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.

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.

Doctoral graduates' attitudes toward scholarly work and Institutional Review Board and Quality Improvement Committee education and submission processes: A pilot study.

BACKGROUND: Educators are challenged to find better ways to prepare doctoral nursing students to conduct scholarly work involving human subjects. PURPOSE: To better understand doctoral nursing students' attitudes toward programmatic scholarly work and Institutional Review Board (IRB)/Quality Improvement Committee (QIC) education and submission processes. METHODS: Recent Doctor of Nursing Practice (DNP) and Philosophy of Nursing (PhD) graduates were recruited using convenience sampling techniques to participate in this cross-sectional, descriptive, mixed-methods pilot study. Data were collected using two researcher-developed instruments. DISCUSSION: Nineteen doctoral nursing students participated in this study. Students most often used a quantitative approach with health care providers to complete their scholarly work requirements. Both PhD and DNP participants were overall satisfied with the IRB/QIC content in the curricula and the submission process. Four themes were identified: (a) Efficiency, (b) Collaboration, (c) Faculty Mentorship, and (d) Areas for Improvement. CONCLUSION: Findings from this pilot study may be used to enhance IRB/QIC processes through revision of administrative processes and student education.

Research on emerging infectious diseases: pros and cons of centralised government controls.

As the world grapples with the constant threat of new pathogens, the role of government oversight in research and response efforts has become a topic of considerable debate in the academic community. In the recently released "SOP [standard operating procedure] for Nipah virus research in Kerala for studies involving human participants / human samples" by the Government of Kerala, the SOP, apart from administrative permission, requires the proposal to be cleared by the Institutional Research Committee at a Government Medical College, and the inclusion of an investigator from a government institution [1]. In these challenging times, it is crucial to weigh the pros and cons of stringent administrative controls to ensure an effective and ethical approach to tackling emerging infectious diseases.

Com Ciência e Com Respeito: episódio 23

Neste terceiro episódio especial sobre o Projeto de Qualificação de CEPs, vamos falar sobre a leitura que o Q-CEP fez das análises éticas feitas pelos CEPs visitados. Confira!

Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness.

This Viewpoint discusses the difficult task of creating a stakeholder-driven, evidence-based approach to assessing institutional review board effectiveness beyond regulatory compliance.

339ª Reunião Ordinária do Conselho Nacional de Saúde - 16 feb. 2023

Applicability and usefulness of the Declaration of Helsinki for forensic research with human cadavers and remains.

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community.

Doe Ógãos, Salve Vidas. A atuação do Serviço Social no processo de captações de órgãos e tecidos para transplantes / Donate Organs, Save Lives. The performance of Social Work in the process of capturing organs and tissues for transplants

O estudo "Doe órgãos, salve vidas: a atuação do Serviço Social no processo de captações de órgãos e tecidos para transplantes" apresenta a contribuição do Serviço Social na doação de órgãos e tecidos de acordo com o espaço sócio ocupacional, empiricamente o hospital estadual Adão Pereira Nunes (HEAPN) localizado no município de Duque de Caxias, cidade da região metropolitana do Estado do Rio de Janeiro. A pesquisa é baseada em um questionário aplicado às profissionais de Serviço Social que atuam na unidade hospitalar, e uma análise de documentos à qual constam o número de doações efetivas realizadas nos respectivos anos de 2019 e 2020 e o script do trabalho realizado pela CIHDOTT na referida unidade. Sendo assim, verificou-se que a contribuição feita pelo o Serviço Social no HEAPN junto a CIHDOTT na doação de órgãos e tecidos é prestando acolhimento das às famílias, e sua atuação é voltada a vertente social da doação de órgãos e tecidos, se dá de forma espontânea, simples e esporádica, no que se refere a localização de familiares dos potenciais doadores, orientação quanto aos procedimentos de certidão de óbito e sepultamento, e encaminhamento necessário a rede assistencial. A partir desses resultados conclui-se que o trabalho realizado pelos(as) Assistentes Sociais no processo de doação de órgãos e tecidos, não é padronizado, o que varia de instituição para instituição de saúde, e que o trabalho desempenhado pela CIHDOTT apesar dos inúmeros desafios postos decorrentes de uma série de questões que perpassam a temática, é efetuado de maneira inteiramente organizada e eficiente, o que resulta em efeitos satisfatórios a temática.

Utilización de pautas éticas en investigación por participantes en congreso científico estudiantil internacional, 2015 / Usage of ethical guidelines in research by participants in international student scientific congress, 2015

El cumplimiento de normas éticas contribuye a la protección de los participantes humanos en una investigación. Objetivo: Describir la utilización de la norma- tiva de ética en investigación por expositores de trabajos libres, XXX Congreso Científico Internacional, Federación Latinoameri- cana de Estudiantes de Medicina (FELSOCEM), Panamá, 2015. Metodología: Estudio descriptivo transversal. Instrumento au - toadministrado previo consentimiento informado escrito. Se re- alizó un muestreo por conveniencia entre participantes inscritos presentando trabajo(s) libre(s). Se consideró cumplimiento de las normas éticas en investigación 1) contar con aval institucional, 2) aprobación de comité de ética en investigación (CEI) y 3) obten - ción de asentimiento/consentimiento informado. Se registró la in - formación en base de datos EpiInfo vs 3.5.4 (CDC, Atlanta, EUA). El estudio fue aprobado por CEI Facultad de Ciencias Médicas UNAH y FELSOCEM. Resultados: Participaron 98 asistentes, edad promedio 22 años (desviación estándar +2.53), 60 (61.2%) sexo femenino, procedentes de 12 países, 73 (75.2%) con más del 60% de pensum académico alcanzado. Presentaron 105 trabajos libres: 42 (40.0%) casos clínicos, 63 (60.0%) protocolos/trabajos de investigación (44.4% descriptivo, 38.1% analítico, 17.5% ex- perimental). Cumplieron tres criterios éticos de investigación 33 (31.4%), dos criterios 39 (37.1%), un criterio 26 (24.8%), ningún criterio 7 (6.7%). Discusión: El 56.2% (59) de los trabajos presen- tados no cumplió con las normas éticas en investigación. En época de pandemia, la revisión ética es aún más relevante. Los eventos científicos de asociaciones estudiantiles ofrecen una oportunidad de fortalecer la conducta responsable en investigación en años formativos, lo cual debe ser promovido por el comité organizador de cada congreso...(AU)

A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era.

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.

National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic: An analysis.

The world currently faces an unprecedented pandemic outbreak of coronavirus disease (Covid-19). The novel nature of the virus and very high infection rates have not only increased the urgency to find a vaccine or cure but have also led to drastic changes in the mode of conduct of research. Thus, the Indian Council of Medical Research has developed the "National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during Covid-19 Pandemic" for guidance during the review of research. Here, we attempt to analyse the strengths and limitations of these guidelines to assess if the unique ethical challenges faced during research in the current situation are adequately identified and addressed and if foundational values and principles of research ethics have been taken into account in these guidelines.

Governing AI-Driven Health Research: Are IRBs Up to the Task?

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

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.

There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator-initiated registration-directed trial (IIRDT) in Japan, Korea, Taiwan, and Singapore, aiming at obtaining pharmaceutical approval in participating regions. Differences in regulatory and operational procedures were identified while coordinating the trial. In Japan, regulatory authority reviews should be performed after approval by institutional review boards for IIRDT, whereas in other regions these can be done in parallel. There were disparities in Good Manufacturing Practice-related documents between regions. Several differences were found regarding investigational product (IP) management, specifically concerning labeling, import/export procedures, and customs clearance costs. On the other hand, safety reporting procedures were relatively well-harmonized in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A). Regions also differed in per-patient costs, due to varying regulations for academic registration-directed trials. In conclusion, the observed differences among Asian regions should be harmonized to facilitate international academic trials in Asia and thus resolve unmet patient needs worldwide. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? International clinical trials have become common because they make it possible to accrue patients faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international clinical trials, especially in academia. WHAT QUESTION DID THIS STUDY ADDRESS? We conducted an academic international clinical trial on new drug applications in four Asian countries and clarified pharmaceutical regulatory differences and operational difficulties. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? The study identified differences between countries in terms of regulatory affairs, institutional review board (IRB) review processes, investigational new drug (IND) dossiers, investigational product (IP) management procedures, and clinical trial costs, while safety reporting procedures were relatively harmonized. Japan utilizes investigator-initiated registration-directed trials, an advanced regulatory system for new drug application by academia, but the other countries do not. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Harmonization of pharmaceutical regulations and trial initiation procedures, and regulatory reform of clinical trial costs are important to accelerate academic international clinical trials for new drug applications.

Ethical and Practical Concerns about IRB Restrictions on the Use of Research Data.

In response to researcher noncompliance with ethical and regulatory provisions governing research with humans, protocol deviations, and unanticipated problems with research, institutional review boards (IRBs) or institutions sometimes impose restrictions on the use of research data, although specific cases in which this happens are unlikely to be known publicly. We review IRB policies at top research institutions in the United States about restrictions on the use of research data and describe potential reasons for restricting the use of such data in the context of ensuring compliance with human subjects research standards. We also discuss ethical considerations related to restricting the use of research data and argue that IRBs have limited regulatory authority to take such actions. Finally, we offer recommendations regarding decision-making about restricting the use of research data and call for additional guidance in this area.

Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual-Level Intervention.

Individual-cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as sufficient to grant a waiver of consent, then a loophole emerges in research oversight. Such loopholes are morally hazardous for study participants, the integrity of science, and public trust in the research enterprise. We conclude by articulating the standards that research ethics committees should use to evaluate requests for waivers of consent in individual-cluster trials.

Ethical Considerations When Using a Mobile Eye Tracker in a Patient-Facing Area: Lessons from an Intensive Care Unit Observational Protocol.

This article describes the process of designing, approving, and conducting an investigator-initiated protocol to use an eye-tracking device in a health care setting. Participants wore the device, which resembles eyeglasses, in a front-facing manner in an intensive care unit for the study of personnel gaze patterns, producing a visual record of workflow. While the data of interest for our study was not specifically the health information protected by the privacy rule of the Health Insurance Portability and Accountability Act (HIPAA), a wide variety of such data was captured by the eye-tracking device, and the prospective consent of all people who might have been incidentally videotaped was not feasible. The protocol therefore required attention to unique ethical considerations-including consent, privacy and confidentiality, HIPAA compliance, institutional liability, and the use of secondary data. The richness of eye-tracker data suggests various beneficial applications in health care occupational research and quality improvement. Therefore, sharing our study's successful design and execution, including proactive researcher-institutional review board communication, can inform and encourage similarly valuable, ethical, and innovative audiovisual research techniques.