A new research study involving social media highlights how challenging it is for IRBs when technology continually speeds up the evolution of human research protection.
“Our IRB is very interested in how technology is changing things in research,” says Madelaine Faulkner, MPH, project director of Health eHeart, a cardiovascular study at the University of California, San Francisco (UCSF).
Health eHeart is unique in that the entire study is conducted online. Researchers check in with participants through e-visits, and the goal is to enroll one million participants worldwide over a 10-year period, Faulkner says.
“We are trying to understand how your heart changes over time,” she says. “You qualify to participate if you’re over 18 years and have an email address; we want people who are healthy or not healthy.”
The study collects data from participants on their family history, lifestyle, sleep, quality of life, and other information. It also has a mechanism for collecting electronic health record data for participants who provide the study with their patient portal login, she says.
“We’re also working on pulling UCSF data,” notes Faulkner, who discussed the topic of engaging the community using social media at a research community forum held by the Office for Human Research Protections (OHRP) on March 12, 2015, in Denver.
The study is partnering with the university’s clinical data research network (CDRN), as well, she says.
Participants who have a patient portal will be able to see their own health results, and they can upload those into the Health eHeart study. “It’s great the way it has been integrated,” Faulkner says. “The IRB was very involved in its integration, and it was a lot of work.”
Bluetooth technology also makes it possible for study participants who have defibrillator to send their activity data to the study, Faulkner says.
The IRB approved online informed consent for the study and online HIPAA consent to address privacy, she adds.
One of the chief issues that concern IRBs when studies involve social media is confidentiality, notes Lisa Denney, MPH, CIP, interim human research protection director at UCSF.
“What’s happening with these new technologies is it’s really not understood how individual data will be protected, where it will be stored, and how consent will be given for its future use,” Denney says.
“And it’s the technical aspects,” she adds. “IRBs now are expected to understand IT security systems, which is very far from what IRBs have historically been worried about.”
Here are some of the ways the study’s use of technology might impact the IRB and human research protection:
• Using social media. “We use social media to touch base with our community members and to, hopefully, have visibility with people who are not part of the Internet study,” Faulkner says.
“Our hope is that by using social media we can continue to engage participants,” she adds. “We’re not getting a conversion rate of participants from social media.”
Also, the study’s social media person engages with other heart- and health-related communities to support them. For example, the StopAFib group recently had a conference, and Health eHeart’s social media contact posted information about their conference and gave them a shout-out, Faulkner explains. “We gave them a hashtag, which is a cool phenomenon that is like putting in a buzz word, and it is used to search Twitter.”
• Crowd-sourcing research ideas. The study plans to incorporate participants’ voices into the research, crowd-sourcing their research ideas: “We ask patients, ‘What’s the best way to disseminate the findings of this study?’” Faulkner adds. “We’re turning clinical research on its head a little bit.”
• Maintaining community engagement. On Facebook’s newsfeed, the study’s site presents engaging health news that can be entirely unrelated to the study and cardiovascular disease. “We try to put on something engaging so that it resonates with a wide group of people,” Faulkner says.
Initially, the IRB was concerned about the study having a Facebook page because of concerns over it being a way people could see who was enrolled in the study, Faulkner says.
The solution was to limit the public’s ability to post on the main page, she explains.
The website has attracted many followers who are not enrolled in the study, so someone visiting the page could not automatically assume that everyone who “likes” it is a participant in the study, she adds.
Also, the study has a Health eHeart study page. Some of the people who interact on the page are study participants, but many are not, she says.
“It’s about heart content and fun things, and it’s not an official arm of the study at all,” she says. “We don’t push this to participants actively, although there is a link in the newsletter.”
When a viewer first sees the Health eHeart website, he or she can click to join the study or merely browse the site to learn more about the research. The site’s registration process is secure and unique to that site, Faulkner says.
• Creative marketing to potential volunteers. Since the study’s enrollment goals are high — about 26,500 people from more than 85 countries have enrolled so far — researchers have to be creative in how they market to potential participants. They market the study electronically through partners, including healthcare Internet groups and device companies. For instance, one device company, which has 250,000 users of its product, will send its users a message about Health eHeart, Faulkner says.
In reviewing studies that involve new technologies and social media, IRBs might need to have an information technology expert on the board or at least consult with one, Denney says.
“When we’re talking about Facebook, you have to understand Facebook’s securities and what it can do with that information,” she explains. “Those issues are ones the IRB is grappling.”
Without a better understanding of how security and data collection work on social media sites, an IRB might not make the best decision, Denney adds.
It’s a struggle for IRBs to protect research participants’ confidentiality and privacy in the world of social media studies, she says.
“When researchers do social media studies, that’s not our data anymore,” Denney says.
Another new area where technology and human research protection clash is when researchers use body cameras to observe people’s daily habits. “These cameras could be taking a picture every five seconds, so how do you consent the individuals who are suddenly bystanders in the project?” Denney asks. “How do you inform these people about the researcher taking pictures for research purposes?”
Even subtler problems can arise. If a study is using smartphones to collect data, then participants might find that the apps they upload on the phones could be automatically collaborating with GPS and recording information about the person’s location, Denney says.
“The real risk is that data is being used in a way that a person didn’t consent to or which puts the individual at risk,” she adds. “Health eHeart has done a good job of making individuals aware of their participation in this study, and we are managing the data.”