New Common Rule Suggests Changes for Informed Consent Documents
Consent is a recipe, not a checklist
IRBs often spend too much time wordsmithing informed consent forms and not enough time on the big issue of comprehension, one IRB director says.
“All too often, IRBs focus too much on the words in the consent document,” says Joshua Fedewa, MS, CIP, associate director of the human research protection program at the University of Texas Southwestern Medical Center in Dallas.
Researchers and IRBs do a good job of ensuring consent forms contain all of the elements of informed consent. But when the document is reviewed in the IRB office, IRB professionals often start to tweak the wording or rework the form to make certain it can be read at a sixth-to-eighth-grade reading level, Fedewa says.
Nowhere in the regulations does it say that informed consent forms must be written at a middle-school reading level, he says.
“So we need, as IRB professionals, to stick to what regulations say, and that level of understanding may differ according to which informed consent is being discussed,” Fedewa says.
For example, an oncology study can be very complicated. Informed consent for cancer research can be very long and filled with jargon. For the general public, this type of informed consent would not be comprehensible, but the people who enroll in this type of study have greater medical literacy than the general public, he explains.
“If a cancer patient has exhausted all treatment options and is taking part in Phase I of a cancer study, this person might have a level of understanding that is greater than about anyone in the IRB office,” Fedewa says.
This scenario highlights why it is important to aim for informed consent comprehension that is specific to a particular study and its population rather than shooting for a blanket reading level aimed at middle schoolers, he says.
“Instead of focusing on the words, are you finding out what the informed consent process is? Do you know the time between presentation of the document and signing of the document? How do you know what undue coercion is in actions and not just in words?” he says.
The goal is for an informed consent document to present the research study in a fair light. This means the risks and benefits are simply stated without overemphasizing the benefits and sugar-coating the risks, Fedewa says.
“Make sure the informed consent is a discussion and not a sales pitch,” he says. “Make sure when training new coordinators that they understand it’s a discussion where you’ve given them the information, and they’re making their own decision.”
With the new Common Rule, IRBs should keep in mind that one important word has been added to its section on informed consent. The old Common Rule said informed consent should provide subjects with sufficient opportunity to consider whether to participate in a study. The new Common Rule added the word “discuss,” as in this phrase: “discuss and consider whether to participate.”
This means researchers should make sure they discuss the consent form with potential participants, Fedewa says.
“How IRBs interpret that word is very important,” he notes. “Is it a discussion between researchers and subjects, or between subjects and their friends and families?”
IRBs might think about how investigators are facilitating a discussion and following the new regulations.
“The most powerful way to do this is to make sure investigators are, at a minimum, presenting the informed consent and also asking open-ended questions to determine subjects’ understanding of the research,” Fedewa says. “See that subjects have the opportunity to discuss it after they are informed about the research study.”
The University of Texas Southwestern Medical Center IRB has not changed how it evaluates the proposed informed consent process as a result of the new Common Rule because the IRB already was proactive in encouraging discussion in informed consent. The consent templates will be updated to comply with the new regulations, he says.
“We have a form that the investigator fills out to tell us how they will identify participants and how the consent process is done,” Fedewa says. “After recruitment is complete and the subject wants to hear more about the study, we ask them how they’ll make sure a consent discussion occurs.”
The Common Rule changes give IRBs and investigators an opportunity to rethink the whole informed consent process.
“Think of informed consent more as a recipe and not just a list to checkmark and make sure these elements are in the form, and after that, you’re good,” Fedewa says. “Think of a good consent form as a starting point, an opportunity to improve informed consent so participants have a better opportunity to understand the study.”
IRBs often spend too much time wordsmithing informed consent forms and not enough time on the big issue of comprehension, one IRB director says.
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