Nippon Medical School's Ethical Review Processes for Studies Involving Human Subjects.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.

The Declaration of Helsinki in bioethics literature since the last revision in 2013.

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

A Call to Revise the Declaration of Helsinki's Placebo Guidelines.

Since its introduction in 1964, the World Medical Association's Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

A Declaration of Helsinki for animals.

OBJECTIVE: This article examines the ethical principles underlying the Declaration of Helsinki as an internationally agreed justificatory framework for human medical research. The aim of the analysis is to consider the potential usefulness of these principles for defining an internationally agreed ethical 'best practice' in clinical veterinary research (CVR). It is suggested that the specific ethical responsibilities of the clinician to protect the interests of their patient when conducting medical research may be translated into the veterinary setting. Through exploring risk and harm, unproven interventions, vulnerability and informed consent, the article identifies the ethical risks of CVR. It is shown that veterinary regulators in the UK and the European Union have addressed these concerns to varying degrees; however, disagreements over the appropriateness of specific CVR practices are identified. A commitment to collaborative exploration of the benefits and challenges of implementing a Declaration of Helsinki for Animals is proposed.

Research Ethics in the Age of Digital Platforms.

Scientific research is growingly increasingly reliant on "microwork" or "crowdsourcing" provided by digital platforms to collect new data. Digital platforms connect clients and workers, charging a fee for an algorithmically managed workflow based on Terms of Service agreements. Although these platforms offer a way to make a living or complement other sources of income, microworkers lack fundamental labor rights and basic safe working conditions, especially in the Global South. We ask how researchers and research institutions address the ethical issues involved in considering microworkers as "human participants." We argue that current scientific research fails to treat microworkers in the same way as in-person human participants, producing de facto a double morality: one applied to people with rights acknowledged by states and international bodies (e.g., the Helsinki Declaration), the other to guest workers of digital autocracies who have almost no rights at all. We illustrate our argument by drawing on 57 interviews conducted with microworkers in Spanish-speaking countries.

Ethical analysis of cadaver supply and usage processes for research within the scope of the Helsinki Declaration.

Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system-cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity of medical progress, human-especially cadaver-research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research.

Applicability and usefulness of the Declaration of Helsinki for forensic research with human cadavers and remains.

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community.

Giving and taking: ethical treatment assignment in controlled trials.

The current version of the Declaration of Helsinki states that 'the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention(s) … '. This wording implies that it is acceptable for patients to be assigned to receive an unproven new intervention and to be denied a best current proven intervention. We assert that patients being invited to participate in controlled trials cannot, ethically, be expected to forego proven beneficial forms of care. Patients being treated in controlled trials should not knowingly be disadvantaged compared with similar patients being treated in usual clinical care, where they have access to beneficial care. In this article, we have tried to separate for discussion 'the withholding of effective care from trial participants', 'informed consent to treatment', 'blinding' and 'use of placebos'.

A call for urgent action to safeguard our planet and our health in line with the helsinki declaration.

In 2015, the Rockefeller Foundation-Lancet Commission launched a report introducing a novel approach called Planetary Health and proposed a concept, a strategy and a course of action. To discuss the concept of Planetary Health in the context of Europe, a conference entitled: "Europe That Protects: Safeguarding Our Planet, Safeguarding Our Health" was held in Helsinki in December 2019. The conference participants concluded with a need for action to support Planetary Health during the 2020s. The Helsinki Declaration emphasizes the urgency to act as scientific evidence shows that human activities are causing climate change, biodiversity loss, land degradation, overuse of natural resources and pollution. They threaten the health and safety of human kind. Global, regional, national, local and individual initiatives are called for and multidisciplinary and multisectorial actions and measures are needed. A framework for an action plan is suggested that can be modified for local needs. Accordingly, a shift from fragmented approaches to policy and practice towards systematic actions will promote human health and health of the planet. Systems thinking will feed into conserving nature and biodiversity, and into halting climate change. The Planetary Health paradigm ‒ the health of human civilization and the state of natural systems on which it depends ‒ must become the driver for all policies.

Relación Transversal, Vertical y Sagital en Sujetos con Deformidad Facial Candidatos a Cirugía Ortognática / Transverse, Vertical and Sagittal Relationship in Subjects with Facial Deformity Candidates for Orthognathic Surgery

RESUMEN: El objetivo de este estudio fue evaluar la relación entre la clase esqueletal sagital y las condiciones transversales o verticales en sujetos con deformidad facial sin presencia de asimetría facial; Se realizó un análisis cefalomét rico de la clase esqueletal sagital, transversal y vertical en 115 sujetos con indicaciones de cirugía ortognática. Se consideró algunos datos del análisis cefalométrico de Steiner y el análisis cefalométrico de Ricketts en sentido sagital para determinar la clase esqueletal facial. A nivel transversal se determinó la dimensión transversal facial, dimensión transversal maxilar y dimensión transversal mandibular. A nivel vertical se determinó la dimensión vertical oclusal y dimensión vertical total. Al comparar las mediciones transversales y verticales entre sujetos de sexo femenino y masculino, se observó que los hom- bres presentaban mayores dimensiones que las mujeres (p=0,0001) en todos los análisis realizados. Los sujetos clase III presentaron mayor dimensión transversal facial (p=0,0002) y transversal mandibular (p=0,001) que los sujetos clase II. Además, se observó que los sujetos clase III presentaban mayor dimensión vertical total (p=0,002) que los sujetos clase II; Es posible concluir que existe características faciales transversales y verticales que se pueden relacionar con la posición sagital de las estructuras maxilo-mandibulares.

ABSTRACT: The aim of this study is to evaluate the relationship between sagittal skeletal class and transverse or vertical conditions in subjects with facial deformity without presence of facial asymmetry; A comparative study was conducted between the results of the cephalometric analysis of the sagittal, transverse and vertical skeletal class in 115 subjects with indications for orthognathic surgery. The Steiner cephalometric analysis in the sagittal direction was used to determine the facial skeletal class and the Ricketts cephalometric analysis in the sagittal analysis. At the transverse level it was determined the facial transverse dimension, maxillary transverse dimension and mandibular transverse dimension. At a vertical level it is determined the occlusal vertical dimension and total vertical dimension. When comparing cross-sectional and vertical measurements between female and male subjects, it was observed that male subjects presented greater dimensions than female subjects (p=0.0001). Class III subjects present greater facial transverse dimension (p=0.0002) and mandibular transverse dimension (p=0.001) than class II subjects. Also, it was observed that class III subjects had a greater total vertical dimension (p=0.002) than class II subjects; It is possible to conclude that there are facial characteristics transverse and vertical that can be related with the sagittal position of the maxillo-mandibular structures.

Ten years of the Helsinki Declaration on patient safety in anaesthesiology: An expert opinion on peri-operative safety aspects.

: Patient safety is an activity to mitigate preventable patient harm that may occur during the delivery of medical care. The European Board of Anaesthesiology (EBA)/European Union of Medical Specialists had previously published safety recommendations on minimal monitoring and postanaesthesia care, but with the growing public and professional interest it was decided to produce a much more encompassing document. The EBA and the European Society of Anaesthesiology (ESA) published a consensus on what needs to be done/achieved for improvement of peri-operative patient safety. During the Euroanaesthesia meeting in Helsinki/Finland in 2010, this vision was presented to anaesthesiologists, patients, industry and others involved in health care as the 'Helsinki Declaration on Patient Safety in Anaesthesiology'. In May/June 2020, ESA and EBA are celebrating the 10th anniversary of the Helsinki Declaration on Patient Safety in Anaesthesiology; a good opportunity to look back and forward evaluating what was achieved in the recent 10 years, and what needs to be done in the upcoming years. The Patient Safety and Quality Committee (PSQC) of ESA invited experts in their fields to contribute, and these experts addressed their topic in different ways; there are classical, narrative reviews, more systematic reviews, political statements, personal opinions and also original data presentation. With this publication we hope to further stimulate implementation of the Helsinki Declaration on Patient Safety in Anaesthesiology, as well as initiating relevant research in the future.

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations.

OBJECTIVES: To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. DESIGN: Cross sectional analysis. DATA SOURCES: PubMed, the 17 World Health Organization's trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. STUDY SELECTION CRITERIA: RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. RESULTS: This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated. CONCLUSIONS: This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

Anti-doping research and the Helsinki Declaration: (mis)match?

The fight against doping in sport is internationally coordinated by the World Anti-Doping Agency (WADA). Through its World Anti-Doping Code, WADA aims to harmonize anti-doping policies, rules and regulations. One key reference document bound to the Code is the International Standard for Laboratories (ISL), which mainly specifies the criteria that must be met for laboratory accreditation, as well as standards to adopt for the production of valid test results and evidentiary data. Within the ISL, the Code of Ethics refers to the Helsinki Declaration as a guiding framework for anti-doping research. However, inasmuch as anti-doping research structurally differs from human subject research as considered by the Helsinki Declaration, the applicability of the latter to anti-doping research can be called into question. In this work, we discuss how key principles of the Helsinki Declaration apply to anti-doping research and highlight frictions, incompatibilities and misalignments. Furthermore, we indicate possible solutions for operationalizing the Helsinki principles within the context of anti-doping research.