As a consequence of the COVID-19 pandemic, the number of decentralized clinical trials, trials conducted in whole or in part at locations other than traditional clinical trial sites, significantly increased. While these trials have the potential advantage of access, participant centricity, convenience, lower costs, and efficiency, they also raise a number of important ethical and practical concerns. Here we focus on a number of those concerns, including participant safety, privacy and confidentiality, remote consent, digital access and proficiency, and trial oversight. (...) Awareness of these ethical complexities will help foster the development of processes and cooperative solutions to promote safe, ethical trials going forward, optimized to decrease burden and increase access for all participants. (shrink)

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal‐wide definition adopted by the Office of Science and Technology Policy. The (...) second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects.These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations. (shrink)

On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...) biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM's proposal are critically flawed. (shrink)

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

Volume 20, Issue 9, September 2020, Page 23-25.

Pickering et al. argue that judgments of competence should in part be based on the harm that could result from the decision. The centerpiece of their reasoning is that it is inconsistent...

Volume 19, Issue 6, June 2019, Page 62-64.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator (...) transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: the ethical significance of compliance with website “terms of use”; the ethics of recruiting from the online networks of research participants; and the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices. (shrink)

Peterson, Karlawish, and Largent’s “Supported Decision Making with People at the Margins of Autonomy” brings welcome attention to the rights of people with cognitive impairment and provides...

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)

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...) that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

Background Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.Methods We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and (...) while ongoing. We used a priori and grounded theory to analyze the data and constant comparative method to induce higher order themes.Results Interviewees perceived determination of scientific value as the responsibility of the investigator and, secondarily, other parties who review or oversee research. Interviewees reported that ongoing trials are rarely reevaluated due to emerging evidence from external sources, evaluation is complex, and there would be value in the development of standards for monitoring and evaluating evidence systematically. Investigators, IRBs, and/or data monitoring committees (DMCs) could undertake these responsibilities. Feasibility assessments are performed but are typically inadequate; potential solutions are unclear.Conclusions There are three domains where current approaches are suboptimal and in which further guidance is needed. First, who has the responsibility for conducting scientific review, whether it be the investigator, IRB, and/or DMC is often unclear. Second, the standards for scientific review (e.g., appropriate search terms, data sources, and analytic plan) should be defined. Third, guidance is needed on the evaluation of ongoing studies in light of potentially new and evolving evidence, with particular reference to evidence from outside the trial itself. (shrink)

Title VI of the Civil Rights Act of 1964 and its implementing regulations prohibit federally-funded educational institutions and healthcare centers from engaging in disparate impact discrimination “on the ground of race, color, or national origin” in all of their operations.

We are grateful to everyone who took the time to offer such insightful comments with regard to the protection–inclusion dilemma in research oversight. Nearly all respondents agreed that this dilemm...

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

The sudden emergence of the COVID-19 pandemic brought global disruption to every aspect of society including healthcare, supply chain, the economy, and social interaction. Among the many emergent considerations were the safety and public health of the public, patients, essential workers, and healthcare professionals. In certain locations, clinical research was halted—or terminated—in deference to the immediate needs of patient care, and clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on other diseases. Difficult (...) decisions were made rapidly; flexibility and reconsideration were necessary not only because the intensity and severity of infection varied over time and by locale but also because knowledge of the disease and understanding of its treatment grew. Here we discuss the ethical challenges in decision-making and competing ethical tensions during the pandemic in an effort to advance future preparedness. (shrink)

This paper makes a plea for more reflexive attempts to develop and anchor the emerging concept of responsible research and innovation. RRI has recently emerged as a buzzword in science policy, becoming a focus of concerted experimentation in many academic circles. Its performative capacity means that it is able to mobilise resources and spaces despite no common understanding of what it is or should be ‘made of’. In order to support reflection and practice amongst those who are interested in and (...) using the concept, this paper unpacks understandings of RRI across a multi-disciplinary body of peer-reviewed literature. Our analysis focuses on three key dimensions of RRI that remain particularly opaque. A total of 48 publications were selected through a systematic literature search and their content was qualitatively analysed. Across the literature, RRI is portrayed as a concept that embeds numerous features of existing approaches to govern and assess emerging technologies. Our analysis suggests that its greatest potential may be in its ability to unify and provide political momentum to a wide range of long-articulated ethical and policy issues. At the same time, RRI’s dynamism and resulting complexity may represent its greatest challenge. Further clarification on what RRI has to offer in practice—beyond what has been offered to date—is still needed, as well as more explicit engagement with research and institutional cultures of responsibility. Such work may help to realise the high political expectations that are attached to nascent RRI. (shrink)

This paper explores the interconnectedness of persons with disabilities, technologies and the environment by problematizing Western notions of the independent, autonomous subject. Drawing from Deleuze and Guattari’s reconfiguration of the static subject as active becoming, prevailing discourses valorizing independence are critiqued as contributing to the marginalization of bodies marked as disabled. Three examples of disability “dependencies”—man-dog, man-machine, and woman-woman connectivities—are used to illustrate that subjectivity is partial and transitory. Disability connectivity thus serves a signpost for an expanded understanding of subjectivity (...) and suggests a radically altered ethics that is no longer premised on individual rights. (shrink)

Not at all self-evident, the so-called isomorphisms between the phenomenology and physiology of dreams have been interpreted by Hobson et al. in an arbitrary manner to state that dreams are stimulated by chaotic brainstem stimulation (an assumption also adopted by Vertes & Eastman). I argue that this stimulation is not chaotic at all; nor does it occur in the absence of control from the cerebral cortex, which contributes complexity to brainstem activity as well as meaningful information worth consolidating in the (...) brain during sleep. [Hobson et al.; Vertes & Eastman]. (shrink)

The passion narratives have often been read in ways that reinforce victimization of abused persons, particularly women, who accept any kind of suffering as their way of “carrying the cross” in the footsteps of Jesus. Yet these narratives can also help to galvanize communities of believers toward transformative change. The Johannine Jesus, who goes to calamity's depths for his friends, is one image that offers liberative possibilities.

There is a tension in the Gospel of Matthew between two very different images of God. In the Sermon on the Mount, God is portrayed as being boundlessly gracious and forgiving, while in eight Matthean parables, God is seen as vindictive and punitive. This poses an ethical dilemma: which God is with us and whom should we emulate?

"The term 'model' has become fashionable". What Mary Hesse characterized in the mid-1960s as a trend in logic, mathematics, and the natural sciences, applies today in general for a broad spectrum of disciplines. Today models appear to be of "extraordinary importance" compared to the first half of the twentieth century, when models were neither mentioned nor contemplated, either generally in scientific publications or specifically in the philosophy of science. It is even assumed that models are "the key to science" and (...) that today's science is largely... (shrink)

We surveyed 223 APA members to investigate the roles of therapists' sex, theoretical orientation, interpersonal boundaries, and clients' sex in predicting therapists' assessments of the ethicality of nonerotic dual relationships with their clients. Results indicated that therapists' sex, interpersonal boundaries, and theoretical orientation influenced ethical judgments of these relationships. Theoretical and practical implications of our findings are discussed.

_The Star of Redemption_ is essential reading for anyone interested in understanding religion and philosophy in the twentieth century. Fusing philosophy and theology, the book assigns both Judaism and Christianity distinct but equally important roles in the spiritual structure of the world. Franz Rosenzweig finds in both biblical religions approaches to a comprehension of reality. The major themes and motifs of The Star—the birth, life, death, and the immortality of the soul; Eastern philosophies and Jewish mysticism; the relationship between God, (...) world and humanity over time; and revelation as the real biblical miracle of faith and path to redemption—resonate meaningfully. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reconsidering Buster Keaton’s HeroinesBarbara E. SavedoffIt has become commonplace to acknowledge that art tends to reflect the prejudices and presuppositions of the age in which it is produced. Such acknowledgement can serve not only to place the prejudicial attitudes expressed by artists and authors in their proper context, it can also reassure us that we have avoided the same prejudices, or at least, that we have achieved a greater (...) awareness of and sensitivity to them. But we should not be too easily reassured by these thoughts of our own enlightened progress, for the prejudices that we think we discover in works of art may sometimes be of our own making.Prejudice is, at least in part, a problem of distorted perception. Freeing oneself of prejudice is thus not simply a matter of disposing of false beliefs; it requires new habits of perception—becoming able to see what one could not see before. Since habits of perception can be deeply ingrained, we may find it difficult to recognize their persistence. Therefore even as we attempt to repudiate prejudicial attitudes, we may find ourselves misled by their continuing distortion of our vision. This can lead not only to continuing bias on our part, it can also lead to unwarranted charges of bias against others. For instance, the distorted vision that can pervade our evaluation of people in real life can also pervade our evaluation of characters in films or novels. When this happens, we may unfairly charge the film or novel with the perpetuation of negative stereotypes. There are also other ways in which we may be misled by our own biases. For example, if we expect to find negative stereotypes in the products of a given age, this may lead us to see the stereotypes that we anticipate—whether they are really there or not. The work of art can thus become a mirror of our own prejudices and preconceptions. [End Page 77]This is, I believe, what has occurred with much of the criticism of the portrayal of women in Buster Keaton’s films. Critical essays, commentaries, and even film-schedule blurbs tend either to downplay the strengths of the heroines in his films or brand them unfairly as stupid and incompetent. This unjust characterization of the heroines has become an unquestioned myth planted early in the minds of Keaton’s audiences. For example, some prints of The General contain an “educational” introduction which, among other things, describes Annabelle as yet another one of Keaton’s scatter-brained heroines. 1 The audience is thus primed to see Keaton’s heroines in this light.In my discussion I will expose the gap between the myths surrounding Keaton’s heroines and the actual characterization of those heroines in the films. I will then explore possible explanations for the durability of the myths by looking at whether there is something about Keaton’s films that provokes these prejudicial readings.IKeaton’s short film, The Balloonatic, begins in an amusement park with the hero vainly pursuing one woman after another until he is finally given a black eye by a young woman he has annoyed with his attentions. Discouraged, he wanders over to watch the launching of a hot air balloon, where he is given a pennant to attach to its top. His task completed, he finds himself atop the runaway balloon. When his rash attempt to shoot a bird perched on the balloon brings him rapidly back down to earth, he discovers himself stranded in the wilderness.The hero quickly sets out to adapt to his wilderness environment, but he is thwarted in his efforts by his inexperience and incompetence in the role of outdoorsman. He tries to fish, but when he casts his line, he catches the hook on his pants. He then dams up a stream so that he can pick up the stranded fish, but unbeknownst to him, they fall through a hole in his creel as soon as he puts them in. When he finally does realize what is happening, his dam breaks and he is carried helplessly down stream by the rush of water. Later in the film, we see the hero trying to... (shrink)