Evolving Internet means new ethical issues
Evolving Internet means new ethical issues
Challenges to keeping up with technology
One of the biggest challenges IRBs face is keeping up with ethical issue updates during an ever-evolving period technologically, experts say.
"These new technologies are pushing the boundaries of traditional research and research ethics," says Elizabeth A. Buchanan, PhD, endowed chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout in Menomonie. Buchanan also is the associate editor of the Journal of Empirical Research on Human Research Ethics.
Social media used for research studies is one example, she notes.
"There is a ton of Facebook pages and YouTube streams that run the gamut from data collection to dissemination of information," Buchanan says.
One chief conflict involving electronic data and research is the complexity of handling de-identified data within an Internet landscape where re-identification is easier than ever before, says Joe Konstan, distinguished McKnight professor and distinguished university teaching professor in the department of computer science and engineering at the University of Minnesota in Minneapolis.
The issues include data that are inherently self-identifying even when researchers take names off the data, and the problems of search logs in which data can be re-identified based on the searches. The potential for these breaches in electronic and computer security is greater than for stored files in a locked cabinet, he notes.
Buchanan and Konstan outline some of these major ethical challenges IRBs face in reviewing studies involving electronic data and Internet research:
• Cell phones and privacy: Just two years ago, the cutting edge of new technology involved Internet social media sites. While those still thrive, the latest technological changes have to do with the use of cell phones and mobile apps, Buchanan says.
"On that front, you have issues that bring us back to major concerns like privacy and dissemination of data; is it encrypted when shared with a mobile app?" she explains.
On one hand, mobile technology has created great opportunities for researchers to capture real-time data. For example, an investigator could send out a question asking a subject what he or she is feeling or doing right now, and the answer could be immediate and honest.
"It's giving researchers very interesting access to subjects synchronously," Buchanan says. "The subject just texts back and some mobile application has their responses; it's really moving research forward."
But there is an ethical issue to this type of use of mobile technology. "We have to think through the privacy, confidentiality, and data security issues that come along with these emerging forms," Buchanan says. "And depending on the sensitivity of the data, do we want AT&T or Sprint to be the holder of our data, which is the case when we're using our cell phones?"
IRBs have to inquire about the safety of cell phones when they're used to collect data. There are solutions, such as remote lockdowns in which someone can close access to a phone's data when it's lost or stolen, she adds.
Mobile technologies often rely on grid computing in which data are maintained in cloud storage, meaning an off-site location. This also poses security and privacy risks, Buchanan says.
"Questions IRBs are asking have to do with the security of the cloud," she explains. "Is it a private cloud such that only the researcher has an access key to it, and how are we going to ensure when we put data on a Google document that we're giving data only on Google?"
It's these practical issues that matter from an IRB's perspective. And sometimes the solution is a disclaimer, such as the one written at Penn State: "Your confidentiality will be kept to the degree permitted by the technology being used. No guarantees can be made regarding the interception of data sent via the Internet by any third parties."
With the relative ease of data transfer and greater potential for security issues or inadvertent disclosures, research informed consents now use language that reflects the new reality and emphasizes limits to confidentiality, Buchanan says.
• Electronic medical records and re-identifying data: "In the last few years there has been a huge amount of re-identification of seemingly de-identified data," Konstan says.
The challenge is using datasets with personal information in a way that protects the personal information while still making it available for research, he adds.
Medical record data contain a lot of self-identifying and sensitive information, Konstan says.
"Even pieces that seem harmless may not be," he explains. "You have a date and time for a procedure and the record notes where it was done."
Someone who knows the subject might be able to determine who the person is based on that kind of information, he says.
For instance, there was a radiology report that discussed a patient's drug abuse and history of domestic violence, combined with the exam that noted a potential incident of domestic violence, Konstan says.
"There was enough information in that report that if a person who was a spouse or domestic partner of the patient had seen the de-identified report, it probably would have been obvious that the patient had talked with people at the clinic about what had happened," he says.
There were no security breaches, but this example illustrates how difficult it is to de-identify medical records, particularly when electronic records make it far easier to search for specific details about patients and potential subjects.
• Facebook and YouTube subject recruiting: Pfizer's Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) trial was a completely virtual trial that conducted subject recruitment via Facebook from June 2011 to June 2012. Subjects received medications at their homes and used an electronic app to keep diaries and report outcomes. The trial's purpose was to compare a virtual trial with a traditional trial, according to CATO Research at www.ask-cato.com.
"Pfizer set up a designated Facebook page to recruit subjects," Buchanan says. "Participants communicated with the principal investigator via Facebook and electronic means, and then they had regional sites where people could go for testing and to get blood drawn."
It is becoming more common for clinical trial sites to use Facebook, YouTube, and other social media as part of their recruitment strategies, she notes.
"It's fascinating because you see everything you could imagine," Buchanan says. "Depending on what the trial is, they will use social media in interesting and unique ways, including putting out a YouTube video or Twitter stream."
Just type in "clinical trial recruitment" in the YouTube search engine, and a wide variety of videos pop up. One of the first is a video called "Playing the Clinical Trial Recruitment Game," by a self-proclaimed human guinea pig. This suggests another ethical issue IRBs should consider: fraud in online recruiting. If the study involves an online survey with a relatively high participant incentive — and $100 might meet that threshold for many people worldwide — it could attract an influx of people who are not true potential research subjects, Konstan says. (See story about online recruitment fraud, below.)
IRBs also might question the role trust plays when participants are recruited through the Internet and social media sites.
"It's a different mentality of researchers coming to participants rather than having them come to us through a doctor," Buchanan says. "It raises the issue of do we trust a YouTube video versus our doctor saying there's a clinical trial."One of the biggest challenges IRBs face is keeping up with ethical issue updates during an ever-evolving period technologically, experts say.
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