Immunity certification for COVID-19: ethical considerations.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.

Les restrictions imposées dans le cadre de la lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) ont eu de lourdes conséquences économiques, sociales et sanitaires. Certains pays ont envisagé la mise en place d'une stratégie visant à alléger ces restrictions pour les individus guéris en leur octroyant un document communément appelé «passeport d'immunité¼. Ce document atteste qu'ils ont développé une immunité protectrice contre le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2), le virus à l'origine de la COVID-19. L'Organisation mondiale de la Santé a déconseillé l'usage du certificat d'immunité pour l'instant, car l'incertitude demeure quant à l'existence réelle d'une immunité à long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilité des tests sérologiques censés déterminer si l'individu est immunisé n'est pas avérée. Un tel certificat ne peut être instauré que si les seuils scientifiques en matière d'immunité sont respectés, qu'ils soient fondés sur les anticorps ou sur d'autres critères. Néanmoins, même si le certificat d'immunité est désormais bien accepté par la science, il s'accompagne de nombreuses questions d'ordre éthique en ce qui concerne la limitation des libertés individuelles et la mise en œuvre. Dans le présent document, nous examinons les principales considérations à prendre en compte pour garantir l'acceptabilité éthique du certificat d'immunité visant à lever les mesures de restriction pour certaines personnes durant la pandémie de COVID-19. Cette acceptabilité éthique dépend non seulement de son degré de conformité à des critères scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour atténuer les préjudices potentiels et éviter d'imposer une charge disproportionnée sur les individus dépourvus de certificat, ou de bafouer les droits et libertés de tout un chacun.

Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, económicos y sanitarios. Algunos países han considerado la posibilidad de utilizar la certificación de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infección mediante la expedición a dichas personas de un documento, comúnmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del síndrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organización Mundial de la Salud ha desaconsejado la aplicación de la certificación de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del método de prueba serológica propuesto para determinar la inmunidad. La certificación de la inmunidad solo puede considerarse si se cumplen los umbrales científicos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificación de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones éticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicación. Examinamos las principales consideraciones sobre la aceptabilidad ética de la certificación de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Además de necesitar cumplir criterios científicos sólidos, la aceptabilidad ética de la certificación de inmunidad depende de sus usos y objetivos de política y de las medidas que se apliquen para reducir los posibles daños y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificación y se violen las libertades y derechos individuales.

Passport to freedom? Immunity passports for COVID-19.

The COVID-19 pandemic has led a number of countries to introduce restrictive 'lockdown' policies on their citizens in order to control infection spread. Immunity passports have been proposed as a way of easing the harms of such policies, and could be used in conjunction with other strategies for infection control. These passports would permit those who test positive for COVID-19 antibodies to return to some of their normal behaviours, such as travelling more freely and returning to work. The introduction of immunity passports raises a number of practical and ethical challenges. In this paper, we seek to review the challenges relating to various practical considerations, fairness issues, the risk to social cooperation and the impact on people's civil liberties. We make tentative recommendations for the ethical introduction of immunity passports.

Ethical Implementation of Immunity Passports During the COVID-19 Pandemic.

A number of countries are planning the use of "immunity passports" as a way to ease restrictive measures and allow infected and recovered people to return to work during the COVID-19 pandemic. This paper brings together key scientific uncertainties regarding the use of serological tests to assure immune status and a public health ethics perspective to inform key considerations in the ethical implementation of immunity passport policies. Ill-conceived policies have the potential to cause severe unintended harms that could result in greater inequity, the stigmatization of certain sectors of society, and heightened risks and unequal treatment of individuals due to erroneous test results. Immunity passports could, however, be used to achieve collective benefits and benefits for specific populations besides facilitating economic recovery. We conclude that sector-based policies that prioritize access to testing based on societal need are likely to be fairer and logistically more feasible, while minimizing stigma and reducing incentives for fraud. Clear guidelines need to be set out for which sectors of society should be prioritized for testing, and rigorous mechanisms should be in place to validate test results and identify cases of reinfection.

Doctors that "doctor" sickness certificates: cunning intelligence as an ability and possibly a virtue among Swedish GPs.

The relations of power between healthcare-related institutions and the professionals that interact with them are changing. Generally, the institutions are gaining the upper hand. Consequently, the intellectual abilities necessary for professionals to pursue the internal goods of healthcare are changing as well. A concrete case is the struggle over sickness benefits in Sweden, in which the Swedish Social Insurance Agency (SSIA) and physicians are important stakeholders. The SSIA has recently consolidated its power over the sickness certificates that doctors issue for their patients. The result has been a stricter gatekeeping of sickness benefits. In order to combat the inroads made by state institutions into sickness certification, and into the sphere of medical practice, some doctors have developed cunning "techniques" to maximize the chance to have their sickness certificates accepted by the SSIA. This article attempts to demonstrate that cunning intelligence-the ability of the weak to "outsmart" a stronger adversary-plays an important role in the practice of medicine. Cunning intelligence is not merely a defective form of prudence (phronesis), nor is it simply an instance of instrumental reason (techne), but rather an ability that occupies a distinct place among the intellectual abilities generally ascribed to professionals.

Medical Students as Certified Interpreters.

Spanish speakers make up 13.1% of the US population, and language barriers contribute to health disparities. Medical interpreters are essential for communication between patients with limited English proficiency (LEP) and their clinicians. However, there is a shortage of interpreters nationwide; free clinics, where a large majority of patients with LEP receive care, are especially affected by this shortage. Many medical schools are associated with a free clinic, and medical students who speak Spanish can help fill this gap. Loyola University Chicago Stritch School of Medicine, together with Interpreter Services at Loyola University Medical Center, created an interpreter certification program for medical students. Although there are challenges in certifying medical students as interpreters, doing so helps to build a workforce of well-trained, culturally competent physicians.

Is There Gender Bias on the American Board of Surgery General Surgery Certifying Examination?

BACKGROUND: When oral examinations are administered, examiner subjectivity may possibly affect ratings, particularly when examiner severity is influenced by examinee characteristics (e.g., gender) that are independent of examinee ability. This study explored whether the ratings of the general surgery oral certifying examination (CE) of the American Board of Surgery and likelihood of passing the CE were influenced by the gender of examinees or examiners. MATERIALS AND METHODS: Data collected from examinees who attempted the general surgery CE in the 2016-2017 academic year were analyzed. There were 1341 examinees (61% male) and 216 examiners (82% male). Factorial analysis of variance and logistic regression analyses were used to evaluate the effect of examinee and examiner gender on CE ratings and likelihood of passing the CE. RESULTS: Examinees received similar ratings and had similar likelihood of passing the CE regardless of examinee or examiner genders and different combinations of examiner gender pairs (all P values > 0.05). CONCLUSIONS: These results indicate that CE ratings of examinees are not influenced by examinee or examiner gender. There was no evidence of examiner bias due to gender on the CE.

Using a Scoring Rubric to Assess the Writing of Bioethics Students.

Educators in bioethics have struggled to find valid and reliable assessments that transcend the "reproduction of knowledge" to target more important skill sets. This manuscript reports on the process of developing and grading a minimal-competence comprehensive examination in a bioethics master's degree program. We describe educational theory and practice for the creation and deployment of scoring rubrics for high-stakes performance assessments that reduce scoring inconsistencies. The rubric development process can also benefit the program by building consensus among stakeholders regarding program goals and student outcomes. We describe the Structure of the Observed Learning Outcome taxonomy as a mechanism for rubric design and provide an example of how we applied that taxonomy to define pass/fail cut scores. Details about domains of assessment and writing descriptors of performance are also presented. Despite the laborious work required to create a scoring rubric, we found the effort to be worthwhile for our program.

Objective structured clinical examination (OSCE) in pharmacy education - a trend / Examen clínico estructurado y objetivo (OSCE) en la educación de farmacia - una tendencia

Pharmacy education has undergone a radical change as it evolves towards becoming a more patient oriented profession. With a greater emphasis on problem based teaching and competency, the Objective Structured Clinical Examination (OSCE), supported by its reliability and validity became the gold standard for the evaluation of clinical skills of undergraduate students of medicine and pharmacy worldwide. Core competency evaluation has become a mandatory and critical norm for accountability of educational objectives as the traditional testing tools cannot evaluate clinical competence. Interpersonal and communication skills, professional judgment, skills of resolution etc., may be best assessed through a well structured OSCE in comparison to oral examinations, multiple choice tests and other methods of assessment. Though OSCEs as an objective method of evaluation offer several advantages to both students and teachers, it also has disadvantages and pitfalls in implementation. This article reviews the OSCE as a trend in pharmacy education (AU)

La educación en farmacia ha sufrido un cambio radical a medida que evoluciona hacia convertirse en una profesión más orientada hacia el paciente. Con un mayor énfasis en la enseñanza basada en problemas y competencias, el examen clínico estructurado y objetivo (OSCE), soportado por su fiabilidad y validez, se ha convertido en el patrón-oro para la evaluación de las habilidades clínicas de los estudiantes de grado de medicina y farmacia en todo el mundo. La evaluación de las competencias centrales se ha convertido en una norma obligatoria y crucial para la responsabilidad de los objetivos educativos, ya que los exámenes tradicionales no pueden evaluar la competencia clínica. Las habilidades interpersonales y de comunicación, el juicio profesional, las habilidades de resolución, etc. Pueden evaluarse mejor mediante un OSCE bien estructurado en comparación con los exámenes orales, los exámenes de elección múltiple y otros métodos de evaluación. Aunque los OSCE son un método objetivo de evaluación que ofrece varias ventajas tanto a estudiantes como a profesores, también tiene inconvenientes y problemas de implantación. Este articulo revisa los OSCE como una tendencia en la educación de farmacia (AU)

Desempeño del examen clínico objetivo estructurado como instrumento de evaluación en la certificación nacional como reumatólogo / Performance of an objective structured clinical examination in a national certification process of trainees in rheumatology

Objetivo. Determinar la validez de constructo y la confiabilidad de un examen clínico objetivo estructurado (ECOE) en la evaluación de una certificación nacional como reumatólogo. Método. En 2013 y 2014, se aplicaron sendos ECOE y evaluación teórica (ET) a 32 y 38 residentes aspirantes a la certificación de reumatólogo, respectivamente. Se incluyeron 12 y 15 estaciones calificadas mediante lista de cotejo validada. Previamente, 3 reumatólogos certificados realizaron sendas pruebas piloto. Se calculó la puntuación global del ECOE y se evaluó su desempeño. Resultados. En 2013, la media ± DE del ECOE fue de 7,1 ± 0,6) y ningún aspirante tuvo calificación reprobatoria (CR); la media de la ET fue de 6,5 ± 0,6 y 7 aspirantes (21,9%) tuvieron CR (< 6). En 2014, la media del ECOE fue de 6,7 ± 0,6) y 3 aspirantes (7,9%) tuvieron CR, de los cuales 2 reprobaron la ET; la media de la ET fue de 6,4 ± 0,5) y 7 aspirantes (18,5%) tuvieron CR, 2 de los cuales reprobaron el ECOE. En 2013, la correlación entre el ECOE y la ET fue de r = 0,44, p = 0,006. En ambos años, los reumatólogos certificados obtuvieron mejores calificaciones en el ECOE que los residentes. El porcentaje de aprobados en la ET fue mayor entre quienes aprobaron el ECOE que entre quienes lo reprobaron: 86% vs. 67%, p = 0,02. Se aplicaron 9 estaciones en ambos años y sus puntuaciones mostraron correlación de 0,81 a 0,95, p ≤ 0,01. Conclusión. El ECOE es una herramienta adecuada para evaluar las competencias clínicas de los aspirantes a la certificación (AU)

Objective. To assess reliability and validity of the objectively-structured clinical examination (OSCE) applied in postgraduate certification processes by the Mexican Board of Rheumatology. Method. Thirty-two (2013) and 38 (2014) Rheumatology trainees (RTs) underwent an OSCE consisting of 12 and 15 stations respectively, scored according to a validated check-list, as well as 300-multiple-choice 300 question examination (MCQ). Previously, 3 certified rheumatologists underwent a pilot-OSCE. A composite OSCE score was obtained for each participant and its performance examined. Results. In 2013, OSCE mean score was 7.1 ± 0.6 with none RT receiving a failing score while the MCQ score was 6.5 ± 0.6 and 7 (21.9%) RTs receiving a failing (< 6) score. In 2014, the OSCE score was 6.7 ± 0.6, with 3 (7.9%) RTs receiving a failing score (2 of them also failed MCQ) while the MCQ score was 6.4 ± 0.5 and 7 (18.5%) RTs were disqualified (2 of them also failed OSCE). A significant correlation between the MCQ and the OSCE scores was observed in the 2013 (r=0.44; P=0.006). Certified rheumatologists performed better than RTs at both OSCE. Overall, 86% of RTs obtaining an OSCE passing score also obtained a MCQ passing score, while this was only 67% (P=.02) among those who obtained an OSCE failing score. Nine stations were applied at both consecutive years. Their performance was similar in both certification processes, with correlation coefficients ranging from 0.81 to 0.95 (P≤0.01). Conclusion. The OSCE is a valid and reliable tool to assess the Rheumatology clinical skills in RTs (AU)

Halal pharmaceutical industry: opportunities and challenges.

The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, well-regulated, and harmonized accreditation and halal management system.

Multi-institutional study of self-reported attitudes and behaviors of general surgery residents about ethical academic practices in test taking.

PURPOSE: Correlation exists between people who engage in academic dishonesty as students and unethical behavior once in practice. Previously, we assessed the attitudes of general surgery residents and ethical practices in test taking at a single institution. Most residents had not participated in activities they felt were unethical, yet what constituted unethical behavior was unclear. We sought to verify these results in a multi-institutional study. METHODS: A scenario-based survey describing potentially unethical activities related to the American Board of Surgery In-training Examination (ABSITE) was administered. Participants were asked about their knowledge of or participation in the activities and whether the activity was unethical. Program directors were surveyed about the use of ABSITE results for resident evaluation and promotion. RESULTS: Ten programs participated in the study. The resident response rate was 67% (186/277). Of the respondents, 43% felt that memorizing questions to study for future examinations was unethical and 50% felt that using questions another resident memorized was unethical. Most felt that buying (86%) or selling (79%) questions was unethical. Significantly more senior than junior residents have memorized (30% vs 16%; p = 0.04) or used questions others memorized (33% vs 12%; p = 0.002) to study for future ABSITE examinations and know of other residents who have done so (42% vs 20%; p = 0.004). Most programs used results of the ABSITE in promotion (80%) and set minimum score expectations and consequences (70%). CONCLUSION: Similar to our single-institution study, residents had not participated in activities they felt to be unethical; however the definition of what constitutes cheating remains unclear. Differences were identified between senior and junior residents with regard to memorizing questions for study. Cheating and unethical behavior is not always clear to the learner and represents an area for further education.

Certificates of confidentiality: legal counsels' experiences with and perspectives on legal demands for research data.

The certificate of confidentiality (Certificate) is an important tool for protecting identifiable, sensitive human subjects research data in the United States. However, little is known about the Certificate's effectiveness in protecting identifiable data. We interviewed 24 legal counsel representing U.S. research institutions about their experiences with legal demands for research data. Our respondents reported few, if any, legal demands over the course of their tenure, but two-thirds had experience with legal demands for data protected by a Certificate. They reported such demands often were resolved without disclosure of identifiable research data, typically without court intervention. While our respondents reported similar success protecting identifiable data in court, they often did not rely on the Certificate to do so.

Grounded for an ethical dilemma: disequilibrium in a commercial airline pilot.

This article presents the case of a 41-year-old airline pilot with benign paroxysmal positional vertigo who requests that his diagnosis not be disclosed to his commercial airline employer or his aviation medical examiner because it may result in the suspension of medical certification. The legal and ethical requirements for physicians reporting impaired pilots are discussed as well as practical recommendations for handling such situations. The argument is made that a physician's obligation to honor patient confidentiality should not take precedence over his or her duty to protect the safety and well-being of the airplane passengers and the general public. If the patient chooses not to self-report, a physician has an ethical obligation to report the patient's medical condition to the Federal Aviation Administration.