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AHRQ provides free tool to help with informed consent
Sample forms, language are included
IRBs and researchers now have a new toolkit that will make it easier to ensure proper informed consent has been obtained from subjects with limited literacy and proficiency in English.
The Agency for Healthcare Research and Quality (AHRQ) toolkit is available online as an open-source document and can be downloaded and disseminated without written authorization.
While it's developed for minimal risk research, the toolkit can be adapted for any research study, says Cindy Brach, MPP, senior health policy researcher in the center of delivery, organization, and markets for AHRQ in Rockville, MD.
"The development of the toolkit is an outgrowth of another research project," Brach explains. "We were looking at the impact of HIPAA on health services research."
Health services researchers said they felt there was the potential for HIPAA to have a chilling effect on research. Researchers felt that potential subjects, particularly those with limited literacy and English proficiency, would be confused when studies required both informed consent and HIPAA consent, Brach says.
"Not only individuals with limited literacy and English proficiency benefit from simplified forms," she adds. "Research shows that even well-educated individuals frequently find consent and authorization forms incomprehensible."
So Brach and co-researcher Michael Paasche-Orlow developed sample forms, including forms that combine obtaining informed consent and HIPAA authorization.
"Some IRBs may have some initial discomfort about combining informed consent and HIPAA authorization forms, and think they are not allowed to do that," Brach says.
"But you are allowed to have combination forms," she adds. "You have to meet both human subjects requirements and HIPAA requirements, but it doesn't mean you need two separate forms and two separate processes."
Brach and co-researchers entered into a lengthy discussion with both the Office of Human Rights Protection at the Department of Health and Human Services (HHS) and with the Office of Civil Rights on the HIPAA issues, to make sure they found this consistent with human subjects and HIPAA regulations, Brach says.
"The forms were tested with target populations in both English and Spanish, and changes were made to improve it," Brach says. "Of course, forms are only tools for conducting consent and authorization discussions."
The toolkit chiefly is about how to improve the process of obtaining informed consent and authorization, Brach notes.
"One of the most important features of the toolkit is a method of verifying potential subjects, understanding the so-called 'Teach-back' method," she says.
The toolkit is 80-plus pages. The sample forms and tools and references take up all but the first 15 pages.
One of the sections that will particularly be of interest to IRBs is on improving informed consent and authorization. Strategies include the following:
Identify Mechanisms for Change
"IRBs have the ultimate say in what's acceptable in terms of informed consent and authorization, so we'd like them to do two things," Brach notes. "First, they should educate their researchers about both the process of obtaining consent and authorization and the forms."
The IRBs should give investigators and their institutions the clear message that the informed consent and HIPAA documents are not to manage legal liability, Brach says.
"They're to educate potential subjects about research," she says.
Second, IRB members need to accept that a simplified informed consent form will meet all requirements, Brach says.
"Things do not have to be complex and legalistic in order to satisfy regulations," she adds. "In fact, the regulations require the use of language that is understandable to potential research subjects."
Making these changes entails changing an institution's culture, Brach notes.
"I don't want to give the impression that the toolkit is a silver bullet," she says. "Shifting institutional culture is a huge undertaking."
AHRQ is adding to funding announcements a statement that clearly communicates the expectation to the research community that they will inform potential subjects about human subjects research and HIPAA issues in a way they can understand, she adds.
One method of affecting change is to hire staff trained in plain language to write informed consent documents, Brach says.
"Some find having a centralized staff handle IRB authorization and consent forms an efficient way to encourage these changes," Brach says. "But training researchers in conducting the informed consent and authorization discussion also has to be part of the plan."