Assessment of an electronic system for research ethics committees document management: An observational study.

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.

Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study.

It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1st January 2020 to 20th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

[Time of ethics review of research proposals: results of an observational study]. / Tiempos de evaluación ética de protocolos de investigación: resultados de un estudio observacional.

The review of research protocols by Research Ethics Committees (RECs), essential to ensure the protection of participants, has been managed in the City of Buenos Aires through the PRIISA.BA electronic platform since January 2020. The aim of the present study was to describe ethical review times, their temporal evolution, and predictors of their duration. We conducted an observational study that included all the protocols reviewed between January 2020 and September 2021. Times to approval and to first observation were calculated. Temporal trends in times, and the multivariate association between these and protocol and IRB characteristics were evaluated. 2,781 protocols reviewed in 62 RECs were included. The median time to approval was 29.11 (RIQ 11.29 to 63.35) days, and time to first observation was 8.92 (RIQ 2.05 to 18.18) days. The times were significantly reduced throughout the study period. We detected as variables independently associated with shorter time to approval to be a COVID proposal, having funding and the number of centers to perform the study and having been reviewed by an RECs with more than 10 members. Making observations to the protocol was associated with more time. The results of the present work suggest that ethical review times were reduced during study period. In addition, variables associated with time were identified that could be the object of interventions to improve the process.

Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D2EFT.

A rapidly changing landscape of antiretrovirals and their procurement at scale has permitted the evaluation of new optimised second-line antiretroviral therapy (ART) in low- and middle-income countries. D2EFT is an open-label randomised controlled non-inferiority phase IIIB/IV trial in people living with HIV-1 (PWH) whose first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART is failing. At inception, it compared a standard of care of boosted darunavir with two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) to the novel NRTI-sparing regimen of boosted darunavir with dolutegravir. Implemented in 2017, participating sites were across Africa, Asia and Latin America. Around the time of implementation, the World Health Organization updated its treatment guidelines and recommended scaling up tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD). This situation pushed D2EFT investigators to consider the impact of the roll-out of TLD on the D2EFT research question. The protocol team agreed it was important to study TLD in second-line when an NNRTI regimen was failing, and focused on options to expedite the work by studying the question within the existing trial and network. All key issues (statistical, programmatic and financial) were reviewed to assess the benefits and risks of adding a third arm to the ongoing study, as opposed to developing a new randomised clinical trial with the same control arm and within the same network. The development of a new trial was deemed to be longer than adding a third arm, and to create a challenging situation with two competing clinical trials at the same sites which would slow down recruitment and impair both trials. On the other hand, adding a third arm would be demanding in terms of operationalisation, increased sample size and statistical biases to control. The optimal strategy was deemed to be the addition of a third arm, arriving retrospectively at a simplified multi-arm multi-stage clinical trial design to achieve statistical validity. The D2EFT study maintains additional value in a quickly evolving second-line ART strategy allowed by the progress in global access to ART.

Tiempos de evaluación ética de protocolos de investigación: resultados de un estudio observacional / Time of ethics review of research proposals: results of an observational study

La evaluación de protocolos de investigación por Comités de Ética en Investigación (CEI), esencialpara garantizar la protección de los participantes, se gestiona en la Ciudad de Buenos Aires a través laplataforma electrónica PRIISA.BA desde enero del 2020. El objetivo del presente estudio fue describirlos tiempos de evaluación ética, su evolución temporal, y los predictores de su duración. Se realizóun estudio observacional que incluyó todos los protocolos evaluados entre enero de 2020 y septiem-bre de 2021. Se calcularon los tiempos al dictamen final y a la primera observación. Se evaluaron lastendencias temporales de los tiempos, y la asociación multivariada entre éstos y características de losprotocolos y de los CEI. Se incluyeron 2781 protocolos evaluados en 62 CEI. La mediana de tiempo aldictamen final fue de 29.11 (RIQ 11.29 a 63.35) días, y del tiempo a la primera observación de 8.92(RIQ 2.05 a 18.18) días. Los tiempos se redujeron significativamente a lo largo del período de estudio.Detectamos como variables independientemente asociadas a menor tiempo a la temática COVID, tenerfinanciamiento y el número de centros a realizarse el estudio y haber sido evaluado en un CEI con másde 10 miembros. La realización de observaciones al protocolo se asoció a mayor tiempo. Los resultadosdel presente trabajo sugieren que los tiempos de evaluación ética se redujeron durante el período deestudio. Además, se identificaron variables asociadas con los tiempos, que podrían ser objeto de inter-venciones para mejorar el proceso.(AU)

The review of research protocols by Research Ethics Committees (RECs), essential to ensure theprotection of participants, has been managed in the City of Buenos Aires through the PRIISA.BA elec-tronic platform since January 2020. The aim of the present study was to describe ethical review times,their temporal evolution, and predictors of their duration. We conducted an observational study thatincluded all the protocols reviewed between January 2020 and September 2021. Times to approvaland to first observation were calculated. Temporal trends in times, and the multivariate associationbetween these and protocol and IRB characteristics were evaluated. 2,781 protocols reviewed in 62RECs were included. The median time to approval was 29.11 (RIQ 11.29 to 63.35) days, and time to firstobservation was 8.92 (RIQ 2.05 to 18.18) days. The times were significantly reduced throughout thestudy period. We detected as variables independently associated with shorter time to approval to bea COVID proposal, having funding and the number of centers to perform the study and having beenreviewed by an RECs with more than 10 members. Making observations to the protocol was associatedwith more time. The results of the present work suggest that ethical review times were reduced duringstudy period. In addition, variables associated with time were identified that could be the object ofinterventions to improve the process.(AU)

Conducta Responsable en Investigación. Definiciones y aplicaciones. Ejemplificación a través de un caso argentino: el caso Crotoxina / Responsible Conduct in Research. Definitions and applications. Ilustration through an argentinian case: the Crotoxina case

La integridad de los científicos a la hora de producir conocimiento es una de las áreas más estudiadas actualmente desde la ética en investigación. La sociedad confía en sus científicos y estos deben responder a esa expectativa con sus actos. Proponemos en este artículo presentar la temática de la Conducta Responsable en Investigación (CRI). Hay determinadas áreas sensibles en el proceso de investigación, que son las más difundidas a la hora de incurrir en conductas irresponsables. Estas áreas son definidas internacionalmente como: conflicto de intereses, asignación de crédito/ prácticas de autoría, falsificación y fabricación de datos y Plagio. En la Argentina, en los años 80 un caso de conducta irresponsable en investigación sacudió a la opinión pública, el caso Crotoxina. Utilizaremos el caso para ejemplificar la CRI y diferenciar faltas éticas e ilícitos en términos jurídicos.(AU)

Scientists integrity when producing knowledge is currently one of the most studied areas in ethical research. Society trusts in its Scientists and these must respond to this expectation with their acts. We propose in this article to present the subject of Responsible Conduct in Research. There are some sensible areas in the process of research, which are the most widespread when committing research misconduct. These areas are defined as: Conflict of interest, Authorship/ Authorship practice, data falsification and fabrication, and plagiarism. In Argentina, in the 80´s, a case of research misconduct shook public opinion: the Crotoxina case. We will use the case to Illustrate the RCR and to distinguish ethic faults and illicit in legal terms.(AU)

Proceso de reglamentación de la investigación clínica en la Ciudad Autónoma de Buenos Aires. La ley 3301 y el fortalecimiento de los Comités de Ética en Investigación / Regulation process of clinical research in Buenos Aires City. The law 3301 and the strengthening of Research Ethics Committees

En la Ciudad Autónoma de Buenos Aires se sancionó la Ley N° 3301 sobre Protección de Derechos de Sujetos en Investigaciones en Salud uniendo las normas internacionales, las particularidades locales, la Constitución de la Ciudad y a la Ley Básica de Salud. El nuevo modelo representa un marco legal que logra equilibrar la protección del sujeto y fomentar la investigación clínica en la Ciudad brindando seguridad jurídica a los actores de la actividad y potenciales patrocinadores. La ley estimula en forma concreta -a través de los fondos ingresantes- estudios relativos a temas de salud pública, aquellos que benefician a poblaciones de baja incidencia o cualquier otro tipo de trabajo que no suela ser financiado por la industria. La Ley fortalece especialmente a los Comités de Etica de investigación y al Comité Central de Ética en Investigación, que tiene entre sus facultades la de acreditar y capacitar. Se realizó un análisis FODA sobre su implementación.(AU)

In Buenos Aires City was enacted the Law Nº 3301 about Protection of Human Subjects in Health Research, bonding international guidelines on ethics, local peculiarities, Buenos Aires City Constitution and the local Basic Health Law. The new model represents a legal framework which accomplishes to balance the protection on human subjects and the promotion of clinical research in the City, providing legal security to the participants involved in the activity and potential sponsors. The Law stimulates in concrete terms -through control of the incoming funds- studies related to public health themes, those that benefit low incidence population or any other work that is not usually sponsored by the industry.The Law particularly strengthens the Research Ethics Committes and the Central Research Ethics Committee which has, among others, accreditation and training functions. A SWOT analysis on its implementation is performed.(AU)

Estudio descriptivo cualitativo acerca del conocimiento entre los investigadores locales de las pautas para la integridad en la investigación / Descriptive qualitative study on knowledge about research integrity guidelines among local researchers

INTRODUCCIÓN La investigación científica se basa en la confianza. Los investigadores pueden incurrir en malas conductas, que debilitan la credibilidad. OBJETIVOS Describir y comparar el conocimiento y la valoración de patrones de conducta responsable entre investigadores de la Ciudad Autónoma de Buenos Aires (CABA) según sexo, edad e institución. Describir la frecuencia y el conocimiento de conductas irresponsables entre los investigadores. MÉTODOS Se realizó una encuesta a investigadores de CABA, en las que se solicitó opinión sobre la situación imaginaria de conductas irresponsables. Las variables demográficas fueron edad, sexo, antigüedad y cargo como profesional y como investigador. Las variables de la encuesta fueron ordinales y numerales, con sólo dos campos abiertos. RESULTADOS Con N=86, el 99% consideró que la falsificación de datos debilita la credibilidad en la investigación, el 20% dijo que era habitual y el 76%, poco frecuente. El 93% reconoció el plagio y su significado, el 80% lo calificó como muy grave y el 48% lo consideró habitual. Para el 92%, la incorrecta asignación de créditos era de grave a muy grave, el 62% la consideró habitual, el 52% dijo que se había visto involucrado en una situación como la descripta y el 93% señaló que era de frecuente a muy frecuente. En cuanto al conflicto de intereses, el 87% consideró que debe declararse la práctica privada en el ámbito público y el 89% eligió al comité de ética en investigación como el ámbito propicio para realizar la declaración. DISCUSIÓN Se conoce y percibe la gravedad de las áreas proclives a la mala conducta en investigación. Se requieren cambios culturales y procedimientos que permitan reconocerla, denunciarla y solucionarla.