By Melinda Young, Author

E-consent can help research institutions check all the boxes on their consent process goals: efficient, readable, comprehensible, engaging, and trackable.

“It can improve participant engagement and comprehension,” says Michael Buckley, MS, MBA, manager, enterprise innovation, clinical research informatics, and technology at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City.

MSKCC has been rolling out its e-consent process for a couple of years. The organization started with institutional biospecimen banking protocols and clinical genetic protocols, he says.

“We’ve been working with high-volume protocols we want folks to consider participating in,” he adds. “We wanted to start with them because the number of patients consenting to them is so high, and we wanted feedback from folks using that protocol to do iterative enhancements to the electronic IC [informed consent] module.”

Plus, the genetic research protocols already had a video for participants to view. With the electronic IC module, the video can be embedded in the web browser, saving time, Buckley says.

User feedback surveys at MSKCC suggested investigators saved an average of 10 minutes per informed consent, he says.

“It freed investigators from administrative tasks of printing out informed consent documents, putting names on each form,” Buckley says. “They can spend more time having engaging discussions with potential participants about the protocol.”

With the paper IC process, the hard copy is scanned into the electronic medical record (EMR), a process that can take 24 to 72 hours to complete. With the electronic version, the information is entered into the EMR in less than two minutes, and it goes right to the patient portal for the patient to see.1

Since implementing the electronic IC process, thousands of research participants have consented electronically, increasing at a rate of about 500 per month, Buckley says.

About three out of four people surveyed liked the electronic informed consent process better than the paper process, and most liked the user-friendly interface of the electronic IC, he adds.

MSKCC’s electronic consent process uses embedded educational videos. For example, there is a video of a principal investigator discussing the study and describing potential study participants, Buckley says.

The electronic consent process could provide videos that show how the technology used in a study works. For instance, there could be a video of a surgical protocol that uses a robotic arm. Participants find the electronic consent process engaging. There are drop-in images and graphics or flowcharts with protocol timelines, test dates, and clinic dates, he adds.

“If investigators are taking surveys after particular visits, we take words from the informed consent and put these in a visual, showing what you have after your first visit and second visit,” Buckley explains. “It makes it easier for the patient to digest, and it makes for a better consenting experience — improving comprehension of the protocol.”

Electronic informed consent documents are less work than paper IC forms for IRB staff. They also have improved informed consent audit trails, Buckley says.

Researchers can add visual elements to the electronic IC by simply using their smartphones to film procedures that are sent to the IRB for approval.

“It takes lifeless words on the paper, puts in images and videos, and shows someone talking to the participant about the protocol,” Buckley says. “The research literature says visual aids help improve visual comprehension.”

Researchers can write informed consent documents in the web browser, which has an embedded document authoring system that allows them to see track changes without reliance on emails, he adds.

“It’s like Google Docs but with all the controls and information for tracking,” he explains.

Participants have direct access to the IC form. Once they read and authenticate it, the form is automatically sent to the patient portal at MSKCC if the patient has a portal there, Buckley says.

“The patient portal is a secure portal messaging account that patients can use to talk with clinicians and to receive secure documents,” he says.

Research participants can choose the electronic consent form or a paper form, but they also can keep a hard copy of the electronic consent after they have signed it.

“It’s an agile system,” Buckley notes. “Our overarching goal is to continuously improve and update the informed consent process.”

The electronic IC platform features a number of useful features, including the following:

• It is web-based and browser independent. “It’s an in-house, standalone application that is web-based, agnostic, and browser independent, meaning you can use Chrome, Safari, Firefox — any type of browser,” Buckley says.

Users can login through a security link on desktop computers, laptops, and tablets. Participants sign it with their finger, a stylus, or a mouse.

“Our clinical research informatics and technology group at Memorial Sloan Kettering created that for us,” Buckley says.

The electronic IC platform improves efficiency, reduces redundancy, and provides cleaner data, improved quality, and greater innovation, he adds.

“We’re not forcing people to use electronic consent, but we’re offering that as an option,” Buckley says. “We want to create a nimble system.”

• It is designed by an innovation team with user input. “We have a strategic planning and innovation design group,” he says.

The team works with physicians, study coordinators, and others to see how the electronic informed consent process is working for study participants.

“We get feedback in real time,” Buckley says. “There is a survey to get direct feedback. The design innovation team does facilitated interviews with new-to-informed-consent-process users to hear how things are going and to get feedback on what can be improved.”

The fluid nature of electronic IC has helped them figure out where bottlenecks are in the IC process and to fix issues.

Research participants helped to inform the development process, identifying large themes of what should be enhanced in informed consent. For example, one theme was for participants to choose how they would like to receive their finalized consent document, Buckley explains.

“They might want an electronic copy in the MSK portal account or to receive a hard copy,” he says. “We give participants a choice in how they would like the copy.”

• Videos and images enrich the IC process. In addition to embedded videos, the electronic IC uses various educational tools including colorful images.

“It makes for a richer consent discussion, we think,” Buckley says.

Often, health system patients who are considering participating in research have spent long periods of time in a clinic, waiting for treatment, and this is very taxing, he notes.

If researchers were to review informed consent while they are in the clinic, the electronic version with its videos and illustrations would be a nice change of pace from the usual consent documents they encounter, he adds.

Also, the electronic IC form is not just an electronic version of a paper document, like a PDF file, Buckley says.

“It’s separated by sections and has tabs on the left side, like serious adverse events that they can scroll through,” he explains.“It’s more digestible, and it’s quick to adapt it.”

• The electronic IC process is more efficient and has fewer errors. When investigators used the electronic informed consent, their data entry was 4% more compliant and complete than when paper documents were used.1

For example, the electronic IC form would direct users back to missing fields.

“If someone didn’t put in a name, address, or telephone number — which are required fields — we have smart tools in there to guide folks back to that section,” Buckley says. “If a word is spelled in an unusual way or if an address doesn’t look real, then smart technology surfaces and asks them if they are certain.”

If the electronic IC document is amended by the investigator and approved by the IRB, the changes can be implemented that same day, he says.

“We have a lot of automated systems letting us know if there is a fail point in any transfers of information,” he says.

“We get an automatic alert on our dashboard right away, and we can go back to the study team to rectify that issue.”

REFERENCE

1. Buckley M, Lengfellner J, Koch M, et al. MSK electronic informed consent (eIC) platform for clinical trials; an operational model and suite of tools for obtaining informed consent and managing consent documents. Presented at PRIM&R’s 2018 Advancing Ethical Research Conference, Nov. 14-17, 2018, in San Diego. Poster 17.