Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
  1. Home
  2. Search

Refine search

Refine search

Access:
Content type:
Publication date:
Apply   From and To filters
Subject: Show more
Journals Show more
Publishers: Show more
Societies Show more
Series: Show more
Collections: Show more

Actions for selected content:

Select all | Deselect all
  • View selected items
  • Export citations
  • Download PDF (zip)
  • Save to Kindle
  • Save to Dropbox
  • Save to Google Drive

Save Search

You can save your searches here and later view and run them again in "My saved searches".

Please provide a title, maximum of 40 characters.
Cancel
×

3 results

  • Chapter 7 - Development of Assays to Diagnose COVID-19

  • Edited by Steven C. Schachter, Harvard Medical School, Wade E. Bolton, VentureWell/Rapid Acceleration of Diagnostics (RADx)
  • Book:
    Accelerating Diagnostics in a Time of Crisis
    Published online:
    06 January 2024
    Print publication:
    07 March 2024, pp 125-142

  • Summary

    This chapter covers the development of diagnostic tests that detect and often amplify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids (molecular tests) or directly detect protein antigens (antigen tests). In the Rapid Acceleration of Diagnostics (RADx®) Tech program, tests that could be performed by following the instructions for use (Clinical Laboratory Improvement Amendments-waived point-of-care tests) or at home (over the counter) became more ubiquitous and represented a paradigm shift in infectious disease diagnostics away from reference laboratory testing by trained laboratorians. Understanding the clinical use case and unmet need is essential to the development of successfully commercialized tests. Important considerations include sample type and collection, the timing of testing (asymptomatic, contact of a known case, or symptomatic), biosafety, the limit of detection and sensitivity, specificity, the turnaround time, form factor and workflow, internal controls, early verification and validation, and supply chain bottlenecks.

  • A snapshot of U.S. IRB review of COVID-19 research in the early pandemic

  • Holly A. Taylor, Kimberley Serpico, Holly Fernandez Lynch, John Baumann, Emily E. Anderson
  • Journal:
    Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
    Published online by Cambridge University Press:
    13 September 2021, e205
    • Article
      • You have access
      • Open access
    • PDF
    • HTML
    • Export citation
  • Background/Objective:

    Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

    Methods:

    Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP).

    Results:

    Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19.

    Conclusions:

    Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

  • Chapter 7 - How Should We Choose Target Journals?

  • from Part III - Strategies of Planning Journal Articles
  • Zheng Yan, University at Albany, State University of New York
  • Book:
    Publishing Journal Articles
    Published online:
    27 October 2020
    Print publication:
    05 November 2020, pp 69-81

  • Summary

    After deciding the target submission date, the second planning strategy is to choose the target journal. It could be through the process of finding the two best fits, the author–journal best fit and the journal–author best fit. After presenting students’ intuitive thoughts and four real cases (Chi, Laurel, Justin, and Liz), the chapter discusses multiple core concepts, that is, impact factors, professional rewards, readership benefits, turnaround time, and desk rejection. Based on the discussion of students’ intuitive thoughts, four real-life cases, and four core concepts, several strategies can be used to choose our target journal wisely: finding the first best fit, that is, the fit between the needs of authors and the features of journals. Consider our professional needs, and then search and choose a target journal; finding the second best fit, that is, the fit between features of journals and the needs of readers; developing a shortlist of target journals as early as possible, and reading the latest three issues of these journals and finding at least three-to-five articles.