To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...

First, the authors should be congratulated for bringing our attention to this important issue. They have made important observations about what may be holding us back in efforts to make progress in...

In this article, I will describe how the Utopians whom John Dewey once referenced are possibly the ancestors of Indigenous peoples, in this case, ancestors of the Diné. I will describe a Diné philosophy of education through the Kinaałdá ceremony which was the first ceremony created by the Holy People of the Diné to ensure the survival of the people. I frame this ceremony as an educational experience that illuminates the similarities between the Diné and Utopian philosophies of education. It (...) is through an understanding and experiencing of the Kinaałdá that one can fully experience a real example of the ‘Utopian schools.’ It is through an upbringing within a non-acquisitive paradigm, ontologically and epistemologically, that one can fully envision this society that William Schubert explains through a compilation of various philosophers and theorists in order to make it understandable to an acquisitive society. The oral teachings from my ancestors through songs, stories and ceremonies that have been passed down to the current generations prove that the utopia once existed and that some ‘Utopians’ still exist. This explanation of a Diné philosophy of education through the Kinaałdá ceremony is my lived example of what Dewey seemed to have dreamt or found in another dimension. I claim that the Utopians Dewey witnessed were possibly Indigenous peoples. (shrink)

We use the U.S. Supreme Court’s decision in Citizens United v. Federal Election Commission to assess the reputational risks created by political investment opportunities that allow managers to spend unlimited and potentially undisclosed firm resources on independent political expenditures. This new opportunity raises important ethical questions, as it is difficult, and perhaps impossible, under current law for shareholders to hold managers accountable for this investment choice and the reputational risks it entails. Using firms’ known political activity as a proxy for (...) managers’ likely future use of independent political expenditures, we examine how market participants reacted to Citizens United, conditional on this prior activity and corporate governance attributes related to the concentration of decision rights in senior management and blockholders. The results of our analyses document that firms with both a high level of known political activity and CEO-chairperson of the board duality experienced negative abnormal returns in reaction to Citizens United. In contrast, firms with concentrated ownership experienced positive abnormal returns; however, as known political activity increased, investors discounted the benefits of concentrated ownership. These findings suggest that investors expect this expansion of firms’ political investment opportunities to amplify principal-agent problems inherent in corporate political activity. Additionally, our findings provide evidence for those deliberating the mandatory disclosure of firms’ investments in politics as a means of increasing managerial accountability to both shareholders and the public. (shrink)

Ruba and Repacholi review an important debate in the emotion development literature: whether infants can perceive and understand facial configurations as instances of discrete emotion catego...

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 (...) small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard.Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical.Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review. (shrink)

Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment (...) tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners. (shrink)

This case looks at the question of how to consider obligations of confidentiality by a mental health professional who works for an institution and learns that a student has been using a drug intended for an animal research project. Dr. Paul Appelbaum, MD, a psychiatrist at Columbia University, examines the issue of the limits of confidentiality. Nicholas Steneck, PhD, a scholar in research misconduct at the University of Michigan, explores the obligations to report research misconduct. Walter Limehouse, MD, an ethicist (...) at the Medical University of South Carolina, considers the systems issues raised by this case and offers some suggestions that might change the institutional environment. (shrink)

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)

Volume 19, Issue 9, September 2019, Page 1-4.

This paper considers the morally relevant ways in which population-based research is a distinct type of human subjects research that have unique moral considerations relevant for public health practitioners and researchers. By defining population-based research, the authors distinguish it from public health practice and then consider, in more detail, the ways in which population-based research differs from clinical human subjects research. Based upon the distinctions between these types of research and practice, they identify five important issues that arise in the (...) design and conduct of certain kinds of population-based research. The authors hope that public health practitioners find these distinctions useful in determining when their work may actually be population-based research and that public health researchers use them to identify the areas where ethical issues in their research may arise. (shrink)

In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; (...) the impact of “ego dissolution” on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards’ orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations. (shrink)

Multiple scholars and institutions have asked what distinguishes public health research from public health practice. Most often, they ask in order to have a clear definition of what one does in various public health settings to assess oversight and/or regulation of human subjects research. More importantly, however, whether something is considered public health research or public health practice has real ethical implications in terms of the general moral considerations at stake and the obligations of public health researchers/practitioners to the populations (...) they serve or study.Numerous examples in recent history of research ethics, including the Kennedy Krieger Lead Abatement Study and EPA’s Children’s Environmental Exposure Research Study, suggest that an exploration of the ethics of public health, or more generally population-based research, may be warranted. Although we acknowledge that there are important ethical issues to consider in the implementation of public health practice, we leave that discussion for other authors. (shrink)

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered (...) with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs).Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts.Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets. (shrink)

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical (...) research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/irb quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators. (shrink)

Volume 19, Issue 6, June 2019, Page 64-66.

Michael Choniates (c. 1138–c. 1222), a pupil of Eustathius of Thessalonica, who was Greek Orthodox Metropolitan of Athens for some 25 years up to that city's capture by Frankish crusaders ina.d.1205, is best known to classical scholars as the possessor of probably the last complete copy of Callimachus'HecaleandAetia. He had brought with him from Constantinople many books of all kinds, and added to his collection when in Athens. Although an immense task, it would be well worth trying to identify all (...) Michael's classical allusions, as an indication of how much ancient Greek literature was still available just before Constantinople too succumbed to the crusaders. (shrink)

This case explores the ethical landscape around recontacting a subject's relatives to return genetic research results when the informed consent form signed by the original cohort of subjects is silent on whether investigators may share new information with the research subject's family. As a result of rapid advances in genetic technology, methods to identify genetic markers can mature during the life course of a study. In this case, the investigators identified the genetic mutation responsible for the disorder after a number (...) of their original subjects had died. The researchers now have the ability to inform relatives of the subject about their risk of developing the same disease. Mark Rothstein, JD, from the University of Louisville School of Medicine, provides an overview of the medical/scientific, legal, and ethical issues underlying this case. Lauren Milner, PhD, and colleagues at Stanford University explore how the relationship between researcher and subject affect this debate. Seema Shah, JD, and colleagues at the National Institutes of Health and University of California, Los Angeles discuss whether and how requirements of the duty to warn are applicable in this case. (shrink)

Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset (...) to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)