Electronic Consent Has a Few Obstacles and Drawbacks
Chief obstacle: Fear of change
All but a small percentage of research sites use paper informed consent documents. Although daily activities like shopping, listening to music, watching videos, and interacting in social groups are frequently done in electronic platforms these days, informed consent is not yet fully there.
This is why adoption of electronic consent will not occur overnight.
“There’s a fear of change, a fear of the unknown,” says Raymond Nomizu, JD, co-founder of Clinical Research IO in Cambridge, MA.
“A lot of sites are on tight budgets and do not have the funds for additional technology,” Nomizu says. “Like with any software implementation or change of behavior, there are a lot of questions.”
Security is another possible issue for IRBs. Healthcare organizations have been big targets for cybercriminals in recent years, exposing major security and HIPAA lapses. But research institutions and IRBs can take steps to ensure security.
For example, Quorum IRB uses a third-party firm to audit its security and ensure there are no weak spots, says Kyle Maeda, vice president of information technology at Kinetiq, a division of Quorum IRB in Seattle.
“They do a black-box penetration test to attack our network to see if they can get into it,” he says.
Third-party audits and penetration tests can validate your organization’s cybersecurity measures. The theory is that if there is vulnerability, the test will find it. Most cybercriminals will go after the low-hanging fruit, skipping organizations that have adequate security.
“If you have an alarm system and your neighbor doesn’t, which house would a criminal choose?” Maeda says.
IRBs and research organizations can require e-consent tools to be compliant with FDA regulation 21 CFR part 11, says Mitchell Parrish, JD, RAC, CIP, vice president of legal and regulatory affairs for Kinetiq.
The FDA published its final guidance on the use of electronic consent on Dec. 15, 2016. The guidance discusses how to present information in an electronic informed consent, where to conduct the consent process, how to answer subjects’ questions, how to use electronic signatures, and other issues. The FDA guidance is available at: http://bit.ly/2pckWaX.
The guidance makes vendors responsible for regulatory compliance, but research organizations should ensure the vendor can verify compliance, Parrish says.
When research sites want to use an e-consent tool, their study submission to the IRB will include one. The IRB can ask for written verification that the tool is secure and compliant with part 11.
“The best you can do right now to know that the tool is compliant with part 11 is to work with a vendor that uses a large auditing firm and has something in writing about the audit,” Parrish says. “There is nothing official available right now; there is no governmental certification. So, it’s up to vendors to put themselves through the test.”
Some might question whether an electronic signature can be forged. The answer is that it’s as accurate as a handwritten signature, Maeda says.
“The way electronic signatures work is you need multiple pieces of information to authenticate that it’s you,” he explains. “We don’t need a wet signature; i.e., pen and paper.”
What is needed is a one-time login. Then the participant will validate who he or she is.
“When we set up our accounts, typically, you have user email and date of birth to validate that whoever logs into the system can electronically sign with the appropriate identifying information,” Maeda says.
An organization’s IT department then provides back-end validation. “We make sure we don’t have suspicious logins coming from unauthorized sources,” Maeda explains.
“For example, if someone tries to authenticate with an email and date of birth that do not match, we flag that in the system and don’t allow it.”
IT experts also check for logins from multiple locations. If someone were to attempt to login from Seattle one day and from New York the next day, IT staff would see that and be able to track it, he says.
“We can see the IP addresses someone is coming from,” Maeda says. “It’s fairly straightforward auditing and logging of events and collaborating that information.”
Other security concerns, such as placing participants’ names on the electronic cloud, are misplaced, Maeda says.
“There is a misconception that when data is on my server, it’s more secure, and that’s not always the case,” he says. “There are frameworks that ensure that any kind of application, whether on your premise or in the cloud, is secure.”
When IRBs first are presented with an e-consent process, one of the challenges is ensuring people understand what they’re reading and what the study is about, says Christine Suver, PhD, director of research governance for Sage Bionetworks.
“The first challenge is that people are used to software upgrade agreements that are really long, and they don’t read them,” she explains. “But in research, we have to have a completely different approach and teach people that participating in a health research project is different than a software update.”
Sage Bionetworks installed a small quiz with a set of questions at the end of the consent topic presentation. Research participants complete the quiz to ensure they have read and understood the information.
One of the biggest barriers to electronic consent involves the lack of integration between systems, Maeda says.
“This is a big deal right now at the site level,” he says. “If you have a clinical trial management system, it gets confusing about how to manage all those different logins and systems.”
This problem will resolve itself when industry and research groups press for standards or when research organizations and health systems work toward more seamless data integration, he says.
More research organizations will adopt e-consent as they see the benefits in efficiency and regulatory compliance, but especially in study participant engagement, Suver predicts.
“It’s really helpful to use this new technology,” she says. “It gets people the information they need.”
Adoption of electronic consent is a process that will not occur overnight.
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