McGuireWoods

Background: The post-acute sequelae of SARS-CoV-2 infection represent a growing public health concern. While associations between COVID-19 and metabolic disorders have been reported, less is known about this risk in young, healthy populations. This study aimed to quantify the risk of developing new-onset metabolic disorders following SARS-CoV-2 infection among U.S. active-duty service members. Methods: We conducted a propensity score-matched cohort study using U.S. Military Health System data between July 2020 and June 2021 of active-duty service members (ADSM) aged 18 to 65 years old. COVID-19 infections were identified through ICD-10 codes or laboratory results. A 1:2 matched cohort compared 103,789 COVID-19 exposed individuals with 207,578 controls. Outcomes included incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension (HTN), hyperlipidemia (HLD), metabolic dysfunction-associated steatotic liver disease (MASLD), and metabolic syndrome (MetS) within one year. Cox proportional hazards models calculated adjusted hazard ratios (aHR) while controlling for obesity and overweight status. Results: The median age for both those with and without COVID-19 infection was 26 years (interquartile range 22–33 years), with males comprising the majority of participants (81.1% male, 18.9% female). COVID-19 infection was associated with significantly increased hazards for incident HTN (aHR 1.09; 95% CI, 1.01–1.18), HLD (aHR 1.30; 95% CI, 1.10–1.54), and MASLD (aHR 1.36; 95% CI, 1.15–1.60). However, no significant increased risk was observed for T2DM or MetS. Conclusions: COVID-19 infection was associated with significantly increased risk of developing HTN, HLD, and MASLD, highlighting important long-term metabolic consequences in a young, healthy population.

Twenty-five years ago, the Institute of Medicine recommended voluntary, external accreditation of human research protection programs to enhance the protection of human subjects participating in research and to preserve public trust in our system of protecting human research subjects. Today, accreditation of human research protection programs as well as independent institutional review boards has been well established. It is carried out by a sole accrediting organization, the Association for the Accreditation of Human Research Protection Programs, Incorporated. However, there has been no evaluation of whether accreditation improves human research subject protections or the quality of institutional review board reviews, and whether accreditation is cost-effective. Thus, it is imperative that we find out whether accreditation has achieved its primary objective of enhancing human research subject protections and the quality of institutional review board reviews.

OBJECTIVES: The Common Rule, the U.S. Basic Federal Policy for Protection of Human Research Subjects, was revised extensively in 2018 to modernize the regulations by enhancing protections for human research subjects and reducing unnecessary burden and ambiguity for researchers. It was implemented on January 21, 2019. The purpose of this study was to determine whether the revised Common Rule in fact enhanced human research subject protections and reduced burdens to researchers. METHODS: Analysis of data collected on the performance of human research protection programs from 107-109 Department of Veterans Affairs research facilities between 2016 and 2024 was carried out to evaluate the impact of the revised Common Rule at five and a half years after its implementation. RESULTS: At five and a half years after implementation of the revised Common Rule, when 77% of all active human research protocols were under the revised Common Rule requirements, there was an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring institutional review board (IRB) continuing reviews. However, analysis of human research subject protection performance metric data during the same period revealed that of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval remained unchanged, while three, i.e., required informed consent and Health Insurance Portability and Accountability Act authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated. CONCLUSIONS: The revised Common Rule achieved its objective of reducing the burden of low-risk studies to researchers. However, it impaired, instead of enhancing, human research subject protections.

We report on five SARS-CoV-2 congregate setting outbreaks at U.S. Operation Allies Welcome Safe Havens/military facilities. Outbreak data were collected, and attack rates were calculated for various populations. Even in vaccinated populations, there was rapid spread, illustrating the importance of institutional prevention and mitigation policies in congregate settings.

The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.

This prospective study assessed the dual-curing self-adhesive bulk-fill restorative Surefil one. The restorations were placed and reviewed by dental practitioners who are members of a practice-based research network in the United States. Seven practitioners filled 60 cavities (20 class I, 19 class II and 21 class V) in 41 patients with Surefil one without adhesive, according to the manufacturer’s instructions. The restorations were evaluated using modified USPHS criteria at baseline, 3 months, and 1 year. Patients were also contacted to report postoperative hypersensitivity one to four weeks after placement. The only patient that showed moderate hypersensitivity after 1 year had previously reported symptoms that were unlikely associated to the class I molar restoration. One class II restoration in a fractured maxillary molar was partially lost. The remaining restorations were found to be in clinically acceptable condition resulting in an annual failure rate of 2%. Color match showed the lowest number of acceptable scores (88%) revealing significant changes over time (P = 0.0002). No significant differences were found for the other criteria (P > 0.05). The novel self-adhesive bulk-fill restorative showed clinically acceptable results in stress-bearing class I and II as well as non-retentive class V cavities at 1-year recall.

El presente Amicus Curiae es presentado ante la Honorable Corte Interamericana de Derechos Humanos (en adelante la “Corte” o “Corte I.D.H.”, indistintamente) por el Observatorio de Libertad Religiosa en América Latina (en adelante “OLIRE”) en colaboración con Law in Action, de conformidad con el Artículo 44 y 2.3 del Reglamento de la Corte I.D.H. El objetivo del presente documento busca que la Corte, al momento del análisis y posterior decisión sobre el caso “Pavez Pavez vs. Chile”, considere todos los aspectos relacionados con el reconocimiento, respeto y la debida protección de la multidimensionalidad del derecho a la libertad religiosa para evitar algún tipo de vulneración que afecte tanto la aplicación de justicia en el caso concreto, así como futuros errores en la garantía del contenido protegido del mencionado derecho humano. El caso se relaciona con la presunta responsabilidad internacional del Estado por la inhabilitación de la profesora Sandra Cecilia Pavez Pavez para el ejercicio de la docencia de la asignatura de religión en un centro educativo público con orientación religiosa. La Vicaría para la Educación del Obispado de San Bernardo, en el ejercicio de sus facultades legales, revocó el certificado de idoneidad de la mencionada profesional; requerido por el Decreto 924 del Ministerio de Educación de 1983 para ejercer como profesora de religión, con lo cual Sandra Pavez no pudo continuar ejerciendo el cargo de maestra de la asignatura de religión, aunque la dirección del establecimiento educativo le ofreció un cargo administrativo en la misma escuela.

RETURN TO ISSUEHighlights from the ...Highlights from the LiteratureNEXTSome Items of Interest to Process R&D Chemists and EngineersWenyi ZhaoWenyi ZhaoJacobus Pharmaceutical Co. Inc., Princeton, New Jersey 08540, United StatesMore by Wenyi Zhao, Sylvain GuizzettiSylvain GuizzettiNovAlix, Building A: Chemistry, Bioparc, Bld. Sébastien Brant BP 30170, F-67405 Illkirch Cedex, FranceMore by Sylvain Guizzettihttp://orcid.org/0000-0003-4656-2431, James A. SchwindemanJames A. SchwindemanOlon S.p.A., 9 McGuire Court, Hilton Head, South Carolina 29926, United StatesMore by James A. Schwindeman, David S. B. DanielsDavid S. B. DanielsPfizer Chemical Research & Development, Discovery Park House, IPC 533, Sandwich, Kent CT13 9NJ, U.K.More by David S. B. Danielshttp://orcid.org/0000-0002-9092-1377, James J. DouglasJames J. DouglasEarly Chemical Development, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield SK10 2NA, U.K.More by James J. Douglashttp://orcid.org/0000-0002-9681-0459, Sylvain PetitSylvain PetitUCB Pharma SA, Chemin du Foriest, B-1420 Braine-L’Alleud, BelgiumMore by Sylvain Petithttp://orcid.org/0000-0002-9198-8602, Christopher B. KellyChristopher B. KellyJanssen Research & Development, 1400 McKean Road, Spring House, Pennsylvania 19477, United StatesMore by Christopher B. Kellyhttp://orcid.org/0000-0002-5530-8606, Alex KosanovichAlex KosanovichDow, Texas Operations, 230 Abner Jackson Parkway, ECB/4B137, Lake Jackson, Texas 77566, United StatesMore by Alex Kosanovich, and John Knight*John KnightJKonsult Ltd, Meadow View, Cross Keys, Hereford HR1 3NT, U.K.*Email: [email protected]More by John KnightCite this: Org. Process Res. Dev. 2020, 24, 8, 1351–1363Publication Date (Web):August 12, 2020Publication History Published online12 August 2020Published inissue 21 August 2020https://doi.org/10.1021/acs.oprd.0c00344Copyright © 2020 American Chemical SocietyRIGHTS & PERMISSIONSArticle Views4029Altmetric-Citations-LEARN ABOUT THESE METRICSArticle Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to reflect usage leading up to the last few days.Citations are the number of other articles citing this article, calculated by Crossref and updated daily. Find more information about Crossref citation counts.The Altmetric Attention Score is a quantitative measure of the attention that a research article has received online. Clicking on the donut icon will load a page at altmetric.com with additional details about the score and the social media presence for the given article. Find more information on the Altmetric Attention Score and how the score is calculated. Share Add toView InAdd Full Text with ReferenceAdd Description ExportRISCitationCitation and abstractCitation and referencesMore Options Share onFacebookTwitterWechatLinked InReddit PDF (3 MB) Get e-AlertsSUBJECTS:Reagents,Hydrocarbons,Anions,Amines,Cross coupling reaction Get e-Alerts

ADVERTISEMENT RETURN TO ISSUEPREVHighlights from the ...Highlights from the LiteratureNEXTSome Items of Interest to Process R&D Chemists and EngineersWenyi ZhaoWenyi ZhaoJacobus Pharmaceutical Co. Inc., Princeton, New Jersey 08540, United StatesMore by Wenyi Zhao, Sylvain GuizzettiSylvain GuizzettiNovAlix, Building A: Chemistry, Bioparc, Bld. Sébastien Brant BP 30170, F-67405 Illkirch Cedex, FranceMore by Sylvain Guizzetti, James A. SchwindemanJames A. SchwindemanOlon S.p.A., 9 McGuire Court, Hilton Head, South Carolina 29926, United StatesMore by James A. Schwindeman, David S. B. DanielsDavid S. B. DanielsPfizer Chemical Research & Development, Discovery Park House, IPC 533, Sandwich, Kent CT13 9NJ, U.K.More by David S. B. Danielshttp://orcid.org/0000-0002-9092-1377, James J. DouglasJames J. DouglasAstraZeneca, Silk Road Business Park, Charter Way, Macclesfield SK10 2NA, U.K.More by James J. Douglashttp://orcid.org/0000-0002-9681-0459, Sylvain PetitSylvain PetitUCB Pharma SA, Chemin du Foriest, B-1420 Braine-L'Alleud, BelgiumMore by Sylvain Petithttp://orcid.org/0000-0002-9198-8602, and John Knight*John KnightJKonsult Ltd, Meadow View, Cross Keys, Hereford HR1 3NT, U.K.*E-mail: [email protected]More by John KnightCite this: Org. Process Res. Dev. 2020, 24, 2, 115–124Publication Date (Web):February 7, 2020Publication History Published online7 February 2020Published inissue 21 February 2020https://pubs.acs.org/doi/10.1021/acs.oprd.0c00027https://doi.org/10.1021/acs.oprd.0c00027article-commentaryACS PublicationsCopyright © 2020 American Chemical Society. This publication is available under these Terms of Use. Request reuse permissions This publication is free to access through this site. Learn MoreArticle Views4138Altmetric-Citations-LEARN ABOUT THESE METRICSArticle Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to reflect usage leading up to the last few days.Citations are the number of other articles citing this article, calculated by Crossref and updated daily. Find more information about Crossref citation counts.The Altmetric Attention Score is a quantitative measure of the attention that a research article has received online. Clicking on the donut icon will load a page at altmetric.com with additional details about the score and the social media presence for the given article. Find more information on the Altmetric Attention Score and how the score is calculated. Share Add toView InAdd Full Text with ReferenceAdd Description ExportRISCitationCitation and abstractCitation and referencesMore Options Share onFacebookTwitterWechatLinked InRedditEmail PDF (3 MB) Get e-AlertscloseSUBJECTS:Amines,Catalysts,Functionalization,Organic compounds,Reagents Get e-Alerts