The ongoing pandemic has strained both hospital equipment and personnel resources and caused clinic staff to become less accessible for routine patient care. Additionally, as hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites.
Telemedicine has been promoted by many individuals—including working parents, rural communities, and low-income communities—as a convenient alternative to routine office visits for years. Now, telemedicine is being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means to conduct clinical trials.
Remote office visits and virtual trials have long been technically feasible due to the existence of remote consent (eConsent), the MyStudies app, video chats, online patient forms, and smart devices, but the COVID-19 pandemic accelerated their use. Advantages to remote visits are numerous, especially during a public health emergency, as virtual interactions help ensure social distancing practices are employed and clinical trials are not unnecessarily delayed.
At the 2020 Advancing Ethical Research Conference (AER20), Nichelle Cobb, PhD, discussed the subject of eConsent in the session "Not Your Grandfather's Electronic Informed Consent: An Interactive Tool to Enhance Informed Consent."
Methods for obtaining informed consent remotely were discussed in FDA guidance released January 2021, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The guidance encouraged investigators to consider using electronic methods of obtaining informed consent when possible.
Per this guidance, IRBs should review copies of all subject-facing documents (both paper and electronic), any methods or questions used to gauge participant comprehension, the usability of the eConsent, and the study's plans for answering questions coming from subjects or their representatives.
But, while we know what we're supposed to review, the question of how to review the documents is often more difficult to answer. How should an IRBs quality system be updated to cover this topic? What should a reviewer assess during the review of a virtual trial or eConsent? What subject protections ought to be in place? A few issues to consider include:
- How can IRBs ensure subject selection is equitable if barriers to enter a virtual trial, like the possible requirement for a smartphone and high-speed internet connection, might exclude older and lower-income participants?
- How should consent be facilitated by the study team? Should the consent be sent out a week in advance with instructions to read and gather questions prior to any discussion with the study team? Must a member of the study team be available for a video chat during the consenting process, or would audio communication be sufficient?
- How can an IRB ensure that the individual providing consent is the person who should be providing consent? We assume a wet signature, unlike a typed name, can be traced back to an individual. Is consent or acknowledgement via a check box sufficient?
- Federal regulations require a written copy of the consent and any HIPAA authorization form to be given to the person signing the document. In the case of eConsent, what is the written/paper copy: the entire document, a summary page, a link to the complete document, or something else?
While the pandemic has forced clinical investigators to utilize existing technology and the FDA to release guidelines, IRBs have numerous unanswered questions regarding the review of such documents. COVID-19 may have changed the way clinical trials are conducted forever. I doubt clinical research will go back to the way it was before—and I don't think it should. That said, IRBs need guidance on how to review these studies and their documents sooner rather than later.
What other issues must the IRB consider when reviewing eConsents? I'd love to hear your ideas on the future of clinical trials.
Gretchen Parker, PhD, RAC, CIP, serves as co-chair for Pearl IRB and provides regulatory and clinical research support services for clients. Throughout her career, she has been deeply involved in regulatory affairs, clinical research, and medical writing for the pharmaceutical and medical device industries. She led the AAHRPP accreditation efforts at Pearl IRB and has assisted FDA inspectors on-site. She also led the efforts to update Pearl IRB institutional policies and procedures to comply with the revised Common Rule.
Dr. Parker began her career as a Regulatory and Compliance Analyst at a consulting firm, where she worked with clients, ranging from biotech start-ups to Fortune 500 companies, to plan and implement regulatory strategies, submissions, and research protocols. Her duties engaged her with several US governmental agencies, including FDA, USDA, and EPA.
Dr. Parker received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed her Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research. She has authored and published dozens of scientific articles in major peer-reviewed journals, holds a patent for a diagnostic assay, and is a member of PRIM&R and AAHRPP. She is Regulatory Affairs Certified (RAC) and a Certified IRB Professional (CIP).
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
PRIM&R's next AER Conference takes place virtually—in conjunction with our Social, Behavioral, and Educational Research Conference—November 16–19, 2021. Browse the Research Conducted in the Digital World track to find sessions on eConsent, social media in research, and more. Learn more and register online!