Preparing ethical review systems for emergencies: next steps.

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

Exploring defensive medicine: examples, underlying and contextual factors, and potential strategies - a qualitative study.

BACKGROUND: Medical errors, unsatisfactory outcomes, or treatment complications often prompt patient complaints about healthcare providers. In response, physicians may adopt defensive practices to mitigate objections, avoid complaints, and navigate lengthy trial processes or other potential threats. However, such defensive medicine (DM) practices can carry risks, including potential harm to patients and the imposition of unnecessary costs on both patients and the healthcare system. Moreover, these practices may run counter to accepted ethical standards in medicine. METHODS: This qualitative study involved conducting semi-structured interviews with 43 physicians, among whom 38 were faculty members at medical universities, 42 had administrative experience at various levels of the health system, and 23 had previously served as health system policymakers. On average, the participants had approximately 23.5 years of clinical experience. The selection of participants was based on purposive sampling. Data collection through interviews continued until data saturation was achieved. RESULTS: Based on the findings, DM manifests in both positive and negative forms, illustrated by instances like ordering unnecessary lab tests, imaging, or consultations, reluctance to admit high-risk patients, and avoiding high-risk procedures. The study participants identified a range of underlying and contextual factors contributing to DM, encompassing organizational-managerial, social, personal, and factors inherent to the nature of defensive medical practices. The results also highlight proposed strategies to address and prevent DM, which can be grouped into organizational-managerial, social, and those focused on modifying the medical complaints management system. CONCLUSION: DM is a multifaceted and significant phenomenon that necessitates a comprehensive understanding of its various aspects, including interconnected and complex structures and underlying and contextual factors. While the results of this study offer a solid foundation for informing policy decisions within the healthcare system and include some explanatory policy suggestions, we encourage policymakers to complement the findings of this study with other available evidence to address any potential limitations and to gain a more comprehensive understanding of the policymaking process related to DM.

SARS-Cov-2 and COVID-19, Basic and Clinical Aspects of the Human Pandemic: A Review.

In the last two decades, we have witnessed three major epidemics of the coronavirus human disease namely, severe acute respiratory syndrome (SARS), Middle Eastern respiratory syndrome, and more recently an ongoing global pandemic of coronavirus disease 2019 (COVID-19). Iran, a country of nearly 84 million, in the Middle East, severely involved with the COVID-19 disease. A documented multidimensional approach to COVID-19 disease is therefore mandatory to provide a well-balanced platform for the concerned medical community in our county and beyond. In this review, we highlight the disease status in Iran and attempt to provide a multilateral view of the fundamental and clinical aspects of the disease including the clinical features of the confirmed cases, virology, pathogenesis, epidemiology, and laboratory methods needed for diagnosis.

Ethics of research on stem cells and regenerative medicine: ethical guidelines in the Islamic Republic of Iran.

BACKGROUND: Regenerative medicine plays a major role in biomedicine, and given the ever-expanding boundaries of this knowledge, numerous ethical considerations have been raised. MAIN TEXT: Rapid advancement of regenerative medicine science and technology in Iran, emerged the Iranian National Committee for Ethics in Biomedical Research to develop a comprehensive national ethical guideline. Therefore, the present ethical guideline which comprises eleven chapters was developed in 2019 and approved in early 2020. The titles of these chapters were selected based on the ethical considerations of various aspects of the field of regenerative medicine: (1) ethical principles of research on stem cells and regenerative medicine; (2) ethical considerations for research on stem cells (embryonic stem cells, epiblast stem cells, tissue-specific stem cells, stem cells derived from transdifferentiation, induced pluripotent stem cells [iPSCs], germline pluripotent stem cells, germline stem cells, and somatic cell nuclear transfer [SCNT] stem cells); (3) ethical considerations for research on somatic cells in regenerative medicine (adult somatic cells, fetal tissue somatic cells, and somatic cells derived from pregnancy products [other than fetus]); (4) ethical considerations for research on gametes in regenerative medicine; (5) ethical considerations for research related to genetic manipulation (human and animal) in regenerative medicine; (6) ethical considerations for research on tissue engineering in regenerative medicine; (7) ethical considerations for pre-clinical studies in regenerative medicine; (8) ethical considerations for clinical trials in regenerative medicine; (9) ethical considerations for stem cells and regenerative medicine bio-banks; (10) ethical considerations for privacy and confidentiality; and (11) ethical considerations for obtaining informed consent. CONCLUSION: This article discusses the process of developing the present ethical guidelines and its practical points. We hope that it can play an important worldwide role in advancing ethics of research on stem cells and regenerative medicine.

Distinct genetic variation and heterogeneity of the Iranian population.

Iran, despite its size, geographic location and past cultural influence, has largely been a blind spot for human population genetic studies. With only sparse genetic information on the Iranian population available, we pursued its genome-wide and geographic characterization based on 1021 samples from eleven ethnic groups. We show that Iranians, while close to neighboring populations, present distinct genetic variation consistent with long-standing genetic continuity, harbor high heterogeneity and different levels of consanguinity, fall apart into a cluster of similar groups and several admixed ones and have experienced numerous language adoption events in the past. Our findings render Iran an important source for human genetic variation in Western and Central Asia, will guide adequate study sampling and assist the interpretation of putative disease-implicated genetic variation. Given Iran's internal genetic heterogeneity, future studies will have to consider ethnic affiliations and possible admixture.

Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel.

BACKGROUND: Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research "ethics preparedness" constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. MAIN TEXT: A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. CONCLUSION: It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.

Zika Virus Infection, Basic and Clinical Aspects: A Review Article.

BACKGROUND: Zika virus infection has recently attracted the attention of medical community. While clinical manifestations of the infection in adult cases are not severe and disease is not associated with high mortality rates, Zika virus infection can have an impact on fetal development and lead to severe neurodevelopmental abnormalities. METHODS: To gain insight into different aspects of Zika virus infection, a comprehensive literature review was performed. With regard to epidemiology and geographical distribution of Zika virus infection, relevant information was extracted from CDC and WHO websites. RESULTS: In this review, we discuss different basic and clinical aspects of Zika virus infection including virology, epidemiology and pathogenesis of disease. Laboratory methods required for the diagnosis of disease together with ethical issues associated with Zika virus infection will also be discussed in detail. CONCLUSION: Herein, we have tried to provide a multi-faceted view of Zika virus infection, with greater emphasis on disease status in Eastern Mediterranean Region.

The process of justifying assisted reproductive technologies in Iran.

Infertility is medically defined as one year of unprotected intercourse that does not result in pregnancy. Infertility is a noticeable medical problem in Iran, and about a quarter of Iranian couples experience primary infertility at some point in their lives. Since having children is a basic social value in Iran, infertility has an adverse effect on the health of the couple and affects their well-being. The various methods of assisting infertile couples raise several ethical questions and touch upon certain sensitive points. Although the present Iranian legislative system, which is based on the Shi'a school of Islam, has legalised some aspects of assisted reproductive technologies (ARTs), given the absence of a general officially ratified act (official pathway), such medical interventions are usually justified through a fatwa system (non-official pathway). Officially registered married couples can access almost all ART methods, including third-party gamete donation, if they use such pathways. The process of justifying ART interventions generally began when in vitro fertilisation was given the nod and later, Ayatollah Khamenei (the political-religious leader of the country) issued a fatwa which permitted gamete donation by third parties. This open juristic approach paved the way for the ratification of the Embryo Donation to Infertile Spouses Act in 2003.