Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Patricia Woods; Maura Flynn; Paul Monach; Karen Visnaw; Sara Schiller; Erika Holmberg; Sarah Leatherman; Ryan Ferguson; Westyn Branch-Elliman

doi:10.1016/j.conctc.2021.100804

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Contemp Clin Trials Commun. 2021 Sep:23:100804. doi: 10.1016/j.conctc.2021.100804. Epub 2021 Jun 26.

Authors

Patricia Woods¹, Maura Flynn¹, Paul Monach^{1

2

3

4}, Karen Visnaw¹, Sara Schiller¹, Erika Holmberg¹, Sarah Leatherman¹, Ryan Ferguson^{1

5

6}, Westyn Branch-Elliman^{2

3

7

8}

Affiliations

¹ Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and CSP Coordinating Center, Boston, MA, USA.
² VA Boston Healthcare System, Department of Medicine, Boston, MA, USA.
³ Harvard Medical School, Boston, MA, USA.
⁴ Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, USA.
⁵ Boston University School of Medicine, Boston, MA, USA.
⁶ Boston University School of Public Health, Boston, MA, USA.
⁷ VA Boston Center for Healthcare Organization and Implementation Research (CHOIR), Boston, MA, USA.
⁸ Beth Israel Deaconess Medical Center, Department of Medicine, Division of Infectious Diseases, Boston, MA, USA.

Abstract

Background and objective: The communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety.

Methods: We reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial.

Results: Several processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives.

Conclusions: Future studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.