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Be cautious when asking guardians to sign IC forms
Relationship status is key
Research sites need to be especially cautious about signatures when they work with children or other populations that are unable to provide informed consent and must have a guardian or legal representative sign the IC form, an expert advises.
It's important for clinical research staff and investigators to check the IC form for what the representative has written on the line that asks them to specify their relationship to the patient/subject, says Eunice Newbert, MPH, manager of education and the quality improvement program at Children's Hospital Boston (MA).
"Since we're a pediatric institution, we have a lot of legal guardian signatures," Newbert says. "Whenever there's a parent signature line, there's one next to it that says, 'Specify relationship to the child.'"
Study coordinators should make certain that line has been completed, and they should ensure that the person who is signing the IC form is the person who answers the question about the relationship to the child.
To demonstrate how important this item can be, Newbert relates the story of a situation when study coordinator realized in a panic that the person who had signed the IC document was the nanny and not a legal guardian.
The nanny had brought the child to the appointment and then signed the form, but had left the relationship line blank. The coordinator thought she was the mother, so she filled in the line for her.
"That's a good example of why you should never fill in any information for anybody," Newbert says. "You never assume a relationship."
The situation worked out all right because once the coordinator realized her mistake and called the child's mother and legal guardian, the mother provided the required informed consent, she adds.
In other cases, the adult signing the form could be the child's stepparent, but not a legal guardian. And the step-parent status is indicated on the relationship line. These are situations that should be handled with sensitivity, Newbert notes.
"You don't want to question the person about their guardian status," she says. "We will just report this [to the IRB] and ask for guidance on how to handle it."
In one case, the principal investigator had to have the stepmother fill out a form, and the father, who was the legal guardian, also had to sign the informed consent form.
"This is why you should make sure people complete the form and you evaluate it," Newbert says. "In that 30 seconds it takes for someone to scan the informed consent form, you can pick up these things."
Other issues can arise when a child's parent has a different last name.
"I'm seeing more and more that the mother and father do not have the same last name," Newbert says. "So if you want to look at the consent form a year later, how would you connect the child and the signed consent document based on the signature alone?"
When this situation occurs, the solution might be to make certain the subject's name is documented on the form, something that at times is overlooked, she adds.