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As IRBs focus more on efficiency and streamlining, the chief concern involves maintaining the necessary elements while discarding or simplifying everything else. This delicate balance is especially true for streamlining informed consent documents.
"The greatest efficiency gain is having a phone call upfront," says James MacFarlane, CIP, director of board services for Schulman Associates IRB Inc. of Cincinnati.
One quick call to discuss expectations will improve communication and provide a quick explanation for any issues or nuances that might arise, he notes.
The IC problem could be something as simple as a locked document code needed to get the electronic IC document to open.
"It saves time upfront to know we’re locked out of the consent document that was submitted," MacFarlane says. "But it’s really about engagement and a collaborative spirit."
For instance, an IRB might discuss with investigators their expectations regarding process, communication, and content.
"Those are the big three: understanding our mutual expectations for how we’ll communicate, how we’ll interact throughout the process, and what we expect of the final content," MacFarlane says.
When this type of communication is lacking, the result is having unfinished and problematic informed consent documents, he says.
"One issue that we see most often, and this goes back to miscommunication between the submitting party and the IRB, is an informed consent submitted in a draft stage, and the IRB is not aware it’s a draft and begins to work on that draft," MacFarlane explains. "Then the submitting party submits a different version for the IRB to review."
These kinds of time-wasters occur when communication is lacking.
"So it’s easier and streamlines the process if the submitting party’s rationale comes with the document as submitted, clearly communicating, We want to revise XYZ, and here’s why the revision is important,’" he says.
Another issue that arises and causes inefficiency is the latest trend of sponsors embedding HIPAA privacy authorizations inside IC documents, MacFarlane says.
"IRB regulations don’t require IRBs to review HIPAA, but they do require us to review HIPAA if it’s inside the informed consent," MacFarlane explains. "What is important to know, and this goes back to understanding expectations of both sides, is the HIPAA document may require legal review, which is a separate review from the IRB review."
So anytime an informed consent form arrives with HIPAA embedded in it, there is greater inefficiency in the IC review process, MacFarlane says.
Schulman IRB also improves its review efficiency through the use of living templates with industry sponsors, clinical research organizations, academic medical centers, and other submitting organizations, he notes.
"To streamline the overall consent process, we need mutual collaboration and engagement from all parties," he says. "That comes through in clearly communicated expectations and documentation of content."
Collaborations like Schulman IRB’s occur when the IRB and sponsors work together on creating templates before the IRB begins to review the sponsor’s protocols. The templates also iron out any potential misguided expectations.
Streamlined IC forms must include all of the elements of informed consent, but not all of the elements deserve top billing.
"Of course, the elements are all equal and we have to use all of them," MacFarlane says. "That being said, the element that at times requires the most attention is probably the risk section of the IC form."
Risk speaks to element 1, involving research, its purpose, duration, and risk, and element 2 — foreseeable risks to subjects.
"Risk is the section of the informed consent document that is most often heavily laden with language that may be unfriendly to a lay person, a lot of medical terms and jargon," MacFarlane says.
"So one of the things we can do to streamline the risk section is create tools for internal use, such as checklists that include the basic elements of consent and citations to the regulations," he adds. "We also have internal lists of suggested language to go along with the elements."
The checklist tool can help compare the IC and protocol side-by-side to make sure risks present in the protocol are present in the consent.
"The checklist helps us remember what to look for, and it helps us navigate through the protocol as we compare it side-by-side with the consent," MacFarlane says.