Last March it took 35 days for a full Institutional Review Board (IRB) approval for a clinical trial from the University of Maryland’s School of Medicine, which reviews more than 1,000 applications annually. This March, IRB approval time dropped to 21 days, and just 13 days in February.

And those faster approvals were completed with a staff of just three full-time analysts and four coordinators, compared to eight full-time analysts at this time last year.

Reducing the time for investigators to gain IRB approvals required the School of Medicine (SOM) to streamline its business processes, retrain its staff and alter its hiring practices, to be able to do more with less. A key part of this paradigm shift was the development of new procedures and an investigator’s toolkit complete with essential documents, including up to 40 checklists and 30 worksheets that make the submission process more efficient.

The toolkit is designed also to help investigators take the least burdensome path to FDA regulatory compliance while fully protecting study volunteers, ensuring they are informed of the risks and their rights as research subjects.

“Faster turnaround times will help our faculty researchers to be more productive scientists and make the School of Medicine an even more attractive destination for federal funding, grants and contracts,” E. Albert Reece, M.D., Ph.D., dean of the SOM and the university’s vice president for medical affairs, explained in his monthly newsletter message to the school’s medical community.  “But it is not enough to simply increase the amount of research we do. It is imperative that we increase the impact of that research on human health.”

The dramatic improvement in IRB approval times is a major part of SOM’s Human Research Protection Office (HPRO), which shepherds proposals through IRB review. It also reviews and oversees all human subject research across the University of Maryland campus. With a staff of 25, HPRO conducts scientific and ethical reviews and makes sure all research complies with federal regulations.

All members of the IRB committee review research proposals with a high degree of risk, while certain minimal risk applications may be approved by the IRB without a full committee review.  A big bottleneck in gaining approvals was in the “non-committee” proposals, which could take 25 days to gain approval. Today those approvals are completed in seven to 10 days.

“Our motto for the non-committee reviews is, ‘We process things in real time,’ and that means when an IRB application comes in, somebody looks at it for the initial pre-review within 30 minutes of its submission,” said Susan Buskirk, assistant dean, human research integrity and compliance.

Having measured IRB turnaround times for a decade and faced with a very tight budget, Buskirk knew things had to change. So 13 months ago she led a staff retreat and explained that a new plan for greater efficiency was on the way. She implemented a retraining boot camp on the new, streamlined standard operating procedures (SOPs), which were formally implemented last November.

Buskirk also worked with Huron Consulting Group, whose life sciences advisory services developed a series of SOPs, checklists and worksheets, as well as the toolkit, designed to help higher educational institutions meet regulatory requirements. Combined with SOM’s own checklists, the IRB review process now has a structure and framework.

Among users of Huron’s documents to streamline regulatory compliance are the Harvard School of Public Health, the University of Central Florida, the University of Arizona, and Spectrum Health, a hospital system in Grand Rapids, Mich.

“We are seeing a range of universities and hospitals seeking to use all or parts of the toolkit to think of their business processes in a different way,” said Madeleine Williams, a director of Huron’s Life Sciences Advisory Services.

Buskirk said two more analysts were recently hired, and there is an opening for a sixth. But the job requirements have changed.

“When I took over the office in 2003, one of the first things I did was reclassify the analyst position to a much higher level and pay grade, because the analysts were essentially paper shuffling,” said Buskirk. “Now I am seeking people who have several years’ experience in research or regulatory affairs, are knowledgeable about regulations and ethics, have critical thinking skills and are detail oriented. And I have some candidates with Ph.D. degrees applying.  So I think we are quietly on the cutting edge for streamlining the IRB review.”

--Ronald Rosenberg