Be prepared for what’s up next: E-consent
Better informed consent tips
Technology now is driving the way informed consent documents are formatted and presented, according to an expert.
"People keep trying different strategies and approaches, and there is a whole array of options," says Elizabeth A. Buchanan, PhD, endowed chair in ethics, director of the Center for Applied Ethics at the University of Wisconsin-Stout in Menomonie. Buchanan speaks at national IRB conferences about technology, privacy, and informed consent, including the Office of Human Research Protection (OHRP) Research Community Forum, held May 2, 2013, at Oakland University in Rochester, MI.
"Now, we’re trying to think about how — especially in today’s world — most of us are used to looking at a screen and reading a little bit here and there," Buchanan says. "The days of reading a whole page and 15 pages in a row are really gone."
This means IRBs and human research protection programs increasingly are trying to map innovative strategies for improving informed consent documents, she adds.
"We’re letting the technology drive the way we format these documents," Buchanan explains. "With information overload all around us, we need to find better strategies for showing people information."
One of these changes involves e-consent, including electronic signatures and digital stamps.
"Those conversations are happening across the IRB and research world," Buchanan says.
Research into how people read and comprehend information shows that bulleted lists, boxes, and bold-faced text improve reading and comprehension, she says.
In an e-consent document, each section stands alone visually, making it less daunting than picking up a 15-page narrative, she explains.
For instance, some studies have used electronic slides and other visuals and technology for delivering informed consent, Buchanan says.
IC information can be put on a scrolling Web page in the way online user agreements appear, but it is a less interesting way to present the information, she notes.
"We want to get away from that model of taking a 20-page form and putting it online," Buchanan says.
The goal of e-consent should be to use technology in a way that helps facilitate better informed consent and comprehension while maintaining confidentiality. (See story on electronic IC confidentiality issues, page 102.)
"We want to make sure everything we need to know is in the document, but that the information is moving in a way that makes things easier to digest," Buchanan says. "We have to move towards a language that explains to people the possibilities and not only the realities of how an investigator expects to use data."
"I think many investigators and IRBs still are using the language of the locked file cabinet and paper documents when most of us are using electronic documents, and our language needs to shift," Buchanan notes.
As IRBs and researchers adjust the IC process to accommodate new technology and better data on how people digest and retain complicated information, they should make certain the e-consent meets all ethical and regulatory requirements for informed consent, she adds.
"We still have to remind people of the basic elements of consent," Buchanan says.
"Another piece is consent via mobile devices," she says. "More research is taking place with mobile devices, and so we should call attention to how you provide consent information to someone on their cell phone and make sure researchers follow regulations."
IRBs and researchers also should be aware of the limitations to informed consent in use with social media studies, she notes.
If a study is monitoring dialogue in a chat room, how might a participant opt out of being included in the study?
"If you are looking at a chat room, the speed and flux makes it difficult to consent people in the room, so some venues present more challenges than others," Buchanan says. "Think about best practices, identifying language, and the venue."
Also, in a chat room or other social media research, investigators might use screen shots in the informed consent process to show potential participants what they might see if they take part in the study, she suggests.
Another issue in this type of research involves terms of service agreements on social media websites where researchers are collecting data.
"For example, if one is a member of a Facebook group or has a Facebook page, and a researcher is using that for recruitment, data collection, or dissemination, the researcher is subject to the terms of agreement for Facebook," Buchanan says. "Sometimes that might be a conflict between the terms of service and what the researcher says in the informed consent document."
In the electronic era, information sharing between research participants is both easy and fast, and this also can be a problem, Buchanan says.
"In a study on how individuals were communicating about their research study, participants were sharing information," she explains. "They were unblinding the study by virtue of the information they shared."
Researchers and IRBs can prevent this problem by informing study participants that while they are free to discuss the study with their families, they should not discuss it in online public sites because of the potential of harming the study, Buchanan says.
Recommendations for confidentiality language
Be upfront about confidentiality
As e-consent and informed consent for technology-driven studies increase, investigators and IRBs should take steps to ensure confidentiality and privacy are accurately described and adequately protected.
Informed consent should be upfront and let participants know about the possibility of data being shared with other researchers. This will help avoid conflicts that arise when an investigator is prohibited from sharing data with other studies because participants were not told the data would be shared, says Elizabeth A. Buchanan, PhD, endowed chair in ethics, director of the Center for Applied Ethics at the University of Wisconsin-Stout in Menomonie.
For example, an informed consent document might state, "Confidentiality will be kept to the degree permitted, regarding the technology used," Buchanan suggests.
"Address the uncertainty in data longevity, telling participants that data might be used beyond the timeframe of this research project," she adds. "We don't want to scare anyone off by saying we don't know what will happen to the data, but we should present the statement in a more open fashion."
A better way to word this would be to say, "We're collecting these data and another research team might come along and use these data for great discoveries. That's the intention behind data sharing: to further knowledge and research," Buchanan says.
Informed consent documents now must avoid guarantees of individual privacy and instead educate participants about what data might be used for and what is protected and not protected, she adds.
