Once again, FDA has issued a Warning Letter to a clinical investigator on the informed consent process and enrolling subjects who did not meet study eligibility criteria. The Warning Letter also cited serious record-keeping violations. This Warning Letter was issued by the Center for Biologics Evaluation and Research, which handles approximately 10% of the FDA’s Bioresearch Monitoring inspections. FDA Warning Letters in the past few years have frequently cited study eligibility and informed consent issues. They are two of the most critical areas of FDA concern. In this case 7 of 17 subjects were enrolled who did not meet inclusion/exclusion criteria. That’s pretty significant.
Seven subjects did not sign an informed consent form required by a protocol amendment and two others signed a consent form meant for HIV positive subjects. These subjects were not HIV positive. These are not minor dating errors or forgetting to get initials on page 7 of 12. They are major informed consent violations. The investigator also could not produce electronic records that were important source documents because of computer problems. Another reason to take a look at the previous Guest Commentary on Part 11 (scroll down). This is another good reason for sponsors and clinical site staff to review study eligibility and informed consent requirements. They are among the first places FDA will look.
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This just in: Request for Comments- Exculpatory Language Used in Informed Consent, a joint FDA and OHRP draft guidance document (September 2011)