Need to sharpen up your IRB review process?

Checklists incorporated in IRB meeting process

One strategy that helped a Lexington, KY, university research institution achieve full accreditation was its development of IRB approval checklists.

There are more than 10 checklists that IRB reviewers use depending on the type of review and study, says Judi Kuhl, CIP, BS, a quality improvement program coordinator in the office of research integrity at the University of Kentucky in Lexington.

The institution received full accreditation in June, 2007, from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

Some of the checklists are mandatory for IRB reviewers, and these include the criteria for IRB approval checklist and the IRB continuation review checklist, Kuhl says.

These checklists are included in the protocol approval process documentation.

Other checklists are simply to assist IRB reviewers, and an example of this is the consent/assent checklist, which is used as a quality improvement review, she notes. (See sample of consent/assent checklist.)

"We ask IRB reviewers to use this checklist as a guide to make sure the proper elements are in the informed consent form," Kuhl explains.

For most protocols, an IRB reviewer will use just one checklist. However some studies might require additional ones.

For example, there is a checklist for Veterans Affairs research, called the VA research reviewer checklist, and there's a HIPAA authorization checklist and a HIPAA waiver of authorization checklist.

IRB members accepted the use of checklists as they saw much was required to meet the accreditation standards, Kuhl notes.

"The buy-in was the accreditation process," she says. "As we went through that, we showed IRB members what we as an institution needed to do to meet the highest standards of a research institution."

Then the office of research integrity gradually added new checklists to the process, until all of them were being used and incorporated into the protocol reviews.

As the checklists have been used, they also have been incorporated into the IRB meeting process, Kuhl says.

"At IRB meetings, they will project the checklist on a screen at the end of each protocol, and they'll go through each item on the list and have an assistant checkmark it as it shows up on the computer screen," Kuhl says.

Here are some sample items from the criteria for University of Kentucky's IRB approval reviewer checklist:

  • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result (achieved from research interventions).
  • Risks to subjects are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk.
  • When possible, risks to subjects are minimized by using procedures already being performed on the participants for diagnostic or treatment purposes.
  • The research proposal addresses the likelihood of harm and magnitude of harm (encompassing potential physical, psychological, social, and/or economic risks to the subjects).
  • The research is likely to achieve its proposed aims.
  • The importance of the knowledge expected to result is clear.

Also, here are some sample items on the University of Kentucky's IRB continuation review criteria for IRB approval checklist:

  • Adequate provisions are in place for seeking informed consent.
  • The possibility of coercion or undue influence is minimized.
  • The language is understandable to the subject/subject's [learning ability].
  • No exculpatory language waiving or appearing to waive any of the subject's legal rights.
  • No exculpatory language releasing PI/sponsor/institution/agents from liability for negligence.