7 research outputs found
Clinical importance of the Mandalay spitting cobra (Naja mandalayensis) in Upper Myanmar – Bites, envenoming and ophthalmia
This is an accepted manuscript of an article published by Elsevier in Toxicon on 03/06/2020, available online: https://doi.org/10.1016/j.toxicon.2020.05.023
The accepted version of the publication may differ from the final published version.© 2020 Elsevier Ltd Examination of 18 cobras brought to three hospitals in the Mandalay Region by patients bitten or spat at by them distinguished 3 monocled cobras (Naja kaouthia) and 15 Mandalay spitting cobras (N. mandalayensis), based on their morphological characteristics. We confirm and extend the known distributions and habitats of both N. mandalayensis and N. kaouthia in Upper Myanmar. Clinical symptoms of local and systemic envenoming by N. mandalayensis are described for the first time. These included local swelling, blistering and necrosis and life-threatening systemic neurotoxicity. More information is needed about the clinical phenotype and management of bites by N. mandalayensis, the commoner of the two cobras in Upper Myanmar. Since the current cobra antivenom manufactured in Myanmar has lower pre-clinical efficacy against N. mandalayensis than N. kaouthia, there is a need for more specific antivenom therapy.Published versio
Using central IRBs for multicenter clinical trials in the United States.
Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials
Perceived Barriers to Using Centralized IRB Review in Multicenter Clinical Trials in the United States and Proposed Solutions.
<p>Abbreviations: IRB, institutional review board; OHRP, Office of Human Research Protections.</p
Responsibilities of Institutions and Central IRBs for Multicenter Clinical Trial Protocols<sup>*</sup>.
<p>Abbreviations: IRB, institutional review board; FDA, Food and Drug Administration; FWA, federalwide assurance; HIPAA, Health Insurance Portability and Accountability Act; OHRP, Office of Human Research Protections.</p>*<p>This table provides highlights of a guide for institutions that can help to decouple institutional and IRB responsibilities to assist in the acceptance of centralized ethical review; the detailed guide is provided in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054999#pone.0054999.s001" target="_blank">Appendix S1</a>.</p