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[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
IRB Advisor: What is one of the chief problems you see with informed consent documentation?
Lloyd: A huge problem with documentation is they don't realize you have to document re-consent and assessing cognitive status. It's very important to assess cognitive status, willingness to continue the study, and re-consent. So often what happens is people write a good document and don't document what they've done with informed consent throughout the study. So it's a myth that they're conducting the process as it's supposed to be conducted, which should be interaction throughout the study. A person volunteering for a study has free will to withdraw from the study, and you should be documenting whether the subject wishes to continue the study.
IRB Advisor: How can research sites make sure they're following all of the regulations and rules for informed consent?
Lloyd: Checklists are good to use. However, I would caution against completing just the blanks on the checklist because you may not be focusing on the patient and other issues. If you're just marking checkboxes, you're not assessing the whole person. Some people like to use checklists, and I think they're a good idea, depending on how they're used. For example, a checklist for the elements of the consent document is good. But when people use a checklist for the process, it concerns me. Each study and each person is different, and it's important to be in tune with the subject and not just completing a checklist. A checklist might be good for documentation, but you have to go beyond the checklist for informed consent.