Collaboration and consolidation of IRBs likely will be an ongoing trend that necessitates action to reduce problems and improve streamlining — in other words, best practices.
IRBMED, the IRB office at the University of Michigan Medical School in Ann Arbor, decided the best practice would be to develop a practice and guidance (P&G) committee to document IRB standard procedures and pilot projects.
“There was an effort to work on developing and standardizing some best practices, but there needed to be a formal structure that could support that ongoing development and dissemination of best practices,” says Judith Birk, JD, IRBMED director.
“This was an opportunity to bring it under the direction of a consistent group that we could all evaluate and finalize, and then disseminate the best practices,” Birk explains. “It was just an opportunity to take an action that was started previously and give it consistency.”
The committee also is an opportunity to bring together the regulatory staff and go over regulatory rules, standardizing practices across the boards, says S. Joseph Austin, JD, assistant director for regulatory operations at the University of Michigan Medical School.
The P&G committee, which Austin attends, meets once a week for one hour. “We have five three-person teams in the office to support the boards and perform the regulatory reviews for applications coming in, and for the P&G committee we have representatives from each of those teams,” Austin says.
“We pull in additional individuals for their expertise,” Austin says. “P&G is six to eight people.”
The committee serves as a working group. It creates three different types of documents, including the following:
- a P&G internal document that is instructive on how to do something standard within the office,
- a companion, procedurally oriented piece that delves deeper into the procedures and explains how to work within the electronic application, and
- a statement of practice, a document that alerts the research community about what the IRB’s practices are, including explaining flexibility initiatives and when these will be used.
Typically, someone on the committee will create a draft document, including flexibility initiatives.
“It’s the practice across the country to take advantage of flexibility in the regulations, based on how each institution has chosen to set their FWA after they unchecked the box,” Birk says.
Birk refers to the Federalwide Assurance (FWA) for the Protection of Human Subjects and the growing trend of institutions, like the University of Michigan, “unchecking the box” to allow for more flexibility in federal oversight. What it means is the institution no longer voluntarily applies the Common Rule federal regulations (45CFR46) to all research.
“Institutions that uncheck the box are permitted to develop equivalent protections that may differ from the Common Rule,” Birk explains. “To do so, you can reduce regulatory burden by still offering appropriate protections for human subjects; for example, you can extend the IRB approval beyond one year to two or more years for low-risk studies.”
The P&G committee created the document about flexibility to indicate its procedures for flexibility initiatives, she adds.
Before each P&G committee meeting, members receive materials to review. They’re expected to arrive at the meeting with ideas and suggestions.
“That helps us have productive meetings and move these documents along,” Austin says.
The committee discusses the suggestions and reaches a resolution on what should be done. Then it’s written into a document that will be further vetted at a group meeting. After the committee decides on the document, it might be vetted to other institutional leadership offices and individuals.
“If it’s something that we need the general counsel to weigh in on, it will go there,” Austin says. “If it’s just about workflow or general practices, then it will stay within the office.”
Members of the P&G committee, other than core administrative members, are rotated annually, Birk says.
Also, the committee’s task list is kept fluid so it can be modified quickly to adapt to any emerging office needs, Birk says.
“Several times a year, we use that committee to help us with priority issues to develop and write our guidance,” she says.
The guidance documents are discussed at weekly staff meetings. As people use them, they may offer suggestions or ask for a clarification, Birk says.
“It’s not uncommon for one of our staff members, during a discussion, to actually refer to a practice and guidance document or to ask if they can develop what we’re discussing,” Austin says.
“They’re also very beneficial to new staff joining the office,” he says. “If they don’t know our internal practices, there now are outlines for how to do it and they can reference them.”
The P&G committee’s guidance fills a big gap for the IRB, Birk notes. “Before, we didn’t have a process that tied together all the guidance out there or that gave us a portal to develop new guidance; it really met an unmet need.”