: Forensic DNA testing threatens American civil liberties.

There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goals and approaches, agreement on which is ethically required or recommended for a particular context. We analyse the case (...) of a potential Zika virus human challenge trial to assess whether and how community engagement can help promote the ethical acceptability of research posing risks to bystanders. We conclude that, in addition to having intrinsic value, community engagement can improve the identification of bystander risks, effective approaches to minimizing them, and transparency about bystander risks for host communities. (shrink)

William James’ Principles of Psychology, in which he made famous the ‘specious present’ doctrine of temporal experience, and Edmund Husserl’s Zur Phänomenologie des inneren Zeitbewusstseins, were giant strides in the philosophical investigation of the temporality of experience. However, an important set of precursors to these works has not been adequately investigated. In this article, we undertake this investigation. Beginning with Reid’s essay ‘Memory’ in Essays on the Intellectual Powers of Man, we trace out a line of development of ideas about (...) the temporality of experience that runs through Dugald Stewart, Thomas Brown, William Hamilton, and finally the work of Shadworth Hodgson and Robert Kelly, both of whom were immediate influences on James (though James pseudonymously cites the latter as ‘E.R. Clay’). Furthermore, we argue that Hodgson, especially his Metaphysic of Experience (1898), was a significant influence on Husserl. (shrink)

Leuridan (2010) argued that mechanisms cannot provide a genuine alternative to laws of nature as a model of explanation in the sciences, and advocates Mitchell’s (1997) pragmatic account of laws. I first demonstrate that Leuridan gets the order of priority wrong between mechanisms, regularity, and laws, and then make some clarifying remarks about how laws and mechanisms relate to regularities. Mechanisms are not an explanatory alternative to regularities; they are an alternative to laws. The existence of stable regularities in nature (...) is necessary for either model of explanation: regularities are what laws describe and what mechanisms explain. (shrink)

Many African American children make use of African American English in their everyday lives, and face academic barriers when introduced to Standard American English in the classroom. Research has shown that students who can adapt and use SAE for academic purposes demonstrate significantly better test scores than their less adaptable peers. Accordingly, AAE use and its confirmed inverse relationship to reading achievement have been implicated in the Black-White Test Score Gap, thus becoming the focus of intense research and practical interest. (...) This volume discusses dialectal code-switching from AAE to SAE and stresses the benefits and importance of African American students becoming bi-dialectal. It provides background theory and science supporting the most promising educational approach to date, Contrastive Analysis, a set of longstanding methods drawn from Second Language research and used effectively with students ranging from kindergarten through college. It offers a deeper knowledge of AAE use by students, the critical features of Contrastive Analysis, and detailed information about successful applications which teachers can apply in their own pedagogy. (shrink)

Shadworth Hodgson offers an account of how philosophy relates to science - both physical and psychological - in which three different conceptions of time can be identified. He distinguishes the methods of philosophy, involving analysis of the contents of immediate consciousness, and of science, which presumes the existence of the world of common sense. Hodgson holds that philosophical analysis of immediate consciousness, or the analysis of a present moment in the experience, provides the ultimate justification for knowledge in science. Time (...) as an object of study in science must be distinguished from the temporal structure of immediate consciousness. Time as a target of scientific study is thus differentiable into time in physical science, and time in psychology, where the temporal characteristics of consciousness can be studied, but only from a perspective external to that consciousness. Each of those scientific conceptions of time still presupposes and are evidentially dependent on the analysis of immediate consciousness, itself already temporal. The result is that time as a fundamental unit of experience could not, even in principle, conflict with time as studied in science, because it is presupposed by and the evidential base for claims about time in science. (shrink)

Volume 20, Issue 4, May 2020, Page 41-43.

In the target article, McGuire and colleagues (2009) found that 54% of social networkers would consider using direct-to-consumer personal genome testing (DTC PGT) for their child and that 63% agree...

Mister Rogers’ Neighborhood, which began as The Children’s Corner in 1953 and terminated in 2001, left its mark on America. The show’s message of kindness, simplicity, and individual uniqueness made Rogers a beloved personality, while also provoking some criticism because, by arguing that everyone was special without having to do anything to earn it, the show supposedly created an entitled generation. -/- In Mister Rogers and Philosophy, thirty philosophers give their very different takes on the Neighborhood phenomenon.

Rare genetic diseases collectively impact millions of individuals in the United States. These patients and their families share many challenges including delayed diagnosis, lack of knowledgeable providers, and limited economic incentives to develop new therapies for small patient groups. As such, rare disease patients and families often must rely on advocacy, including both self-advocacy to access clinical care and public advocacy to advance research. However, these demands raise serious concerns for equity, as both care and research for a given disease (...) can depend on the education, financial resources, and social capital available to the patients in a given community. In this article, we utilize three case examples to illustrate ethical challenges at the intersection of rare diseases, advocacy and justice, including how reliance on advocacy in rare disease may drive unintended consequences for equity. We conclude with a discussion of opportunities for diverse stakeholders to begin to address these challenges. (shrink)

This paper examines the outcomes of Preserving the Past Together, a workshop series designed to build the capacity of local heritage managers to engage in collaborative and community-based approaches to archaeology and historic preservation. Over the past two decades practitioners of these approaches have demonstrated the interpretive, methodological, and ethical value of integrating Indigenous perspectives and methods into the process and practice of heritage management and archaeology. Despite these benefits, few professional resources exist to support the development of collaborative relationships (...) between local heritage managers and Tribal nations. Filling this need, Preserving the Past Together’s interactive workshops and keynote lectures involved participants in a discussion of the central themes in collaborative and Indigenous approaches to archaeology today, highlighting the local challenges and opportunities that exist for archaeologists, heritage managers, and Tribal nations to work together to care for the past. This paper presents an overview of the event series’ goals, the strategies it used to foster collaboration among the diverse stakeholders of the Salish Sea, and the next steps the project’s co-directors are taking to further support communication and collaboration between stewards and stakeholders in the Pacific Northwest. (shrink)

BackgroundDeveloping a comprehensive, reproducible literature search is the basis for a high-quality systematic review (SR). Librarians and information professionals, as expert searchers, can improve the quality of systematic review searches, methodology, and reporting. Likewise, journal editors and authors often seek to improve the quality of published SRs and other evidence syntheses through peer review. Health sciences librarians contribute to systematic review production but little is known about their involvement in peer reviewing SR manuscripts.MethodsThis survey aimed to assess how frequently librarians (...) are asked to peer review systematic review manuscripts and to determine characteristics associated with those invited to review. The survey was distributed to a purposive sample through three health sciences information professional listservs.ResultsThere were 291 complete survey responses. Results indicated that 22% (n = 63) of respondents had been asked by journal editors to peer review systematic review or meta-analysis manuscripts. Of the 78% (n = 228) of respondents who had not already been asked, 54% (n = 122) would peer review, and 41% (n = 93) might peer review. Only 4% (n = 9) would not review a manuscript. Respondents had peer reviewed manuscripts for 38 unique journals and believed they were asked because of their professional expertise. Of respondents who had declined to peer review (32%, n = 20), the most common explanation was “not enough time” (60%, n = 12) followed by “lack of expertise” (50%, n = 10).The vast majority of respondents (95%, n = 40) had “rejected or recommended a revision of a manuscript| after peer review. They based their decision on the “search methodology” (57%, n = 36), “search write-up” (46%, n = 29), or “entire article” (54%, n = 34). Those who selected “other” (37%, n = 23) listed a variety of reasons for rejection, including problems or errors in the PRISMA flow diagram; tables of included, excluded, and ongoing studies; data extraction; reporting; and pooling methods.ConclusionsDespite being experts in conducting literature searches and supporting SR teams through the review process, few librarians have been asked to review SR manuscripts, or even just search strategies; yet many are willing to provide this service. Editors should involve experienced librarians with peer review and we suggest some strategies to consider. (shrink)

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...

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...

Institutional Review Boards have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater (...) transparency from the perspective of a variety of stakeholders. IRB transparency will make boards more accountable, improve the quality of their decision-making, facilitate consistency in board decisions, permit empirical study of IRBs, promote research efficiency, and advance trust in the research enterprise, among a variety of other benefits. Regulators should promote IRB transparency, IRBs themselves should commit to sharing as much information as they can within the confines of confidentiality requirements, and investigators can endeavor to take matters into their own hands by sharing IRB correspondence and IRB-approved protocols and consent materials. (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...) largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of relief. (...) Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed. (shrink)

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide support (...) for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests. (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)

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

In this article, we develop a new approach to integrating philosophical phenomenology with qualitative research. The approach uses phenomenology’s concepts, namely existentials, rather than methods such as the epoché or reductions. We here introduce the approach to both philosophers and qualitative researchers, as we believe that these studies are best conducted through interdisciplinary collaboration. In section 1, we review the debate over phenomenology’s role in qualitative research and argue that qualitative theorists have not taken full advantage of what philosophical phenomenology (...) has to offer, thus motivating the need for new approaches. In section 2, we introduce our alternative approach, which we call Phenomenologically Grounded Qualitative Research (PGQR). Drawing parallels with phenomenology’s applications in the cognitive sciences, we explain how phenomenological grounding can be used to conceptually front-load a qualitative study, establishing an explicit focus on one or more structures of human existence, or of our being in the world. In section 3, we illustrate this approach with an example of a qualitative study carried out by one of the authors: a study of the existential impact of early parental bereavement. In section 4, we clarify the kind of knowledge that phenomenologically grounded studies generate and how it may be integrated with existing approaches. (shrink)

When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be “minimal.” Outside the research context, US tort law tolerates a more flexible “reasonable” risk (...) threshold. This article advances a preliminary case that nonconsenting participants and nonconsenting bystanders exposed to similar research risks may be entitled to the same level of protection, but that risks generated by research may not be special in kind. Thus, limiting research risks to those that are “reasonable,” rather than demanding that they be held to the “minimal” standard, may be the best approach for both nonconsenting participants and nonconsenting bystanders. Further work is needed to establish whether the descriptive standards used to support the analogies relied on here are normatively justifiable, as well as the extent to which the minimal risk standard and the reasonable risk standard would lead to meaningfully different outcomes in practice. (shrink)

In its recent review of the US Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala from 1946 to 1948, the Presidential Commission for the Study of Bioethical Issues identified a number of egregious ethical violations, but failed to adequately address issues associated with the intentional exposure research design in particular. As a result, a common public misconception that the study was wrong because researchers purposefully infected their subjects has been left standing. In fact, human subjects have been (...) exposed to disease pathogens for experimental purposes for centuries, and this study design remains an important scientific tool today. It shares key features with other types of widely accepted research on human subjects and can be conducted ethically, provided certain safeguards are implemented. That these safeguards were not implemented in Guatemala is what made that study wrong, rather than the fact of intentional exposure itself. To preserve public trust in the clinical research enterprise, this conclusion ought to be stated explicitly and emphasised. (shrink)

Vermeulen et al. suggest a moral duty exists for physicians to inform patients of “relevant opportunities” for Expanded Access. Such a duty is likely both too broad, leading to important practical challenges, and too narrow, without further steps to promote patient access. However, physicians should be expected to be aware of the EA pathway, disclose it to eligible patients, and support the pursuit of EA options reasonably likely to help.

Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a trusted advisor, at least for some. Patient‐engaged bioethics doesn't mean taking the (...) view that patients are always right, but even when disagreement continues, progress is possible if academics and patients recognize the unique expertise each has to offer. (shrink)

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

When payment is offered for controlled human infection model research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions—regarding risk. Against this backdrop, we commend Grimwade et al 1 for their careful handling of the relevant issues, coupling empirical and conceptual approaches. We agree with foundational elements of the authors’ analysis, including the acceptability of payment for research risk.1 However, in our view, it is preferable to treat payment for risk as a (...) discretionary incentive to achieve adequate recruitment and retention, rather than compensation owed as a matter of fairness. Grimwade et al 1 note that although their ‘Payment for Risk Model’ was ‘created specifically in the context of CHIM research, it has the potential to inform payment in other areas of medical research.’ We agree and would go further: we do not need a special payment framework for CHIMs because there is nothing so novel about them compared with other types of research as to demand a distinct approach. Any successful payment framework must address the following ethical issues: preserving informed consent ; treating participants fairly ; encouraging adequate recruitment and retention; avoiding deception by participants; and preserving public trust.2 Some of these issues may have particular salience in the context of CHIMs, but this study design does not demand consideration of entirely distinct ethical factors when evaluating offers of payment.2 We also agree with Grimwade et al 1 about several other key points.2 Given the burdens involved and …. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: Online review (...) of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (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)

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)

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)

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible (...) to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.