Informed consent flexibility on fed side results in creative IC
Teach-back, other strategies used
In recent years, IRBs have witnessed federal regulators becoming more flexible in applying regulations regarding informed consent (IC) — a shift resulting in more creative and practical IC methods, including electronic, short form, and video consent. Changes are necessary as research evolves and informed consent becomes necessary in new scenarios.
For example, regulators are moving toward requiring informed consent for studies involving genetic screenings and tissue samples.
Recently, lawsuits targeted states over the perceived lack of IC when newborn tissue was retained for research after routine screening at birth, notes Erin Rothwell, PhD, associate professor of research in the division of medical ethics and humanities in the college of nursing at the University of Utah in Salt Lake City.
“Two states were sued successfully by parents who felt like they weren’t properly informed about leftover screening samples,” Rothwell explains.
“What I’ve found is that we’re moving toward a trend with the advance notice of proposed rulemaking where any type of sample is going to be considered human subjects research,” she adds. “So we’re interested in how you engage within that clinical encounter and in a population setting, where you’re trying to consent hundreds of thousands of people.”
One potential IC solution is to provide electronic informed consent, along with video and written materials, Rothwell says.
IRBs and researchers have focused in recent years on evidence-based ways of improving the informed consent process, including using the teach-back method. One innovative approach is the Valid Informed Consent Education (VoICE) project, which was started to provide researchers and others with training on how to obtain informed consent, says Elizabeth A. Bankert, MA, director of the IRB office at Dartmouth College in Hanover, NH.
“We found that there weren’t a lot of educational programs out there to teach people how to obtain consent,” Bankert says. “It was usually just observing somebody else give consent and then doing it yourself with very little formal education.”
“VoICE was created to fill this gap, and it soon will be available online,” Bankert says.
The IC shift also encourages IRBs to waive informed consent when appropriate.
“More and more institutions are looking at, for example, minimum risk research and whether they’re still requiring an informed consent process,” notes Ada Sue Selwitz, MA, director of the office of research integrity at the University of Kentucky in Lexington.
“Now institutions are beginning to waive documentation as the standard,” Selwitz adds. “They’ve unchecked the box, saying it’s minimal risk, and you may still be required to get informed consent, but you don’t have to document.”
As a result, an increasing number of IRBs nationwide are beginning to feel more comfortable using both the waiver of informed consent and waiver of documentation of informed consent, she explains.
The trend — at least for IC in sociobehavioral studies — has shifted from requiring informed consent every time there’s a face-to-face contact with a participant to finding alternatives to formalized consent, she adds.
Examples of when IC might be less formal include research involving discussion groups, surveys, and interviews for sociobehavioral-anthropological studies.
“Also there’s been considerable more use of the short form,” Selwitz says. “In the regulations for years we’ve had the option of using the short form with a witness, and traditionally it’s only been used in individuals who were non-English speakers.”
That’s changing: Now people are using the short form in different ways, she adds.
For example, short forms can be used for research participants with literacy issues or with disabilities such as sight or hearing impairments, that make the traditional informed consent process challenging.
Short forms are amenable to IC in those cases, says Susan Rose, executive director of the Office for the Protection of Research Subjects at the University of Southern California in Los Angeles. Rose is also on the editorial board of IRB Advisor.
“First of all, it’s allowable, which is most important,” Rose says, referring to the Food and Drug Administration’s (FDA’s) Informed Consent Regulations/Guidance (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm).
Using a one-page IC form is a simpler way to explain research to participants, Rose adds.
But the page is only one part of the IC process, and the same is true for participants with limitations and disabilities, she notes.
“With blind subjects we provide oral informed consent; with deaf ones, we could use sign language,” Rose explains. “When participants have different languages, you can use a short form process and use telephone translation services, but you’d need to document that.”
In the case of illiterate participants, there could be one person who provides oral informed consent, and another present to witness it, Rose says.
“You can use pictures and cartoons for informed consent, and those work best, but are expensive and you can’t mandate their use for every study,” she adds.
In recent years, IRBs have witnessed federal regulators becoming more flexible in applying regulations regarding informed consent — a shift resulting in more creative and practical IC methods, including electronic, short form, and video consent.
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