The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care Research During a Pandemic and Beyond

Author:

Jaton Eric1,Stang Jamie2,Biros Michelle1,Staugaitis Abbey1,Scherber Julie1,Merkle Florian12,Mohr Nicholas M.3ORCID,Streib Christopher4,Klein Lauren12ORCID,Puskarich Michael A.12ORCID

Affiliation:

1. From the Department of Emergency Medicine University of Minnesota Minneapolis MN USA

2. and the Department of Emergency Medicine Hennepin County Medical Center Minneapolis MN USA

3. and the Department of Emergency Medicine University of Iowa Carver College of Medicine Iowa City IA USA

4. and the Department of Neurology University of Minnesota Minneapolis MN USA

Publisher

Wiley

Subject

Emergency Medicine,General Medicine

Reference9 articles.

1. CFR ‐ Code of Federal Regulations Title 21. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11. Accessed Jul 3 2020.

2. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‐19 Public Health Emergency. Available at:https://www.fda.gov/media/136238/download. Accessed Jul 3 2020.

3. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support

4. Federal Register/Vol. 81 No. 241/Thursday December 15 2016/Rules and Regulations. Available at:https://www.fs.usda.gov/Internet/FSE_DOCUMENTS/fseprd527654.pdf. Accessed Jul 3 2020.

5. COVID MyStudies Application (App). Available at:https://www.fda.gov/drugs/science‐and‐research‐drugs/covid‐mystudies‐application‐app. Accessed Jul 3 2020.

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