Hasil untuk "Medical philosophy. Medical ethics"

Zhijie CHEN, Suying HUANG, Xiaolin NONG

This study examined 86 retracted articles from the top 15 general medical journals (ranked by 2023 journal impact factor) listed in the Retraction Watch database, spanning from the year 2000 onward. The authors analyze the characteristics of these retractions, including retraction latency, authorship, affiliated institutions, country and discipline distribution, and reasons for retraction. The overall number of retracted papers has increased, with relatively long retraction intervals. The UK and the US were the main countries in terms of retraction volume, and many retracted papers were associated with prestigious institutions. Pharmacology, biostatistics/epidemiology, and cardiovascular science were the main subcategories of disciplines involved in retractions. Academic misconduct accounted for nearly one-third of all retraction causes. Therefore, we suggest strengthening punitive measures against academic misconduct, building a multidimensional deterrence system, enhancing supervision of the entire process of paper review, deepening the application of retraction-related bibliometric analysis, and reinforcing scientific integrity education, constructing a scientific integrity publicity system.

Hana Khaled Aman

Abstract Background Postpartum depression has a rising global prevalence. Although it receives respectable attention in research, it is not adequately considered in practice. Perceived social support is among the most influential protective factors of PPD; however, the role of sources of social support in the development of PPD is not yet fully discovered. Therefore, this research aims to identify the differential effects of the sources of social support on symptoms of PPD while also investigating the mediating role of resilience. Methods The data analysed In this study were collected from 197 women with parturition within six weeks to a year, aged 25 to 41 (M = 30.36, SD = 3.703). Participants were recruited from public and private hospitals and clinics specializing in paediatric and obstetrics/gynaecology care in Cairo, Egypt, and through social media support groups for pregnant and postpartum women. Data were collected using the Arabic multidimensional scale of perceived social support (MSPSS), the Edinburgh Postnatal Depression Scale (EPDS), and the Psychological Capital Questionnaire (PCQ) ‘Resilience’ subscale. Multiple linear regression and mediation analyses by structural equation model (SEM) were performed to test the study’s hypotheses. Results Friends’ social support was the only significant source in the regression model (β = -.242, t = -3.297, p < .001). However, the overall model was also significant (F (3, 193) = 11.692, p < .001). Resilience significantly and partially mediated the relationship between support from significant others (SO) and PPD symptoms (β = -.042, 95% CI [-0.080, -0.004], z = -2.159, p < .031). However, resilience did not indirectly influence the relationship between family support and PPD symptoms (β = -.025, 95% CI [-0.058, 0.008], z = -1.494, p < .135) and family support and PPD symptoms (β = -.027, 95% CI [-0.056, -0.002], z = -1.830, p < .067) were not significant. Conclusions Perceived social support from friends significantly predicts PPD symptoms. The support from significant others impacts symptoms of postpartum depression directly and indirectly through resilience. These findings emphasize social support as protective against PPD risk and enhancing for resilience.

Haiyan WANG, Ting WANG, Wenjun FU et al.

This study systematically reviews literature in classical Traditional Chinese Medicine (TCM), texts concerning radices picrorrhizae (Hu Huanglian), tracing its historical evolution in medicinal use. Radices picrorrhizae, characterized by a bitter taste and cold property, is particularly effective in clearing deficiency heat and is mainly used to treat tidal fever. Because of the similar effect to rhizoma coptidis, it is often mistakenly regarded as the same. The earliest record of radices picrorrhizae in medicinal use appeared in Chongguang Yinggong Materia Medica, and over successive generations of medical practitioners, its applications were gradually refined. A systematic integration of its medicinal history serves not only to elucidate its historical significance and traditional value, but also to provide a reference for its sustainable development and practical guidance for modern pharmacological exploration of its medicinal value.

Saleh Abbas

Cindy Peltier, Sarah Dickson, Viviane Grandpierre et al.

Abstract Background Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. Methods We followed PRISMA guidelines and Arksey and O’Malley’s approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. Results We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. Conclusions Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.

Lina Soledad Garzón Pulido, María Cristina Geney Montes

En Colombia, actualmente, la interrupción voluntaria del embrazo (IVE) está despenalizada hasta la semana 24 y, posteriormente, previo al término del embarazo, si se cumplen las causales indicadas mediante la sentencia C-355 del 2006, las cuales son: (a) si el embarazo pone en riesgo la salud de la mujer; (b) si el embarazo es producto de una violación, y (c) cuando el feto presenta malformaciones incompatibles con la vida. Este trabajo tiene por objeto describir la situación de la IVE en Colombia para los médicos y los pacientes desde su despenalización, mediante un análisis de la literatura y la jurisprudencia. Se caracterizaron los problemas en el ejercicio de la objeción de conciencia y las barreras de acceso a los servicios de IVE. Con base en estos hallazgos, se proponen algunas estrategias para mejorar la implementación de la norma en beneficio de los pacientes y respetar los derechos de los médicos.

Ensieh Madani, Ali Dizani, Saeedeh Saeedi Tehrani et al.

Ethical dilemmas are among the most important ethical problems in medicine. With the advent of COVID-19, the moral problems of physicians have taken on new dimensions as the specific features of this disease pose additional ethical challenges that require particular solutions. One common way to solve ethical dilemmas is to use ethical decision making models. One of the most recent models in ethics of technology is the “ethical cycle” developed by Ibo van de Poel. By describing and comparing several models, this paper examines the application of the ethical cycle to physicians' ethical problems and medical ethics. This model can help solve complex problems in consultations and ethics committee meetings because it is comprehensive and covers various aspects of the discussion.In this model, first the ethical problem is formulated and analyzed and then the potential options for action are proposed.Subsequently, by referring to ethical theories and professional codes of conduct in the medical field, as well as applying the method of "reflective equilibrium," an ethical decision is reached. This decision is specific to each case and may not necessarily be the best solution for other individuals or situations

Fadhil muhaldeen, Abdullah Raoof

Background: Coronavirus disease 2019 (COVID-19) is a new emerging disease caused by SARS-CoV-2, first discovered in Wuhan, China, in December 2019. Infected patients of all age groups with associated medical diseases such as chronic kidney disease (CKD) stage five -end stage renal disease (ESRD) on hemodialysis are likely to have a higher risk of developing severe COVID-19 compared to patients without disease. The study aimed to address morbidity and mortality related to SARS-CoV2 infection in hemodialysis patients at the Kirkuk dialysis centre.Methods: A prospective observational study that enrolled 385 COVID-19 patients with CKD-stage 5 (ESRD), who were on a regular hemodialysis program in the dialysis center in Kirkuk city for a period of 6 months.Results: In hemodialysis patients, the incidence of SARS-CoV2 infection was 80 (20.75%), among these 80 patients, 43(53.75%) required hospital admission due to the severity of the disease, 32 (40%) were admitted to the intensive care unit and received ventilation, 19 patients (23.75%) died from complications related to SARS-CoV-2.Conclusion: There is a significant incidence of hospital admission and the need for ventilation among patients, as well as a notable mortality rate was observed in COVID-19 patients undergoing hemodialysis, with specific risk factors such as bronchial asthma, the presence of AV fistula, and type 2 diabetes mellitus contributing to a higher mortality percentage.

Alejandro Marín Mora, Sebastián Ospina-Henao

Si bien la interrupción terapéutica del embarazo en los casos de fetos anencefálicos ha sido ampliamente discutida, y se han llegado a conclusiones éticas que la justifican (si no existe contraindicación médica y se obtiene el consentimiento informado de la mujer), es importante reevaluar el tema. Por ello, se deben contrastar los principios bioéticos con sentencias judiciales de fenómenos jurídicos que están surgiendo en el mundo, y que pueden provocar cambios en los derechos sexuales y reproductivos. No obstante, esto no debe implicar un cambio en los argumentos bioéticos. Asimismo, debido al resurgimiento a nivel global de un conservadurismo moral, que propone un planteamiento en torno a la objeción de conciencia, se torna imperativo analizar desde la perspectiva bioética si la misma puede ser invocada en casos de interrupción terapéutica del embarazo. Para ello, se deberían ponderar los principios bioéticos y utilizar una bioética laica, pluralista y basada en ética de mínimos, la cual busque la dignidad de las personas que enfrentan una gestación de fetos anencefálicos. En ese sentido, la objeción de conciencia no debería utilizarse como instrumento para negar la atención a estas personas.

Marcos Aurélio Trindade, Marcio Fabri dos Anjos

William Wilson

As the world battles COVID-19, talks are rife about vaccine distribution and health policy overhauls. Amongst all this mayhem a section of patients suffers silently. The patients with chronic systemic diseases requiring regular care at the hospital for follow-ups and dialysis are getting lost in the crowd of COVID suspects. This paper narrates the harrowing ordeal of a patient shunted across hospitals all because of a fever, and in the end it discloses her eventual diagnosis.

Jazlan Jamaluddin, Nurul Nadia Baharum, Siti Nuradliah Jamil et al.

Photo by Ishan @seefromthesky on Unsplash ABSTRACT A strike to highlight the plight facing contract doctors which has been proposed has received mixed reactions from those within the profession and the public. This unprecedented nationwide proposal has the potential to cause real-world effects, posing an ethical dilemma. Although strikes are common, especially in high-income countries, these industrial actions by doctors in Malaysia are almost unheard of. Reviewing available evidence from various perspectives is therefore imperative to update the profession and the complexity of invoking this important human right. INTRODUCTION Contract doctors in Malaysia held a strike on July 26, 2021. COVID-19 cases are increasing in Malaysia. In June, daily cases ranged between 4,000 to 8,000 despite various public health measures. The R naught, which indicates the infectiousness of COVID-19, remains unchanged. During the pandemic, health care workers (HCWs) have been widely celebrated, resulting in a renewed appreciation of the risks that they face.[1] The pandemic has exposed flawed governance in the public healthcare system, particularly surrounding the employment of contract doctors. Contract doctors in Malaysia are doctors who have completed their medical training, as well as two years of internship, and have subsequently been appointed as medical officers for another two years. Contract doctors are not permanently appointed, and the system did not allow extensions after the two years nor does it offer any opportunity to specialize.[2] Last week, Parliament did decide to offer a two-year extension but that did not hold off the impending strike.[3] In 2016, the Ministry of Health introduced a contract system to place medical graduates in internship positions at government healthcare facilities across the country rather than placing them in permanent posts in the Public Service Department. Social media chronicles the issues that doctors in Malaysia faced. However, tensions culminated when and contract doctors called for a strike which ended up taking place in late July 2021. BACKGROUND Over the past decade, HCW strikes have arisen mostly over wages, work hours, and administrative and financial factors.[4] In 2012, the British Medical Association organized a single “day of action” by boycotting non-urgent care as a response to government pension reforms.[5] In Ireland, doctors went on strike for a day in 2013 to protest the austerity measures implemented by the EU in response to the global economic crisis. It involved a dispute over long working hours (100 hours per week) which violated EU employment laws and more importantly put patients’ lives at risk.[6] The strike resulted in the cancellation of 15,000 hospital appointments, but emergencies services were continued. Other major strikes have been organized in the UK to negotiate better pay for HCWs in general and junior doctors’ contracts specifically.[7] During the COVID-19 pandemic, various strikes have also been organized in Hong Kong, the US, and Bolivia due to various pitfalls in managing the pandemic.[8] A recent strike in August 2020 by South Korean junior doctors and medical students was organized to protest a proposed medical reform plan which did not address wage stagnation and unfair labor practices.[9] These demands are somewhat similar to the proposed strike by contract doctors in Malaysia. As each national health system operates within a different setting, these strikes should be examined in detail to understand the degree of self-interest involved versus concerns for patient’s welfare. l.     The Malaysia Strike An anonymous group planned the current strike in Malaysia. The group used social media, garnering the attention of various key stakeholders including doctors, patients, government, and medical councils.[10] The organizers of the strike referred to their planned actions as a hartal. (Although historically a hartal involved a total shutdown of workplaces, offices, shops, and other establishments as a form of civil disobedience, the Malaysian contract doctors pledged no disturbance to healthcare working hours or services and intend a walk-out that is symbolic and reflective of a strike.)[11] The call to action mainly involved showing support for the contract doctors with pictures and placards. The doctors also planned the walk-out.[12] Despite earlier employment, contract medical doctors face many inequalities as opposed to their permanent colleagues. These include differences in basic salary, provisions of leave, and government loans despite doing the same job. The system disadvantages contract doctors offering little to no job security and limited career progression. Furthermore, reports in 2020 showed that close to 4,000 doctors’ contracts were expected to expire by May 2022, leaving their futures uncertain.[13] Some will likely be offered an additional two years as the government faces pressure from the workers. Between December 2016 and May 2021, a total of 23,077 contract doctors were reportedly appointed as medical officers, with only 789 receiving permanent positions.[14] It has been suggested that they are appointed into permanent positions based on merit but the criteria for the appointments remain unclear. Those who fail to acquire a permanent position inevitably seek employment elsewhere. During the COVID-19 pandemic, there have been numerous calls for the government to absorb contract doctors into the public service as permanent staff with normal benefits. This is important considering a Malaysian study that revealed that during the pandemic over 50 percent of medical personnel feel burned out while on duty.[15] This effort might be side-lined as the government prioritizes curbing the pandemic. As these issues remain neglected, the call for a strike should be viewed as a cry for help to reignite the discussions about these issues. ll.     Right to strike The right to strike is recognized as a fundamental human right by the UN and the EU.[16] Most European countries also protect the right to strike in their national constitutions.[17] In the US, the Taft-Hartley Act in 1947 prohibited healthcare workers of non-profit hospitals to form unions and engage in collective bargaining. But this exclusion was repealed in 1947 and replaced with the requirement of a 10-day advanced written notice prior to any strike action.[18] Similarly, Malaysia also recognizes the right to dispute over labor matters, either on an individual or collective basis. The Industrial Relations Act (IRA) of 1967[19] describes a strike as: “the cessation of work by a body of workers acting in combination, or a concerted refusal or a refusal under a common understanding of a number of workers to continue to work or to accept employment, and includes any act or omission by a body of workers acting in combination or under a common understanding, which is intended to or does result in any limitation, restriction, reduction or cessation of or dilatoriness in the performance or execution of the whole or any part of the duties connected with their employment” According to the same act, only members of a registered trade union may legally participate in a strike with prior registration from the Director-General of Trade Unions.[20] Under Section 43 of the IRA, any strike by essential services (including healthcare) requires prior notice of 42 days to their employer.[21] Upon receiving the notice, the employer is responsible for reporting the particulars to the Director-General of Industrial Relations to allow a “cooling-off” period and appropriate action. Employees are also protected from termination if permitted by the Director-General and strike is legalized. The Malaysian contract healthcare workers’ strike was announced and transparent. Unfortunately, even after legalization, there is fear that the government may charge those participating in the legalized strike.[22] The police have announced they will pursue participants in the strike.[23] Even the Ministry of Health has issued a warning stating that those participating in the strike may face disciplinary actions from the ministry. However, applying these laws while ignoring the underlying issues may not bode well for the COVID-19 healthcare crisis. lll.     Effects of a Strike on Health Care There is often an assumption that doctors’ strikes would unavoidably cause significant harm to patients. However, a systematic review examining several strikes involving physicians reported that patient mortality remained the same or fell during the industrial action.[24] A study after the 2012 British Medical Association strike has even shown that there were fewer in-hospital deaths on the day, both among elective and emergency populations, although neither difference was significant.[25] Similarly, a recent study in Kenya showed declines in facility-based mortality during strike months.[26] Other studies have shown no obvious changes in overall mortality during strikes by HCWs.[27] There is only one report of increased mortality associated with a strike in South Africa[28] in which all the doctors in the Limpopo province stopped providing any treatment to their patients for 20 consecutive days. During this time, only one hospital continued providing services to a population of 5.5 million people. Even though their data is incomplete, authors from this study found that the number of emergency room visits decreased during the strike, but the risks of mortality in the hospital for these patients increased by 67 percent.[29] However, the study compared the strike period to a randomly selected 20-day period in May rather than comparing an average of data taken from similar dates over previous years. This could greatly influence variations between expected annual hospital mortality possibly due to extremes in weather that may exacerbate pre-existing conditions such as heart failure during warmer months or selecting months with a higher incidence of viral illness such as influenza. Importantly, all strikes ensured that emergency services were continued, at least to the degree that is generally offered on weekends. Furthermore, many doctors still provide usual services to patients despite a proclaimed strike. For example, during the 2012 BMA strike, less than one-tenth of doctors were estimated to be participating in the strike.[30] Emergency care may even improve during strikes, especially those involving junior doctors who are replaced by more senior doctors.[31] The cancellation of elective surgeries may also increase the number of doctors available to treat emergency patients. Furthermore, the cancellation of elective surgery is likely to be responsible for transient decreases in mortality. Doctors also may get more rest during strike periods. Although doctor strikes do not seem to increase patient mortality, they can disrupt delivery of healthcare.[32] Disruptions in delivery of service from prolonged strikes can result in decline of in-patient admissions and outpatient service utilization, as suggested during strikes in the UK in 2016.[33] When emergency services were affected during the last strike in April, regular service was also significantly affected. Additionally, people might need to seek alternative sources of care from the private sector and face increased costs of care. HCWs themselves may feel guilty and demotivated because of the strikes. The public health system may also lose trust as a result of service disruption caused by high recurrence of strikes. During the COVID-19 pandemic, as the healthcare system remains stretched, the potential adverse effects resulting from doctor strikes remain uncertain and potentially disruptive. In the UK, it is an offence to “willfully and maliciously…endanger human life or cause serious bodily injury.”[34] Likewise, the General Medical Council (GMC) also requires doctors to ensure that patients are not harmed or put at risk by industrial action. In the US, the American Medical Association code of ethics prohibits strikes by physicians as a bargaining tactic, while allowing some other forms of collective bargaining.[35] However, the American College of Physicians prohibits all forms of work stoppages, even when undertaken for necessary changes to the healthcare system. Similarly, the Delhi Medical Council in India issued a statement that “under no circumstances doctors should resort to strike as the same puts patient care in serious jeopardy.”[36] On the other hand, the positions taken by the Malaysian Medical Council (MMC) and Malaysian Medical Association (MMA) on doctors’ strikes are less clear when compared to their Western counterparts. The MMC, in their recently updated Code of Professional Conduct 2019, states that “the public reputation of the medical profession requires that every member should observe proper standards of personal behavior, not only in his professional activities but at all times.” Strikes may lead to imprisonment and disciplinary actions by MMC for those involved. Similarly, the MMA Code of Medical Ethics published in 2002 states that doctors must “make sure that your personal beliefs do not prejudice your patients' care.”[37] The MMA which is traditionally meant to represent the voices of doctors in Malaysia, may hold a more moderate position on strikes. Although HCW strikes are not explicitly mentioned in either professional body’s code of conduct and ethics, the consensus is that doctors should not do anything that will harm patients and they must maintain the proper standard of behaviors. These statements seem too general and do not represent the complexity of why and how a strike could take place. Therefore, it has been suggested that doctors and medical organizations should develop a new consensus on issues pertaining to medical professional’s social contract with society while considering the need to uphold the integrity of the profession. Experts in law, ethics, and medicine have long debated whether and when HCW strikes can be justified. If a strike is not expected to result in patient harm it is perhaps acceptable.[38] Although these debates have centered on the potential risks that strikes carry for patients, these actions also pose risks for HCWs as they may damage morale and reputation.[39] Most fundamentally, strikes raise questions about what healthcare workers owe society and what society owes them. For strikes to be morally permissible and ethical, it is suggested that they must fulfil these three criteria:[40]      a.     Strikes should be proportionate, e., they ‘should not inflict disproportionate harm on patients’, and hospitals should as a minimum ‘continue to provide at least such critical services as emergency care.’      b.     Strikes should have a reasonable hope of success, at least not totally futile however tough the political rhetoric is.      c.     Strikes should be treated as a last resort: ‘all less disruptive alternatives to a strike action must have been tried and failed’, including where appropriate ‘advocacy, dissent and even disobedience’. The current strike does not fulfil the criteria mentioned. As Malaysia is still burdened with a high number of COVID-19 cases, a considerable absence of doctors from work will disrupt health services across the country. Second, since the strike organizer is not unionized, it would be difficult to negotiate better terms of contract and career paths. Third, there are ongoing talks with MMA representing the fraternity and the current government, but the time is running out for the government to establish a proper long-term solution for these contract doctors. One may argue that since the doctors’ contracts will end in a few months with no proper pathways for specialization, now is the time to strike. However, the HCW right to strike should be invoked only legally and appropriately after all other options have failed. CONCLUSION The strike in Malaysia has begun since the drafting of this paper. Doctors involved assure that there will not be any risk to patients, arguing that the strike is “symbolic”.[41] Although an organized strike remains a legal form of industrial action, a strike by HCWs in Malaysia poses various unprecedented challenges and ethical dilemmas, especially during the pandemic. The anonymous and uncoordinated strike without support from the appropriate labor unions may only spark futile discussions without affirmative actions. It should not have taken a pandemic or a strike to force the government to confront the issues at hand. It is imperative that active measures be taken to urgently address the underlying issues relating to contract physicians. As COVID-19 continues to affect thousands of people, a prompt reassessment is warranted regarding the treatment of HCWs, and the value placed on health care. [1] Ministry of Health (MOH) Malaysia, “Current situation of COVID-19 in Malaysia.” http://covid-19.moh.gov.my/terkini (accessed Jul. 01, 2021). [2] “Future of 4,000 young doctors who are contract medical officers uncertain,” New Straits Times - November 26, 2020. https://www.nst.com.my/news/nation/2020/11/644563/future-4000-young-doctors-who-are-contract-medical-officers-uncertain [3]  “Malaysia doctors strike, parliament meets as COVID strain shows,” Al Jazeera, July 26, 2021.  https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow [4] R. Essex and S. M. Weldon, “Health Care Worker Strikes and the Covid Pandemic,” N. Engl. J. Med., vol. 384, no. 24, p. e93, Jun. 2021, doi: 10.1056/NEJMp2103327; G. Russo et al., “Health workers’ strikes in low-income countries: the available evidence,” Bull. World Health Organ., vol. 97, no. 7, pp. 460-467H, Jul. 2019, doi: 10.2471/BLT.18.225755. [5] M. Ruiz, A. Bottle, and P. Aylin, “A retrospective study of the impact of the doctors’ strike in England on 21 June 2012,” J. R. Soc. Med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. [6] E. Quinn, “Irish Doctors Strike to Protest Work Hours Amid Austerity,” The Wall Street Journal, 2013. https://www.wsj.com/articles/no-headline-available-1381217911?tesla=y (accessed Jun. 29, 2021). [7] “NHS workers back strike action in pay row by 2-to-1 margin,” The Guardian, 2014. https://www.theguardian.com/society/2014/sep/18/nhs-workers-strike-pay-unison-england (accessed Jun. 29, 2021); M. Limb, “Thousands of junior doctors march against new contract,” BMJ, p. h5572, Oct. 2015, doi: 10.1136/bmj.h5572. [8] J. Parry, “China coronavirus: Hong Kong health staff strike to demand border closure as city records first death,” BMJ, vol. 368, no. February, p. m454, Feb. 2020, doi: 10.1136/bmj.m454; “MultiCare healthcare workers strike, urging need for more PPEs, staff support,” Q13 FOX, 2020. https://www.q13fox.com/news/health-care-workers-strike-urging-need-for-ppes-risks-on-patient-safety (accessed Jun. 29, 2021); “Bolivia healthcare workers launch strike in COVID-hit region,” Al Jazeera, 2021. https://www.aljazeera.com/news/2021/2/9/bolivia-healthcare-workers-strike-covid-hit-region (accessed Jun. 29, 2021). [9] K. Arin, “Why are Korean doctors striking?” The Korea Herald, 2020. http://www.koreaherald.com/view.php?ud=20200811000941 (accessed Jun. 29, 2021). [10] “Hartal Doktor Kontrak,” Facebook. https://www.facebook.com/hartaldoktorkontrak. [11] “Hartal,” Oxford Advanced Learner’s Dictionary. https://www.oxfordlearnersdictionaries.com/definition/english/hartal (accessed Jun. 29, 2021). [12] “Hartal Doktor Kontrak,” Facebook. https://www.facebook.com/hartaldoktorkontrak. [13] R. Anand, “Underpaid and overworked, Malaysia’s contract doctors’ revolt amid Covid-19 surge,” The Straits Times, 2021. [14] Anand. [15] N. S. Roslan, M. S. B. Yusoff, A. R. Asrenee, and K. Morgan, “Burnout prevalence and its associated factors among Malaysian healthcare workers during covid-19 pandemic: An embedded mixed-method study,” Healthc., vol. 9, no. 1, 2021, doi: 10.3390/healthcare9010090. [16] Maina Kiai, “Report by the Special Rapporteur on the Right to Freedom of Peaceful Assembly and Association,” 2016. [Online]. Available: http://freeassembly.net/wp-content/uploads/2016/10/A.71.385_E.pdf. [17] ETUI contributors, Strike rules in the EU27 and beyond. The European Trade Union Institute. ETUI, 2007. [18] National Labor Relations Board, National Labor Relations Act. 1935, pp. 151–169. [19] Ministry of Human Resources, Industrial Relations Act 1967 (Act 177), no. October. 2015, pp. 1–76. [20] Article 10 of the Federal Constitution states that all citizens have the right to form associations including registered trade or labor unions. A secret ballot with two-third majority will suffice to call for a strike required for submission to the DGTU within 7 days as stated in Section 25(A) of the Trade Union Act 1959. [21] Ministry of Human Resources Malaysia, Guidelines on Strikes, Pickets and Lockouts in Malaysia. Putrajaya, 2011. [22] Ordinance Emergency which was declared in Malaysia since 12 January 2021. Under the Ordinance Emergency, the king or authorized personnel may, as deemed necessary, demand any resources. [23]  “Malaysia doctors strike, parliament meets as COVID strain shows,” Al Jazeera, July 26, 2021.  https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow [24] S. A. Cunningham, K. Mitchell, K. M. Venkat Narayan, and S. Yusuf, “Doctors’ strikes and mortality: A review,” Soc. Sci. Med., vol. 67, no. 11, pp. 1784–1788, Dec. 2008, doi: 10.1016/j.socscimed.2008.09.044. [25] M. Ruiz, A. Bottle, and P. Aylin, “A retrospective study of the impact of the doctors’ strike in England on 21 June 2012,” J. R. Soc. Med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. [26] G. K. Kaguthi, V. Nduba, and M. B. Adam, “The impact of the nurses’, doctors’ and clinical officer strikes on mortality in four health facilities in Kenya,” BMC Health Serv. Res., vol. 20, no. 1, p. 469, Dec. 2020, doi: 10.1186/s12913-020-05337-9. [27] G. Ong’ayo et al., “Effect of strikes by health workers on mortality between 2010 and 2016 in Kilifi, Kenya: a population-based cohort analysis,” Lancet Glob. Heal., vol. 7, no. 7, pp. e961–e967, Jul. 2019, doi: 10.1016/S2214-109X (19)30188-3. [28] M. M. Z. U. Bhuiyan and A. Machowski, “Impact of 20-day strike in Polokwane Hospital (18 August - 6 September 2010),” South African Med. J., vol. 102, no. 9, p. 755, Aug. 2012, doi: 10.7196/SAMJ.6045. [29] M. M. Z. U. Bhuiyan and A. Machowski, “Impact of 20-day strike in Polokwane Hospital (18 August - 6 September 2010),” South African Med. J., vol. 102, no. 9, p. 755, Aug. 2012, doi: 10.7196/SAMJ.6045. [30] M. Ruiz, A. Bottle, and P. Aylin, “A retrospective study of the impact of the doctors’ strike in England on 21 June 2012,” J. R. Soc. Med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. [31] D. Metcalfe, R. Chowdhury, and A. Salim, “What are the consequences when doctors strike?” BMJ, vol. 351, no. November, pp. 1–4, 2015, doi: 10.1136/bmj.h6231. [32] D. Waithaka et al., “Prolonged health worker strikes in Kenya- perspectives and experiences of frontline health managers and local communities in Kilifi County,” Int. J. Equity Health, vol. 19, no. 1, pp. 1–15, 2020, doi: 10.1186/s12939-020-1131-y. [33] The study has shown that there were 9.1% reduction in admissions and around 6% fewer emergency cases and outpatient appointments than expected. An additional 52% increase in expected outpatient appointments cancelations were made by hospitals during that period. D. Furnivall, A. Bottle, and P. Aylin, “Retrospective analysis of the national impact of industrial action by English junior doctors in 2016,” BMJ Open, vol. 8, no. 1, p. e019319, Jan. 2018, doi: 10.1136/bmjopen-2017-019319. [34] D. Metcalfe, R. Chowdhury, and A. Salim, “What are the consequences when doctors strike?” BMJ, vol. 351, no. November, pp. 1–4, 2015, doi: 10.1136/bmj.h6231. [35] R. Essex and S. M. Weldon, “Health Care Worker Strikes and the Covid Pandemic,” N. Engl. J. Med., vol. 384, no. 24, p. e93, Jun. 2021, doi: 10.1056/NEJMp2103327. [36] M. Selemogo, “Criteria for a just strike action by medical doctors,” Indian J. Med. Ethics, vol. 346, no. 21, pp. 1609–1615, Jan. 2014, doi: 10.20529/IJME.2014.010. [37] Malaysian Medical Association, “Malaysian Medical Association Official Website.” https://mma.org.my (accessed Jun. 29, 2021). [38] M. Toynbee, A. A. J. Al-Diwani, J. Clacey, and M. R. Broome, “Should junior doctors strike?” J. Med. Ethics, vol. 42, no. 3, pp. 167–170, Mar. 2016, doi: 10.1136/medethics-2015-103310. [39] R. Essex and S. M. Weldon, “Health Care Worker Strikes and the Covid Pandemic,” N. Engl. J. Med., vol. 384, no. 24, p. e93, Jun. 2021, doi: 10.1056/NEJMp2103327. [40] M. Selemogo, “Criteria for a just strike action by medical doctors,” Indian J. Med. Ethics, vol. 346, no. 21, pp. 1609–1615, Jan. 2014, doi: 10.20529/IJME.2014.010; A. J. Roberts, “A framework for assessing the ethics of doctors’ strikes,” J. Med. Ethics, vol. 42, no. 11, pp. 698–700, Nov. 2016, doi: 10.1136/medethics-2016-103395. [41] “Malaysia doctors strike, parliament meets as COVID strain shows,” Al Jazeera, July 26, 2021.  https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow

Kristi L Kirschner

Natalie Gold, J. Craigie, Tania Gergel

Visiting Senior Research Fellow, Department of Philosophy, King's College London, London, UK Senior Lecturer, Centre of Medical Law and Ethics, Dickson Poon School of Law, King's College London, London, UK Wellcome Trust Senior Research Fellow, Mental Health, Ethics and Law research group, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK

Sruthi Rothenfluch

Julia Bolzon

The 13th World Congress of Bioethics, hosted by the International Association of Bioethics (IAB), is happening this June 14–17 in Edinburgh, Scotland. Professor Søren Holm, President of the IAB, has commented on the Congress’ choice location of Edinburgh as the birthplace of the Scottish Enlightenment, indicating that it is “characterized by a fruitful flow of ideas between different subject areas,” which he hopes this year’s Congress will emulate.[1] The IAB was formed in 1992, with members spanning academic disciplines and the globe alike. As an international and cross-disciplinary association, it exists to foster open dialogue on “any and all” bioethical issues, and to develop the field of bioethics into “an inclusive global discourse.”[2] To continue what he calls the “New Enlightenment” emerging from Edinburg, Chairman Professor Graeme Laurie wrote that the Congress’ theme is to explore what bioethics can contribute to “individuals, public interests and public goods.” All delegates are encouraged to treat the Congress in the spirit of “a festival of knowledge” rather than a traditional academic conference, seeking to discover what bioethics can offer to the pressing scientific, technological, global, and health issues of our time.[3] The reason for the Congress’ theme is the recognition that increasing emphasis on “the primacy of the individual” downplays the interconnectedness between the individual and the other on a familial, local, and global level. The reality is that medical, scientific, and biotechnological advances do not just affect the person at hand, but have ramifications that reverberate throughout the public realms of family, community, and the globe. Whether the issue is gene editing, global health pandemics, or reproductive tourism, the fields of bioethics, public health, and law have to increasingly account for realities that reverberate across time and space. What are the effects of proceeding with embryonic gene editing twenty, thirty, or fifty years in the future? What are the consequences of gestational surrogacy that is legal in one country but not in another? Who will these realities affect, and how? In what way can we know (or not know) the ramifications in advance? With a focus on the relationship and differing values at play between individual and public interests/public goods, the thorny issues and conflicts that exist between “person-centric” and “community-centric” ethics should come to the fore. Exactly what these issues are and how they will be discussed remains to be seen. The IAB is currently undergoing a call for abstracts in the areas broadly titled Arts + Ethics; Global Bioethics; Individuals, Public Interests and Public Goods; and Public Health, Ethics and Law. This Congress is not the only international gathering to address the responsible use of biotechnology and the role that bioethics “can and should play for the benefit of future generations.”[4]  Last May, 200 delegates from thirty countries gathered in Atlanta, Georgia, for a Global Summit called BEINGS: Biotechnology and the Ethical Imagination, to “reach consensus on the direction of biotechnology for the 21st Century.”[5] Dr. Paul Wolpe, the Director of the Center for Ethics at Emory University and the Summit’s founder, had been dreaming of this idea for years. His goal is to establish an aspirational vision for the future of biotechnology, through generating a “global consensus document” on “how we should think about, direct, or limit our biotechnological efforts.”[6] BEINGS was held to stimulate as much discussion as possible between leading visionaries in the fields of science, policy, ethics, law, philosophy, humanities, religion, and the arts, to begin a process that would result in drafting an international consensus on the future of human cellular biotechnology. It’s a grossly ambitious task, guided by equally exemplary and wide-sweeping questions: • What should be the goals of biotechnology; is progress itself an ethical aim or obligation? • How do we honor the sanctity of life (assuming that “sanctity of life” continues to be a morally useful construct)? • What is “human flourishing” insofar as biotechnology can contribute to it? • How do we navigate the spectrum of differing perspectives on risk, such as those that take a more precautionary, risk-aversive approach to those that privilege provable harm approaches? • How do we protect vulnerable populations, honor global cultural differences, and respect and include diverse opinions? • Who should ultimately regulate technologies (e.g., government, private sector, self-regulation)? • How do we assure fairness, justice, and global sharing of the fruits of modern biotechnology?[7] The trouble with such global gatherings (as noble and necessary as they may be) lies not so much within their aim but within the heart of biotechnology itself, which makes the task of regulation frankly impossible. The floodgates of biotechnology have long since been opened, making regulation today less a matter of outright prohibition and more like a temporary yellow light that will eventually turn green once the going looks clear. This metaphor finds reality in the case of mitochondrial transfer and three-parent IVF in the UK last February, and more recently with the testing of CRISPR on human embryos. While BEINGS may be asking the right questions, and the IAB facilitating necessary global discussion, the challenges of biotechnology run much deeper than we are equipped to handle. In the next segment, I shall begin to outline the way in which biotechnology far surpasses our ability to control or even think about its ramifications.

Jorge Luis Rivera-Agosto

On September 16, 2016, the U.S. Department of Health and Human Services (HHS) presented a final rule, in conjunction with a complementary policy of the National Institutes of Health (NIH), amending Tile 42, Chapter 1 of the Code of Federal Regulations[1]. This final rule will bring about a new era for the different stakeholders in the health care industry: patients, providers, researchers and our government[2]. It represents a big step toward increased access to information about certain clinical trials, a topic that affects subjects’ informed consent directly. The regulation’s aim is to specify “how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov”. As such, it does not create new requirements on data, design, or conduct of clinical trials[3]. All stakeholders in the field of research ethics have engaged in continuous debate regarding the need for “increased access to information about clinical trials”[4]. The lack of publications[5] (researchers that don’t publish their findings for a variety of reasons such as that their data won’t be of benefit to the whole community) of clinical trials and biased literature[6],[7] (when researchers publish positive rather than negative findings) concerning clinical trials outcomes are major concerns. The problems previously mentioned are what this regulation tackles. First, Section 11.22 of the final rule explains which clinical trials must be registered in the webpage. It states that all clinical trials initiated after September 27, 2007, or any clinical trial initiated before or continued after such date, must figure in ClinicalTrials.gov[8]. Therefore, all clinical trials initiated after January 18, 2017 –the ruling’s official effective date– must meet certain criteria to enter the site. For device clinical trials, they must be a pediatric postmarket surveillance of a device product or an interventional, non-feasibility study with one or more subjects[9]. For drug clinical trials, they must be an interventional, non-phase 1 study with one or more subjects[10]. As the Comments and Response Section of the Final Rule suggests, this Sections aims to broaden the spectrum of clinical trials that enter the site while specifying what kind of trial they are. Revealingly, this poses problems, because not all clinical trials can fit into the categories that the NIH has created; and thus, will become a major procedural problem for sponsors during registration. In addition, this undermines the Final Rule’s spirit, because it anticipates that the information on the site will not necessarily be correct or accurate; undermining subjects’ access to information and, ultimately, their informed consent. Second, the most notable section of the new ruling is Section 11.28. It contains all the information that must be disclosed for each clinical trial. Studies that started before January 18, 2017 will submit the information required by section 402(j)(2)(A)(ii) of the Public Health Service Act[11] as usual[12]. This means that this ruling’s information requirement won’t affect them directly. However, for studies after the effective date, a plethora of information must be disclosed. Some of these requirements include: when stating the primary purpose of the study, the study’s sponsor must select, as to clarify, what is the study’s aim. They can be for future treatment, prevention, diagnosis, supportive care, screening, health services research, basic science, device feasibility or other aim[13]. In addition, when stating study type, the party must declare if it’s an interventional, observational, or expanded access program study[14] (even though the HHS understands that these three criteria don’t reflect the nature of all studies). Finally, the study completion date[15] and specification of primary and secondary outcomes[16] are also in the final rule. The HHS, NIH, and JAMA[17] see in this new regulation a better way for potential research subjects to access information about trials. They argue four points: (a) there is more access to information about clinical trials[18]; (b) there are better references about clinical trials for investigators and IRBs[19]; (c) there is more information about unapproved products; and (d) for people looking into certain trials, there is more information about similar marketed products[20]. Again, they argue that this will help patients and researchers in knowing more in general about the clinical trials that affect them. Although this may seem like we are a entering “new era” of clinical trial disclosure, several questions remain: will more information be beneficial for subjects? Will subjects be able to understand this new information? Will parties in a subject trial explain the new rule to their subjects? I think that this new rule lacks the subject’s voice, their understanding. It falls short on what information they need to give an informed consent. As noted by the BMJ in 2012, there hasn’t been a lot studies about what subjects want to know about clinical trials and in the limited studies conducted, it has been showed that subjects have different information needs[21]. Nonetheless, the 2012 study demonstrated that most were interested in information, among other things, about investigators’ conflicts of interest and subjects’ voluntariness and confidentiality –all missing in this final rule. Certainly, this will pave the way for data exchange and greater transparency in the scientific community. But again, the question lingers: will it be of benefit for subjects? And if it does benefit subjects, how exactly? As STAT investigated[22] last year, there’s a widespread behavior towards non-compliance and non-penalization, will it be different this time? References     [1] Clinical Trials Registration and Results Information Submission, 81 FR 64981 (September 21, 2016). [2] Collins, Francis S. and Kathy L. Hudson “Clinical Trials: Sharing of Data and Living Up to Our End of the Bargain.” National Institutes of Health. September 16, 2016. Accessed September 29, 2016. https://directorsblog.nih.gov/2016/09/16/clinical-trials-sharing-of-data-and-living-up-to-our-end-of-the-bargain/. [3] 81 FR 64982. [4] Steinbrook R. “Registration of clinical trials—voluntary or mandatory?” N Engl J Med. 2004 Oct 28;351(18):1820–2. [5] Evans T, Gülmezoglu M, Pang T. “Registering clinical trials: an essential role for WHO.” Lancet. 2004 May 1;363(9419):1413–4. [6] Dickersin K, Davis BR, Dixon DO, George SL, Hawkinse BS, Lachin J, Peduzzi P, Pocock S; “The Society for Clinical Trials supports United States legislation mandating trials registration.” Clinical Trials. 2004;1(5):417–20. [7] Scherer RW, Langenberg P, von Elm E. “Full publication of results initially presented in abstracts.” Cochrane Database of Systematic Reviews. 2007 Apr 18;(2):MR000005. [8] 81 FR 65143; §11.22(a)(1) & §11.22(a)(2). [9] 81 FR 65143; §11.22(b)(1). [10] 81 FR 65143; §11.22(b)(2). [11] Codified as 42 U.S.C. 282(j)(2)(A)(ii). [12] 81 FR 65143-65144; §11.28(a)(1). [13] 81 FR 65144; §11.28 (a)(2)(D). [14] 81 FR 65144; §11.28 (a)(2)(E). [15] 81 FR 65144; §11.28 (a)(2)(T). [16] 81 FR 65144; §11.28 (a)(2)(W) & 81 FR 65144; §11.28 (a)(2)(X). [17] Hudson KL, Lauer MS, Collins FS. “Toward a new era of trust and transparency in clinical trials.” JAMA. doi:10.1001/jama.2016.14668. [18] McCray AT. “Better access to information about clinical trials.” Ann Intern Med. 2000 Oct 17;133(8):609-14. [19] Berlin JA, Morris S, Rockhold F, Askie L, Ghersi D, Waldstreicher J. “Bumps and bridges on the road to responsible sharing of clinical trial data.” Clinical Trials. 2014 Feb;11(1):7-12. [20] Rogawski MA, Federoff HJ. “Disclosure of clinical trial results when product development is abandoned.” Sci Transl Med. 2011 Sep 28;3(102):102cm29. [21] See Kirkby HM, Calvert M, Draper H, et al. What potential research participants want to know about research: a systematic review. BMJ Open 2012;2: e000509. doi:10.1136/ bmjopen-2011-000509. [22] Piller, Charles “Law ignored, patients at risk.” STAT. December 13, 2015. Accessed September 30, 2016. https://www.statnews.com/2015/12/13/clinical-trials-investigation/.

Z. Mukhamedova

J. Schildmann, J. Vollmann

Liliana Spinella

El objetivo principal del presente trabajo consiste en introducir algunas cuestiones relevantes en torno a la discusión sobre el patentamiento de genes humanos a partir del análisis del Caso Association for Molecular Pathology et al v. Myriad Genetics Inc. et al en Estados Unidos. Nos proponemos subrayar las nociones centrales que se postulan en esta sentencia de la Corte Suprema del año 2013.