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, Patricia Woods, Maura Flynn, Paul Monach, Karen Visnaw, Sara Schiller, Erika Holmberg, Sarah Leatherman, Ryan Ferguson, Westyn Branch-Elliman
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.
Conflict of interest statement
All authors have no conflicts of interest to report.
© 2021 Published by Elsevier Inc.
Figures
References
- Guan W-j, Ni Z-y, Hu Y. Clinical characteristics of coronavirus disease 2019 in China. N. Engl. J. Med. 2020
- Kamerow D. Covid-19: the crisis of personal protective equipment in the US. BMJ. 2020;369
- Ranney M.L., Griffeth V., Jha A.K. Critical supply shortages—the need for ventilators and personal protective equipment during the Covid-19 pandemic. N. Engl. J. Med. 2020;382(18):e41.
- Human Subjects Protection Issues Related to COVID-19: Frequently Asked Questions. 2020.
- Development VOoRa . 2020. Human Subjects Protection Issues Related to COVID-19, Webinar. Session 4/2/2020.
- US Food and Drug Administration . 2020. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards.
- VA Office and Research and Development. Spring Research Town Hall; 2020.
- Mayo Clinic Emergency Access Program . 2020. Frequently Asked Questions, June 2020 Update.
- Branch-Elliman W., Lehmann L.S., Boden W.E., Ferguson R., Monach P. Pragmatic, adaptive clinical trials: is 2020 the dawning of a new age? Contemp Clin Trials Commun. Sep 2020;19:100614. doi: 10.1016/j.conctc.2020.100614.
- Branch-Elliman W., Elwy A.R., Monach P. Bringing New Meaning to the Term “Adaptive Trial”: Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science. Open forum infectious diseases. 2020, November;7(11) p. ofaa490. US: Oxford University Press.
- Raimondo M.G., Biggioggero M., Crotti C., Becciolini A., Favalli E.G. Profile of sarilumab and its potential in the treatment of rheumatoid arthritis. Drug Des. Dev. Ther. 2017;11:1593.
- Natale J.E., Lebet R., Joseph J.G. Racial and ethnic disparities in parental refusal of consent in a large, multisite pediatric critical care clinical trial. J. Pediatr. 2017;184:204–208. e1.
- Saberi P. Research in the time of coronavirus: continuing ongoing studies in the midst of the COVID-19 pandemic. AIDS Behav. 2020:1–4.
- World Health Organization . 2016. Guidance for Managing Ethical Issues in Infectious Disease Outbreaks.
- Baumann J. Reams of useless COVID data drive reckoning on clinical trials. Bloomberg News. September. 2020;30 Accessed 10/14/2020.
- North C.M., Dougan M.L., Sacks C.A. Improving clinical trial enrollment — in the covid-19 era and beyond. N. Engl. J. Med. 2020;383(15):1406–1408. doi: 10.1056/NEJMp2019989.
- Nuffield Department of Public Health . Oxford University; 2020. Recovery Trial FAQ for Sites.
- Grein J., Ohmagari N., Shin D. Compassionate use of remdesivir for patients with severe covid-19. N. Engl. J. Med. 2020;382(24):2327–2336. doi: 10.1056/NEJMoa2007016.
- Wilson K., Chotirmall S., Bai C., Rello J. 2020. COVID-19: Interim Guidance on Management Pending Empirical Evidence; p. 3. Last updated April.
- Geleris J., Sun Y., Platt J. Observational study of hydroxychloroquine in hospitalized patients with covid-19. N. Engl. J. Med. 2020 doi: 10.1056/NEJMoa2012410.
- Magagnoli J., Narendran S., Pereira F. medrxiv; 2020. Outcomes of Hydroxychloroquine Usage in United States Veterans Hospitalized with Covid-19.
- Mehra M.R., Desai S.S., Ruschitzka F., Patel A.N. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet. 2020
- Mehra MR, Ruschitzka F, Patel AN. Retraction—hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet doi:10.1016/S0140-6736(20)31324-6.
Source: PubMed