In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University\'s human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB.

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research.

Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students\' education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students\' classroom-based research. Our qualitative content analysis of a subsample of ten colleges\' IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates.

Although the ECG is an important diagnostic tool in medical practice, the competency of ECG interpretation is considered to be poor. Diagnostic inaccuracy involving the misinterpretation of ECG can lead to inappropriate medical judgements and cause negative clinical outcomes, unnecessary medical testing and even fatalities. Despite the importance of assessing ECG interpretation skills, there is currently no established universal, standardised assessment tool for ECG interpretation. The current study seeks to (1) develop a set of items (ECG questions) for estimating competency of ECG interpretation by medical personnel by consensus among expert panels following a process based on the RAND/UCLA Appropriateness Method (RAM) and (2) analyse item parameters and multidimensional latent factors of the test set to develop an assessment tool.
This study will be conducted in two steps: (1) selection of question items for ECG interpretation assessment by expert panels via a consensus process following RAM and (2) cross-sectional, web-based testing using a set of ECG questions. A multidisciplinary panel of experts will evaluate the answers and appropriateness and select 50 questions as the next step. Based on data collected from a predicted sample size of 438 test participants recruited from physicians, nurses, medical and nursing students, and other healthcare professionals, we plan to statistically analyse item parameters and participant performance using multidimensional item response theory. Additionally, we will attempt to detect possible latent factors in the competency of ECG interpretation. A test set of question items for ECG interpretation will be proposed on the basis of the extracted parameters.
The protocol of this study was approved by the Institutional Review Board of Ehime University Graduate School of Medicine (IRB number: 2209008). We will obtain informed consent from all participants. The findings will be submitted for publication in peer-reviewed journals.

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Consensus guidance for the development and identification of high-quality Alzheimer\'s disease clinical trials is needed for protocol development and conduct of clinical trials.
An ad hoc consensus committee was convened in conjunction with the Alzheimer\'s Association to develop consensus recommendations.
Consensus was readily reached for the need to provide scientific justification, registration of trials, institutional review board oversight, conflict of interest disclosure, funding source disclosure, defined trial population, recruitment resources, definition of the intervention, specification of trial duration, appropriate payment for participant engagement, risk-benefit disclosure as part of the consent process, and the requirement to disseminate and/or publish trial results even if the study is negative.
This consensus guidance should prove useful for the protocol development and conduct of clinical trials, and may further provide a platform for the development of education materials that may help guide appropriate clinical trial participation decisions for potential trial participants and the general public.

The world currently faces an unprecedented pandemic outbreak of coronavirus disease (Covid-19). The novel nature of the virus and very high infection rates have not only increased the urgency to find a vaccine or cure but have also led to drastic changes in the mode of conduct of research. Thus, the Indian Council of Medical Research has developed the \"National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during Covid-19 Pandemic\" for guidance during the review of research. Here, we attempt to analyse the strengths and limitations of these guidelines to assess if the unique ethical challenges faced during research in the current situation are adequately identified and addressed and if foundational values and principles of research ethics have been taken into account in these guidelines.

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.

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It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach - i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three \'threads\' of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelinesbut not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint - provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter\'s section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint - especially if the institution is aware of the REC\'s explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC\'s actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC\'s conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.