar têm seu padrão de vulnerabilidade ampliado por estarem em ambiente desconhecido, sobre o qual não possuem domínio nem conhecimento; e também por estarem subordinados ao médico, que tem poder para determinar condutas terapêuticas que podem comprometer a existência do paciente e seus projetos de vida. A vulnerabilidade pode ser reduzida por meio do consentimento informado, que prioriza informação, compreensão e possibilidade de deliberação e que respeita a autodeterminação do paciente na escolha do tratamento proposto. Nesse sentido, o consentimento informado é capaz de reduzir o padrão de vulnerabilidade do paciente em ambiente de internação hospitalar.

Abstract This text aims at identifying vulnerability as an inherent characteristic of human beings and introducing informed consent as a strategy to minimize it in the context of hospital care. Subjects who experience hospitalization are enclosed in an unknown environment upon which they have no control or knowledge. In addition, they are subordinate to the physician, who possesses the power to determine therapeutic conducts that may compromise their existence and life goals. As a result, their degree of vulnerability is increased. Vulnerability can be reduced through the informed consent that prioritizes information, understanding, possibility of deliberation and respects the patient’s self-determination in the choice of the proposed treatment. Thus, the application of the informed consent process can reduce the patient' s vulnerability pattern in a hospital environment.

Resumen Este texto trata acerca de la identificación de la vulnerabilidad como una característica inherente al ser humano y presenta al consentimiento informado como estrategia para minimizarla en el contexto de la asistencia hospitalaria. Los sujetos que atraviesan una internación hospitalaria tienen su patrón de vulnerabilidad ampliado porque se encuentran en un ambiente desconocido sobre el cual no poseen dominio ni conocimiento; y también porque están subordinados al médico, el cual tiene poder para determinar conductas terapéuticas que pueden comprometer su existencia y sus proyectos de vida. La vulnerabilidad puede reducirse mediante el consentimiento informado que da prioridad a la información, la comprensión, la posibilidad de deliberación y que respeta la autodeterminación del paciente en la elección del tratamiento propuesto. En este sentido, el empleo del proceso de consentimiento informado es capaz de reducir el patrón de vulnerabilidad del paciente en el ambiente de internación hospitalaria.

Protocolo de Atención Ortodóncica en Pacientes con Trastorno del Espectro Autista (TEA) / Orthodontic Care Protocol for Patients with Autistic Spectrum Disorder (ASD)

RESUMEN: Actualmente se observa un aumento en el número de personas con necesidades especiales en atención en salud, dentro de ellos, aquellos pacientes diagnosticados con trastorno del espectro autista, quienes presentan altos requerimientos de tratamiento ortodóncico a causa de maloclusiones. A pesar de que padres y/o cuidadores se encuentran motivados a mejorar su calidad de vida mediante el mejoramiento de la estética dento-facial y la función oral, también son pacientes que no son tratados en clínicas convencionales dado alguna dificultad en el comportamiento que presenten en una atención odontólogica. Por la enorme dificultad que se puede encontrar en la atención clínica, el presente trabajo indica un protocolo de atención ortodóncica en pacientes con trastorno del espectro autista, útil para realizar una completa ayuda de cada paciente que permita un adecuado diagnóstico, plan de tratamiento y pronóstico en la especialidad de ortodoncia.

ABSTRACT: There is currently an increase in the number of people with special oral health care needs, including those patients diagnosed with autism spectrum disorder who often require orthodontic treatment due to malocclusions. Although parents and / or caregivers are motivated to improve their quality of life by improving dento-facial aesthetics and oral function, these are also patients who do not receive treatment in conventional clinics due to behavioral problems they may present during dental care. In light of the difficulties that can be encountered during clinical dental care, the present study presents a protocol of orthodontic care in patients with autism spectrum disorder. The protocol is useful in that it allows an adequate diagnosis, treatment plan and prognosis in the orthodontic specialty required by each patient.

LA FORMALIZACIÓN DEL CONSENTIMIENTO INFORMADO EN INVESTIGACIÓN Y LA PÉRDIDA SENTIMENTAL DEL PACIENTE / FORMALIZATION OF INFORMED CONSENT IN RESEARCH AND THE PATIENT'S EMOTIONAL LOSS / A FORMALIZAÇÃO DO CONSENTIMENTO INFORMADO EM PESQUISA E A PERDA SENTIMENTAL DO PACIENTE

El consentimiento informado en investigación se inscribe en la relación médico-paciente, que ha sufrido, y sigue sufriendo, importantes cambios: desde el planteamiento clásico, como relación de amistad, al planteamiento contemporáneo, como relación entre extraños (enemigos potenciales, siguiendo tesis ilustradas sobre la sociedad), que es regulada por normas éticas y legales. El principal objetivo de estas últimas es conseguir, mediante requisitos formales, que dicha relación no perjudique al paciente. Bajo esta luz, se examina y compara el consentimiento informado en las principales normativas internacionales y en la ley española. Especialmente, nos centramos en la hoja de información al paciente, la comprensión, la voluntariedad, la certificación y la comunicación de los resultados de la investigación. Se concluye con la observación de la seria limitación intrínseca de la que adolecen estas normativas, que impiden, más que favorecen, el trato adecuado al paciente.

Informed consent for research is part of the doctor-patient relationship, which has suffered and continues to suffer important changes. These range from the classic approach, such as friendship, to the contemporary approach, namely, a relationship between strangers (potential enemies, according to illustrated notions of society) regulated by ethical and legal standards. The primary objective of these standards is to ensure, through formal requirements, that the relationship does not harm the patient. With this perspective in mind, the study examines and compares informed consent in light of the most important international standards and under Spanish law. There is a particular focus on the patient information sheet, understanding, willingness, certification and communication of research results. The study concludes there are serious inherent constraints in these regulations that prevent rather than promote treating the patient properly.

O consentimento informado em pesquisa está apoiado na relação médico-paciente, que sofreu, e continua sofrendo, importantes mudanças: da proposta clássica, como relação de amizade, à proposta contemporânea, como relação entre estranhos (inimigos potenciais, seguindo teses ilustradas sobre a sociedade), que é regulada por normas éticas e legais. O principal objetivo destas últimas é conseguir, mediante requisitos formais, que essa relação não prejudique o paciente. Sob esse prisma, examina e compara-se o consentimento informado nas principais normativas internacionais e na lei espanhola. Especialmente, centra-se no prontuário do paciente, na compreensão, na voluntariedade, na certificação e na comunicação dos resultados da pesquisa. Conclui-se com a observação da séria limitação intrínseca da qual sofrem essas normativas, que impedem, mais do que favorecem, o tratamento adequado do paciente.

The Nuremberg Code: its history and implications.

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.

The case for a new system for oversight of research on human subjects.

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.

Participation of healthy volunteers in research projects.

Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide-lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient-volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day-to-day ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self-experimentation readily can transgress ethical guide-lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase-1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.

Implanon and medical indemnity: a case study of risk management using the Australian standard.

The contraceptive implant Implanon (Organon) was introduced in Australia in May 2001, and in the next 18 months was associated with an unprecedented number of adverse incident reports to medical indemnity insurers, including almost 100 unintended pregnancies. The medical indemnity insurer, MDA National, responded to this by applying the Australian and New Zealand Standard for Risk Management (AS/NZS 4360: 1999) in two stages. The first stage was to contain potential costs by moving the treatment into the general practice procedural category, resulting in a one-year moratorium on its use for most general practitioner members (prudential risk management). The second stage was to manage the clinical risk by developing strategies to reduce identified risks associated with the procedure. The Royal Australian College of General Practitioners (RACGP) was enlisted to develop guidelines for use of Implanon, with a consent form and checklists for doctors and patients, enabling MDA National to reinstate the treatment to the general practice non-procedural category. This case demonstrates the need for early risk assessment and development of risk-management tools for new treatments and devices, a role that is appropriate for the RACGP.