Compliance Corner

Audits show researcher IC errors occur often

A big one? Using incorrect IC form

Clinical trial sites frequently make mistakes when conducting the informed consent process with prospective study participants, a compliance expert says.

"One of the responsibilities of an IRB is to observe the consent process, and I conduct random and directed audits of the process," says Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, Vanderbilt University Medical Center, Nashville, TN.

When Lloyd finds a trend in informed consent mistakes, she addresses it by developing an education session for research staff.

"I offer to come directly to the department that's having the problem and tailor education to that department and study," she says.

Since informed consent is an area in which there were problems across departments, she developed a training series that focused informed consent.

The problems ranged from documentation to process. (See table on common informed consent mistakes, below.)

Compliance specialist finds these common informed consent errors

Clinical trial sites often make similar mistakes when conducting informed consent with study participants.

Wendy Lloyd, LPN, CCRP, CIP, a regulatory affairs and compliance specialist at Vanderbilt University Medical Center in Nashville, TN, conducts audits of research sites and has found these common errors:

  • Sites use expired consent documents.
  • Consent documents are used that have not been approved by the IRB.
  • The site has left off the names of key study personnel who will be consenting subjects.
  • The person consenting the subject did not sign the form.
  • Principal investigators have not maintained consent documents for the amount of time stated in the protocol.
  • A research site cannot locate a consent document, or the subject was not consented.
  • There are incomplete questions or sections in the informed consent document.
  • Subjects were enrolled for the study when they did not meet the inclusion/exclusion criteria.
  • The informed consent form listed an incorrect contact phone number.
  • The informed consent document was not signed and dated at the time the consent was provided.
  • The consent form used was for the wrong study.
  • There are multiple consent documents for the same patients, and there is no explanation of how this occurred.

CR investigators and managers who wish to prevent having poor audit findings involving informed consent, could take these steps to prevent problems:

• Understand what auditors or monitors will look for in the IC process:

The U.S. Food and Drug Administration (FDA) will send out warning letters when informed consent forms are incomplete, such as lacking documentation of the training and qualification of key study personnel who are conducting the IC process, Lloyd says.

"This is a huge issue with the FDA," she adds.

Both internal and outside auditors or monitors will look specifically at a site's documentation of the informed consent process and the forms themselves, focusing on these elements, Lloyd says:

— Does the consent document include all necessary elements?

— Does the document reflect and comply with the protocol?

— Has the IRB stamped its approval, and has the sponsor approved the document?

— Is the written form legible and understandable?

— Did the subject sign and ate the form prior to engaging in study screening procedures?

— Does the research site have a written policy for obtaining consent?

— Are there medical records documentation of the consenting process?

— Has the CR site implemented changes in the protocol only after receiving IRB approval, and was this done in a timely manner?

— Is the correct version of the protocol and consent form being used?

"You need to document completely and thoroughly the informed consent interactions," Lloyd says. "It's ongoing throughout the study."

• Audit your own informed consent documents.

"I encourage research sites to randomly audit their own consent documents and documentation," Lloyd says. "Also, it's a huge help for these sites to monitor FDA warning letters and OHRP determination letters."

By becoming familiar with the regulations, state laws, institutional, and IRB policies, creating SOPs, staying organized, and requesting department-specific education are all good strategies for improving IC compliance, she adds.

"Verify your subjects' eligibility criteria prior to enrollment by having a second sign-off, a second person confirming eligibility," Lloyd suggests. "Verify that the consent is completely filled-out with no blanks."

Network with other research institutions to discuss the informed consent process because this is a good way to discover errors, she adds.

"You may not realize you're doing something wrong until someone else brings it up," she says.

Lloyd offers these ideas for what auditors and monitors look for in the informed consent document:

— Does the informed consent document include all necessary elements?

— Have option sections been addressed in the form?

— Are the IRB's approval and expiration dates listed?

-—Is the IC document used correct for this particular population?

— Is the most recently revised IC document?

— Is the signed document kept in one place?

"It's a best practice to keep all of your documentation in one place," Lloyd says.

Research sites also should get into the habit of including times with the dates when subjects sign the informed consent form. This is important because it can prevent findings that the subject began trial screening activity prior to fully consenting to the study.

For instance, the study coordinator or investigator should write in notes the time and date the consent form was signed because auditors might find a problem if the date of the signature and date of the first screening procedure are the same, Lloyd says.

By placing the time along with the date, the CR site can prove that the subject signed the form in the morning and did not start his or her first screening procedure until some hours after the informed consent process was complete, she adds.