Virtual IRB has quick turnaround for reviews
All board meetings are teleconferenced
The newly accredited MaGil IRB in Rockville, MD, has review process timelines that might seem impossible to other organizations, including a self-imposed deadline of four hours from the time an IRB review submission is made to the time it is seen by IRB members.
MaGil IRB’s expedited reviews have a two-to-four-day turnaround time, while the full board reviews are completed within a week, says Lisa Georgoff, CIP, IRB administrator at MaGil IRB.
“The reason our CEO started this business is because he had been working in the industry and heard of problems of researchers dealing with large, bloated IRBs that were not customer friendly and took weeks to get back to them, and he thought we could do better,” Georgoff says.
At the virtual IRB meetings, held twice a week, the board’s five members discuss studies via a video conference. When a study requires an expertise the board does not possess, an outside consultant/expert is brought in, she adds.
The virtual meetings take place in the daytime, and one of the IRB’s employees takes notes electronically, documenting all of these in the meeting minutes. On the IRB’s electronic platform, a board member can make a comment or ask a question that is time-stamped, Georgoff explains.
“The system captures who reviewed it and when they reviewed it, so we have documentation that it was reviewed,” she adds. “This increases the speed and efficiency by not having clients print something out and fax it or scan it and then making sure it gets to the right person’s desk.”
Everything about MaGil IRB is virtual from the submission forms to documents being made available virtually to IRB members and staff around the clock. Researchers can make submissions via computer, smartphone, tablet, or any other device with Internet access, Georgoff says.
“We have an investigator’s handbook on our website,” she says. “It has a checklist that helps to explain the submission process and includes definitions of risk and other terms.”
The 21-page Investigator’s Handbook includes a list of all required items for IRB review, definitions of protocol exceptions and deviations, special considerations for vulnerable populations, subject recruitment guidelines, and 23 sections in all. One example is the section on the IRB site visits: The handbook states that MaGil IRB may make site visits to the performance site or arrange for an outside agency to visit the site to obtain additional information about community attitudes, conditions surrounding the conduct of the research, and to make certain risks to subjects are minimized.
Other available checklists are for expedited reviews, exemptions, continuing reviews, initial protocol reviews, protocol deviations, and modification reviews.
The IRB, founded in 2009, completed a successful routine audit by the Food and Drug Administration (FDA) last year. In March 2013, the IRB was accredited through the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
“One of our challenges is being the first virtual IRB and correcting misconceptions,” Georgoff says. “We don’t have face-to-face board meetings.”
But the recent accreditation and last year’s FDA audit show that the IRB’s virtual work is compliant with all regulations, she notes.
Part of the IRB’s best practices involves using an electronic platform that can monitor response time. Documents are signed electronically with signatures that are time-stamped and verifiable, Georgoff says.
“We can prove that on this date last year we did this audit and it was signed. Everything is time-stamped, verifiable, and trackable to ensure that it was in fact signed on a certain date on this computer by the person with this email address,” she explains. “We can ensure that all signatures are compliant with regulations.”
The IRB also conducts internal audits on a continual basis, reviewing policies and procedures to check for both quality and regulatory compliance.
“We submit test forms to make sure they’re getting routed to where they should and to make sure everything is working the way it should,” Georgoff says.
One of the IRB’s major quality improvement measures was to hire a consulting firm to audit the organization, its standard operating procedures (SOPs), and to help the organization build an IRB that would be AAHRPP compliant, Georgoff says.
The consultants helped the organization improve the SOPs, all necessary items were included, she adds.
MaGil IRB’s electronic system makes it possible to update SOPs immediately when new regulations or other changes occur, Georgoff notes.
“If we need to make a change to a form on our website, we can have it downloaded and submitted electronically very quickly,” she adds. “So if it needs to be updated with new regulations, the form can be revised the day the regulatory change occurs.”
The IRB’s SOPs are extensive and searchable. In the table of contents there are links that take users to the correct section. There are no links to checklists and other forms that are referenced in the SOPs, but these can be found easily in another electronic folder, Georgoff says.
“We refer to the SOPs often,” she adds. “We have periodic compliance checks where we go to a certain section and double check to make sure everything is working properly.”
To ensure quality as well as speed, the IRB uses its internal checklists to verify that IRB review submission forms contain all the necessary information. If something is missing, an IRB specialist contacts the researcher.
“We manually look at the checklist and application, and if things are missing, we request the required documents,” Georgoff says.