Including Pregnant Women in Research

by Jim Gearhart

eConsent Barriers: One Site’s Perspective

What eConsent Barriers Exist?

In a recent blog I speculated on possible eConsent barriers and why few research sponsors and investigators have adopted eConsent technologies for their studies. I suggested that concerns over the regulatory environment, system confidentiality, or instability of the market could be dampening interest. A Principal Investigator (PI) at a research site in Utah thoughtfully commented on the article and posed another possibility: that eConsents are not living up to their promise. Dr. Mark Johnston shared his observations after participating in three studies that utilized eConsent. Overall, Dr. Johnston—who has worked in clinical practice and research for 20 years—warned against equating “new” and “technology” with “better,” expanding on his hesitation with the following three areas of caution.

 

1. The Push-Button Mentality

Dr. Johnston worries that eConsent tools shift the focus of discussions about research away from the details of a study to the operation of the eConsent tools. He described this as a “push-button mentality.” He worries that the mechanics of reviewing a study within a program on a tablet or other screen will become an obstruction if study participants and members of the study team pay more attention to completing a process than understanding the information presented.

During the eConsent studies he participated in, Dr. Johnston observed that “everyone tends to look at the device, not the patient.”

 

2. Interfering With the PI-Participant Interaction

Another possible eConsent barrier is the potential disruption of an essential element of the informed consent process: the communication between researchers and participants. “It gets in the way of the human touch,” Dr. Johnston said.

Dr. Johnston does not see eConsent tools, at least to date, as substitutes for personal discussions. For one, the tools he has tried make it difficult for readers of the forms to identify where they have questions. In addition, Dr. Johnston said that, “Although some subjects may feel they don’t really have any questions, a thoughtful and careful inquiry by the investigator often elicits questions the subject wanted to ask, or discloses misunderstanding of the consent by the subject.”

Human interaction can pick up nuances that the button-pushing may miss; he adds, “There is a delicacy of communication that needs to be maintained,” and eConsent may not help that happen.

 

3. Limited Efficiency Gains

Dr. Johnston has not yet seen the improvements in efficiency that we might assume comes with a new technology.

He has noticed that documenting the informed consent process works better in eConsent than in hard copy, especially for elderly subjects or those with writing difficulties. But his experience suggests that, at least so far, eConsent technology has extended rather than shortened the time sites need to enroll a research subject. For example, Dr. Johnston recounted a distracting process as researcher and subject passed one tablet back and forth between them.  His team members would often print a hard copy of the consent and review that with the participant, returning to the eConsent tool only to complete the formal signing.

Further adding time to enrollment are the requirements of the eConsent programs Dr. Johnston’s team has used, combined with how his team prefers to work, resulting in “lots of processing, uploading, and passing around” of the consents. Technical glitches have also created delays. “We had a vendor in the Pacific Time Zone,” Dr. Johnston recalled, “and every ICF time stamp was one hour earlier than the actual time of the signature at the research site. This required written clarification on the printed consents.”

Dr. Johnston concluded that, “All of the maintenance of the device (monitoring charging, update status, software upgrades) as well as the practical use (the time spent explaining the technology to subjects, the supervision of use during the consent process, the follow-up internet logins, printing hard copies of the eConsents and updating dates/time stamps) are experienced as inefficient.” Dr. Johnston estimated that using eConsent tools added 15-20 minutes of processing time for each subject.

 

Unknown Results

In our conversations, Dr. Johnston emphasized that he is interested in finding any improvements to how sites can conduct research. “I want to see things better. I care about the process and the people I work with. Over the past 10 years, I have seen many developments, such as the change from CRFs to eCRFs. There have been some tremendous advantages, but with tradeoffs.” He lamented the lack of data around eConsent’s promise, which, if available, could help bolster the industry’s confidence in this new technology. He is interested to see what research into eConsent’s effectiveness can show.

Regarding the future of eConsent he said, “Comparisons of [paper consent] against [eConsent] could bring confidence, and answer some of these questions.”

 

Post Script: From Quorum

Over our 25-year history, Quorum Review IRB has taken an active role in analyzing the informed consent process and leading the conversation around improving it. We are deeply grateful to Dr. Johnston for sharing his observations about eConsent, and, in service of our mission to advance the well-being of all people and drive research forward together, we are thrilled to highlight his real-world experience. Quorum has developed an eConsent tool to overcome these barriers, and we will continue to work with the research community and encourage improvement of the consenting experience for sites and participants.