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Background: Historically, some of the worst abuses of human research participants have involved populations which are vulnerable to coercion, harm, or exploitation, such as prisoners, children, and people with compromised decision-making abilities. Although there has been considerable philosophical and ethical debate about how to protect vulnerable populations, there have been only a handful of empirical studies on vulnerable population policies. Methods: We conducted a cross-sectional study on vulnerable population policies from the 105 top funded U.S. academic research institutions. We used deductive and inductive methods to develop our framework for coding the policies. We tested for associations between policies and research and development expenditure rank, public vs. private status, geographic region, and Association for Accreditation of Human Research Protection Programs accreditation (AAHRRP). Results: U.S. academic institutions have a variety of policies for research with vulnerable populations. Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. As expected, the most highly prevalent policies pertained to populations covered in subparts B, C, and D of the Common Rule (pregnant women, fetuses, neonates, prisoners, and children) but other groups were well-represented, including people with disabilities; people with impaired decision-making capacity; students/trainees; and people with limited English proficiency including illiteracy. AAHRRP accreditation was positively associated with eight different types of policies. Conclusion: U.S. academic institutions have a variety of policies for research with vulnerable populations. Additional research is needed to better understand the types of safeguards that institutions have adopted to protect vulnerable populations and the factors that influence policy development. [ABSTRACT FROM AUTHOR]

Problem: As community-engaged research (CER) methods evolve, Institutional Review Boards (IRBs) must adapt policies to facilitate CER research. This paper describes a novel collaboration between hospital-based therapy dog volunteer teams (CERs), academic faculty, and an IRB. Subjects: CER volunteers delivered a canine-assisted intervention to hospitalized adults in a clinical trial. Methods: IRB members and faculty developed a human subjects protections training tailored to the volunteer handlers' role as study interventionists including an interactive video- and discussion-based training with a knowledge assessment. Findings: Fourteen volunteer handlers were trained. The expedited IRB review period was similar to national average rates (18 days.) Volunteer handlers have conducted 107 research visits with little patient attrition. Conclusion: Tailored human subjects trainings facilitate research with interventions delivered by people who are not typically involved in research. Bespoke CER human subjects training requires collaboration between researchers and IRBs and flexibility in IRB policy regarding CER. [ABSTRACT FROM AUTHOR]

Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students' education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students' classroom-based research. Our qualitative content analysis of a subsample of ten colleges' IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates. [ABSTRACT FROM AUTHOR]

Since their inception, Institutional Review Boards (IRBs) have been charged with protecting the vulnerable in research. More recently, attention has turned to whether IRBs also have a role to play in ensuring representative study samples and promoting the inclusion of historically under-represented groups. These two aims—protecting the vulnerable and including the under-represented—can pull in different directions, given the potential for overlap between the vulnerable and the under-represented. We conducted a pilot, online national survey of IRB Chairs to gauge attitudes and practices with regard to protecting the vulnerable and including the under-represented in research. We found that IRBs extend the concept of vulnerability to different groups across various contexts, are confident that they effectively protect vulnerable individuals in research, and believe that IRBs have a role to play in ensuring representative samples and the inclusion of under-represented groups. [ABSTRACT FROM AUTHOR]

The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance. [ABSTRACT FROM AUTHOR]

The problem : Running an efficient institutional review board (IRB) can be challenging. The research subjects : To ensure an efficient committee, our IRB adopted several operational metrics. Methods : Analysis of retrospective data from the IRB records, database, and annual reports over 12 years. Results : The IRB roster comprises 11 members. The average medical to nonmedical member ratio is 5:6, and the male to female ratio is 4:7, which has not been consistent over the years. One thousand three hundred and twenty-four proposals were reviewed including 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) with a median turnaround time to approval of 4.0, 35.0, and 68.0 days, respectively. Training of the IRB members was conducted to enhance their knowledge and skills. IRB at King Hussein Cancer Center has managed to stay abreast and efficient during the COVID-19 pandemic, by working remotely. Conclusion : Running an efficient IRB mandates implementing a number of operational metrics. [ABSTRACT FROM AUTHOR]

An evidence-based approach to research ethics is critical to ethical research but little is known about how trauma survivors—especially those from vulnerable populations—respond to laboratory-based trauma research. One hundred four incarcerated women (N = 64 rape survivors) reported their traumatic life experiences, listened to and responded to an audio recording of a dating interaction that culminates in a completed rape, and then reported their responses to their participation. Compared to the control group (N = 40), rape survivors (N = 64) had more posttraumatic stress disorder symptoms and these symptoms were associated with more emotional responding. Both groups showed a positive benefit–cost ratio with regard to their participation did not differ on their overall reactions to research participation. These findings suggest that laboratory-based trauma research methods are associated with consistently positive experiences, which can help inform researchers and institutional review boards about the risks and benefits of such research. [ABSTRACT FROM AUTHOR]

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices. [ABSTRACT FROM AUTHOR]

Background . Independent ethics review of research is required prior to the implementation of all health research involving human participants. However, ethics review processes are challenged by protracted turnaround times, which may negatively impact the implementation of socially valuable research. Previous research has documented delays in ethics review in developed and developing countries. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. Methods . This descriptive cross-sectional study employed a mixed-method approach, with qualitative and quantitative components. Seven IRBs were purposively sampled from the 15 accredited IRBs operational in Tanzania during the study period, April 2017–April 2018. Quantitative data were analysed using STATA software and qualitative data were analysed thematically. Results . The median time for review across all IRBs was 32 days, with a range of 1–396 days. Qualitative results identified five key themes related to turnaround time from interviews with participants. These included: (1) procedures for receiving and distribution of protocols, (2) number of reviewers assigned to protocols, (3) duration of reviewing protocols, (4) reasons for delayed feedback, and (5) training of research ethics committee members. Conclusion. The study showed that the median days for ethical approval in Tanzania was 32 days. We observed from this study that electronic submission systems facilitated faster turnaround times. Failure to adhere to the submission checklists and guidelines was a major obstacle to the turnaround time. [ABSTRACT FROM AUTHOR]

Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements. [ABSTRACT FROM AUTHOR]

Indigenous communities across Canada have established principles to guide ethical research within their respective communities. Thorough cataloging and description of these would inform university research ethics boards, researchers, and scholars and facilitate meaningful research that respects Indigenous-defined ethical values. A scoping study was conducted of all relevant peer-reviewed literature and public-facing Indigenous research ethical guidelines from First Nations, Metis, and Inuit communities and organizations in Canada. A total of 20 different Indigenous research ethics boards, frameworks, and protocols were identified. Analysis resulted in three key themes: (1) balancing individual and collective rights; (2) upholding culturally-grounded ethical principles; and (3) ensuring community-driven/self-determined research. Findings demonstrate how employment of Indigenous ethical principles in research positively contributes to research outcomes. [ABSTRACT FROM AUTHOR]

This article reflects on ethical issues that arose during the course of two different evaluation projects that used photovoice method to engage with marginalized populations. The evaluations serve as case studies for a critical discussion about potential barriers that researchers may face when employing photovoice method while trying to balance the principles of community-based participatory research with the requirements of Institutional Review Boards. We reflect on ethical dilemmas related to the meaning of photography within the cultural context of participants' lives, the compensation of participants as collaborators, and the representation and dissemination of participant photos. We conclude by examining how researchers may approach ethical requirements without compromising the important collaborative relationships central to photovoice method. We additionally call on researchers to engage with ethics review committees to create a new "participant–researcher" category with its own set of protocols that recognizes the nuanced role members of disenfranchised communities play in the research process. [ABSTRACT FROM AUTHOR]

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees. [ABSTRACT FROM AUTHOR]

Ethical implications of laboratory-based experimental trauma research are not well studied. Female rape survivors (N = 62) and controls (N = 79) listened to an audio recording of a sexual assault and completed mental health measures and the Reactions to Research Participation Questionnaire-Revised in the first session and again several weeks later. In the first session, mental health symptoms were associated with stronger emotional reactions and personal benefits from participation. Rape survivors also reported stronger emotional reactions than controls, but also more personal benefits, more satisfaction, and fewer perceived drawbacks from participation. Several weeks later, both groups reported diminished posttraumatic stress disorder symptoms and rape survivors' reports of stronger emotional reactions and greater satisfaction with their participation remained significant. Benefit–cost ratios indicate positive responses to participation across groups and time. Findings suggest significant benefits to laboratory trauma research for participants. [ABSTRACT FROM AUTHOR]

While research on Institutional Review Boards (IRBs) has been conducted on issues ranging from quality, process, and effectiveness, gaps remain. Social science researchers have raised issues regarding decisions by IRBs applied to the social sciences based on biomedical research. To date, little is known about the experience of social scientists in criminology and criminal justice with IRBs and this research seeks to fill this gap. An online survey, including open- and closed-ended questions drawn from the validated IRB-Researcher Assessment Tool, was administered to members of the Academy of Criminal Justice Sciences and the American Society of Criminology about their experiences with IRBs. Results revealed that researchers report experiencing challenges with their IRBs including timeline delays of their research, bias against their research, and decisions that protect legal liability rather than human subjects ethics. Recommendations for improving IRB reviews of protocols and challenges unique to criminology and criminal justice are discussed. [ABSTRACT FROM AUTHOR]

The first coronavirus disease 2019 (COVID-19) patient in the state of New Jersey (NJ) was admitted on March 2, 2020. With the number of hospitalized patients increasing exponentially in the following days and no established treatment approaches, research was to play a significant role in this fight. To facilitate review of all COVID-19 research proposals in a large health care network in NJ, we established the COVID-19 Research Review Committee (RRC) and implemented a peer-review process prior to the Institutional Review Board submission. The RRC was tasked with processing, soliciting, reviewing, and prioritizing research proposals and was comprised of a multidisciplinary group of reviewers. Within a 9-week period, three network-wide requests for proposals were released with 238 proposals submitted and 93 approved, an approval rate of 39%. The establishment of the RRC helped ensure scientific merit, better utilization of resources, collaborations across disciplines and network hospitals, and compliance with applicable regulatory and ethical standard. [ABSTRACT FROM AUTHOR]

Review of clinical research by institutional review boards (IRBs) is integral to the protection of human subjects and necessary for the conduct of legal and ethical research. Because such review is time and resource intensive, it is critical to identify common issues that contribute to delayed review and approval of research. Hence, the aim of this quality improvement project was to identify factors associated with long delays in IRB approval and identify potential strategies to streamline the review process. In collaboration with the human subjects research protection program at a large academic health center in the northeastern United States, we conducted a content analysis of minutes of convened IRB meetings for every new protocol (initial submission) approved between January and September 2019 that required greater than or equal to two full board reviews prior to approval (n = 33). We also examined characteristics of new protocols that were reviewed less than twice at convened meetings during the same time frame (n = 244). Using χ2 or Fisher's exact tests, the characteristics of protocols with multiple reviews by the convened IRBs were compared with those protocol submissions reviewed by the convened IRBs only once. Three factors significantly associated with increased delays were researcher conflict of interest (30% vs. 12%, respectively, p <.01), need for radiation safety evaluation (36% vs. 20%, respectively, p =.03), and protocols that were clinical trials (73% vs. 60%, respectively, p <.01). Other factors associated with delayed IRB approval were excessive technical jargon (93.94%, n = 31), inadequate description of data security or inability to meet data security requirements of the institution (75.76%, n = 25), protocol design affecting patient safety (57.58%, n = 19), and lack of clarity regarding compensation and payment or study duration (n = 18, 54.54% each). Approaches to mitigate delays in approval and increase the efficiency and efficacy of the IRB process are recommended. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic, first reported in China, soon spread worldwide, has evolved into one of the most complex global public health crises the world has encountered in the last several decades. Conducting military medical research is vital to study the unique influences of military service conditions on soldiers' health and to improve the medical response in various emergency periods. The Israel Defense Forces (IDF) Medical Corps maintains an Institutional Review Board (IRB) which reviews clinical studies conducted within the IDF. During the COVID-19 pandemic, the IRB of the IDF had to rapidly implement procedural modifications in order to comply with expanding urgent demands for research without compromising ethical standards. The ethical dilemmas and the IDF policy and perspective are outlined in this article. [ABSTRACT FROM AUTHOR]

In recent years, Research Ethics Committees in academic colleges of education have constituted to review research proposals in the field of education. Yet, little is known about their work, composition, challenges, and relationships with external partners. This study explores the views and attitudes of 13 members and chairpersons of Research Ethics Committees in colleges of education in Israel, and two policy makers at the Ministry of Education about their roles, responsibilities, challenges, and limitations. Findings revealed an instrumental attitude towards the ethics committee. Committees are perceived as supportive rather than enforcing. Interviews shed light on the complex relationships between committee members, college lecturers/researchers, ethics regulators, and academic management. Moreover, the findings emphasized the lack of formal training and broad discussion on ethics. The study calls for strengthening committees' raison d'être and the internalization of ethics among committee members, researchers, and lecturers in the field of education. [ABSTRACT FROM AUTHOR]

Despite the promise of social network research, this method raises important ethical questions regarding privacy and confidentiality. Although researchers and bioethicists have considered research obligations in relation to marginal or vulnerable populations, the views of people who inject drugs (PWIDs) have not been sufficiently considered. To elicit participants' views of research obligations, we conducted in-depth interviews with a subset (n = 40) of active PWIDs enrolled in a large social network study. Findings suggest participants have an expectation of confidentiality but believe this obligation need not be absolute and can be waived if a participant violates community norms or place others at risk. Ethics boards should recognize that marginalized populations are able to articulate complex moral views about privacy and confidentiality. Engaging participants in dialogue about the responsible conduct of research presents an opportunity to correct under- or overestimations of research vulnerabilities when such decisions are restricted to the perspectives of investigators or Institutional Review Board members. [ABSTRACT FROM AUTHOR]

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research. [ABSTRACT FROM AUTHOR]

Obtaining parental consent for youth to participate in research is a standard requirement in the United States. However, the assumption that involving parents is the best way to protect youth research participants is untenable for some populations. This study draws on interviews with 19 LGBTQ+ mixed-race participants to examine lay views of parental consent requirements for LGBTQ+ youth research participants. Qualitative data analysis found concerns about potentially outing LGBTQ+ youth to intolerant parents. Interviewees also asserted that adolescents aged 16 and older are competent enough and should have the autonomy to consent themselves. Finally, interviewees raised several methodological concerns regarding the biased research that may result from parental consent requirements. We agree with others that U.S. Institutional Review Boards should end uncritical requirements for parental consent for older adolescents and should routinize the use and study of alternative protective measures. [ABSTRACT FROM AUTHOR]

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny. [ABSTRACT FROM AUTHOR]

Safety surveillance, using appropriately consistent review criteria, could improve human participants' well-being in clinical trials. To establish a globally consistent framework, the quality of the current content for review by institutional review boards (IRBs), as mandatory oversight entities, requires evaluation. This study collected and analyzed forms reporting serious adverse events (SAEs) to IRBs/Research Ethics Committees(RECs) to compare them with the well-structured form presented in the literature using completeness and accuracy scores. We found sub-optimal completeness and accuracy scores when compared with perfect scores (p < .05). Less than half of the retrieved forms had queries on causality assessment (=43.1%). Thus, contents of SAE forms require improvement for IRB oversight and, further, there is a need to develop a well-structured form that could improve international consistency. [ABSTRACT FROM AUTHOR]

Research ethics boards (REBs) are charged with applying ethical standards to protect the rights and interests of research subjects. Little, however, is known about how REB members perceive probable impacts of research participation for subjects. Drawing on in-depth interviews with 40 Canadian REB members, we identify three frequently reported epistemic strategies, including reliance on a local REB culture or ethos, use of resident authorities, and protective imagination. Far less commonly described strategies included direct or indirect contact with research subjects. REB members also reflected upon significant gaps in their knowledge and thus the importance of knowing what we don't know. Recommendations arising from this support an evidence-based practice for ethics review involving clear epistemic standards for REBs learning about subjects' experiences. [ABSTRACT FROM AUTHOR]

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB's operating environment before seeking research approval, and issues related to tribal data management practices. [ABSTRACT FROM AUTHOR]

When results were analyzed, we found that the following five statements were indicated by the highest percentage of respondents as being important in determining study participation: (a) Purpose of the study, 56%; (b) Procedures of the study, 51%; (c) Amount of time participation takes, 38%; (d) Information about how data are protected, 32%; (e) Statement that participating is not part of your medical care, 32%. Finally, several yes/no questions were included that probed perceptions of fairness about when studies with tight timelines should be able to "jump ahead" and be reviewed more quickly: when it was your own study, a colleague's study, or a student/post-doc/trainee's study. Finally, investigators were divided about whether it would be fair for their own study, a colleague's study, or a student's study to jump ahead of other studies if they had a tight timeline (respectively, 52%, 58%, and 50% affirmative responses). In addition, this study did not compare how IRB members' assessment of the risks of a singular research procedure in isolation may differ from their assessment of the procedure in the context of a complete study protocol. [Extracted from the article]

In the 25 or so years since the first social media (SM) platform hit the online world, researchers have been drawn to these virtual spaces for scholarly purposes: SM has created unprecedented opportunities for research endeavors ([39]) - either as an effective way to recruit participants ([10]), as intervention platforms ([41]; [42]), or as a general source of data. Ethical questions revolved around whether SM data should be considered human subjects research or text, how these deliberations influence practices of consent, and whether SM users have perceived expectations of privacy when using SM platforms ([24]; [26]; [50]; [55]). As discussed above, as we drive forward into an era of big data, machine learning, and AI, the fundamental issues of whether, when, and how SM researchers should ask SM users' permission to analyze and interpret their SM data are still important concerns for researchers in the field and in communities more broadly. In their article, "Attitudes and Knowledge of Teenagers Regarding Research Ethics of Data Usage at Social Media", Khatatbeh et al. report on their survey of 393 Jordanian 10- to 19-year-olds that explored knowledge and attitudes of users to consent, use of their SM data, and trust in SM research. [Extracted from the article]

Researchers increasingly use social media (SM) to recruit, retain, and trace participants, yet empirical literature investigating the ethics of engaging participants via SM is lacking. We conducted a survey of 401 Australian researchers and human research ethics committee (HREC) members to examine their experience, attitudes, and ethical concerns toward engaging participants via SM. Data revealed that researchers and HREC members share similar concerns and attitudes about using SM in general and in research. We identified a strong demand for additional support, training, and guidance on SM research ethics. This need reflects researchers' and HREC members' limited confidence and knowledge of ethical issues in this context and a lack of awareness of available SM-specific ethical guidelines. [ABSTRACT FROM AUTHOR]

As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are "concise" and presented in ways that "facilitate comprehension." The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron. [ABSTRACT FROM AUTHOR]

Along with a dearth of regulatory guidance, little empirical research has examined factors related to participant payment in research. We conducted a cross-sectional study of 100 institutional review board (IRB)–approved sociobehavioral human subjects research protocols at a large research university in Southern California. The proportion of studies that paid participants differed significantly by type of research (p <.001) and study population (p =.009). The average payment amount also differed significantly by study population (p <.001) and type of participation (in-person vs. remote; p <.001). In addition, studies that required more visits (p <.001) and more time (p =.011) paid significantly more than studies with fewer and shorter visits, respectively. These findings provide data to help inform future ethical payment practices. [ABSTRACT FROM AUTHOR]

Researchers and research ethics committees share a common goal of conducting ethically sound research. However, little is known of researchers' experiences in obtaining ethics approval for suicide-related studies. This study aimed to investigate what concerns researchers have received on suicide-related ethics applications and how they dealt with it. Thirty-four respondents, recruited through the International Association for Suicide Prevention, filled out an online survey. The study found that researchers have received important concerns regarding potential harm and researchers' responsibilities to participants. Researchers modified their application and/or consulted their research ethics committee in response to the concerns, which had a positive/neutral impact on their given study. Anticipating concerns and improved collaboration between researchers and research ethics committees should protect the quality of suicide prevention research. [ABSTRACT FROM AUTHOR]

Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 implemented remedial action plans. Using data from 2011 through 2018, we demonstrated that 70% of these facilities' lapse rates remain significantly improved. In contrast, none of the 10 facilities with their lapse rates that were higher than the national averages in 2 out of 3 years from 2011 to 2013 and that did not implement remedial action plans showed any improvement. Thus, implementation of effective remedial measures in facilities with high lapse rates can result in long-lasting improvement in the majority of these facilities. [ABSTRACT FROM AUTHOR]

In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They further claimed that any attempts to measure the quality and performance of IRBs without using such measures, to be developed by them in the unforeseeable future, were not helpful. The realities are that nearly 50 years after its establishment, there has been no systematic assessment of the quality and performance of IRBs, and that nearly two decades after the deaths of Jesse Gelsinger and Ellen Roche and the implementation of reform processes to improve our system of protecting human subjects, there is still plenty of room for improvement. The challenges today are for Taylor to come up with a tool to measure the ethical quality of IRB reviews, for Lynch et al. to develop measures for assessing the effectiveness of IRBs in protecting human subjects, and for the IRB community to decide whether to continue to wait for Taylor and Lynch et al. to develop their promised tools or to start taking advantage of performance measurements to improve the quality and performance of IRBs by using existing IRB performance metrics or to improve those existing performance metrics. [ABSTRACT FROM AUTHOR]

In 2016, the U.S. National Institutes of Health (NIH) announced a new policy requiring single institutional review board (sIRB) review for multisite studies. However, adherence to the new policy requires the separation of regulatory institutional review board (IRB) work per Federal guidance from site-specific local compliance concerns. In particular, genomic research is subject to a wide range of state laws, institutional requirements, and local population preferences. In this qualitative study, we explored the anticipated needs of genomics researchers and IRB administrators around implementing the policy. We observed multiple uncertainties, particularly about intersite communication processes, sIRB selection processes, and roles of the reviewing IRB and local sites regarding local context information relevant to genomics. Optimal implementation of the NIH policy may require additional guidance for researchers and IRB administrators. [ABSTRACT FROM AUTHOR]

The process of creating a new Institutional Review Board (IRB) or Research Ethics Committee (REC) presents many challenges; however, little has been published to describe this experience. Thus, many questions about creating a new IRB/REC and the challenges they face remain. The establishment of a new federal-wide single IRB provided a rare opportunity to describe these experience and outcomes. A census of the activity and outcomes of this new board is reported for its first 3 years of operation: The convened board approved 50 protocols, required an average of 93.24 days and 2.76 reviews for protocol approval, and issued an average of 31.82 stipulations per protocol. The census data helped to identify several issues that impacted the board's outcomes and it serves as a baseline for future comparisons. The overall dynamics, challenges, and outcomes of this new single IRB are discussed. [ABSTRACT FROM AUTHOR]

This commentary uses personal research ethics experience in South Africa to consider the position of Tsan who recommends a consortium to develop common metrics / performance indicators for determining quality of RECs / IRBs. Terms such as performance, quality and throughput need clarification in research metrics before effective metrics may be useful. [ABSTRACT FROM AUTHOR]

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs. [ABSTRACT FROM AUTHOR]

Residents serve as both trainees and employees and can be considered potentially vulnerable research participants. This can lead to variation in the institutional review board (IRB) review. We studied sites participating in the Assessment of Professional Behaviors Study sponsored by the National Board of Medical Examiners (2009-2011). Of the 19 sites, all but one were university affiliated. IRB review varied; 2/19 did not submit to a local IRB, 4/17 (23%) were exempt, 11/17 (65%) were expedited, and 2/17 (12%) required full Board review; 12/17 (71%) required written informed consent. The interval from submission to approval was 1 to 2 months (8/17); the range was 1 to 7 months. Although most stated there were no major barriers to approval, the most common concern was resident coercion and loss of confidentiality. Local IRB review of this educational research study varied. [ABSTRACT FROM AUTHOR]

Institutional review boards (IRBs) have been criticized for overstepping their authority by requiring research protocols to meet requirements that go beyond regulatory approval criteria. The youngest National Cancer Institute (NCI) central IRB (CIRB), the Cancer Prevention and Control (CPC) CIRB, was studied with the NCI Stipulation Analysis Review Tool (StART), which categorized 1,049 stipulations in 51 determination letters covering 30 approved protocols. NCI StART reduced the potential for subjective uncertainty in assessing the wide range of content in the stipulations. The tool determined the board functioned in accordance with federal mandates, with 80% of rendered stipulations aligning with IRB approval criteria. A complementary article provides background data and findings from the first 3 years' experience of the CPC CIRB. [ABSTRACT FROM AUTHOR]

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers' CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs' review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs. [ABSTRACT FROM AUTHOR]

Investigators of nonexempt human subjects research conducted without prior institutional review board (IRB) approval often have difficulties in publishing data obtained from such research. Retrospective review and approval of such research has been suggested as a potential pathway for an IRB to help these investigators to publish those data. However, under the Common Rule, an IRB has no authority to retrospectively review and approve human subjects research. Prevention remains the best strategy to ensure that no nonexempt human subjects research is initiated prior to IRB approval. [ABSTRACT FROM AUTHOR]

When legal challenges to research confidentiality arise, researchers are expected to resist while the institutions that approve their research provide legal support to enable that resistance. Although researchers have done their part, university administrators have been much less consistent doing theirs. Canada’s federal policy now affirms university administrations “must” provide independent legal representation and “encourages” them to develop policies that articulate how they will do so. A national survey of Research Ethics Board (REB) Chairs and administrators found only one such policy, which turned our attention to factors that impeded creation of others like it. Administrative inertia, a lack of clear lines of responsibility, and resource issues top the list of justifications respondents offered. Implications for researchers, REBs, and university administrators are discussed. [ABSTRACT FROM AUTHOR]

Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised “Real-Time IRB,” a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care. [ABSTRACT FROM AUTHOR]

Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR’s overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight. [ABSTRACT FROM AUTHOR]

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval. [ABSTRACT FROM AUTHOR]

Governments, funders, and institutional policies increasingly encourage and even mandate the involvement of nonscientists in the ethical review of research, most famously in institutional review boards (IRBs), but also on community advisory boards (CABs) and other committees that contribute to research governance. In spite of these requirements, few have examined how different factors such as recruitment strategies, training, and different qualifications shape the contributions of nonscientists to the research enterprise. This pilot study begins to fill in this lacuna by interviewing nonscientist members of IRBs and community members of CABs. Results suggest patterned differences in demographics, recruitment strategies, training, and perceived qualifications between community members on these two types of boards with potential implications for how we perceive the scope of contributions that nonscientists can provide to the ethical review of research and the strategic ways these contributions can be elicited. [ABSTRACT FROM AUTHOR]

Informed consent requirements for conducting research with human participants are set by institutional review boards (IRBs) following established guidelines. Despite this, researchers continue to face challenges in seeking and obtaining informed consent. This study discusses researchers’ views of such problems in Lebanon and Qatar, which vary in research regulation. We conducted in-depth interviews with 52 academic researchers from various fields of research in both countries and analyzed them using thematic analysis. Important disjunctions emerged between IRB requirements and actual practice. Variations in obtaining informed consent were affected by the research context, type of research, and the prevalent cultural norms and values. Regulatory systems and guidelines for informed consent do not necessarily ensure ethical research conduct. Implications for improvement are presented. [ABSTRACT FROM AUTHOR]

The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards’ (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers. [ABSTRACT FROM AUTHOR]

We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics that did not show improvement all had initial noncompliance/incidence rates of <1.0%, ranging from 0% to 0.98%. The initial noncompliance/incidence rates of the 21 performance metrics that showed improvement ranged from 0.05% to 60%. However, of the 21 performance metrics that showed improvement, 10 had initial noncompliance/incidence rates of <1.0%, suggesting that improvement could be achieved even with a very low initial noncompliance/incidence rate. We conclude that performance measurement is an effective tool in improving the performance of human research protection programs. [ABSTRACT FROM AUTHOR]