No-tech solution to compliance wins award

Placemats: Simple, effective, easy

In the age of smart phones, iPads, electronic checklists, text message reminders, and other tools, it would be easy to forget that sometimes the best solution is the simplest: no-tech. At least that’s what one research and human subjects protection expert discovered when trying to find a way to improve IRB meeting and review quality.

The solution uses old-fashioned materials with a novel twist: laminated, 11-by-17-inch placemats containing research guidelines and rules. IRB members each have an IRB “cheat sheet” placemat in front of them at every meeting.

“You have to find something that works. I like using a placemat because it addresses the issue at hand and provides continuing education in a nonintrusive manner,” says David Vulcano, LCSW, MBA, CIP, RAC, AVP & responsible executive, clinical research, clinical research group, Hospital Corporation of America (HCA) in Nashville, TN. HCA’s IRB placemats received the 2012 Best Practices Award for Excellence in Human Research Protection from the Health Improvement Institute.

The educational placemats have been well received by IRB staff and members, and there is anecdotal evidence that they are used as references during IRB review meetings, Vulcano says.

“Sure, we could have developed an iPad app to come up with this sort of thing, but then there are people who don’t have iPads, or taking it out increases the temptation to play games or check emails,” Vulcano explains. “Sometimes technology for technology’s sake is not a solution.”

Vulcano came up with the idea for the placemats after trying to find a way to keep IRB meetings on track and well-informed about research regulations, particularly decisions that have regulated criteria.

“Training is expensive and time-limited, and you start to forget a lot of the training you have,” he notes. “Part of my job is to make sure the IRBs are educated in the regulations.”

Policy books are useful, but all too often these remain unopened while they’re having discussions. Likewise, rules and regulations can easily be put on an iPad or laptop computer, but these have other purposes, as well, and can be distracting, he adds.

“The challenge was getting this information in front of IRB members while they’re having a meeting so they could make sure all IRB meeting criteria are addressed,” Vulcano says.

Vulcano liked the idea of putting a poster on the wall, as he had seen one commercial IRB have “The 8 Criteria To Approve Research” poster, but that would be a little challenging in most healthcare delivery settings when IRBs meet in rooms used for multiple purposes. Also, at every meeting the IRB with the poster held, no one got up to look at the poster, he notes.

“How can we achieve getting this information in front of everyone’s eyes during the meeting, yet do so in the most pleasant, unobtrusive and non-threatening manner?” he says. “Then the idea hit me — put the information on a placemat. Many meetings have food, and they put placemats out.”

The placemat idea proved very easy to implement. They were cheap, costing $20 to $25 for a set of 14 different placemats. Each of HCA’s 32 IRBs has one set of the placemats. The placemats are rotated so members see different ones at each meeting. IRB coordinators collect the placemats after each meeting and distribute them again at the next one.

The biggest challenge was deciding which regulatory information to put on the placemats so there wouldn’t be 50 different ones.

“We did this based on the most common criteria-based IRB decisions we are faced with,” Vulcano says. “For example, we don’t do a lot of reviews of prisoner studies, so we don’t have a placemat for that.”

After implementation companywide, the reports were mostly positive. When IRB members were asked whether they thought the placemats enhanced IRB discussions, 85% of IRB members said “yes.”1

Also, Vulcano decided to not put all of the necessary information on a single placemat because it would result in very small fonts and be unreadable. Instead, the placemats contain simple, clear content with one or two themes per mat. (See sample from an IRB placemat, this page.)

The placemat topics include:

• establishment of a quorum and checklist for meeting minutes;

• eight criteria required to approve research;

• required elements of informed consent part 1, including 12 items;

• required elements of informed consent part 2, including 14 items;

• waiver of some or all of the elements of informed consent, waiver of documentation of informed consent, and waiver of HIPAA authorization;

• requirements of a HIPAA authorization;

• special documentation for device studies;

• humanitarian use devices (HUDs)/humanitarian device exemption (HDE);

• de-identified data;

• “limited data-set” requirements;

• exemption from IRB review;

• expedited review (for studies of no greater than minimal risk);

• expedited review and eligibility criteria for expedited review of request for reapproval (continuing review);

• special documentation for pediatric studies.

“One day an IRB member will see the requirements of HIPAA in front of them,” Vulcano says. “At the next meeting there might be a placemat with special documentation for device studies in front of them. This provides for constant reminders without the humdrum of formal and traditional didactic training, which is expensive and often not welcome.”

IRB coordinators can make certain the placemats are rotated so members do not see the same placemat at consecutive meetings.

Both IRB members and staff have responded positively to the placemats, Vulcano notes.

“The only two complaints we’ve gotten were from one IRB coordinator who said the members spill jelly and butter on them and she has to wipe them off, and an IRB chair said members were just reading the placemat instead of paying attention during the meeting,” he says. “If they’re bored during meetings, I’d rather have them read the placemat than check their iPhone for messages.”

Reference

1. Vulcano DM. The development and acceptance of a simple tool to aid IRB compliance. Poster presented at the 2012 PRIM&R Conference, Dec. 4, 2012.