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)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol discussions but (...) little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (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)

BackgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.MethodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to (...) 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.ResultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.ConclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (...) (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and... (shrink)

J’ai souvent l’impression que dans les domaines tels que les études platoniciennes où l’on ne fait que réfléchir sur les textes anciens qui ont déjà attiré un nombre immense de générations de lecteurs posant les mêmes questions, ce ne sont pas tant les idées ou les hypothèses qui déterminent la qualité d’une approche que la manière dont elles sont exprimées. La recherche du Socrate historique, la volonté de prouver qu’on peut le trouver dans les textes des socratiques si différents les (...) uns de... (shrink)

As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.

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)

Institutional review board delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in (...) the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improv... (shrink)

Despite having faced severe criticism in the past, mereological approaches to group ontology, which argue that groups are wholes and that groups members are parts, have recently managed a comeback. Authors such as Katherine Ritchie and Paul Sheehy have applied neo-Aristotelian mereology to groups, and Katherine Hawley has defended mereological approaches against the standard objections in the literature. The present paper develops the mereological approaches to group ontology further and proposes an analysis of group membership as parthood plus further (...) restrictions. While all mereological accounts agree that group members are parts of the group, it has become clear that this analysis is insufficient. I discuss three proposals to develop the mereological analysis of group membership and then put forward a combined solution to the puzzle. According to my proposal, the members of a reading group are agents who are part of the group and have been designated to contribute to the group. (shrink)

Can our cultural membership excuse us from responsibility for certain actions? Ought the Aztec priest be held responsible for murder, for instance, or does the fact that his ritual sacrifice is mandated by his culture excuse him from blame? Our intuitions here are mixed; the more distant, historically and geographically, we are from those whose actions are in question, the more likely we are to forgive them their acts, yet it is difficult to pinpoint why this distance should excuse. (...) Up close, historically or geographically, we tend to be less forgiving: few of us excuse the Taliban for what they did to women and homosexuals; and if there is less of an outcry concerning treatment not all that dissimilar in Saudi Arabia and elsewhere, this is probably only because these actions are less well publicized. (shrink)

Why do we have obligations to the community to which we happen to belong? For communitarians, membership does more than provide the context for asking this question. In fact, the simple fact of membership goes some way towards justifying our obligations. According to the strong version of the communitarian thesis, membership is the fundamental consideration justifying political obligation; but for the weaker version, membership is one consideration among others and at times may be the less weighty (...) one. John Horton's theory of associative obligations can be read as moving back and forth between strong and weak communitarianism. His communitarianism is strong when he rejects value pluralism, arguing that one consideration, membership, is fundamental. However, Horton also advances claims that are compatible with not only the weak version of the communitarian thesis but also value pluralism. They suggest that, if membership is one reason among others to justify obligations, it is not fundamental as it can be defeated by other considerations. (shrink)

The following paper explores the categorisation of groups. Indeed, there are different ways to distinguish human groups from one another: on the one hand, sociological analyses focus their attention on the distinction between being inside and outside of groups; on the other hand, collective action theories mainly focus on the distinction between collectives and aggregates, based on the kind of action that groups can perform, i.e., joint or not. In this paper, we offer an alternative view by adopting the agent’s (...) perspective and creating a scale based on the importance the agent attributes to his or her membership to different groups. While this perspective seems to lose objectivity as it does not allow the formulation of an unambiguous scale that applies to all individuals, it does allow us to understand the process of identification and the consequent phenomenon whereby very often we act in accordance with other people’s actions, in a collective way, without prior coordination. A practical example based on the so-called “acting white” will be explored in order to test the paper’s proposal. The analysis intends to offer a common ground on the basis of which it would be possible to have further inquiries on the social dimension of self-experience. (shrink)

Many types of human research activities present risks and burdens to third parties (e.g., bystanders). Few human protection policies directly address the protection of research bystanders, though some address it in passing. In what follows, I re‐iterate reasons why bystanders are entitled to protections. I also argue that Institutional Review Boards (IRBs) are in the best position to signal to researchers and sponsors that bystanders should be protected in research. In some cases, IRB review would consist of evaluating bystander protection (...) strategies directly; in other cases, this might entail merely certifying that another institutions, like a drug regulator, has taken adequate measures to protect the welfare of research bystanders. (shrink)

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...) acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. (shrink)

Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining of ‘coercion’ (...) and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

In recent years, membership has dropped in traditional voluntary associations such as Rotary Clubs, Jaycees, and bowling leagues. At the same time, concern is rising about the growth of paramilitary and hate groups. Scholars have warned that these trends are undermining civic society by creating a dangerous number of isolated, mistrustful individuals and organized, antisocial renegades. In this provocative book, however, Nancy Rosenblum takes a new, less narrowly political approach to the study of groups. And she reaches more optimistic (...) conclusions about the state of civil society. Rosenblum argues that we should judge associations not only by what they do for civic virtue, but also by what they do for individual members. She shows that groups of all kinds--among them religious groups, corporations, homeowner associations, secret societies, racial and cultural identity groups, prayer groups, and even paramilitary groups--fill deep psychological and moral needs. And she contends that the failure to recognize this has contributed to an alarmist view of their social impact. For example, she argues that, although extremist groups have obvious antisocial aims, they constrain individuals who would be even more dangerous as maladjusted loners. And she examines the rapid growth of small "support groups"--which are usually dismissed as politically irrelevant--and shows that the moral support people find in such places as prayer groups and self-help groups helps to cultivate the social trust some scholars say is disappearing. Rosenblum concludes that, for practical and principled reasons, American democracy should permit expansive freedom of association, illustrating her case with discussion of specific cases in law. Rosenblum recognizes, however, that freedom has a price. She reminds us that some groups have oppressive and even criminal tendencies, and she explores what liberal democracy should do to ensure that individuals also have freedom within associations and freedom to exit. Throughout, Rosenblum writes eloquently and with a powerful moral voice, drawing on law, practical politics, and psychology to produce an original political theory of the moral uses of pluralism. The book adds remarkable depth and subtlety to one of the leading subjects in contemporary social and political debate. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...) ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct (...) by some investigators. The authors contend that, by fostering a climate in which investigators perceive that they receive fair and unbiased treatment, IRBs optimize the likelihood of collegial compliance with appropriate participant protections. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

I was recently asked to report on editorial trends in the Hastings Center Report, past and future. What I reported is that HCR has been going in two seemingly contrasting directions. One has to do with moral decision‐making in clinical ethics—the core theme in bioethics for fifty years, but still developing. A second editorial trend is treatment of larger social and political issues that bear on health, such as public health interventions and access to health care. I could also have (...) noted a continuing stream of pieces on emerging technologies, from whole‐genome screening for newborns to artificial intelligence in clinical diagnoses to the so‐called de‐extinction of extinct animals and plants through various genetic and reproductive tricks. This January‐February 2019 issue of HCR reflects all these trends. (shrink)

This paper considers Kamp and Partee's account of graded membership within a conceptual spaces framework and puts the account to the test in the domain of colors. Three experiments are reported that are meant to determine, on the one hand, the regions in color space where the typical instances of blue and green are located and, on the other hand, the degrees of blueness/greenness of various shades in the blue–green region as judged by human observers. From the locations of (...) the typical blue and typical green regions in conjunction with Kamp and Partee's account follow degrees of blueness/greenness for the color shades we are interested in. These predicted degrees are compared with the judged degrees, as obtained in the experiments. The results of the comparison support the account of graded membership at issue. (shrink)

In their target article, Friesen et al. (2023) offer recommendations primarily aimed at IRBs for reaching a better balance in the ongoing challenge of the protection-inclusion dilemma. The authors...

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)

Political membership refers to the condition of being a member of a particular political community. It is a relational concept by virtue of the fact that it presupposes a political relation shared by several individuals. Thus, a simple way to think about political membership is in terms of the rights and duties common to all full members of a specific community that it enforces. Those privileges and obligations are commonly delimited by political boundaries which regulate the relations among (...) members and aliens. (Published: 27 February 2012) Citation: Ethics & Global Politics, Vol. 5 , No. 1, 2012, pp. 57-69. DOI: 10.3402/egp.v5i1.14926. (shrink)

IRBs in action -- Everyone's an expert? Warrants for expertise -- Local precedents -- Documents and deliberations: an anticipatory perspective -- Setting IRBs in motion in Cold War America -- An ethics of place -- The many forms of consent -- Deflecting responsibility -- Conclusion: the making of ethical research.

A decade after the fall of Communism in Europe, the Czech Republic'smembership in the European Union is still a matter of a relatively shortwaiting period of 4 years. Not so the imagination of this membership andthe creation of a political concept created to promote this goal: thespecific Central European policy initiated by Thomas G. Masaryk andrevitalized by Václav Havel. Despite the deep differences in thepolitical thought and philosophical orientations of both Presidents, notto mention the historic rupture of 41 years (...) of Totalitarianism, theirperceptions of Europe as an Imagined Community are identical. (shrink)

Infamously, Rawls assumed a democratic society to be “a complete and closed social system,” in that “entry into it is only by birth and exit from it is only by death.” Since the beginning of the present millennium, however, debates about the ethical issues related to immigration have been prominent. In this context, these methodological departure points seem long outdated, if not simply biased. This paper will rework Rawls’s theory of migration for application to the case of provisional immigrants by (...) reworking its theoretical underpinnings. I will argue that once his assumptions are adjusted, Rawlsian notions of ‘stability’ in conjunction with his idea of a ‘society understood as a fair system of cooperation’ justify inclusive membership regimes. In other words, Rawlsian domestic justice requires inclusive membership regimes for provisional immigrants. (shrink)

In the literature on refugeehood in political theory, there has been a recent turn towards what have been called “state system legitimacy” views. These views derive an account of states’ obligations to refugees from a broader picture of the conditions for international legitimacy. This paper seeks to develop the state system legitimacy view of refugeehood by subjecting the most developed version of it—the account developed by David Owen—to critical scrutiny. We diagnose an ambiguity in Owen’s theory of refugeehood, in the (...) concept of political membership, and unpack the implications of this ambiguity for state system legitimacy views. First, we reconstruct the key aspects of Owen’s account of refugeehood and show how it represents an advance over competing theories. Then we discuss the methodological underpinnings of Owen’s account, showing the constraints and opportunities faced by state system legitimacy views. Next, we raise some problems for the conceptual distinctions that Owen develops between different types of refugee protection: asylum, sanctuary, and refuge. The underlying feature that leads to these problems is an ambiguity in the concept of political membership, which is at the core of Owen’s view of refugeehood. Finally, we distinguish two interpretations of political membership in the institution of refugeehood and chart out some possible ways forward for state system legitimacy views. The critique developed here is a sympathetic one, aimed at the further development of state system legitimacy views. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:IRBs Under the MicroscopeJonathan D. Moreno (bio)The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will (...) continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services’s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.Underlying these proximate causes for the IRB blitz is a growing realization that the already considerable clinical trial enterprise will expand significantly over the next few years. Congress is talking about giving the politically popular NIH half again the budget it currently receives, which in turn will stimulate more commercially supported research. The director of the National Cancer Institute is considering a five-fold increase in the number of subjects enrolled in oncology studies over the next several years. Phase I cancer studies are among the most ethically sensitive, so IRBs will have more work cut out for them if this goal is reached. Adding to the rush of interest in IRBs are the government’s recent apology to the survivors of the syphilis study in Tuskegee, continuing congressional dissatisfaction with the way the Pentagon handled its vaccine distribution during the Gulf War, and the controversy about AZT trials in developing countries.On the HillCongressman Christopher Shays, the moderate Connecticut Republican who has developed an interest in human research issues, convened hearings on human [End Page 329] subjects research and the IRB system on 11 June 1998. Shays chairs the House Government Reform/Human Resources Subcommittee. The committee’s ranking minority member is Edolphus Towns of Brooklyn, NY, who shares Shays’s interest in this area.The immediate rationale for the hearings was the release that day of the DHHS-IG report, Institutional Review Boards: A Time for Reform. The subtitle was changed from A System in Jeopardy apparently after some people in DHHS expressed reservations about its seemingly alarmist tone, but the IG staffers who testified before Shays’s subcommittee insisted that they stood behind the message that the IRB system is in trouble if considerable reforms are not undertaken. Among the factors in the research environment cited as support for the bleak forecast: managed care, commercialization, multi-site trials, high IRB workloads, minimal IRB oversight of approved studies, conflicts of interest, insufficient training of IRB members and investigators, and lack of IRB self-studies (DHHS-IG 1998).As is normally the case for congressional oversight hearings, the first panel of witnesses consisted of executive branch officials, including Eric Meslin, Executive Director of the National Bioethics Advisory Commission, and Gary Ellis, Director of the Office for Protection from Research Risks (OPRR). Shays pressed Ellis on the extent to which OPRR conducts on-site investigations of complaints about abuse of human subjects. Admitting that on-site investigations are rare, Ellis suggested that the agency is inadequately staffed to follow up on complaints as quickly as it might wish. The members of Congress who were present at the hearings generally expressed concern about the DHHS-IG’s findings.The second panel that day, which Shays was unable to attend, set a different tone. Four of the panelists—Paul Appelbaum of the University of Massachusetts at Worcester, Robert Levine of Yale University, Angela Bowen of the Western IRB (a private clinical trials review firm), and I—were invited as authorities on the current condition of the IRB system. Bert Spilker... (shrink)

In this paper, we demonstrate how the collaborative and sequential unfolding of a story ties into the constitution of a membership categorization device which we have glossed as ‘us and them’. The data come from a focus group activity where first and second generation immigrants to Denmark have been asked to discuss their situation in Denmark. Using Ethnomethodological Conversation and Membership Categorization Analysis, we present one story which involves a story-teller and his family and an elderly Danish couple (...) living in the same block of flats. In the telling of the story, co-participants align and affiliate, and disalign and disaffiliate, at sequentially relevant junctions. We will argue that not only do such phenomena indicate listenership and possible agreement to the moral of the story in its telling, but also to the morally implicative categorical work involved in the story’s telling. (shrink)

In “IRB and Research Regulatory Delays Within the Military Health Care Setting: Do They Really Matter? And If So, Why and for Whom?,” Freed and colleagues (Freed et al. 2016) proposed four areas of...

The NIH has initiated a plan to mandate use of central IRBs for all multi-site research. This manuscript argues against the mandate, proposing that there is inadequate evidence to support the purported gains in efficiency and that the ethical integrity of research may suffer with any exclusion of the local review voice.

The HSA constitution stipulates that "any person maybe admitted to membership by the Council, subject to confirmation by the Society et the next meeting and shall continue a member so long as he pays dues as determined in the by-laws." Annual dues for students are three dollars, for all others, five dollars. Application for membership should include name, position, institution and address, and should be submitted, with payment of dues, to Professor Donald P. Verene, Treasurer, HSA, Department of (...) Philosophy, Northern Illinois University, Dekalb, Illinois 60115. (shrink)

This paper addresses theoretical problems arising from the vagueness of language terms, and intuitions of the vagueness of the concepts to which they refer. It is argued that the central intuitions of prototype theory are sufficient to account for both typicality phenomena and psychological intuitions about degrees of membership in vaguely defined classes. The first section explains the importance of the relation between degrees of membership and typicality (or goodness of example) in conceptual categorization. The second and third (...) section address arguments advanced by Osherson and Smith (1997), and Kamp and Partee (1995), that the two notions of degree of membership and typicality must relate to fundamentally different aspects of conceptual representations. A version of prototype theory—the Threshold Model—is proposed to counter these arguments and three possible solutions to the problems of logical selfcontradiction and tautology for vague categorizations are outlined. In the final section graded membership is related to the social construction of conceptual boundaries maintained through language use. (shrink)

It is increasingly acknowledged that animals have an intrinsic moral status, in part due to the influential work of many moral philosophers. However, surprisingly little has been written by philosophers on whether animals are owed social membership and the rights that attach to membership in society. In this paper, I explore why the idea of social membership matters, particularly in relation to domesticated animals, and how it can guide legal and political reforms. Focusing on social membership (...) identifies neglected avenues for transformative change, and offers new ways of challenging the deeply-embedded ‘human use typologies' that currently govern our relations to domesticated animals. It also raises fascinating philosophical questions about the definition of ‘society' and the role of an ethics of membership. Ultimately, we will need to develop a new philosophy of interspecies society. (shrink)

The inauguration of Michigan’s BioTrust for Health, a research biobank for leftover neonatal blood spots, posed several novel questions for the state’s Department of Community Health institutional review board. The IRB’s response to these questions affirmed that respect for persons requires consent from donors for tissue donation to a public health biorepository with a research mission. It also acknowledged that the existence of potential risks and benefits to groups as well as to individuals necessitated new institutional collaborations between the IRB (...) and the appointed community oversight board for the BioTrust to foster consideration of the impacts on all stakeholders. (shrink)

The world’s elderly population is growing, and in Chile they represent 16.2% of the total population. In Chile, old age is marked by retirement, with a dramatic decrease in income that brings precariousness. Older adults are economically, socially, and psychologically vulnerable populations. This condition increases their likelihood of disengaging from their usual social environment, facilitating their isolation, sadness, and discomfort. From the perspective of social identity, well-being can be explained by two principles: social groups’ importance for health and people’s psychological (...) identification with those groups. This study analyzes the relationships between belonging to the neighborhood and extra-neighborhood groups and neighborhood social identification with WB. Urban or rural location and gender are measured, and the sample is 1,475 older Chilean adults of both sexes. The results show that the majority are not members of social groups, and the remaining 48% are members of one or two groups or organizations. Only 4.47% belong to three groups or organizations. Those who belong to groups obtain higher scores, emotional–mental WB, and positive emotions than older adults who do not belong to any organization. Urban and rural older adults have the same level of WB. Membership in close social organizations or distant ones causes different WB associations. Membership in neighborhood councils reduces gender differences in self-assessment of health. This result supports the idea that participation in heterogeneous groups with a shared sense of belonging to the neighborhood is associated with higher WB and lower perceived loneliness. Social identification with the neighborhood, rather than belonging to the group, had the most widespread impact on WB and health indicators. The variable social identification with the neighborhood was consistently associated with indicators of hedonic WB. (shrink)

Mark Rowlands gives a compelling argument that, if John Rawls's contractarianism is consistently applied, and Rawls's premises fully explained, then we have powerful reasons to believe that representatives behind the Veil of Ignorance should be blind to species membership in the same way that they are blind to economic status and natural talent.1I argue that even if we suppose this to be correct, these agents would not choose the two principles of justice, but instead ones that more closely resemble (...) utilitarian principles. (shrink)

Organizational membership seems to be linked to a more participatory and informed political culture, to foster electoral participation, and to promote positive feelings toward democracy. More recently, the social capital and associative democracy debates have introduced new arguments about the positive effects of associational involvement. However, little attention has been paid to the problems of measuring associational involvement and to their consequences for our theories. This article discusses the various problems of validity and reliability of our measurements of associational (...) membership. It is shown that different questionnaire formats produce substantially different results. The article also addresses the issue of measurement errors and emphasizes the problems they introduce when doing cross-national comparisons. (shrink)

This paper focuses on the REC and its political context to clarify the process of ethical review. The examples initially considered are taken from a Research Ethics Review editorial to develop the social explanation of the membership and function of a research ethics committee. It is suggested that the management and administration of medical matters are not always best understood solely in medical terms. The conclusion of the paper is that the larger political relationships determine the membership and (...) function of the research ethics committee. The REC is defined as the political mechanism for formally socializing medical research and its lay members as similarly socializing the REC. (shrink)

This paper is concerned with a version of Kamp and Partee's account of graded membership that relies on the conceptual spaces framework. Three studies are reported, one to construct a particular shape space, one to detect which shapes representable in that space are typical for certain sorts of objects, and one to elicit degrees of category membership for the various shapes from which the shape space was constructed. Taking Kamp and Partee's proposal as given, the first two studies (...) allowed us to predict the degrees to which people would judge shapes representable in the space to be members of certain categories. These predictions were compared with the degrees that were measured in the third study. The comparison yielded a test of the account of graded membership at issue. The outcome of this test was found to support the conceptual spaces version of Kamp and Partee's account of graded membership. (shrink)

Rosenblum argues that we should judge associations not only by what they do for civic virtue, but also by what they do for individual members.

The recent resurgence of Sacks’ work on membership categorization has highlighted the growing analytic interest in how members’ social category orientations operate at multiple levels of interactional work. One of the outcomes of this, highlighted in Stokoe’s discussion, is the re-emergence of the question of whether membership categorization analysis has been, is, or can be an approach in its own right. In this brief discussion I consider the emergence of ‘MCA’ as an approach to the study of social-knowledge-in-action, (...) the relationship between MCA and contemporary directions in conversation analysis, and finally the future of MCA as it continues to develop. (shrink)