Try out these quick tips on improving IC process

Pay attention to signatures, other details

It's the little details that matter in the informed consent process.

At least, it's often the little things an investigator might forget that could lead to compliance problems down the road.

So the office of research integrity at the University of Kentucky in Lexington, KY, has developed a check and balance system that tries to catch these small mistakes before they escalate into bigger issues.

"At UK, we have a pretty good system in place that enables us to identify where the problems are," says Judi Kuhl, CIP, BS, QI program coordinator in the office of research integrity.

"At continuation of review time we ask investigators to submit copies of signed informed consent forms for the last two subjects enrolled," Kuhl says.

"We hand-write the beginning date and ending date in a stamp in the top right corner," she explains. "This is a great way for us to identify which consent form is valid, and it hopefully helps the PI see which is valid."

By reviewing those most recent signed informed consent forms, the IRB also is able to identify other potential documentation problems, Kuhl notes.

"We also have lines on there for the investigator to sign and for the person who is authorized to obtain consent to sign and for the subject to sign," she says. "We look at those signatures and have a policy that says that only those individuals who are authorized to obtain consent may sign the form."

When PIs submit a protocol for review they are required to include a list of study staff. Next to each name on the list, there are "yes" and "no" boxes to check in answer to a question about whether that person is authorized to provide informed consent.

"So when we get the signed consent forms, our continuing review people will go back and make sure the person who is listed on the IC form was listed as authorized to give consent, based on what we have listed in the protocol," Kuhl explains.

For instance, there might be a study analyst who is not authorized to obtain informed consent. If this same person had signed a subsequent IC form, then the IRB would catch the mistake and notify the investigator, Kuhl says.

Also, each consent form has a line for listing who has signed the consent form.

"If the person signing the form is a legally-authorized representative, they'll mark this on the consent form," Kuhl explains. "If the person signing is a father or guardian, they'll indicate that."

The IRB also checks signed IC forms for the dates subjects sign the forms to make sure these are valid.

"We look at the date the subjects sign the form and look at the consent form approval period to make sure the subject has indeed signed within that time period," Kuhl says. "Sometimes, we notice that they did not sign within the time period, or maybe they weren't asked to sign a correct form — the most recent form."

Possible actions after mistakes

When any mistakes are found in the IC process, the IRB will take one of three actions:

  1. The IRB might ask that the subject is reconsented, Kuhl says.
  2. The IRB might provide the principal investigator with more information about the informed consent process, and this might include a one-on-one meeting with the IRB chair. Also there is an on-line PI self-assessment form the PI could be asked to complete, she says.
  3. Or the IRB might ask to have a member observe the informed consent process, particularly if the study involves a vulnerable population or is sensitive in some way, Kuhl adds.

Another QI strategy the IRB has employed is the use of checklists and templates to make certain each informed consent document contains all eight of the federal mandates found in 45CFR 46.116, Kuhl says.

Also, the IRB soon will have templates for cover letters to be used in survey studies when there is a waiver of documentation, but the letter will serve as a less formal informed consent process, Kuhl says.

"We have had in place for many years an informed consent template that we ask investigators to use when they develop their informed consent documents," she says. "We want the cover letters also to include the eight elements because the IRB hasn't waived informed consent — only the documentation with the subject's signature."

The letter, which is still being tweaked, will feature conversational language to explain what the survey's for and how the information collected will be used, Kuhl adds.

Another possible template will feature a telephone script for investigators to use when conducting telephone interviews for a study.

These additional templates should resolve what are traditionally weak areas in informed consent, Kuhl notes.

"We found this weak point when I did a quality improvement review of the elements of informed consent," she explains.

The new templates should help PIs who might have difficulty distilling their informed consent template into a less formal survey letter or telephone conversation, Kuhl adds.