Innovative Medicine and Research on COVID-19 (C19): Addressing Potential Ethical, Oversight, and Regulatory Barriers

Principal Investigator(s):  View help for Principal Investigator(s) James M. DuBois, Washington University in St. Louis. School of Medicine; Bryan Sisk, Washington University in St. Louis. School of Medicine

Version:  View help for Version V1

Name File Type Size Last Modified
  IRB Professional Data 03/10/2022 01:04:PM
  Researcher Data 03/10/2022 01:06:PM
  Supporting Documentation 03/10/2022 01:06:PM

Project Citation: 

DuBois, James M., and Sisk, Bryan. Innovative Medicine and Research on COVID-19 (C19): Addressing Potential Ethical, Oversight, and Regulatory Barriers. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2022-03-10. https://doi.org/10.3886/E164581V1

Project Description

Summary:  View help for Summary Responses to two separate but related surveys containing open-ended questions to IRB professionals and researchers in the United States who studied COVID-19 during the spring and summer of 2020. These questions focused on ethical, logistical, and practical challenges to overseeing and performing COVID-related research early in the pandemic.
Funding Sources:  View help for Funding Sources United States Department of Health and Human Services. National Institutes of Health. National Institute on Aging (3R01AG058254-03S1); National Center for Advancing Translational Sciences (UL1 TR002345)

Scope of Project

Subject Terms:  View help for Subject Terms COVID-19; Research ethics; ELSI
Geographic Coverage:  View help for Geographic Coverage United States
Time Period(s):  View help for Time Period(s) 4/2020 – 8/2021 (Data collection and analysis of survey data from IRB professionals and COVID-19 researchers. )
Collection Date(s):  View help for Collection Date(s) 4/2020 – 7/2020 (Survey data collection of IRB professionals and COVID-19 researchers. )
Universe:  View help for Universe COVID-19 Researchers, IRB professionals reviewing COVID-19 research
Data Type(s):  View help for Data Type(s) survey data; text
Collection Notes:  View help for Collection Notes Please review the provided ReadMe file for additional information about data collection and the contents of this dataset. 

Methodology

Sampling:  View help for Sampling This study employed criterion-based convenience sampling to identify US-based researchers conducting COVID-19 research and IRB professional reviewing COVID-19 research. Both researchers and IRB professionals were contacted using publicly available contact information. Researcher contact information was located from ClinicalTrials.gov, Scopus, and Embase Conference Abstracts. Recruitment of IRB professionals was supported by Public Responsibility in Medicine and Research (PRIM&R), who agreed to distribute study recruitment materials in their electronic newsletter, as well as posting recruitment information on their IRB Forum blog page and their COVID-19 webpage. 
Collection Mode(s):  View help for Collection Mode(s) web-based survey
Unit(s) of Observation:  View help for Unit(s) of Observation Individuals
Geographic Unit:  View help for Geographic Unit United States

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Published Versions

V1 [2022-03-10]

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