Having IC templates can backfire
Over-reliance can lead to unnecessary information
For years now, IRB managers have been developing and using tools, including checklists and templates. The goal is to improve IRB review consistency and to expedite the approval turnaround process. While checklists and tools are useful, they can also be a problem.
"Reliance on tools, such as informed consent templates, can hinder the consent process and impose a number of additional requirements that may not be rooted in human subjects protections," says Megan Kasimatis Singleton, JD, MBE, CIP, associate director of human research protections at the University of Pennsylvania in Philadelphia.
Singleton and Tracey Ziolek, MS, CIP, director of human research protections at the University of Pennsylvania spoke about demystifying consent requirements at a recent research community forum co-hosted by several Philadelphia-based institutions and the Office for Human Research Protections (OHRP), held in Philadelphia in October.
"For example, an IRB might provide a consent template as a starting point for researchers to develop their consent forms," Singleton explains. "Templates often can become a source of perceived requirements and some people might rely too much on the document."
This is problematic because one size never fits all for informed consent, she says.
"A consent template is just a tool and not a step-by-step guide that tells you exactly how your consent document needs to be formatted," she adds. "Often there’s over-reliance on templates, and this occurs in a way that does not serve subjects best."
Since there are no regulations requiring the use of templates, this is an area where researchers and human research protection programs (HRPPs) could go overboard.
"We found that reliance on this perceived requirement could be a hindrance in consenting creatively and in tailoring the informed consent form to your study," Singleton says.
Singleton and Ziolek discussed various scenarios of when IRBs might be turning recommendations into requirements at the recent OHRP informed consent conference.
"Workshop attendees discussed several hypothetical cases evaluating potential institutional consent requirements," Singleton says.
"In one scenario, an institution committed to reducing the length of consent forms revised their guidance document on consent form development to indicate that all studies with complex study visit schedules must include a procedures table in their consent document," she explains.
"Should that really be a requirement for approving the study, or is that something that could simply be recommended?" Singleton says. "Our argument is that at some point when everything becomes a requirement the goal of the consent document and process may be overlooked."
The workshop attendees agreed that while the use of a table may be helpful in improving subject comprehension, it may be inappropriate to require a table format in order for the consent form to be approved, she says.
"Attendees noted that the requirement of a table may also limit the research team’s willingness to consider other creative and potentially more useful options for presenting information such as diagrams, PowerPoint presentations, or a personal study calendar," Singleton says.
Tools, templates, and checklists can be useful, but there are two ways IRBs can prevent them from being abused, Singleton says:
First, when templates and other tools are used they should not be considered equivalent to the regulatory requirements for informed consent. They could be used by IRB staff to check against IRB submissions to make sure they adhere to regulations, but there shouldn’t be a focus on exact formatting of the consent document to align with the tools, she says.
Secondly, IRBs should educate investigators about how to use these as guides, but emphasize that they are not requirements, she says.
"IRBs and researchers should think critically about the potential impact of reliance on standardized tools on the ability to create consent processes and forms that are tailored to the study’s target population," Singleton says.
For example, if an IRB hands out its template, saying it is simply a guide for how the consent should be written and then sends a submission back if it doesn’t adhere to specific points on the template, then the HRPP is sending the message that informed consent must meet this specific framework to be acceptable, she explains.
"You are creating a requirement by putting this expectation forth and reviewing each consent document against the template," Singleton says.
Researchers who cut and paste template language into their informed consent documents may include information that might not make sense for their study population. It’s common for researchers to rely heavily on a template and to believe the template is representative of what the IRB expects to see, rather than tailoring the consent document to their study and target population.
"If you’ve never written a consent form before, you won’t necessarily know what should be in it and what shouldn’t be included and the template may often be used as a source of text for the form," Singleton says.
A better approach would be for researchers to think about what their study participants need to know to make an informed decision about study participation and how that information may be best presented to the specific target population.
This should provide the foundation for the development of the IC form, she suggests.
"This is not saying templates are not a good tool," Singleton says. "They can be a great tool. The education around the tool is important, but it’s also important for IRBs and institutions to think about whether over-reliance on templates has led us to stray from an approach to consent that is focused on the subjects."