Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead.

PURPOSE OF THE REVIEW: Laboratory-developed tests (LDTs) are essential for the clinical care of immunocompromised individuals. These patients often require specialized testing not available from commercial manufacturers and are therefore dependent on the laboratory to create, validate, and perform these assays. Recent paradigm-shifting legislation could alter the way that LDTs are operationalized and regulated. RECENT FINDINGS: On March 5th, 2020 the Verifying Accurate and Leading-Edge In-Vitro Clinical Tests Development Act (VALID) was introduced in the US Congress. This statute would overhaul existing regulatory framework by unifying the oversight of LDTs and commercial in-vitro diagnostic tests (IVDs) through the FDA. If enacted, LDTs would be subject to regulatory requirements like those found in commercial submissions for market review. Stakeholders continue to discuss the details and scope of the proposed legislation in the setting of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, where LDTs are integral to the national COVID-19 response. SUMMARY: Congressional lawmakers have introduced legislation to alter the regulatory framework governing LDTs. Moving forward, a balance must be struck to ensure the availability of safe and accurate testing without delays or overregulation that could be harmful to patients. The downstream implications of how VALID and other legislation will impact laboratories, clinicians, and patients warrant close examination.

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges.

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing health care costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This article outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health information and obtaining informed consent. The article provides lessons learned to help form mutually beneficial partnerships between researchers and NHs to conduct studies that grow and advance NH research initiatives and clinical care.

Protocolo del Sistema Nacional de Vigilancia Epidemiológica, SINAVE. No. 01 / Protocol of the National Epidemiological Surveillance System, SINAVE. No. 01

El documento es una presentación del Manual de Normas y Procedimientos del Sistema Nacional de Vigilancia Epidemiológica (SINAVE), que incluye 13 documentos, iniciando con este que explica la estructura del Sistema de Vigilancia y el resto que aborda alguno de los aspectos epidemiológicos que se han estudiado con el objeto de conocer tendencia, evolución, e identificación de regiones geográficas afectadas y los grupos poblacionales vulnerables, así como el conocimiento del estado de salud de la población e identificación precoz de los brotes para su intervención inmediata y control. En el documento, se afirma que: La vigilancia epidemiológica, permite llevar a cabo un estudio minucioso de los brotes y enfermedades que pueden afectar al país, brindando la base para poder orientar las políticas de salud en la prevención, reducción de la morbilidad y mortalidad por causas prevenibles a través de la recolección y el análisis del flujo de información con evidencia científica, interpretación y difusión de los datos sustentados. Además que, el desarrollo del manual, se basa en la necesidad de contar con un SINAVE único, actualizado y estandarizado. Y enfatiza que, su propósito, es servir de guía para la obtención de información y conocimientos epidemiológicos relevantes sobre riesgos y daños a la salud, a través del desarrollo y fortalecimiento del Sistema Nacional de Vigilancia Epidemiológica (SINAVE), con la finalidad de coadyuvar a las acciones de prevención y protección de la salud, definidas por el Ministerio de Salud en sus políticas, prioridades y normativa.

Establishing research priorities in prevention and control of vector-borne diseases in urban areas: a collaborative process.

BACKGROUND: In 2015, following a call for proposals from the Special Programme for Research and Training in Tropical Diseases (TDR), six scoping reviews on the prevention and control of vector-borne diseases in urban areas were conducted. Those reviews provided a clear picture of the available knowledge and highlighted knowledge gaps, as well as needs and opportunities for future research. Based on the research findings of the scoping reviews, a concept mapping exercise was undertaken to produce a list of priority research needs to be addressed. METHODS: Members of the six research teams responsible for the "VEctor boRne DiseAses Scoping reviews" (VERDAS) consortium's scoping reviews met for 2 days with decision-makers from Colombia, Brazil, Peru, Pan-American Health Organization, and World Health Organization. A total of 11 researchers and seven decision-makers (from ministries of health, city and regional vector control departments, and vector control programs) completed the concept mapping, answering the question: "In view of the knowledge synthesis and your own expertise, what do we still need to know about vector-borne diseases and other infectious diseases of poverty in urban areas?" Participants rated each statement on two scales from 1 to 5, one relative to 'priority' and the other to 'policy relevance', and grouped statements into clusters based on their own individual criteria and expertise. RESULTS: The final map consisted of 12 clusters. Participants considered those entitled "Equity", "Technology", and "Surveillance" to have the highest priority. The cluster considered the most important concerns equity issues, confirming that these issues are rarely addressed in research on vector-borne diseases. On the other hand, the "Population mobility" and "Collaboration" clusters were considered to be the lowest priority but remained identified by participants as research priorities. The average policy relevance scores for each of the 12 clusters were roughly the same as the priority scores for all clusters. Some issues were not addressed during the brain-storming. This is the case for governance and for access and quality of care. CONCLUSIONS: Based on this work, and adopting a participatory approach, the concept mapping exercise conducted collaboratively with researchers from these teams and high-level decision-makers identified research themes for which studies should be carried out as a priority.

Chronic disease as risk multiplier for disadvantage.

This paper starts by establishing a prima facie case that disadvantaged groups or individuals are more likely to get a chronic disease and are in a disadvantaged position to adhere to chronic treatment despite access through Universal Health Coverage. However, the main aim of this paper is to explore the normative implications of this claim by examining two different but intertwined argumentative lines that might contribute to a better understanding of the ethical challenges faced by chronic disease health policy. The paper develops the argument that certain disadvantages which may predispose to illness might overlap with disadvantages that may hinder self-management, potentially becoming disadvantageous in handling chronic disease. If so, chronic diseases may be seen as disadvantages in themselves, describing a reproduction of disadvantage among the chronically ill and a vicious circle of disadvantage that could both predict and shed light on the catastrophic health outcomes among disadvantaged groups-or individuals-dealing with chronic disease.

[Healthcare research in forensic commitment or poking around in the dark : Consensus paper on the necessity for more uniform and better data]. / Versorgungsforschung im Maßregelvollzug oder das Stochern im Nebel : Konsenspapier zur Notwendigkeit einheitlicher und besserer Daten.

Complex trends in occupancy determined by many influencing factors, clear state-specific differences in imprisonment practices as well as recently implemented statutory alterations to the appropriate paragraphs in criminal law, underline the necessity for qualitative high-grade concomitant research of German forensic commitment; however, neither the structural prerequisites nor an adequate data situation are currently present in order to do justification to this aim. Not even the total number of patients currently accommodated in forensic commitment can be elucidated from the publicized (partial) statistics. This consensus paper, which was formulated by three research institutes active at the state level, describes the limited possibilities for current forensic healthcare research and raises the demand for a nationwide uniform data situation on patients in forensic commitment. Furthermore, how the appropriate elicitation instrument should be organizationally and structurally achieved, is sketched from a scientific perspective. This article aims at initiating a discussion on a sustainable improvement in the prerequisites for healthcare research in German forensic commitment and targets a sensitization of decision makers in politics and administration for this topic.

A critique of the regulation of data science in healthcare research in the European Union.

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire - a brave new world?

The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

[An approach to research in the political agendas of the health sector in Colombia between 1990 and 2010]. / Una aproximación a la investigación en las agendas políticas del sector salud en Colombia entre 1990 y 2010.

OBJECTIVE: To understand health research in Colombia in the context of governmental and legislative agendas related to the health sector between 1990 and 2010. METHODS: Official sources were used such as development plans, bills and institutional documents. RESULTS: The National Government, the Ministry of Health and Social Protection (MSPS by its acronym in Spanish) and the Colombian Congress have focused their attention on health research as a public concern at certain presidential periods due to their interest in reducing the gap between research and health needs. In the 1990s, government plans showed greater interest in formulating a Science and Technology (S&T) policy in health led by the Ministry, an entity that had directorates, commissions and committees responsible for promoting and planning health research. In Congress, some health system reform projects included initiatives to formulate a health research policy that were not approved. DISCUSSION: Health research is recognized as a fundamental tool to help solve health problems. However, said recognition by governmental and legislative actors has not been constant and the institutionality in the health sector has been precarious considering that there is no permanent interest in formulating an S&T policy in health.

OBJETIVO: Entender la investigación en salud en Colombia como parte de agendas gubernamentales y legislativas relacionadas con el sector salud entre 1990 y 2010. MÉTODOS: Se usaron fuentes documentales oficiales como planes de desarrollo, proyectos de ley y otras publicaciones institucionales. RESULTADOS: El Gobierno Nacional, el Ministerio de Salud y Protección Social (MSPS) y el Congreso colombiano han puesto la atención a la investigación en salud como un problema público en diferentes periodos presidenciales debido al interés de reducir la brecha entre la investigación y las necesidades en salud. En los planes gubernamentales durante los años noventa se presentó mayor interés en la formulación de una política de Ciencia y Tecnología (CyT) en salud liderado por el MSPS, entidad que contaba con direcciones, comisiones y comités encargados de promover y planear la investigación en salud. En el Congreso, algunos proyectos de reforma al sistema de salud incluyeron iniciativas para formular una política de investigación en salud que no fueron aprobadas. DISCUSIÓN: La investigación en salud es reconocida como fundamental para contribuir a solucionar los problemas de salud. Sin embargo, este reconocimiento no ha sido constante por parte de los actores gubernamentales y legislativos, la institucionalidad en el sector salud ha sido precaria y no hubo insistente interés por formular una política de CyT en salud.

Freedom of Information Act: scalpel or just a sharp knife?

The concluding statement of the Burns Commission, established to evaluate whether changes are needed to the Freedom of Information Act (FOIA), ruled no major legislative changes were required. As such Freedom of Information (FOI) legislation still enables anyone to obtain information from public authorities. In this brief report article we explore arguments regarding FOI as an instrument for healthcare research using an international research programme as a case study.