Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions

Julie R Bromberg; Evelyn Nimaja; Andrew W Kiragu; Karla A Lawson; Lois Lee; Isam W Nasr; Charles Pruitt; Stephanie M Ruest; Michael J Mello

doi:10.1002/eahr.500135

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions

Ethics Hum Res. 2022 Jul;44(4):39-44. doi: 10.1002/eahr.500135.

Authors

Julie R Bromberg¹, Evelyn Nimaja², Andrew W Kiragu³, Karla A Lawson⁴, Lois Lee⁵, Isam W Nasr⁶, Charles Pruitt⁷, Stephanie M Ruest⁸, Michael J Mello⁹

Affiliations

¹ Research associate in the Department of Emergency Medicine at The Warren Alpert Medical School of Brown University and a research program manager at the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.
² Senior research assistant at the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.
³ Associate professor of pediatrics at the University of Minnesota, an associate of the Children's Respiratory and Critical Care Specialist Group, and a pediatric intensivist at Hennepin Healthcare.
⁴ Director of the Dell Children's Trauma and Injury Research Center at Dell Children's Medical Center and an associate professor of surgery and perioperative care at the University of Texas at Austin Dell Medical School.
⁵ Associate professor of pediatrics and emergency medicine at the Harvard Medical School and a senior associate of medicine in the Division of Emergency Medicine at Boston Children's Hospital.
⁶ Director of the Pediatric Trauma Program in the Division of Pediatric Surgery at the Johns Hopkins Children's Center and an assistant professor of surgery within the Johns Hopkins Department of Surgery.
⁷ Associate professor of pediatrics at the University of Utah and a child advocacy coordinator for the Division of Pediatric Emergency Medicine at Primary Children's.
⁸ Assistant professor of the Departments of Pediatrics and Emergency Medicine at The Warren Alpert Medical School of Brown University and a pediatric emergency physician at the Hasbro Children's Hospital.
⁹ Professor in the Department of Emergency Medicine at The Warren Alpert Medical School at Brown University, a professor of health services, policy, and practice at the Brown University School of Public Health, the director of the Master of Science in Population Medicine program at The Warren Alpert Medical School of Brown University, and the director of the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.

Abstract

The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

Keywords: Covid-19 pandemic; assent; electronic informed consent; human research ethics; human subjects research; informed consent.

MeSH terms

COVID-19* / prevention & control
Child
Clinical Trials as Topic
Electronics
Humans
Informed Consent*
Multicenter Studies as Topic
Pandemics
United States

Abstract

MeSH terms

Grants and funding