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)

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)

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.

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)

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)

Researchers and Institutional Review Board members often disagree about the permissibility of some parts or all of the former’s proposed research. At least sometimes, this disagreement is reasonable. This is often because there are competing values and no clear solution as to how to balance these values. Arguably, given that there are multiple reasonable ways in which these values might be balanced, IRBs are subject to an asymmetric public justification requirement. This requirement implies that IRBs should defer to (...) researchers when the disagreement is reasonable. After briefly defending this claim, this paper examines its implications with respect to three questions that IRBs face. We argue that IRBs should not impose a strict limit on payments to participants, that they should take a more expansive view of what types of research are authorized by broad consent forms, and there should be no hard cap on risks participants might choose to undergo. (shrink)

Institutional review boards (IRBs) play a crucial role in ensuring the ethical conduct of human subjects research, but face challenges including inconsistency, delays, and inefficiencies. We propose the development and implementation of application-specific large language models (LLMs) to facilitate IRB review processes. These IRB-specific LLMs would be fine-tuned on IRB-specific literature and institutional datasets, and equipped with retrieval capabilities to access up-to-date, context-relevant information. We outline potential applications, including pre-review screening, preliminary analysis, consistency checking, and decision support. While addressing (...) concerns about accuracy, context sensitivity, and human oversight, we acknowledge remaining challenges such as over-reliance on artificial intelligence and the need for transparency. By enhancing the efficiency and quality of ethical review while maintaining human judgement in critical decisions, IRB-specific LLMs offer a promising tool to improve research oversight. We call for pilot studies to evaluate the feasibility and impact of this approach. (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)

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)

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.

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.

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...

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)

Many discussions have been held on the impact of climate change, infrastructure development, and minimizing the displacement and resilience in developing countries, including Bangladesh. Climate change is one of the risk factors for vulnerability. Nonetheless, the role of the IRB (Institutional Review Board) regarding climate change issues during protocol review is lacking. Currently, the Bangladesh Bioethics Society (BBS) has organized workshops on the IRB on climate change in health research. This initiatives represent a new episode in Bangladesh. This article highlights (...) information about the current awareness programme that may be of interest to readers and policy guidelines. The perceptions and expectations of IRB members regarding workshops were captured through qualitative assessment to improve future workshops on climate change. (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)

We interviewed 85 institutional review board chairs from a national sample of IRBs that review mental health research, asking them to rate the helpfulness of various resources that might be accessed when reviewing an ethically challenging research protocol. Each resource was rated on a four-point scale, and spontaneously offered comments were recorded, transcribed, and analyzed as well. A majority of IRB chairs indicated that talking to scientific colleagues and experts, participant representatives, and ethics experts was very helpful when reviewing (...) ethically challenging research. Fewer chairs felt that more guidance from the Office for Human Research Protections would be very helpful. In addition, we found that chairs whose committees reviewed fewer protocols were more likely to consider increased access to Internet resources and research ethics experts to be very helpful. Based on these findings, we hypothesize that increasing IRB access to scientific experts, participant representatives, and ethics experts might aid IRBs in addressing ethical challenges when reviewing protocols, but increased OHRP guidance probably would not, and less experienced chairs may need more targeted resources. (shrink)

There are notable data gaps for safety, dosing and effectiveness of many health products for pregnant and lactating individuals. There have been growing calls to timeously include this population in clinical trials to generate evidence-informed interventions for them and their foetus/nursing infants. This echoes calls for a better evidence base to address the HIV prevention needs of this population. Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are centrally positioned to review if enrolment of pregnant/breastfeeding individuals is ethically (...) acceptable, according to leading ethics guidance. To perform this task, REC/IRBs may benefit from a better understanding of current recommendations from these international ethics guidelines. We aimed to identify pregnancy-related recommendations from key international ethics guidance documents, to identify areas of conflict and to support RECs/IRBs to efficiently and systematically identify whether ethics recommendations are met. We found a rich abundance of relevant ethics recommendations. We also found that most guideline recommendations are synergistic, with the most notable divergence arising in the terminology used for when it is acceptable to transition from preclinical (animal) studies to exposing pregnant/lactating humans to the study product. We developed a brief resource setting out guidance-informed queries that REC/IRB reviewers could use to focus their review. REC/IRBs are well-placed to judge the ethical acceptability of enrolling pregnant and lactating individuals in clinical trials of HIV prevention, leveraging rich, largely synergistic ethics recommendations from leading documents. (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)

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...) process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. (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)

In this issue, Chapman et al. (2025) recommend large changes to Institutional Review Boards (IRBs) to address group harms in research. We agree with the concerns underlying their recommendations. R...

The emergence of innovative neuroimaging technologies, particularly highly portable magnetic resonance imaging (pMRI), has the potential to spawn a transformative era in neuroscience research. Resourced academic institutional review boards (IRBs) with experience overseeing traditional MRI have a special role to play in ethical governance of pMRI research and should facilitate the collaborative development of nuanced and culturally sensitive guidelines and educational resources for pMRI protocols. This paper explores the ethical challenges of pMRI in neuroscience research and the dynamic leadership (...) role that IRBs should play to promote ethical oversight of emerging pMRI research. (shrink)

Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often (...) interacted with CIRBs, but supported local reviews, and offered advantages and disadvantages of each. Interviewees argued that local IRBs can provide "local knowledge" of subjects and PIs, and "curbside consults" with PIs, facilitating mutual trust. PIs may interact more fully and informally, and hence effectively with local IRBs. IRBs also felt additional responsibility to protect "their own" subjects. Respondents mentioned a few advantages of CIRBs (e.g., CIRBs may streamline reviews), though far more rarely and cursorily. Overall, interviewees were wary of CIRBs, which they saw as varying widely in quality, depending on who happened to be members. Both local and centralized IRBs appear to have unintended consequences. For instance, discrepancies arose between IRBs that appeared to reflect differences in institutional culture and history, and personalities of chairs and/or vocal members, more than in local community values per se, and thus do not seem to be the intent of the regulations. While some critics see CIRBs as solutions to many IRB problems, critical tradeoffs and uncertainties emerge. Conclusions: These data have critical implications for future policy and research. Debates need to evolve beyond simply a binary discussion of whether CIRBs should replace local IRBs, to examine how and to what degree different models might operate, and what the relative advantages and disadvantages of each are. While some critics see CIRBs as panaceas, certain problems appear likely to continue. Careful consideration needs to be given to whether the advantages of local IRBs outweigh the problems that result, and whether a system can be developed that provides these benefits, while avoiding the disadvantages of local IRBs. (shrink)

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)

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

Background Performance evaluation is vital for IRB operations. As the number of IRBs and their responsibilities in reviewing and supervising clinical research grow in China, there is a significant need to evaluate their performances. To date, little research has examined IRB performance within China. The aim of this study was to ascertain the perspectives and experiences of IRB employees and researchers to understand the current status of IRBs; compare collected results with those of other countries; and identify shortcomings (...) to improve IRB performance. Methods This study was conducted in China from October 2020 to September 2021, using an online survey with the IRB-researcher assessment tool-Chinese version. Results 757 respondents were included in the analysis and classified into IRB employees, researchers, or those who are both IRB employees and researchers. Overall, the score for an ideal IRB was significantly higher than that of an actual IRB. Compared to the US National Validation study, Chinese participants and American participants both agree and differ in their perspectives on the most and least important ideal items. Conclusion This investigation provides a benchmark of the perceived performance of actual IRBs in China. IRBs in China can be precisely adjusted by targeting identified areas of weakness to improve their performances. (shrink)

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted (...) in order to provide an effective mechanism of oversight for health‐related AI research. (shrink)

Compared with high-income countries (HICs), developing ‘Chat-IRB’—application-specific large language models for research ethics review—may have different implications for resource-constrained Research Ethics Committees or Institutional Review Boards (IRBs) in low- and middle-income countries (LMICs). While certain concerns raised by Moodley, Malpani, and Reis—including resource challenges, reviewing research conducted in LMICs, and automation bias—are not entirely unique to LMIC IRBs, the hurdles they must overcome in developing a contextualised Chat-IRB will likely be greater. Crucially, Chat-IRB for LMICs presents a significant (...) opportunity to strengthen ethics capacity and bolster oversight through: (1) stimulating greater investment in generating open-access, LMIC-centred research ethics scholarship that also serves as training data; (2) leveraging existing WHO or UNESCO programmes to develop an ‘always available’ training resource and review tool should international funding for ethics education and capacity-building be reduced or withdrawn; (3) mitigating inadequate human capacities by providing a ‘minimal acceptable standard’ of review, especially during time-sensitive matters; and (4) a national-level Chat-IRB as a centralised ‘governance’ mechanism and first-line defence against ethics dumping, IRB shopping, and other exploitative research practices. Taken holistically, purpose-built for LMICs, Chat-IRB represents a critical—but potentially unrecognised—opportunity for HICs to advance ethics capacity-building, and strengthen research oversight within LMICs. (shrink)

There is at present, far too little empirical research into the actual decision-making process of Institutional Review Boards and it is sobering to be reminded by Robert Klitzman's article that while theoretical debates might rage and prove fertile ground for new theories and better ways of approaching research ethics; ethics committee members must try to make sense of these concepts and apply them in very practical situations.1 Klitzman provides important insights into the ….

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)

Institutional Review Boards can play vital roles in observing, monitoring, and responding to research integrity issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to (...) best oversee research to protect these participants from harm.For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest, and may interact with IRBs. In 2002, the Institute of Medicine report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research. (shrink)