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Human rights may feel self-apparent to us, but less than 80 years ago, one of the most advanced countries at the time acted based on an utterly contrary ideology. The view of social Darwinism that abandoned the idea of the intrinsic value of human lives instead argued that oppression of the inferior is not only inevitable but desirable. One of the many catastrophic outcomes is the medical data obtained from inhuman experiments at concentration camps. Ethical uncertainty over whether the resulting insights should be a part of the medical literature provides a chance to consider the seemingly irreplaceable social construct of human dignity. Would any medical benefit justify the utilization of this illicit data? Would utilization even qualify as an insult to the dignity of the exploited subjects, or is this a question about intersubjective meaning? This work discusses the wisdom in blind adherence to human dignity, the possibility of retrospective insults, moral complicity, contrary viewpoints, and possible resolutions., (© 2024. The Author(s).)

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate., (© 2024 by The Hastings Center. All rights reserved.)

Competing Interests: Competing interests: P. Di Cano declares grants from the Ontario Ministry of Transportation and from Transport Canada to her institutions, and a grant from the Canadian Institutes of Health Research (CIHR), outside the submitted work. C. Wickens is a member of the Drugs and Driving Committee of the Canadian Society of Forensic Science and declares reimbursement of travel expenses to attend committee meetings. She also serves as the board director (unpaid) of the Canadian Association of Road Safety Professionals (2015–2024) and as a member of the Executive Committee of the International Council on Alcohol, Drugs and Traffic Safety (2021–2027). I. Boileau is the Canada Research Chair in Endocannabinoid Imaging and declares a grant from CIHR, outside the submitted work. No other competing interests were declared.

Background: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients., Methods: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws., Results: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones., Conclusion: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond., (© 2024. The Author(s).)

The COVID-19 pandemic has necessitated rapid research to aid in the understanding of the disease and the development of novel therapeutics. One option is to conduct controlled human infection trials (CHITs). In this article I examine the history of deliberate human infection and CHITs and their utilization prior to the COVID-19 pandemic, key ethical considerations of CHITs in the COVID-19 setting, an analysis of the World Health Organization's (WHO) Key criteria for the ethical acceptability of COVID-19 human challenge studies, and a review of the two COVID-19 CHITs that have already commenced, their compliance with the WHO criteria and other ethical considerations., (© 2023. Journal of Bioethical Inquiry Pty Ltd.)

Objective: This study aims to establish best practices and guidelines to ensure that experimental research utilizing Postmortem Human Subjects (PMHS) for injury prevention adheres to relevant ethical principles, which are also commonly accepted in research involving human tissues and living subjects. Furthermore, it reviews existing literature to underscore the pivotal role of PMHS testing in evaluating the efficacy of safety systems, with a particular focus on airbag performance., Methods: This paper conducts an examination of the primary ethical principles governing human subject research as outlined in the Declaration of Helsinki (1965) and traces their evolution up to the latest framework proposed by the Council for International Organizations of Medical Sciences (CIOMS) in 2002. Input was solicited from international experts and laboratories experienced in PMHS testing to understand how these ethical principles are implemented in practice. This is complemented by a comprehensive review of literature that assesses the contribution of PMHS testing to airbag performance enhancements in frontal impacts., Results: The findings underscore the importance of informed consent from donors or their next-of-kin, as highlighted in CIOMS declarations, to ensure the ethical integrity of the donation process in line with international standards. The study also finds it customary for an independent review board to evaluate the research methodology and the necessity of employing PMHS tissue over alternative methods, such as computational models or crash test dummies. Despite various national regulations on human subject participation and living tissue research, no specific legal framework governing PMHS tissue use was identified. The systematic literature review revealed that PMHS testing has been crucial in identifying potential injury mechanisms not detected by Anthropomorphic Test Devices (ATD), significantly contributing to the enhancement of computer human body models and the biofidelity of crash test dummies., Conclusion: The International Council on the Biomechanics of Injury (IRCOBI) recognizes the need to provide guidance for research involving human cadaveric tissue to be conducted with the highest ethical standards. This study proposes five recommendations to ensure adherence to these ethical principles in PMHS testing, highlighting the paramount importance of obtaining informed consent and securing independent committee approval. Moreover, IRCOBI emphasizes that until a thorough understanding of tissue damage tolerance levels is achieved and human surrogates, such as ATDs or Human Body Models (HBM), reach full biofidelity, the use of human cadavers remains indispensable for developing effective injury prevention strategies and measures.

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.

Rules are needed for human research in commercial spaceflight.

In the midst of the Covid-19 pandemic, ethicists, researchers, and journalists have recommended studies that deliberately infect healthy volunteers with the coronavirus as a scientific means of expediting vaccine development. In this essay, we trace the history of infection challenge experiments and reflect on the Nuremberg Code of 1947, issued in response to brutal human experiments conducted by Nazi investigators in concentration camps. We argue that the Code continues to offer valuable guidance for assessing the ethics of this controversial form of research, with respect particularly to the acceptable limits to research risks and the social value of research necessary to justify exposing human participants to these risks., (© 2021 by The Hastings Center. All rights reserved.)

Competing Interests: Competing interests: None declared.

Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [EJ has received consulting fees from WHO and funding from The Wellcome Trust for research on the ethics of human challenge studies. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. MJS is he has received funding from The Wellcome Trust for previous research on the ethics of human challenge studies. No competing interests: SB,CE,GK,MK,KL,ER,CS,PGS, SS, RU]., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Randomized controlled trials (RCTs) enroll hundreds of millions of subjects and involve many human lives. To improve subjects' welfare, I propose a design of RCTs that I call Experiment-as-Market (EXAM). EXAM produces a welfare-maximizing allocation of treatment-assignment probabilities, is almost incentive-compatible for preference elicitation, and unbiasedly estimates any causal effect estimable with standard RCTs. I quantify these properties by applying EXAM to a water-cleaning experiment in Kenya. In this empirical setting, compared to standard RCTs, EXAM improves subjects' predicted well-being while reaching similar treatment-effect estimates with similar precision., Competing Interests: The author declares no competing interest., (Copyright © 2021 the Author(s). Published by PNAS.)

Background: The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses., Objectives: To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing, RESULTS: Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika., Conclusions: One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives.

In 1966, Henry Beecher published his foundational paper "Ethics and Clinical Research," bringing to light unethical experiments that were routinely being conducted by leading universities and government agencies. A common theme was the lack of voluntary consent. Research regulations surrounding laboratory experiments flourished after his work. More than half a century later, we seek to follow in his footsteps and identify a new domain of risk to the public: certain types of field experiments. The nature of experimental research has changed greatly since the Belmont Report. Due in part to technological advances including social media, experimenters now target and affect whole societies, releasing interventions into a living public, often without sufficient review or controls. A large number of social science field experiments do not reflect compliance with current ethical and legal requirements that govern research with human participants. Real-world interventions are being conducted without consent or notice to the public they affect. Follow-ups and debriefing are routinely not being undertaken with the populations that experimenters injure. Importantly, even when ethical research guidelines are followed, researchers are following principles developed for experiments in controlled settings, with little assessment or protection for the wider societies within which individuals are embedded. We strive to improve the ethics of future work by advocating the creation of new norms, illustrating classes of field experiments where scholars do not appear to have recognized the ways such research circumvents ethical standards by putting people, including those outside the manipulated group, into harm's way., Competing Interests: The authors declare no competing interest.

Competing Interests: The authors declare no competing interest.

Competing Interests: Competing interests: We have read and understood BMJ policy and declare the following interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute (RTI) International. SOM, JM, and AB have no competing interests to declare.

In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under limited circumstances and assuming various criteria have been met. In this perspective, some three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.

Background: Research ethics review committees (RERCs) and Human Research Protection Programs (HRPPs) are responsible for protecting the rights and welfare of research participants while avoiding unnecessary inhibition of valuable research. Evaluating RERC/HRPP quality is vital to determining whether they are achieving these goals effectively and efficiently, as well as what adjustments might be necessary. Various tools, standards, and accreditation mechanisms have been developed in the United States and internationally to measure and promote RERC/HRPP quality., Methods: We systematically reviewed 10 quality assessment instruments, examining their overall approaches, factors considered relevant to quality, how they compare to each other, and what they leave out. For each tool, we counted the number of times each of 34 topics (divided into structure, process, and outcome categories) was mentioned. We generated lists of which topics are most and least mentioned for each tool, which are most prevalent across tools, and which are left unmentioned. We also conducted content analysis for the 10 most common topics., Results: We found wide variability between instruments, common emphasis on process and structure with little attention to participant outcomes, and failure to identify clear priorities for assessment. The most frequently mentioned topics are Review Type , IRB Member Expertise , Training and Educational Resources , Protocol Maintenance , Record Keeping , and Mission , Approach, and Culture . Participant Outcomes is unmentioned in 8 tools; the remaining 2 tools include assessments based on adverse events, failures of informed consent, and consideration of participant experiences., Conclusions: Our analysis confirms that RERC/HRPP quality assessment instruments largely rely on surrogate measures of participant protection. To prioritize between these measures and preserve limited resources for evaluating the most important criteria, we recommend that instruments focus on elements relevant to participant outcomes, robust board deliberation, and procedures most likely to address participant risks. Validation of these approaches remains an essential next step.

This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)., (Copyright © 2020. Published by Elsevier Ltd.)

Global fatalities related to COVID-19 are expected to be high in 2020-2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods-that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

COVID-19 poses an extraordinary threat to global public health and an effective vaccine could provide a key means of overcoming this crisis. Human challenge studies involve the intentional infection of research participants and can accelerate or improve vaccine development by rapidly providing estimates of vaccine safety and efficacy. Human challenge studies of low virulence coronaviruses have been done in the past and human challenge studies with severe acute respiratory syndrome coronavirus 2 have been proposed. These studies of coronaviruses could provide considerable benefits to public health; for instance, by improving and accelerating vaccine development. However, human challenge studies of severe acute respiratory syndrome coronavirus 2 in particular might be controversial, in part, for ethical reasons. The ethical issues raised by such studies thus warrant early consideration involving, for example, broad consultation with the community. This Personal View provides preliminary analyses of relevant ethical considerations regarding human challenge studies of severe acute respiratory syndrome coronavirus 2, including the potential benefits to public health and to participants, the risks and uncertainty for participants, and the third-party risks (ie, to research staff and the wider community). We argue that these human challenge studies can reasonably be considered ethically acceptable insofar as such studies are accepted internationally and by the communities in which they are done, can realistically be expected to accelerate or improve vaccine development, have considerable potential to directly benefit participants, are designed to limit and minimise risks to participants, and are done with strict infection control measures to limit and reduce third-party risks., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

A TV debate in April 2020 between two French doctors regarding the benefits of testing a coronavirus vaccine in Africa where there are no masks or treatments available has led to international criticism. This case highlights a problematic ethical double standard in multinational clinical research: trials that would be considered unethical in high income countries (e.g., placebo-controlled where there is an existing treatment) are nonetheless justified in low-and-middle-income countries because the existing standards of care are less (i.e., no access to a treatment). Underlying this ethical double standard in some multinational clinical trials is a moral imperialism and persistent colonialist thinking that must be rejected., (© 2020 IMSS. Published by Elsevier Inc.)

Significance: Scar management is an important concern in plastic surgery. Scar models that best mimic in vivo human scarring are essential for understanding scar development and progression, assessing the efficacy of therapeutics, and providing reliable and valid research outcomes. Recent Advances: In 2016, Lanier et al. proposed a new in vivo patient model, the Northwestern Abdominoplasty Scar Model, that overcomes the prior limitations of both animal and human models, with greater representativeness of the human scarring process, expedited recruitment, smaller sample requirements, and greater flexibility in the types and number of interventions that can be studied simultaneously. Critical Issues: Existing animal models suffer from limitations that impede generalization to human scars. Human scar studies are difficult to conduct and rarely used due to recruitment difficulties, ethical concerns regarding purposeful wounding, and inherent variability based on location, type of scar, and the heterogeneity of the host response between humans. Although overcoming many of these hurdles, the Northwestern Abdominoplasty Scar Model still has a few limitations. In addition, there remains a need for further study of and comparison between the Northwestern Abdominoplasty Scar Model and existing human and animal models, to inspire more widespread acceptance of a standardized human scar model. Future Directions: The Northwestern Abdominoplasty Scar Model is a critical stepping stone toward better human scar models. This model hopefully will inspire other in vivo patient models utilizing elective surgery to overcome recruitment and ethical concerns.

The Covid-19 crisis has underscored the importance of the collection and analysis of clinical and research data and specimens for ongoing work. The federal government recently completed a related revision of the human subjects research regulations, founded in the traditional principles of research ethics, but in this commentary, we argue that the analysis underpinning this revision overemphasized the importance of informed consent, given the low risks of secondary research. Governing the interests of a community is different from governing the interests of individuals, and here we suggest that, moving forward, the analyses of the risks of secondary research protocols be assessed from the perspective of the former., (© 2020 The Hastings Center.)

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies., (© 2020 John Wiley & Sons Ltd.)

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.

Background: In an effort to alter eye color during World War II, devout Nazi researcher Karin Magnussen had adrenaline eye drops administered to inmates at the concentration camp Auschwitz-Birkenau. A Sinti family, with a high prevalence of heterochromia iridis, was forced to participate in this study. Members of this family, as well as other victims, were later killed and had their eyes enucleated and sent to Magnussen for examination. Magnussen articulated the findings of these events in a manuscript that has never been published. The author is the first ophthalmologist to review this manuscript. The generation who experienced the atrocities of World War II will soon be gone and awareness of what happened during this tragic chapter of world history is fading., Objectives: To describe these events to raise awareness among future generations., Methods: A literature review and archival search was conducted., Results: Magnussen's research was based on an animal study published in 1937. For Magnussen's study, adrenaline drops were administered to inmates, including a 12-year-old girl from the Sinti family. As there was a reported case of deaf-mutism within the family, Waardenburg syndrome seems to be the most plausible explanation for this family's heritable heterochromia., Conclusions: The effort to change eye color was doomed to fail from the beginning because there was a probable diagnosis of Waardenburg syndrome. Extinction of humans for ophthalmological research is an insane act beyond imagination. For the sake of these victims, and for the generations who still feel their pain, it is imperative to tell their stories.

This article considers a case in which a prominent researcher repeatedly made protocol deviations year after year while the institutional review board and university leadership failed to adequately address his continuing noncompliance. This article argues that, in addition to reporting this researcher's pattern of noncompliance to the Office for Human Research Protections, as required by federal regulations, the university should implement a remedial action plan., (© 2020 American Medical Association. All Rights Reserved.)

The use of deception is typically prohibited in studies that pose greater than minimal risk overall. This approach prevents researchers from using deception to conceal significant risks or to deceive participants about the purpose, potential benefits, or other aspects of a study that are relevant to deciding whether to accept such risks. Yet this approach also mistakenly blocks appropriate research. In particular, it keeps researchers from using deception in studies that pose greater than minimal risk, even when participants are informed accurately about the risks and other aspects of the study that are relevant to deciding whether to participate. Rather than prohibiting deception when the overall study poses greater than minimal risk, policies should prohibit deception when the aspect of the study about which participants are deceived poses greater than minimal risk., (© 2020 by The Hastings Center. All rights reserved.)