QI Quick Tips
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Follow tips for better IC documentation
Informed consent templates are useful when an IRB office starts a new process or when there are new employees or new investigators submitting applications, but an experienced office can improve IC review quality by weaning its staff off of templates, an expert suggests.
"I tell people to spend 30 seconds looking at what you need; don't rely on templates," says Eunice Newbert, MPH, manager of education and the quality improvement program at Children's Hospital Boston.
"Informed consent templates are to help investigators and are not required," she adds.
For example, IRB staff should know without using a template to pay close attention to common IC omissions and mistakes, such as a signature that is missing or placed on the wrong line, Newbert says.
"If a parent signs the witness signature line, then the informed consent is invalid," she adds. "We can report it as a deviation and fix things, but you have to think about whether it is fair to the subject."
The solution is prevention through training staff to mentally note the placement of signatures on every IC form.
"If you spend 30 seconds looking at all signature lines to see if someone signed the wrong line and to have this corrected, then it can make a huge difference," Newbert says. "It's better to do this instead of waiting and two years later to be audited."
Newbert offers several additional quick quality improvement tips, including these:
Signature dates. IRB staff also should watch for IC signature and date discrepancies. If the investigator's signature is dated earlier than the subject's, then there is a problem, Newbert says.
The Food and Drug Administration (FDA) pays close attention to signature dates, Newbert notes.
"I read FDA warning letters, and next to problems with enrolled ineligible subjects, they have a suspicion of how a person's signature is dated," she explains. "The signature date is one of the ways the FDA can determine whether a study began prior to informed consent."
If the subject is enrolled on the same day he or she signs the IC form, then time-stamp or write down the time the signature was obtained and verified, she suggests.
Have a back-up plan for lost forms. IRBs should have a back-up plan for lost data. For instance, if a case report form is missing — both the hard copy and electronic one — then there should be a way to replace the data, Newbert notes.
"You could look at the medical records and verify that data," she says.
If informed consent forms are missing, there should be notes somewhere in the medical records or clinical notes that the informed consent was obtained on a specific date, Newbert explains.
"If you lose a consent form, then report it as a deviation to the institution, sponsor, and applicable agencies," she says. "A lot of times people will go back and get a reconsent, but these days people need to document it additionally, keeping all signed and updated versions."
Use the correct IC form. One of the most common mistakes is when researchers use the wrong version of the informed consent form. They also might update their form in the continuing review process but do not report it as a deviation, Newbert says.
"Our institution created an informed consent library for the purpose of minimizing nonactive consent forms," she explains. "You can log into this IC library and download only the most recently approved version."
The library works remarkably well, Newbert says.
"Investigators are responsible for making sure that whatever they're downloading is current," she adds. "So if they know there is an amendment that needs to be uploaded, and if it's not uploaded, then the IRB has to specifically upload the document."
A few years after the IC library was created, Newbert discovered that investigators were relying a little too much on it, and she had them correct the mistake.
"I did internal audits and would go into their regulatory binders and say, 'Where are your informed consent versions?' They said, 'We have the informed consent library now,'" she recalls. "I'd say, 'No, no, no — the library only maintains the most recent version, not the previous ones. You have to keep the older versions in your files.'"
Verify parent/guardian signature. "Since we're a pediatric institution, we have a lot of legal guardian signatures," Newbert says. "Whenever there's a line that says to specify relationship to the child, we need to ensure it is complete and accurate."
The person who signs the line must be the person who writes down the relationship to the child and who has the legal right to give permission for the child, she adds.
"We've had a couple of situations where it's a stepparent or aunt sign the form, and that's not a legal guardian, and they can't provide permission," Newbert says.
"Once there was a situation where a coordinator called in a panic after realizing that the person who signed the consent form was the nanny of the child," she adds. "The coordinator thought the nanny was the mother."
This example demonstrates how researchers should never assume a relationship. The coordinator had seen the woman taking care of the child and had her sign the informed consent form. But the woman left the line blank where it asked for her relationship to the child, so the coordinator wrote "mother." As it turned out, the child's actual mother did consent to the child's enrollment, and everything was worked out once the error was discovered, Newbert notes.
IRBs and researchers also should be aware that children's names and their parents' names do not always match. Often the child's mother will sign the form and her name is different from the child's and the father's. This makes it challenging to match subjects to parental signatures, she adds.