Governing the Access to COVID-19 Tools Accelerator: towards greater participation, transparency, and accountability.

The Access to COVID-19 Tools Accelerator (ACT-A) is a multistakeholder initiative quickly constructed in the early months of the COVID-19 pandemic to respond to a catastrophic breakdown in global cooperation. ACT-A is now the largest international effort to achieve equitable access to COVID-19 health technologies, and its governance is a matter of broad public importance. We traced the evolution of ACT-A's governance through publicly available documents and analysed it against three principles embedded in the founding mission statement of ACT-A: participation, transparency, and accountability. We found three challenges to realising these principles. First, the roles of the various organisations in ACT-A decision making are unclear, obscuring who might be accountable to whom and for what. Second, the absence of a clearly defined decision making body; ACT-A instead has multiple centres of legally binding decision making and uneven arrangements for information transparency, inhibiting meaningful participation. Third, the nearly indiscernible role of governments in ACT-A, raising key questions about political legitimacy and channels for public accountability. With global public health and billions in public funding at stake, short-term improvements to governance arrangements can and should now be made. Efforts to strengthen pandemic preparedness for the future require attention to ethical, legitimate arrangements for governance.

Presenting a Comprehensive Definition of Unnecessary Healthcare Services and Their Drivers: A Systematic Review and Meta-synthesis.

Background: Providing unnecessary healthcare services is a major common problem in every health system. The scope and cause of healthcare services must be identified in order to be managed and controlled. Finding the most complete definition of the problem and its causes are the goals of this meta-synthesis. Methods: A comprehensive search strategy was performed using a wide range of keywords and databases. Based on the defined inclusion and exclusion criteria, 22 articles were selected for content analysis and meta-synthesis. The Graneheim and Lundman method was used for content analysis. The MAXQDA software Version 18.2.0 was used for the first round of content analysis. Content analysis and meta-synthesis were used to comprehensively define the term "unnecessary healthcare services" and find the etiologic factors driving healthcare providers to unnecessary healthcare services. Results: The term "unnecessary healthcare services" is defined as "overproviding healthcare services that could be harmful, low-value, insufficient, and inappropriate." The etiologic pattern of unnecessary healthcare services shows intrinsic and extrinsic factors as a driving force for unnecessary healthcare services. Conclusion: A multilayer strategy for efficient management and prevention of unnecessary healthcare services is appropriate due to the multifaceted character of these services. This approach consists of the modification of the intrinsic factors and extrinsic drivers.

The scientific productions in Iranian biomedical ethics: A combined study of bibliometrics and social network analysis.

This study aims at increasing our understanding of the research activities of Iranian researchers and institutions in the field of biomedical ethics from 1995 to 2015. A combination of bibliometrics and social network analysis was used to examine the bibliographic data of 580 documents published on Iranian biomedical ethics in Web of Science and Scopus databases to investigate the publication trend, scientific impact, subject keywords network, and social network analysis indicators for international and cross-institutional co-authorship networks. The results showed that the publication of documents has had a consistent and increasing growth and that the citation trend has grown along with it. The analysis of thematic clusters by keyword co-occurrence network shows that Iranian biomedical ethics research has dealt with various topics and that has introduced different research directions. Researchers from 28 countries were identified in the international collaboration network. The main partners of Iranian researchers were from the US (17.8%) and the UK (9.2%). However, there is a tendency to develop and complete cooperation with researchers from different countries. The cross-institutional collaboration network comprises of 63 institutes, of which Tehran University of Medical Sciences (38%), Shahid Beheshti University of Medical Sciences (11%) and Shiraz University of Medical Sciences (7%) have the largest share in publishing documents. The superiority of the first two universities based on centralization indicators in the cross-institutional collaboration network has caused the exchange of cross-network knowledge between and via these players. The network density indicator shows that almost half of the co-authorship links within the international collaboration network and 8% of the co-authorship links within the cross-institutional collaboration network have been implemented and that these networks are not very coherent.

WHO guidance on ethics in outbreaks and the COVID-19 pandemic: a critical appraisal.

In 2016, following pandemic influenza threats and the 2014-2016 Ebola virus disease outbreaks, the WHO developed a guidance document for managing ethical issues in infectious disease outbreaks. In this article, we analyse some ethical issues that have had a predominant role in decision making in response to the current COVID-19 pandemic but were absent or not addressed in the same ways in the 2016 guidance document. A pandemic results in a health crisis and social and political crises both nationally and globally. The ethical implications of these global effects should be properly identified so that appropriate actions can be taken globally and not just in national isolation. Our analysis, which is a starting point to test the broader relevance of the 2016 WHO document that remains the only available guidance document applicable globally, concludes that the WHO guidance should be updated to provide reasoned and thoughtful comprehensive ethics advice for the sound management of the current and future pandemics.

Assessing research misconduct in Iran: a perspective from Iranian medical faculty members.

BACKGROUND: Research misconduct is a global concern in biomedical science. There are no comprehensive data regarding the perception and situation of scientific misconduct among the Iranian medical faculty members. We conducted a nationwide survey to assess the research misconduct among the medical faculty members in Iran. METHODS: We used the Persian version of the research misconduct questionnaire (PRMQ) on the Google Forms platform. We sent the survey link to a systematic random sample of medical faculty members in Iran (N = 4986). Descriptive analyses were performed on the individual items of the PRMQ, with frequencies and percentages for categorical and Likert-type response items, and means and standard deviation (S.D.) for continuous variables. Chi-square analysis was conducted to test hypotheses examining differences in the frequency of responses related to factors influencing misconduct. We also defined four tenure categories (TC) based on the working years of the participants as tenured faculty members. All the analyses were performed using R 3.6.0. RESULTS: The response rate was 13.8% (692 responses). Nearly 70% of the respondents agreed that their publication output would be of higher quality if there were no publication pressure. Approximately three-quarters (N =499, 72.1%) of the respondents had been aware of some instances of research misconduct during the previous year according to their understanding of misconduct. Among the participants, 18.5% perceived the effectiveness of their associated organisation's rules for reducing research misconduct to be high or very high. Pressure for tenure was identified as the item most frequently perceived with a strong behavioural influence on engaging in research misconduct (80.2%). CONCLUSIONS: This study confirms that research misconduct needs to be actively addressed among the medical faculty members. Making policies with a focus on boosting awareness regarding the occasions of scientific misconduct and its management seems to be indispensable in the future in Iran.

Iranome: A catalog of genomic variations in the Iranian population.

Considering the application of human genome variation databases in precision medicine, population-specific genome projects are continuously being developed. However, the Middle Eastern population is underrepresented in current databases. Accordingly, we established Iranome database (www.iranome.com) by performing whole exome sequencing on 800 individuals from eight major Iranian ethnic groups representing the second largest population of Middle East. We identified 1,575,702 variants of which 308,311 were novel (19.6%). Also, by presenting higher frequency for 37,384 novel or known rare variants, Iranome database can improve the power of molecular diagnosis. Moreover, attainable clinical information makes this database a good resource for classifying pathogenicity of rare variants. Principal components analysis indicated that, apart from Iranian-Baluchs, Iranian-Turkmen, and Iranian-Persian Gulf Islanders, who form their own clusters, rest of the population were genetically linked, forming a super-population. Furthermore, only 0.6% of novel variants showed counterparts in "Greater Middle East Variome Project", emphasizing the value of Iranome at national level by releasing a comprehensive catalog of Iranian genomic variations and also filling another gap in the catalog of human genome variations at international level. We introduce Iranome as a resource which may also be applicable in other countries located in neighboring regions historically called Greater Iran (Persia).

Oversight of Dual-Use Research: What Role for Ethics Committees?

The World Health Organization (WHO) Global Guidance Framework for the Responsible Use of the Life Sciences addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process.

Priority-setting for early access to COVID-19 vaccines in Islamic Republic of Iran.

Background: Priority-setting for early access to vaccines during a pandemic optimizes the impact of vaccine rollout, however, low- and middle-income countries (LMICs) have little experience in policymaking on this. In the Islamic Republic of Iran, the national clinical ethics committee developed a policy for early access to COVID-19 vaccines with support from the national committee on COVID-19 vaccine. Aims: This paper reports the process and results of a national COVID-19 vaccine priority-setting in the Islamic Republic of Iran and discusses its ethical and cultural aspects. Methods: A multidisciplinary team of experts planned and developed a national guideline following an extensive literature review and face-to-face consultations. Results: We present the list of priority groups and subgroups, tiered through a 4-phase process, as well as the ethical values and sociocultural issues underpinning COVID-19 vaccine prioritization in the Islamic Republic of Iran. Conclusions: Our experience shows that a transparent and well-reasoned policymaking process can inform fair prioritysetting for pandemic vaccines, especially in LMICs.

The extent of government intervention in the public health system and individual freedoms during the Covid-19 pandemic: a theoretical analysis.

The concept of individual freedom has complex and multifaceted dimensions that significantly affect the limits of permissible government interventions aimed at restricting such freedoms and maintaining public health. Therefore, the boundary between individual freedom and the social obligations of the government must be carefully clarified. During the Covid-19 pandemic, the need for such clarifications clearly increased. This study intended to investigate the concept of freedom according to major theories and to observe their application in analyzing the relations between individuals and the government in the health system, particularly during public health emergencies. The findings revealed that "justice-based", "development-based" and "accountability-based" conceptions of freedom provide a more appropriate rationale for implementation of public health restrictive measures by health authorities during infectious disease outbreaks including pandemics such as COVID-19. Even in minimal governments that are built upon a free-market system and unrestricted conception of individuals' freedom, such public health interventions are justifiable in the light of the 'Catastrophic Moral Horror' where there is an extreme risk to the health of citizens.

COVID-19 vaccination in children as a global dilemma through an ethical lens: A retrospective review.

Background and Aims: COVID-19 pandemic led to a need to rapidly vaccinate as many people as possible. Children are an important part of the population with different characteristics which vaccinating them is a matter of great importance as it should be decided considering all aspects and ethics. Here, we present different aspects of COVID vaccination in children including the potential challenges. Methods: We searched on PubMed, Google Scholar and Scopus in this regard, and all of the relevant papers published until June 28, 2021 were included if we could access their full-texts. Results: We found various expert opinions in this regard and tried to summarized them. Saving lives has similar ethical value as preventing evitable adverse event. Accordingly, mandating the children to receive the SARS-CoV-2 vaccine, needs risk-benefit weighing with special consideration of ethical challenges. Conclusion: Considering the vast range of benefits resulted from pediatric vaccination both for the children and the community, implementing the program in a scientific manner and also with the least financial expenses for the families seems to be reasonable and makes it both ethical and moral.

Respecting patients' rights in hospitals: patients' and health-care workers' perspectives.

Considering the importance of respecting and observing patients' rights, this study aimed to assess the level of observance of hospitalized patients' rights from both patients' and health-care workers' (HCWs) perspectives. This cross-sectional descriptive-analytic study reports the responses of 486 patients and 887 HCWs in a public referral university hospital. The study illustrates that patients and HCWs think patients' rights are respected at a medium level; however, HCWs reported lower levels of respect for patients' rights than patients, and senior HCWs reported even lower levels than their younger colleagues. Older patients and those hospitalized in internal medicine wards reported lower respect for autonomy and responsiveness, and patients' companions reported lower levels of respect for patients' rights than the patients themselves.

Access to health care for Afghan immigrants and refugees: an ethico-legal analysis based on the Iranian health law system.

The right to health is an internationally recognized and established human right with a long history of appreciation, indicating that governments should guarantee the highest possible level of access to health and provide health-care serivces with no discrimination based on nationality, race, gender, language or religion. The present study explored this topic using an analytic-descriptive approach. We reviewed related laws, policies and other available documents with the aim to investigate the ethico-legal aspects of Afghan refugees' and immigrants' access to health care and the challenges in in this regard within the Iranian health law system. According to the results of this study, the Iranian health law could be interpreted to include all Afghan immigrants in the country's public health system as a legal commitment. In addition, while basic and primary health coverage is available for all Afghan immigrants in Iran, provision of other medical and rehabilitative health services to documented and undocumented immigrants follow different methods. In order to alleviate the current situation, we recommend strategies such as supporting policy changes intended to register undocumented immigrants, which naturally results in an increase in their access to health care.

Proposing a set of ethical guidelines for Iranian physiotherapists: results of a modified Delphi technique.

The code of ethical conduct for physiotherapy services must be compatible with the local culture. The ethical guidelines proposed here were developed through a literature review, focus group discussions, and finally a modified Delphi technique to achieve consensus after the data were analysed. At first, the collection of different ethical codes yielded 132 items. In the second stage, repetitive items were discarded, some new items were added, and the various codes were categorised into three domains. Overall, 175 items were considered in the Delphi stage. Subsequently, the items were reduced to 134 in total - 59 in the treatment domain, 41 in research, and 34 in the education domain. The resulting code of ethics will support patients, researchers, students, and teachers in the field of physical therapy with sensitivity to current Iranian legislation and culture.

Conflicts and Challenges of Truth-Telling in Dentistry: A Case-Based Ethical Analysis.

Objectives : The basis of truth-telling is respecting the autonomy of patients and developing an ability to make informed decisions with valid consent. The purpose of this study was to ethically analyze the conflicts about truth-telling in dentistry. Materials and Methods: This case analysis focused on the issues of truth-telling in medicine and dentistry. The challenges encountered by dentists with respect to ethical issues related to truth-telling were discussed and analyzed by the research team. Results: The literature review showed that the issue of truth-telling in dentistry has been addressed from three aspects: Truth-telling about other dentists' medical errors, truth-telling about dangerous, refractory, or incurable diseases, and truth-telling to children or incompetent individuals for decision-making. Conclusion: When the duty of the dentist in truth-telling is conflicted with some other moral obligations, the conflict between the prima facie duties arises. The principle-based ethical theories provide a suitable conceptual framework for moral judgement in such conflicts. In cases of conflicts related to truth-telling, a balance should be maintained between principles and rules such as fidelity, respect for autonomy, maintaining trust in dentist-patient relation, and best interest of patients. The decision in truth-telling should be made individually for each patient based on the specific contextual conditions.

A proposed framework for holding intensive 3Rs workshops in laboratory animal science.

Principles of 3Rs are the backbone of today's animal research. Applying 3Rs in practice requires proper education and training. Although this could be achieved via long-term courses ranging from several weeks to years, in some circumstances a short-term course may be the only viable option. In this paper we define scientific and ethical objectives for running short-term 3Rs workshops. To meet these objectives, we propose a 2-day workshop curriculum and an ethical framework. The curriculum comprises theoretical and practical sessions and covers Replacement, Reduction, and Refinement strategies. The ethical framework defines the responsibilities of lecturers and attendees, and proposes the animals and facilities requirements to run the proposed workshop curriculum. The attendees will be assessed at the end of the workshop and they receive certificates for working under supervision until they are deemed competent at their intended functions. The proposed curriculum and framework are not subscriptive, instead they share the experience gained through running more than 60 laboratory animal 3Rs workshops.

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Priority Setting of Ventilators in the COVID-19 Pandemic from the Public's Perspective.

Background: Ventilator allocation plan for a public health crisis should be developed through recognizing the values of society and engaging the general public. This study was conducted to assess the Iranian citizens' attitude about some principles and criteria for allocation of ventilators in the current COVID-19 epidemic.Materials and Methods: An electronic self-administered questionnaire was publicly distributed through social networks of Telegram and WhatsApp to perform this cross-sectional study. The questionnaire consisted of 11 statements about the selection and prioritization of patients for the use of a ventilator.Results: 1262 persons, including 767 citizens and 495 health care providers participated in this study. More than 95% of participants agreed upon the necessity to avoid discrimination and avoid prioritization according to patients' gender, economic and political status. While 40.9% of citizens and 49.6% of healthcare workers believed that a ventilator can be disconnected from a patient with a poor prognosis to help another patient who has a better prognosis (P-value = 0.13), 34.3% of people and 29.6% of healthcare workers believed that the earlier admitted patients have the right to receive the device even if the likeliness of his/her survival is less than the next patient (P-value = 0.009).Conclusions: Maximizing health benefits as a measure of ventilator allocation in the pandemic of COVID-19 is an accepted criterion. Meanwhile, periodic evaluation of patients and disconnecting the device from a patient that no longer benefits from ICU services requires its scientific and ethical basis to be brought in public discourse.

The second strategic plan of medical ethics: a national report.

Medical ethics faces several challenges in different aspects of education, research, and treatment in medicine and healthcare practice. Design and implementation of a national strategic plan can pave the way for the development of a roadmap in various countries to strengthen ethics and address these challenges. To create a comprehensive plan compatible with the Iranian healthcare system, a multidisciplinary team of main stakeholders compiled a national strategic plan of medical ethics following several focus group discussion sessions and two workshops (2014-2017). Ultimately, the plan was confirmed by the Supreme Council for the Medical Ethics of the Ministry of Health and Medical Education. The current paper is a national report of the process and the medical ethics strategic plan in Iran. We have also tracked signs of progress and achievements in the country. In conclusion, this valuable effort has led to significant success in the implementation of medical ethics in clinical medicine, medical research, and education by using all the resources in our country. The participation of all the stakeholders, especially healthcare professionals in this way is required.

Initial drafting of telemedicine's code of ethics through a stakeholders' participatory process.

Telemedicine can improve access to healthcare services; however, it has raised ethical concerns demanding special considerations. This study aimed at developing the codes of ethics for telemedicine, and hence several approved national and international ethical guidelines related to telemedicine practice were reviewed, and 48 semi-structured interviews were conducted with medical ethics and medical informatics experts as well as with physicians and patients who had telemedicine experiences. Content analysis was then performed on the interviews' transcripts and a draft on code of ethics was prepared, which was further reviewed by the experts in the focus group meetings to reach a consensus on the final document. The final document consisted of a preface, five considerations, and 25 ethical statements. Considering the growing trend of adopting telemedicine worldwide, this document provides an ethical framework for those who use telemedicine in their medical practice.