As an IRB office prepared for accreditation, staff looked for methods to increase compliance. An answer quickly formed: use the IRB’s electronic system to develop smart checklists.
“Our system has the capability of having smart checklists, which are checklists that show only the things relative to the submission, and they have the ability to link to the submission,” says Fanny Ennever, PhD, CIP, manager of regulatory policy development for the human subjects protection program at Boston Medical Center, Boston University Medical Campus.
IRB staff completed hundreds of smart checklists in 2017, including separate checklists for initial approvals, initial exemptions, amendments, and continuing reviews. The checklists are designed to help reviewers remember all of the details they need to check and to document regulatory and institutional requirements.1
One of the chief benefits is that it frees up the board’s time in reviewing studies.
“We want to make sure the issues that result from inattention by the submitter are taken care of,” she explains. “So when the board does the review, IRB members don’t have to waste their time handling petty errors.”
Using a checklist for these pre-reviews is one way of ensuring consistency and compliance.
For example, one overarching issue on a checklist has to do with whether the study is internally consistent. So if the study protocol lists inclusion/exclusion criteria, the submission’s list of inclusion/exclusion criteria should be identical, Ennever says.
Making this checklist electronic can be complicated.
There are separate checklists for new study submissions, continuing review, etc. Plus, each person viewing the same checklist will see different things because of where their answers lead, says Khaled Khattar, BBA, IRB application administrator and website editor at Boston Medical Center and Boston University Medical Campus.
When the IRB created the checklists, the challenge was to communicate the rules to Khattar, who spent several weeks working continuously on the checklist.
“I think we have more than 1,000 rules in the electronic checklist,” Khattar says. “It was simple except when you come to the rules.”
The checklists also vary according to which box is checked. One answer leads one way; another goes in a different direction. For instance, a checklist for an amendment will look different if there is a consent form versus an amendment without a consent form, Ennever says.
“The checklist only shows things that are relevant,” says Matthew Ogrodnik, CIP, IRB administrator at Boston Medical Center and Boston University Medical Campus. “It depends on which information is provided in the application, and this drives the questions that appear. So you are only focusing on things that should be in that application.”
If the study will enroll minors, then the checklist will pull up all possible regulatory categories for minors, and the study must fit into one of those categories and meet criteria within those categories, he adds.
“It’s best practice to record the protocol justifications, using the example of enrolling children, so if you need to go back and look for the justification, you’ll know where it is,” Ennever says.
The checklist’s workflow allows for stops and starts. If IRB staff cannot complete each item the first time going through the study and checklist, the system will generate a red incomplete.
“You can send it to the principal investigator to go through and adjust items that are still incomplete, and you don’t have to restart the checklist,” Ogrodnik explains. “It’s a visual cue that lets you see exactly what was left incomplete — you go directly to the items in red.”
The electronic checklist also has room for comments. IRB staff can write, “This section is missing,” or “This doesn’t match up with the protocol,” he says.
If a comment notes that the investigator did not complete the funding section correctly, IRB staff can provide a link that takes the investigator to the funding section.
“All of the back-and-forth mostly happens through the list of stipulations we send back,” Ogrodnik says.
The following is an example of how the checklist works:
• 17.2 Verbal consent/assent – waiver of documentation of informed consent
“Will this research include an informed consent process, but require a waiver of documentation of consent?
- Yes, because the research presents no more than minimal risk of harm to the participants and involves no procedures for which written consent would normally be required outside of the research.
- Yes, because the only record linking the participant to the research would be the consent document and the main risk in the research would be the potential harm because of a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
Reviewer Comments Editor:
17.2: They have not requested a waiver of documentation of consent in 17.2, but there are no signature lines in the consent form. Do they intend to obtain signed consent or waive documentation? This needs to be clarified.”1
Smart checklists use reviewers’ time more efficiently by eliminating duplicate entries and making it easy to see what is incomplete. But they were labor-intensive to create, Ennever says.
“It was a lot of work, and we’re very fortunate we had a computer expert, Khaled, who was able to make a change when needed,” she says.
One of its chief benefits is that it serves as a good training tool for IRB staff, Ogrodnik notes.
“You catch everything on the first review,” he says. “I wouldn’t want to go back to the old system.”
1. Ennever F, Ogrodnik M, Khattar K. Smart checklists in the Boston Medical Center and Boston University Medical Campus electronic system. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, held Nov. 5-8, 2017, in San Antonio. Abstract: 33.