Anesthesia outcomes in lysosomal disorders: CLN3 and GM1 gangliosidosis.

Natural history studies of pediatric rare neurometabolic diseases are important to understand disease pathophysiology and to inform clinical trial outcome measures. Some data collections require sedation given participants' age and neurocognitive impairment. To evaluate the safety of sedation for research procedures, we reviewed medical records between April 2017 and October 2019 from a natural history study for CLN3 (NCT03307304) and one for GM1 gangliosidosis (NCT00029965). Twenty-two CLN3 individuals underwent 28 anesthetic events (age median 11.0, IQR 8.4-15.3 years). Fifteen GM1 individuals had 19 anesthetic events (9.8, 7.1-14.7). All participants had the American Society of Anesthesiology classification of II (8/47) or III (39/47). Mean sedation durations were 186 (SD = 54; CLN3) and 291 (SD = 33; GM1) min. Individuals with GM1 (6/19, 31%) were more frequently prospectively intubated for sedation (CLN3 3/28, 11%). Minor adverse events associated with sedation occurred in 8/28 (28%, CLN3) and 6/19 (32%, GM1) individuals, frequencies within previously reported ranges. No major adverse clinical outcomes occurred in 47 anesthetic events in pediatric participants with either CLN3 or GM1 gangliosidosis undergoing research procedures. Sedation of pediatric individuals with rare neurometabolic diseases for research procedures is safe and allows for the collection of data integral to furthering their understanding and treatment.

Analysis of factors influencing the organizational capacity of Institutional Review Boards In China: a crisp-set Qualitative Comparative Analysis based on 107 cases.

BACKGROUND: Institutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees. METHOD: The cross-sectional survey for this research was conducted from July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors. RESULTS: Through a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3). CONCLUSIONS: The results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees.

Views of IRB members regarding phase 1 pediatric oncology trials.

There is significant debate over whether phase 1 pediatric oncology trials are ethical and approvable. We thus surveyed IRB members to answer four questions. First, do IRB members think the potential medical benefits of average phase 1 pediatric oncology trials justify the risks? Second, do they think these trials are ethically appropriate? Third, do they think these trials are approvable? Fourth, how do the views of IRB members on the first two questions compare to the views of the US public? Of the 80 respondents who answered the test questions correctly, 18.8% stated that the potential medical benefits of average phase 1 pediatric oncology trials outweigh the risks, 32.5% stated that the potential medical benefits and risks are about equal, and 48.8% stated that the risks outweigh the potential medical benefits. Compared to the general public, IRB members were significantly more likely to think the risks outweigh the potential medical benefits (p = 0.01). Finally, 68.8% of IRB members indicated that average phase 1 pediatric oncology trials are approvable, and 56.3% indicated that these trials are appropriate in children. These findings suggest two-thirds of IRB members believe average phase 1 pediatric oncology trials are approvable. Yet, almost half regard the risks as outweighing the potential medical benefits and almost half think these trials are inappropriate. These findings raise important questions regarding why IRB members and the general public evaluate the same risk/benefit profile differently, and whether it is possible to reconcile the two perspectives.

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.

A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project.

An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit-such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)-requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.

Research Ethics Committees (RECs)-or Institutional Review Boards (IRBs), as they are known in the US-were created about 50 years ago to independently assess the ethical acceptability of research projects involving human subjects, their fundamental role being the protection of the dignity and rights of research participants. In this paper we develop some critical reflections about the current situation of RECs. Our starting point is the definition of the role they should ideally play, a role that should necessarily include a collaborative approach and the focus on the ethics component of the review. This ideal is unfortunately quite far from reality: inadequacies in the functioning of RECs have been discussed for decades, along with reform proposals. Both in the US and in the European Union (EU), reforms that aim at the centralization of the review process were recently approved. Even though these reforms were needed, they nonetheless raise concerns. We focus on two such concerns, related in particular to Regulation (EU) No 536/2014: the risk of narrowing the scope of the ethics review and that of disregarding the local context. We argue that the COVID-19 pandemic paved the way for the transition towards the centralized model and that an analysis of its impact on the research review process could provide some interesting insights into possible shortcomings of this new model. We conclude by identifying three objectives that define the role of a REC, objectives that any reform should preserve.

How ethics committees and requirements are structuring health research in the Philippines: a qualitative study.

BACKGROUND: The last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries. METHODS: Semi-structured interviews were conducted from July to October 2020 to elicit health researchers' perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs. RESULTS: Across the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics-more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding. CONCLUSION: The broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture.

The Problem is Not Monsters: The FRANKENCON Panel on Science and Ethics.

In November of 2019, the University of California Santa Cruz hosted a 3-day interdisciplinary conference to commemorate the 200th anniversary of the publication of Frankenstein, by Mary Shelley. A panel of senior researchers convened to discuss the impact of the novel on modern discussions of scientific ethics. The panel featured Nandini Bhattacharya, George Blumenthal, Michael M. Chemers, David Haussler, and Jenny Reardon. In the process, the panelists acted as the Institutional Review Board for a proposal from Victor Frankenstein himself.

Conservation publications and their provisions to protect research participants.

Social science methods are increasingly applied in conservation research. However, the conservation sector has received criticism for inadequate ethical rigor when research involves people, particularly when investigating socially sensitive or illegal behaviors. We conducted a systematic review to investigate conservation journals' ethical policies when research involves human participants, and to assess the types of ethical safeguards documented in conservation articles. We restricted our review to articles that used social science methods to gather data from local people about a potentially sensitive behavior: hunting. Searches were conducted in the Web of Science, Scopus, and Google Scholar for research articles in English published from January 2000 to May 2018. Only studies conducted in countries in south and Southeast Asia, Africa, and Central and South America were considered. In total, 4456 titles and 626 abstracts were scanned, with 185 studies published in 57 journals accepted for full review. For each article, any information regarding ethical safeguards implemented to protect human participants was extracted. We identified an upward trend in the documentation of provisions to protect human participants. Overall, 55% of articles documented at least one ethical safeguard. However, often safeguards were poorly described. In total, 37% of journals provided ethics guidelines and required authors to report ethical safeguards in manuscripts, but a significant mismatch between journal policies and publication practice was identified. Nearly, half the articles published in journals that should have included ethics information did not. We encourage authors to rigorously report ethical safeguards in publications and urge journal editors to make ethics statements mandatory, to provide explicit guidelines to authors that outline journal ethical reporting standards, and to ensure compliance throughout the peer-review process.

Publicaciones sobre Conservación y sus Aportaciones para Proteger a los Participantes de la Investigación Resumen La metodología de las ciencias sociales cada vez se aplica más en la investigación para la conservación. Sin embargo, el sector de la conservación ha recibido críticas por un rigor ético inadecuado cuando la investigación involucra a las personas, particularmente cuando se investigan comportamientos ilegales o socialmente sensibles. Realizamos una revisión sistemática para investigar las políticas éticas de las revistas de conservación cuando la investigación involucra a participantes humanos y para evaluar los tipos de salvaguardas éticos documentados en los artículos de conservación. Restringimos nuestra revisión a artículos que usaron metodología social para recolectar datos de la gente local sobre un comportamiento potencialmente sensible: la cacería. Las búsquedas se realizaron en los sitios Web of Science, Scopus y Google Scholar enfocadas en los artículos de investigación en inglés publicados entre enero del 2000 y hasta mayo del 2018. Solamente consideramos los estudios realizados en los países del sur y sureste de Asia, África y Centro y Sudamérica. Un total de 4456 títulos y 626 resúmenes fueron escaneados. Revisamos completamente 185 estudios publicados en 57 revistas aceptadas. Se extrajo cualquier información con respecto a los seguros éticos implementados para proteger a los participantes humanos. En general, el 55% de los artículos documentaron al menos un seguro ético. Sin embargo, con frecuencia los seguros eran descritos pobremente. En total, el 37% de las revistas proporcionaron guías éticas y requirieron que los autores reportaran los seguros éticos en los manuscritos, pero se identificó una discrepancia significativa entre las políticas de las revistas y las prácticas de publicación. Casi la mitad de los artículos publicados en las revistas que deberían haber incluido información ética no la tuvo. Alentamos a los autores a que reporten con rigurosidad los seguros éticos en las publicaciones y les urgimos a los editores de dichas revistas que hagan obligatorias las declaraciones éticas, que proporcionen a los autores guías explícitas que resuman los estándares de reportaje ético de las revistas en línea, y que aseguren el cumplimiento por medio del proceso de revisión por pares.

Ethical considerations when conservation research involves people.

Social science is becoming increasingly important in conservation, with more studies involving methodologies that collect data from and about people. Conservation science is a normative and applied discipline designed to support and inform management and practice. Poor research practice risks harming participants and, researchers, and can leave negative legacies. Often, those at the forefront of field-based research are early-career researchers, many of whom enter their first research experience ill-prepared for the ethical conundrums they may face. We draw on our own experiences as early-career researchers to illuminate how ethical challenges arise during conservation research that involves human participants. Specifically, we considered ethical review procedures, conflicts of values, and power relations, and devised broad recommendations on how to navigate ethical challenges when they arise during research. In particular, we recommend researchers apply reflexivity (i.e., thinking that allows researchers to recognize the effect researchers have on the research) to help navigate ethical challenges and encourage greater engagement with ethical review processes and the development of ethical guidelines for conservation research that involves human participants. Such guidelines must be accompanied by the integration of rigorous ethical training into conservation education. We believe our experiences are not uncommon and can be avoided and hope to spark discussion to contribute to a more socially just conservation.

Consideraciones Éticas cuando la Investigación para la Conservación Involucra a la Gente Resumen Las ciencias sociales cada vez son más importantes para la conservación pues más estudios involucran metodologías que recolectan datos de y sobre la gente. La ciencia de la conservación es una disciplina normativa y aplicada diseñada para apoyar e informar al manejo y a la práctica. La investigación deficiente corre el riesgo de dañar a los participantes y a los investigadores, además de que puede dejar un legado negativo. Es común que investigadores que recién inician sus carreras estén al frente de investigación basada en el campo, muchos de los cuales comenzaron su experiencia mal preparados para los dilemas éticos que podrían enfrentar. Partimos de nuestras propias experiencias como investigadores de carrera temprana para ilustrar cómo emergen los retos éticos durante la investigación para la conservación que incluye a participantes humanos. Específicamente, consideramos los procedimientos de revisión ética, los conflictos de valores y las relaciones de poder y con ellas diseñamos recomendaciones de comité sobre cómo navegar los retos éticos cuando surjan durante la investigación. Particularmente, recomendamos a los investigadores que apliquen la reflexividad (es decir, el pensamiento que permite a los investigadores reconocer el efecto que ellos tienen sobre la investigación) para ayudar a navegar los retos éticos y para alentar un mayor compromiso con los procesos de revisión ética y con el desarrollo de las directrices éticas para la investigación de la conservación que involucra a participantes humanos. Dichas directrices deben estar acompañadas por la integración de un entrenamiento ético riguroso dentro de la educación para la conservación. Creemos que nuestras experiencias no son poco comunes y pueden evitarse y esperamos iniciar una discusión para contribuir a una conservación más justa socialmente.

Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. MAIN TEXT: We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. CONCLUSION: Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

Response to Correspondence from Kolstoe and colleagues concerning our paper entitled, Research approvals iceberg: How a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us. Here we present an alternative point of view towards the concerns raised.

Ethical Issues in Conducting Research With Children and Families Affected by Disasters.

PURPOSE OF REVIEW: We review topical evidence on ethical issues in conducting disaster research with children and families affected by natural disasters, with an emphasis on analyzing specific vulnerabilities associated with children and families affected by disasters, identifying significant findings and trends of ethical guidelines and approaches, and discussing key observations into ethical research in a disaster setting. RECENT FINDINGS: Current evidence indicates that there is a wide range of research methods for child disaster studies. Vulnerability as a concept in child disaster studies is more prevalent with several scholars underscoring the need for an ethical approach to disaster research. Current disaster research evidence suggests that there is specifically an interest in conducting disaster research with children and families. With the increase in investigations, it is strongly recommended that investigators adhere to ethical standards in research practice when conducting research with vulnerable populations (e.g., children) within a postdisaster context.

A risk-based framework for biomedical data sharing.

The problem of biomedical data sharing is a form of gambling; on one hand it incurs the risk of privacy violations and on the other it stands to profit from knowledge discovery. In general, the risk of granting data access to a user depends heavily upon the data requested, the purpose for the access, the user requesting the data (user motives) and the security of the user's environment. While traditional manual biomedical data sharing processes (based on institutional review boards) are lengthy and demanding, the automated ones (known as honest broker systems) disregard the individualities of different requests and offer "one-size-fits-all" solutions to all data requestors. In this manuscript, we propose a conceptual risk-aware data sharing system; the system brings the concept of risk, from all contextual information surrounding a data request, into the data disclosure decision module. The decision module, in turn, imposes mitigation measures to counter the calculated risk.

Sexual Health Research With Young Black Men Who Have Sex With Men: Experiences of Benefits and Harms.

Young Black men who have sex with men (YBMSM) are often underrepresented in sexual health research because of concerns about safety, privacy, and the potential for research harms. Empirical data are needed to understand YBMSM experience of participating in research, benefits and harms (discomfort), to inform policy and regulatory decisions. Using qualitative methods, this article examines 50 YBMSM, aged 15-19 years, experiences of benefits/harms, challenges of participating in sexual health research, and contextual factors impacting research experiences. Participants were asked about benefits and harms experienced in answering questions about sexual orientation, first same-sex attraction, and same-sex sexual experiences after completing an in-depth interview. Interviews were transcribed and coded. Inductive open coding was used to identify themes within and between interviews. Participants were able to describe perceived direct benefits resulting from research interview participation, including awareness of risky sexual behaviors, a safe space to share early coming out stories and same-sex sexual experiences, and a sense of empowerment and comfort with one's sexual orientation. Indirect benefits described by participants included perceptions of helping others and the larger gay community. Few participants described harms (discomfort recalling experiences). Our data suggest that participating in qualitative sexual health research focused on sexual orientation, sexual attraction, and early same-sex sexual experiences may result in minimal harms for YBMSM and multiple benefits, including feeling more comfortable than in a general medical visit.

Institutional review board training when patients and community members are engaged as researchers.

Background: Patient engagement efforts often rely on a participatory research approach, which means engaging patients and community members in all aspects of research. As research team members, they require familiarity with the principles of human subject protection, privacy, and institutional review boards (IRB). However, the time required for individual IRB training may be a barrier to engaging community members in participatory research. As more community members participated in research, the State Networks of Colorado Practices and Partners (SNOCAP) was faced with finding a balance between including community members as part of the research team and the significant time commitment and institutional requirements for human subjects research oversight. Objective: Design and implement a community training on human subject protection in research. Methods: The SNOCAP team worked with the leadership from the Colorado Multi-Institutional Review Board (COMIRB) to develop a training programme that included the ethical principles and guidelines for the protection of human subjects. Results: The final training programme was based on the core principles of the Belmont Report: respect for persons, beneficence and justice. Privacy was taught using the Health Insurance Portability and Accountability Act (HIPAA) national guidelines. Conclusions: The members of the High Plains Research Network Community Advisory Council were fully engaged in developing the training programme, as well as in the training itself. They were committed to the principles and guidelines for protecting the rights and welfare of human subjects. Patients and community members have become a critical part of our research team. They understand the principles of human subjects protection and privacy and incorporate these principles into their research activities.

Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies.

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.

Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network.

OBJECTIVE: The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review. STUDY DESIGN: We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 2012. Three randomized trials, 1 observational study, and 1 follow-up study of a trial were selected. IRB logs and communications were reviewed and abstracted by trained team members. RESULTS: Seven or 8 IRBs reviewed each protocol. Monthly IRB meeting frequency varied from 1 to 6. Full board review was required by all IRBs for the primary trials but not by all for the observational protocols. The overall duration from submission to approval (P = .024) and number of stipulations (P = .007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (P = .011) and IRB review-to-initial letter (P < .007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with the increasing number of IRB review stipulations (both values P < .001). Significant delays (>60 days) were few and not consistent across IRBs or protocols. Most stipulations were stylistic or editorial modifications rather than regulatory requests. All protocols were approved without changes, and no more than 1 IRB meeting was needed at each site. CONCLUSION: Findings confirm unnecessary duplication and variability and some similarities in IRB review processes and outcomes for multisite perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.

Harmonization and streamlining of research oversight for pragmatic clinical trials.

The oversight of research involving human participants is a complex process that requires institutional review board review as well as multiple non-institutional review board institutional reviews. This multifaceted process is particularly challenging for multisite research when each site independently completes all required local reviews. The lack of inter-institutional standardization can result in different review outcomes for the same protocol, which can delay study operations from start-up to study completion. Hence, there have been strong calls to harmonize and thus streamline the research oversight process. Although the institutional review board is only one of the required reviews, it is often identified as the target for harmonization and streamlining. Data regarding variability in decision-making and interpretation of the regulations across institutional review boards have led to a perception that variability among institutional review boards is a primary contributor to the problems with review of multisite research. In response, many researchers and policymakers have proposed the use of a single institutional review board of record, also called a central institutional review board, as an important remedy. While this proposal has merit, the use of a central institutional review board for multisite research does not address the larger problem of completing non-institutional review board institutional review in addition to institutional review board review­and coordinating the interdependence of these reviews. In this article, we describe the overall research oversight process, distinguish between institutional review board and institutional responsibilities, and identify challenges and opportunities for harmonization and streamlining. We focus on procedural and organizational issues and presume that the protection of human subjects remains the paramount concern. Suggested modifications of institutional review board processes that focus on time, efficiency, and consistency of review must also address what effect such changes have on the quality of review. We acknowledge that assessment of quality is difficult in that quality metrics for institutional review board review remain elusive. At best, we may be able to assess the time it takes to review protocols and the consistency across institutions.

Vulnerable Research Participant Policies at U.S. Academic Institutions.

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.