The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research.

ABSTRACT: In orthopaedic clinical research, as in other fields, sex and gender-specific analyses are not consistently performed, despite evidence of sex differences in outcomes. Both institutional review boards (IRBs) and journal editors have a role in impacting the rate at which such analyses are performed and reported. The authority, responsibilities, and potential actions of IRBs are discussed herein, with the aim of setting investigator expectations and propelling changes to the study plan before the research is initiated.

A transformative solution to build effective, transparent, and resilient "fit-for-purpose" national health research ethics systems.

The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers' capacity and enhance the quality and efficiency of human reviews of the research proposals by REC.

The CEP-Conep System in 2020: confronting COVID-19, challenges and lessons learned. / O Sistema CEP-Conep em 2020: enfrentamento da COVID-19, desafios e lições aprendidas.

This paper presents the structuring dimensions of the CEP-Conep System in order to understand the actions promoted by the National Research Ethics Commission in response to demands for the processing and ethical analysis of research protocols related to COVID-19 in 2020. Based on CEP-Conep System public documents, an assessment of legislation, from 1988 to 2020, and its extension in terms of the number of Committees, users, and protocols, from 2012 to 2020 was presented. The minutes of Conep's Ordinary Meetings (RO), for 2020, of a confidential nature, were analyzed, to verify adaptations to the pandemic. At the end of 2020, the System had 844 Committees, 854,741 users, and 701,791 analyzed protocols. The Commission centralized the analysis of COVID-19 protocols, in January 2020, and promoted three decentralizations, as more knowledge was generated, with vaccine protocols for COVID-19 remaining centralized. The history of the CEP-Conep System provided ballast for the adoption of management, educational and communication measures that accelerated the approval of protocols and made the process transparent. The absence of indicators made it impossible to evaluate the performance in 2020, which was apparently satisfactory.

O artigo apresenta dimensões estruturantes do Sistema CEP-Conep para compreender as ações promovidas pela Comissão Nacional de Ética em Pesquisa nas respostas às demandas de tramitação e análise ética de protocolos de pesquisa relativos à COVID-19 no ano de 2020. Foi elaborado estudo de caso a partir de documentos públicos do Sistema CEP-Conep, para evidenciar seu marco regulatório, de 1988 a 2020, e sua extensão em termos de quantidade de comitês, usuários e protocolos, de 2012 a 2020. Foram examinadas as atas das reuniões ordinárias (RO) da comissão, de 2020, de caráter sigiloso, para caracterizar as adaptações à pandemia. No final de 2020, o sistema contabilizava 844 comitês, 854.741 usuários, e 701.791 protocolos analisados. A comissão centralizou a análise de protocolos de COVID-19, em janeiro de 2020, e promoveu três descentralizações, à medida que mais conhecimento era gerado, permanecendo centralizados os protocolos de vacinas para COVID-19. O histórico do Sistema CEP-Conep proveu lastro para a adoção de medidas de gestão, educativas e de comunicação que aceleraram a apreciação de protocolos e deram transparência ao processo. A ausência de indicadores não permitiu avaliar a performance em 2020, aparentemente satisfatória.

Polymedia Literacy and Other Ethical Considerations for Online Ethnographic Research on Social Networking Sites.

Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities.

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey.

Background: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing.

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

BACKGROUND: Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations. METHODS: Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes. RESULTS: Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications. CONCLUSIONS: Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

Evaluating research ethics committees in Vietnam and Laos: Results of a validated self-assessment tool.

BACKGROUND: There is an increase in human subject research in developing countries and conducting them in an ethical manner depends on the research ethics oversight in these countries. The purpose of this study is to evaluate the operational, financial, and educational characteristics of research ethics committees (RECs) at institutions in Vietnam and Laos. METHODS: A validated self-assessment tool designed to assess nine major characteristics of RECs was translated into Vietnamese and Laotian. The translated surveys were delivered to and completed by representatives from RECs at institutions in Vietnam and Laos. The surveys were collected, translated back into English, and scored. The data was analyzed to identify potential areas of strength and areas for improvement. RESULTS: The mean survey score for the 19 RECs surveyed was 165.3 out of a maximum of 200 points with a standard deviation of 22.9. Committees scored the highest in the review of specific protocol items (95.6%), submission arrangements and materials (89.5%), and the policies referring to review procedures (85.6%) domains. RECs scored the lowest in the resources domain (65.5%), with only 26.3% of committees having an annual budget. Nearly all RECs have standard operating procedures (94.7%) and policies for disclosing conflicts of interest (89.5%). Most committees use prior ethics training as a criterion to select REC chairs (78.9%) and members (73.7%), with the majority of committees requiring a training course in ethics (76.5%). 68.4% of committees have continuing education in ethics for members and only 42.1% of committees have a budget for member training. CONCLUSION: This study demonstrated that RECs in Vietnam and Laos have strong foundational review processes for research protocols. Important areas of improvement include improved institutional oversight, financial and administrative resources, and the continued ethics education for current committee members.

Apresentação | Comitê de Ética e Pesquisa | Cursos EAD

A Comissão de Residência Multiprofissional em Saúde, por meio do Comitê de Ética em Pesquisa da SMS-SP, traz a Beatriz Abrantes e Doralice da Cruz para uma apresentação sobre o CEP, com breve histórico, funcionamento, legislação e a importância da avaliação ética dos projetos de pesquisa com seres humanos, considerando a instância quando desenvolvimento dos trabalhos de conclusão da residência.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

Indigenous governance, ethics and data collection in Australian clinical registries.

OBJECTIVES: To examine Indigenous Governance of Data processes in Australian clinical registries. DESIGN, SETTING, PARTICIPANTS: Audit (via desktop review and interviews) of registries in the Australian Register of Clinical Registries from 17 January 2022 to 30 April 2023. MAIN OUTCOME MEASURES: The number of clinical registries collecting ethnicity data, reporting Aboriginal and/or Torres Strait Islander representation on registry governance or steering committees, and reporting human research ethics committee approval. RESULTS: A total of 107 clinical registries were reviewed. Of these registries, 65 (61%) collected ethnicity data; when these were grouped by geographical coverage, those most likely to collect ethnicity data were binational (24/40 [60%]), national (19/26 [73%]) or state based (19/26 [73%]). Of the registries that collected ethnicity data, 29 (45%) classified their ethnicity item as Aboriginal and/or Torres Strait Islander. Only eight clinical registries (7%) reported Aboriginal and/or Torres Strait Islander representation on their governance or steering committees. Human research ethics approval was reported in 94 registries (88%), with only 11 (12%) having Aboriginal human research ethics committee approval. CONCLUSION: Significant variability is evident in clinical registry recording of Indigenous governance of data, meaning that Aboriginal and Torres Strait Islander communities remain invisible in data which is used to inform policy, clinical models of care, health services and initiatives. Radical change is required to facilitate meaningful change in quality indicators for clinical registries nationally.

Research Ethics of Involving Adolescents in Health Research Studies: Perspectives From Australia.

PURPOSE: Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews. METHODS: Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo. RESULTS: Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism. DISCUSSION: Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment.

Caracterización del síndrome post COVID-19 en personal de un centro de salud. Honduras, 2022 / Characterization of post COVID syndrome in personnel of a health center. Honduras, 2022

Antecedentes. Se ha observado una frecuencia considerable en la persistencia de síntomas en pacientes que han superado un episodio de COVID-19 agudo. El síndrome post COVID, lo presentan aquellos pacientes que mantienen signos o síntomas 3 meses tras el comienzo del episodio agudo. Objetivo. Caracterizar el síndrome post COVID, en el personal de salud del Triaje Mayangle, Tegucigalpa, abril 2022. Métodos. Estudio cuantitativo, descriptivo-transversal. El universo del estudio fue el personal (72) que laboraba en centro de Triaje. La recolección de la información se realizó a través de un cuestionario en línea, procesándose en Microsoft Excel versión 2017. Resultados. El 71% (51) eran mujeres y 29% (21) hombres, 66 personas afirmaron haber sufrido la infección COVID-19 confirmado con pruebas de laboratorio, (RT-PCR, detección de antígenos y/o detección de anticuerpos); 6 negaron haber cursado la enfermedad siendo excluidas del estudio. Un 68% (45/66) reportó reinfección. Las manifestaciones clínicas persistentes más frecuentes 4 semanas después del inicio de la enfermedad fueron dolor de cabeza 60.6%, fatiga 43.9%, tos 33.3%, pérdida del olfato 33.3%, caída de cabello 25.8%, insomnio 25.8%. Las manifestaciones que persistieron 12 semanas posteriores fueron dolor de cabeza 33.3%, fatiga 28.8%, caída de cabello 18.2%, tos 15.2%, pérdida del olfato 13.6% y dolor torácico 13.6%. Discusión. El 75.8% de los participantes que sufrieron COVID-19 persistieron con síntomas a las 12 semanas del diagnóstico. La estimación más reciente de personas que viven con la condición post COVID-19 a nivel mundial ha superado 65 millones y, sin opciones claras de diagnóstico o tratamiento...(AU)

Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Single IRB Review and Local Context Considerations: A Scoping Review.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.

Rationale and Study Checklist for Ethical Rejection of Participants on Crowdsourcing Research Platforms.

Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs.