Ethics and administrative jurisprudence of the rights of subjects of research in pandemic (COVID-19): role of the scientific ethics committees: Chile / Ética y jurisprudencia administrativa de los derechos de los sujetos de investigación en pandemia (COVID-19): función de los comités éticos científicos: Chile

RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.

SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.

A data flow process for confidential data and its application in a health research project.

BACKGROUND: The use of linked healthcare data in research has the potential to make major contributions to knowledge generation and service improvement. However, using healthcare data for secondary purposes raises legal and ethical concerns relating to confidentiality, privacy and data protection rights. Using a linkage and anonymisation approach that processes data lawfully and in line with ethical best practice to create an anonymous (non-personal) dataset can address these concerns, yet there is no set approach for defining all of the steps involved in such data flow end-to-end. We aimed to define such an approach with clear steps for dataset creation, and to describe its utilisation in a case study linking healthcare data. METHODS: We developed a data flow protocol that generates pseudonymous datasets that can be reversibly linked, or irreversibly linked to form an anonymous research dataset. It was designed and implemented by the Comprehensive Patient Records (CPR) study in Leeds, UK. RESULTS: We defined a clear approach that received ethico-legal approval for use in creating an anonymous research dataset. Our approach used individual-level linkage through a mechanism that is not computer-intensive and was rendered irreversible to both data providers and processors. We successfully applied it in the CPR study to hospital and general practice and community electronic health record data from two providers, along with patient reported outcomes, for 365,193 patients. The resultant anonymous research dataset is available via DATA-CAN, the Health Data Research Hub for Cancer in the UK. CONCLUSIONS: Through ethical, legal and academic review, we believe that we contribute a defined approach that represents a framework that exceeds current minimum standards for effective pseudonymisation and anonymisation. This paper describes our methods and provides supporting information to facilitate the use of this approach in research.

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.

Research on COVID-19: Stories from IRB Members, Research Administrators & Investigators.

This symposium is separated into two sections. The first includes twelve personal stories from IRB members, administrators, or staff about their experiences during the COVID-19 pandemic. The second section includes twelve personal stories from researchers. Six commentaries on these narratives are offered by experts in research ethics, regulatory oversite, IRB administration, the logistics of clinical research, and investigator responsibilities. These narratives and commentaries offer an inside look at how the COVID-19 pandemic affected the physical logistics of clinical research already underway, demanded immediate investment in scientific investigation of vaccines and treatments, and rerouted the usual decision pathways that guide ethical practice.

Challenges of Clinical Research Administration During the COVID-19 Pandemic.

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.

IRBs During COVID-19: Tried and True.

The COVID-19 pandemic threw health care logistics and clinical research processes into disarray. This collection of narratives describes the challenges faced by IRB administrators, staff, and committee members as they navigated the SARS-CoV-2 pandemic. The authors transitioned to remote meetings, adjusted to ever-changing information, and untangled the ethical implications of supporting open studies while making room for an influx of new protocols that addressed the pressing public health emergency.

Perseverance.

The COVID-19 pandemic disrupted and displaced the old normal, necessitating adaptation. The narratives in this issue of NIB give us a glimpse into the experience of conducting research during a pandemic. The authors were on a mission to pursue research despite the challenges the pandemic imposed. They described difficulties of the Institutional Review Board process and the necessity of asking for accelerated IRB approval. The authors also discussed challenges they faced with research participant recruitment during a pandemic and concerns about keeping staff safe from the risk of transmission. The authors adapted and adjusted to the personal and professional restraints the COVID-19 pandemic placed upon them. Despite these difficulties, the authors remained committed to maintaining the integrity of their research.

Human Research During the COVID-19 Pandemic: Insights From Behind-the-Scenes.

The researchers' stories collected here demonstrate how many ethical and practical challenges routinely associated with conducting human research were amplified during the COVID-19 pandemic. These challenges include designing studies to minimize risks and maximize potential benefits, working with institutional review boards (IRBs), recruiting and enrolling participants, obtaining valid informed consent, promoting data integrity, managing budget constraints, and finding time to fulfill research obligations along with other duties. By offering insights about not only the barriers and challenges researchers encountered but also the creative solutions they and their colleagues found to conduct research, this behind-the-scenes peek at researchers' experiences helps us to identify barriers and potential lasting improvements for human subjects research even in the best of times.

Research During the Pandemic: Views from Both Sides of the Fence.

The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.

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.