Electronic informed consent a growing force in HRPPs
Electronic forms track how subjects use the data
For decades, IRBs and ethics panels have lamented the sorry state of informed consent documents. The complaints have included too much legal and medical jargon; too long and cumbersome; too visually unappealing; too much focus on minutia and too little focus on risks; and unlikely to be read and understood by potential research subjects.
What if an IRB were told of an informed consent document that has resolved all of these problems? There is only one catch: It’s not on paper.
Electronic informed consent is a growing force for human research protection, and to at least one medical ethics director, this change has been needed for a long time.
Paper consent forms have become antiquated and are not up to the job of 21st century informed consent, says Arthur L. Caplan, PhD, director of the division of medical ethics at New York University Langone Medical Center in New York, NY.
Informed consent presented in non-paper formats is better suited for young people, people with impairments, and low-literacy populations, he notes.
"We definitely need to be moving toward an electronic and visual consent form, and these would have many advantages," Caplan explains. "These allow people to move at their own level of literacy: You can set it hard, moderate, easy, and you can let people spend as much time as they like with the electronic form, asking it questions or reading up more on concepts that are hard to understand if they want to."
For example, there is a mobile app for research informed consent that can track how long a person spends looking at a particular section and whether the person flagged a certain word to learn its definition. This provides valuable data for where to make readability improvements to the IC, says Anthony Costello, chief executive officer of Mytrus in Davis, CA. Mytrus is a clinical technology firm that specializes in patient-centric technology and in technology for clinical trials.
Electronic consent has enormous advantages for use in international and low-literacy settings, Caplan says.
"You can document their informed consent by recording it, which is useful overseas when faced with populations that don’t write or have a written culture," Caplan says. "You can use your iPhone video camera or an app on a portable device to record the response, which stands up much better because it’s harder to forge that than to forge a signature."
"Also, electronic IC is easier to update when new information is available," he adds. "I think the only reason we haven’t moved in that direction sooner is because local IRBs didn’t have the resources to invest in these kinds of technology."
Federal regulators have approved electronic consent processes, and IRBs increasingly are on board. The biggest obstacle today is the cost, Costello says.
"There’s a perception that the current paper consent system might not work well, but it’s cheap," he explains. "When you build an iPad app and distribute iPads, you have built-in, associated costs."
Plus, any new technology has to go through an adoption curve: "It takes a while to get comfortable with new technology, and we’re going through the start-up curve," Costello says.
Now that the research industry is moving more to sponsored research and there are increasing numbers of central IRBs, these organizations have more resources for driving a change to electronic consent, Caplan says.
"They want to improve efficiency and reliability of informed consent," he says. "It’s all good, and it’s overdue."
Potential uses for electronic IC include the following:
• IC on a tablet. Informed consent on a tablet computer is an educational tool as well as a documentation tool. Companies have begun to put an IC form on the tablet to make it easy to manage hundreds of signed IC documents on one device, Costello notes.
But IC on a tablet can be useful in many more ways. For instance, a tablet IC can show potential research participants a video that explains some key information about the clinical trial, he says.
"Patients can watch an animated video we produce about the study," he says. "We use cartoon characters to keep them engaged about the main aspects of clinical trials."
As people read the written consent on the tablet, they can change font size for readability and flag words they don’t understand, and some terms and sections can be hyperlinked to dictionaries or any other additional information.
Electronic consent can include graphics, video, and photos to illustrate procedures and other points in the IC, Caplan says.
"We know that’s how people understand better, and we can use illustrations and film clips to demonstrate techniques," he says.
• Data on what potential subjects read and what they understand. "We capture metrics," Costello says. "We see how long they spent reading the form, which things they flagged, and whether they seemed to be understanding certain things better."
Electronic IC can track participants’ eye movements across a screen and collect data on which words they linger on, Caplan says.
"I’ve used one where it asked me a question if I was lingering on a word," he adds.
• Test participants on retained knowledge. Electronic forms can include a knowledge assessment section where participants are asked questions about the study.
"They can focus on the main aspects of the trial, and it’s usually seven or eight questions in a multiple choice questionnaire," Costello says. "If they get one wrong, we circle them back to that section of the informed consent to read the correct information and then take the quiz question again; we reiterate this until they pass the entire quiz."
Participants also have the option to stop reviewing the IC form, he adds.
"Most patients do read the document and may read it quickly, but they don’t just ignore it the way we thought they may have with paper," Costello says. "The other important learning we’ve had so far is that patients learn a lot from video, and it’s helpful to have a knowledge assessment at the end."
• Electronic signature capability. "Electronic signatures are being used all over for clinical trials now," Costello says. "Everyone who collects data signs in with a username and password, and 21 CFR11(c) clearly specify that a user name and password is equivalent to a handwritten signature."
Electronic IC forms also can collect a participant’s signature on the tablet, and the actual signature will appear on any printout copies of the form, he adds.
Whether participants sign on a tablet or sign in and use a password, the electronic IC copy will record the time and date of the consent.
• Feedback loop. One of the chief advantages of using electronic consent is that it continually provides metrics that can be used to improve the IC document.
For instance, if an IC form has words or phrases that a majority of participants find difficult, electronic feedback data lets investigators and sponsors know about this problem.
"The big advantage is if patients are flagging words as they go through the app, the site and sponsor can see all of the words that are being flagged," Costello says. "If one word is disproportionately flagged by patients, then they can amend the document by putting in a new sentence or description; they can write the consent so there’s less confusion."
This feedback loop isn’t possible — or at least isn’t as data-driven — with paper informed consent forms, he adds.
"In the paper consent you’d never collapse any of those metrics across multiple patients and learn from them," Costello says. "The big advantage of this in the long run is it will bring radical improvements in how patients understand consent."
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