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)

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.

The New 2019 Institutional Review Board Common Rule Update: Implications for Plastic Surgery Research.

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.

Navigating the Intersection between Genomic Research and Clinical Practice.

The Risk Assessment Program (RAP) at Fox Chase Cancer Center (Philadelphia, PA) is a multi-generational prospective cohort, enhanced for personal and family history of cancer, consisting of over 10,000 individuals for whom data on personal and family history of cancer, risk factors, genetic and genomic data, health behaviors, and biospecimens are available. The RAP has a broad research agenda including the characterization of genes with known or potential relevance to cancer, gene-gene and gene-environment interactions, and their contribution to clinically useful risk assessment and risk reduction strategies. Increasingly, this body of research is identifying genetic changes which may have clinical significance for RAP research participants, leading us to confront the issue of whether to return genetic results emerging from research laboratories. This review will describe some of the important fundamental points that must be debated as we develop a paradigm for return of research results. The key issues to address as the scientific community moves toward adopting a policy of return of research results include the best criteria for determining which results to offer, the consent document components necessary to ensure that the participant makes a truly informed decision about receiving their results, and associated logistical and cost challenges.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

From Experimental Technique to Clinical Practice: Which Pathway in Transplant Surgery?

The question of whether a medical procedure is to be considered experimental or routine practice has enormous practical implications. In transplant surgery, as compared with pharmacologic clinical trials, the transition from experimental procedure to normal care is far from clear cut. Clinical trials comprise 4 well-established phases of evaluation going from phase I, aimed at assessing safety and identifying side effects in a few healthy volunteers, to phase IV, which involves entire populations and is aimed at long-term postmarketing surveillance. In transplant surgery, technical progress and experimentation follow more atypical and individual routes. As compared with pharmacologic research, the decision about "routine practice readiness" of a surgical procedure does not rely on a standardized formal act but rather on experts' capacity to find a consensus based on best practices and on ad-hoc criteria as well. Independent assessment by a panel of experts and oversight by an institutional review board are key to facilitating meaningful protection of transplant recipients and allowing the research to go forward. The framework of the human subjects protection regulations should also consider the transplant of organs that have previously been part of a research project.

Improved ethical guidance for the return of results from psychiatric genomics research.

There is an emerging consensus that genomic researchers should, at a minimum, offer to return to individual participants clinically valid, medically important and medically actionable genomic findings (for example, pathogenic variants in BRCA1) identified in the course of research. However, this is not a common practice in psychiatric genetics research. Furthermore, psychiatry researchers often generate findings that do not meet all of these criteria, yet there may be ethically compelling arguments to offer selected results. Here, we review the return of results debate in genomics research and propose that, as for genomic studies of other medical conditions, psychiatric genomics researchers should offer findings that meet the minimum criteria stated above. Additionally, if resources allow, psychiatry researchers could consider offering to return pre-specified 'clinically valuable' findings even if not medically actionable-for instance, findings that help corroborate a psychiatric diagnosis, and findings that indicate important health risks. Similarly, we propose offering 'likely clinically valuable' findings, specifically, variants of uncertain significance potentially related to a participant's symptoms. The goal of this Perspective is to initiate a discussion that can help identify optimal ways of managing the return of results from psychiatric genomics research.

Fatores de risco para cair em idosos no ambiente hospitalar / Factores de riesgo de caída en ancianos en el ambiente hospitalario / Risk factors of falls in elderly in hospital environment

RESUMO Introdução: quedas podem causar várias conseqüências, incluindo ainda a fraturas e lesões, a interferência na realização de atividades diárias de idosos. Objetivo: caracterizar os fatores de risco associados com quedas em idosos internados em ambiente hospitalar. Métodos: estudo descritivo transversal, realizado com 99 pacientes idosos internados em um hospital universitário localizado na cidade de Natal / RN / Brasil. A coleta de dados ocorreu entre os meses de junho a setembro de 2013, após a aprovação do Comitê de Ética em Pesquisa, sob aparentemente 121.028. I Meio dada were bem analisado por dois Estatísticos Testes Qui-Quadrado e Mann-Whitney. Resultados: 25,3 porcento dos idosos caem e 31,3 porcento tinham dificuldade para caminhar. A hipertensão arterial sistêmica mostrou significância com dificuldade para caminhar. Além disso, a fadiga apresenta associação com a ocorrência de uma queda. O piso dificuldade foi associada com a necessidade de ajuda andando, andando limitação, para tomar banho, subir escadas, dor e com mobilidade condicionada. Ainda assim, havia uma associação entre dificuldade em andar e uso de insulina, bem como entre a queda eo uso de agentes antiplaquetários. Além disso, o segmento referente à evolução da escala de Tinetti mostrou significância com dificuldade para caminhar. Conclusões: Os dados apresentados sobre fatores de risco de quedas em idosos internados em ambiente hospitalar destacar a importância de um fatores de cuidados seguros centrado mais prevalente, considerando todos os riscos de alterações orgânicas e suas condições clínicas e ambientais hospitalização(AU)

RESUMEN Introducción: las caídas pueden causar diversas consecuencias, que incluyen además de las fracturas y lesiones, interferencias en la realización de las actividades cotidianas del anciano. Objetivo: caracterizar los factores de riesgo asociados a las caídas en ancianos ingresados en ambiente hospitalario. Métodos: investigación transversal y descriptiva, realizada con 99 ancianos ingresados en un hospital universitario localizado en la ciudad de Natal/RN/Brasil. La recolección de datos ocurrió entre los meses de junio a septiembre de 2013, después de la aprobación del Comité de Ética en Investigación, bajo parecer 121.028. Los datos fueron analizados por medio de dos tests estatísticos: Qui-Quadrado y Mann-Whitney. Resultados: del total ancianos 25,3 presentaron caída y 31,3 por ciento dificultad para andar. La hipertensión arterial sistémica presentó significancia con la dificultad para andar. Además de eso, la fatiga presentó asociación con la ocurrencia de caída. La dificultad para piso estuvo asociada a la necesidad de ayuda para andar, limitación para andar, para tomar baño, subir escalera, dolor y movilidad perjudicada. Aún, hubo asociación entre la dificultad para andar y uso de insulina, así como entre la caída y el uso de antiagregante plaquetario. Además, el segmento referente a la marcha de la escala de Tinetti presentó significancia con la dificultad de andar. Conclusiones: los datos presentados sobre los factores de riesgo de caídas en ancianos ingresados en ambiente hospitalario destacan la importancia de un cuidado seguro centrado en los factores de riesgo más prevalentes, al considerar todas las modificaciones orgánicas, así como las condiciones clínicas y ambientales propias de la internación(AU)

ABSTRACT Introduction: Falls can cause various consequences, which include in addition to fractures and injuries, interference in the performance of daily activities of the elderly. Objective: To characterize the risk factors associated with falls in elderly patients in the hospital. Methods: Descriptive cross-sectional survey, conducted with 99 elderly admitted to a university hospital in the city of Natal/RN/Brazil. Data collection took place between June and September 2013, after approval of the Research Ethics Committee, under opinion 121.028. Data were analyzed using statistical tests chi-square and Mann-Whitney. Results: The 25.3 percent of the elderly were down 31.3 percent and difficulty walking. The Hypertension showed significance with difficulty walking. In addition, fatigue was associated with the occurrence of falls. The difficulty walking was associated with the need for help to walk, limitation to walk, bathing, climbing stairs, pain and impaired mobility. Still, there was an association between difficulty walking and insulin use, as well as between the fall and the use of antiplatelets. Moreover, the segment referring to the march of Tinetti scale showed significance with walking difficulties. Conclusions: The data presented on the risk factors of falls in elderly patients admitted to hospital environment emphasize the importance of a safe-centered care in the most prevalent risk factors, to consider all organic changes, as well as clinical and environmental conditions own hospitalization(AU)

Compliance with research standards within gynecologic oncology fellowship: A Gynecologic Oncology Fellowship Research Network (GOFRN) study.

OBJECTIVES: Participation in clinical and basic science research is emphasized in gynecologic oncology training. We sought to identify trends in adherence to expected research practices and reasons for non-adherence among gynecologic oncology fellows. METHODS: An anonymous 31-question online survey assessing academic behaviors, including IRB compliance, authorship assignment, data sharing, and potential barriers to non-adherence was distributed to all SGO gynecologic oncology fellow members in July 2016. Descriptive statistics and univariate analyses were performed. RESULTS: Of 190 members, 35.3% (n=67) responded. 73% (n=49) of respondents reported personal non-compliance and 79.1% (n=53) reported having witnessed others being non-complaint with at least one expected research practice. Areas of compliance failure included changing a research question without appropriate IRB amendment (20%; n=14), conducting research under a nonspecific IRB (13.9%; n=9), and performing research without IRB approval (6.1%; n=4). Longer institutional time for IRB approval was significantly associated with IRB non-adherence (p<0.05). First year fellows were more likely to use a nonspecific IRB (p=0.04) or expand a question without amending the IRB (p=0.04). When asked about storage of protected health information (PHI) for research, 53% reported non-secure storage with 17.1% (n=6) having done so for >1000 patients. Thirty respondents (45.5%) assigned authorship to someone who failed to meet ICMJE criteria and twelve (18.5%) accepted authorship without meeting ICMJE criteria. Most commonly cited reasons for non-adherence were: cumbersome IRB processes (80.3%), pressure from senior authors (78.8%), fear of someone else publishing first, (74.2%) and lack of support navigating appropriate research practices (71.2%). CONCLUSIONS: Fellow non-compliance with expected research practices is high, particularly with regards to secure storage of PHI and appropriate authorship assignment. Time-consuming and cumbersome IRB procedures, perceived pressure from senior authors, and lack of research support contribute to non-adherence. Further support and education of gynecologic oncology fellows is needed in order to help address these barriers.

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities.

Due to issues related to informed research consent, older adults with cognitive impairments are often excluded from high-quality studies that are not directly related to cognitive impairment, which has led to a dearth of evidence for this population. The challenges to including cognitively impaired older adults in research and the implications of their exclusion are a transdisciplinary issue. The ethical challenges and logistical barriers to conducting research with cognitively impaired older adults are addressed from the perspectives of three different fields-social work, emergency medicine, and orthopaedic surgery. Issues related to funding, study design, intervention components, and outcomes are discussed through the unique experiences of three different providers. A fourth perspective-medical research ethics-provides alternatives to exclusion when conducting research with cognitively impaired older adults such as timing, corrective feedback and plain language, and capacity assessment and proxy appointments. Given the increasing aging population and the lack of evidence on cognitively impaired older adults, it is critical that researchers, funders, and institutional review boards not be dissuaded from including this population in research studies.

Formas de Revisión Ética de Proyectos de Investigación Biomédica / Differentiated review of biomedical research projects by ethics committees

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.

Pautas éticas internacionales para la investigación relacionada con la salud con seres humanos / International Ethical Guidelines for Health-related Research Involving Humans

En el proceso de revisión, se usaron las revisiones bibliográficas como fuentes para profundizar el debate sobre la ética. Las declaraciones, informes y documentos de orientación de fuentes autorizadas han cumplido una función prominente en estas deliberaciones, como el Código de Nüremberg (1947), la Declaración Universal de Derechos Humanos de las Naciones Unidas (1948), el Pacto Internacional de Derechos Civiles y Políticos de las Naciones Unidas (1966), el Informe Belmont (1979), la Norma sobre Buenas Prácticas Clínicas (BPC) de la Conferencia Internacional sobre Armonización de los Requisitos Técnicos aplicable al Registro de Sustancias Farmacéuticas para Uso Humano (ICH) (1996), la Convención de Oviedo del Consejo de Europa (1997), la Declaración Universal sobre Bioética y Derechos Humanos de la UNESCO (2005), las Consideraciones éticas en ensayos biomédicos de prevención de la infección por el VIH del ONUSIDA/OMS (2007/2012), las Pautas y orientación operativa para la revisión ética de la investigación en salud con seres humanos de la OMS (2011) y la Declaración de Helsinki de la Asociación Médica Mundial (2013). Algunas de estas pautas se han usado ampliamente, en particular el documento del ONUSIDA y la OMS (2012) para la pauta 7 relativa al involucramiento de la comunidad. Igualmente, los libros de texto, los marcos éticos existentes para la investigación con seres humanos y los informes sobre la investigación con seres humanos fueron fuentes valiosas de información. El grupo de trabajo revisó artículos publicados en las principales revistas de ética como (en orden alfabético): el American Journal of Bioethics, BMC Medical Ethics, el Cambridge Quarterly of Healthcare Ethics, Developing World Bioethics, el Hastings Center Report, el Journal of Bioethical Inquiry, el Journal of Empirical Research on Human Research Ethics, el Journal of Law, Medicine and Ethics, el Journal of Medical Ethics, el Journal of Medicine and Philosophy, Medicine, Health Care and Philosophy, así como otros artículos de las principales revistas médicas o científicas, como el BMJ, The Lancet, el New England Journal of Medicine y Science. Las revisiones bibliográficas se usaron de tres maneras. Primero, buscamos las principales pautas éticas sobre la investigación con seres humanos y libros de texto sobre la ética de investigación para detectar nuevos temas o puntos de vista en los debates existentes. Por ejemplo, muchas pautas han incluido pronunciamientos sobre los biobancos, que fue una de las razones para fusionar las pautas del CIOMS sobre la investigación epidemiológica con las de investigación biomédica. También realizamos búsquedas en Embase y MEDLINE sobre artículos de análisis y trabajos con posiciones fuertes ante ciertos temas. Por ejemplo, el análisis de componentes y la prueba de riesgo neto son dos enfoques recientes en las evaluaciones de riesgo-beneficio. No hay ningún acuerdo entre los bioéticos sobre cuál de estos enfoques es preferible. El grupo de trabajo leyó documentos pertinentes sobre estos enfoques y formuló un enfoque intermedio. Se adoptó un proceso similar para la vulnerabilidad. En publicaciones recientes ha surgido el consenso de que la vulnerabilidad ya no puede aplicarse a grupos enteros. Como resultado, el grupo de trabajo eliminó el enfoque de grupo. En su lugar, las pautas se centran en aquellas características que conducen a considerar vulnerables a ciertos grupos y en las protecciones específicas que se necesitan en esas situaciones. Tercero, se realizaron revisiones bibliográficas para abordar temas relativamente nuevos, como los procedimientos para solicitar de manera informada no ser incluido en relación con los biobancos o la información que se brinda a los participantes en una investigación sobre los hallazgos que hayan sido solicitados o no. El grupo de trabajo revisó documentos sobre estos temas y asumió una posición sobre ellos.

Dificuldades e desafios em revisar aspectos éticos das pesquisas no Brasil / Dificultades y desafíos en revisión de aspectos éticos en investigación en Brasil / Difficulties and challenges in reviewing ethical aspects of research in Brazil

RESUMO Objetivo Refletir sobre os problemas enfrentados pelos pesquisadores de diferentes áreas, sobretudo de Ciências Humanas e Sociais, durante o processo de avaliação dos projetos de pesquisa pelos Comitês de Ética em Pesquisa no Brasil. Método Estudo teórico-reflexivo, baseado na literatura científica e análise crítica dos autores. Resultados Embora a Resolução 466/2012, que trata de pesquisas com seres humanos, apresente inovações de conteúdo, ainda permanecem obscuras questões relacionadas aos participantes de pesquisa, além do moroso processo de avaliação dos projetos. Conclusão Dificuldades enfrentadas por pesquisadores, principalmente de áreas como Ciências Humanas e Sociais, precisam ser transpostas para que as diretrizes éticas se tornem aplicáveis, tanto em termos de princípios quanto de procedimentos, às distintas tradições de pesquisas. É premente que as normas regulamentadoras de investigações com seres humanos sejam gerenciadas por sistema com capacidade operacional satisfatória, considerando as especificidades das diferentes áreas do conhecimento.

RESUMEN Objetivo Reflexionar sobre los problemas que enfrentan los investigadores de diferentes áreas, especialmente de Humanidades y Ciencias Sociales durante el proceso de evaluación de los proyectos de investigación por parte de los Comités Éticos de Investigación en Brasil. Método Estudio teórico y reflexivo basado en la literatura y análisis crítico de los autores. Resultados Aunque la Resolución 466/2012, presente innovaciones de contenido, siguen oscuras algunas cuestiones relacionadas con los participantes de investigación, además del largo proceso de evaluación de proyectos. Conclusión Las dificultades que enfrentan los investigadores, especialmente de áreas como Humanidades y Ciencias Sociales, necesitan ser incorporadas donde las normas éticas sean aplicables, en términos de principios y de procedimientos, a las tradiciones distintas de investigación. Es urgente que los estándares apropiados de investigación con seres humanos sean administrados por sistema con capacidad operativa satisfactoria, teniendo en cuenta las especificidades de las diferentes áreas del conocimiento.

ABSTRACT Objective To reflect on the problems faced by researchers from different areas, especially of Humanities and Social Sciences, when submitting research projects for evaluation by the research ethics committees in Brazil. Method A theoretical and reflective study based on international literature and the critical analysis of the authors. Results Although Resolution 466/2012, which addresses human research, contains some innovations, issues related to the research participants remain obscure and the project evaluation process is time-consuming. Conclusion The difficulties faced by researchers, especially in the fields of Humanities and Social Sciences, must be transposed to ensure that the ethical guidelines are applicable, in terms of principles and procedures, to the different research traditions. Appropriate human research standards must be managed by a system with a satisfactory operational capacity, according to the specificities of the different areas of knowledge.

[Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study]. / Die Rolle von Ethikkommissionen für die nationale Versorgungsforschung - eine Querschnittsstudie des Aufwandes zur Erlangung von Sekundärvoten anhand der DACAPO-Studie.

BACKGROUND: Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). METHODS: Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. RESULTS: The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). CONCLUSION: Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed.

Institutional review boards: what's old? What's new? What needs to change?

SUMMARY: Institutional review boards have come under fire for being burdened with work, causing delays in the progress of human subject research without improvements in the protection of human subjects. Over the years, there have been increases in the numbers of clinical trials, the use of multisite studies, and the amount of bureaucracy, but there have been no changes to the system to accommodate these advancements. Proposed changes include the use of a centralized institutional review board for multisite studies and harmonization of reporting requirements among agencies. The purposes of this article are to review the history, structure, and purpose of the institutional review board, to assess the criticisms of the current system, and to discuss solutions for improvement.