Research portals bolster medical center compliance efforts

By the very nature of their work, researchers in academic medical centers are good at gathering, analyzing and reporting on large data sets. But on the business side of managing large research projects, the investigators often feel overwhelmed by a blizzard of regulatory forms covering all stages of the grant-sponsored project life cycle, including submissions to institutional review boards (IRBs).

Federal regulations have empowered university and hospital IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs perform oversight functions for research conducted on human subjects, and institutional animal care and use committees (IACUCs) monitor animal research. To ensure that research protocols are ethically and safely executed, there are forms for conflicts of interest, bio-hazardous materials, radioactive isotopes and restricted subjects such as children or pregnant women, just to name a few.

What may surprise people who do not work in this field is that until quite recently those have remained paper-based processes, presenting research office administrators with real knowledge management headaches.

"The challenge has been reams of paper," says Nick Stier, managing director of Huron Education, an arm of Huron Consulting Group, which offers a portal-based solution to track research projects. "When these boards meet, someone literally comes in with a hand truck to bring all the paper into the room," he says. "Plus, there are other intermediary steps, such as department chair reviews, and at each step people may add comments or suggestions. Tracking all those changes in a paper world is tough."

But a movement is underway in the field to deploy electronic research administration systems to facilitate the preparation and processing of both pre- and post-award tasks, and also to reduce or eliminate paper from transactions. That automation promises to mitigate regulatory, financial and legal risks and speed up the regulatory approval process.

For instance, moving to a Web-based system called IRBNet in January 2008 has had a transformative effect on operations at Nemours, a large children's health system, with research and clinical care sites spanning Florida, Delaware, New Jersey and Pennsylvania.

Paul Garfinkel, the director of Nemours' Office of Human Subjects Protection, says that until a few years ago there was little collaboration between researchers in different geographic regions, and all processes were paper-based. "We had inconsistencies among reviewers and difficulty managing forms," he explains. "We had no ability to develop standardized processes and procedures. Now we can share information across institutions instantaneously. We have added videoconferencing technology and are able to hold remote meetings face to face."

Expediting reviews

By working across campuses, Nemours can spread the workload more fairly enterprisewide. It was able to set up a new oncology IRB across four separate oncology centers.

Among the tools in IRBNet are objective metrics that allow Nemours to compare turnaround time and other quality and efficiency measures with other institutions that use the software across the National Research Network (NRN). The NRN Benchmark Report is provided annually for free as a service to  the IRB community. (Although it is a for-profit company, IRBNet is a member-based organization.)

"We have seen improvements in turnaround time in all review processes," Garfinkel says. Reviews by full boards, which meet once a month, are down to 38 days. Expedited reviews are handled in fewer than 10 days, sometimes only two days. "It doesn't get much better than that," he says.

Sara Dubberly, director of sponsored projects and research business management at the Children's Hospital of Philadelphia (CHOP), has been using Huron Consulting Group's Click Portal for more than two years. She describes the system as having a similar feel to TurboTax. CHOP's 500 investigators are led by a series of queries through the process of entering all the information the IRB will need about their projects. They  can't go forward in the system if they've missed a step.

"We want to be mindful of providing help to investigators," Dubberly explains. "If they spend only the time they have to on compliance and regulations, they'll have more time for research and patient care. The easier you make compliance, the more likely you are to get it." Having all the files in electronic format helps tremendously when CHOP faces an audit from the U.S. Food & Drug Administration (fda.gov). "Before, when FDA auditors would arrive, we might provide them with a 2-foot-high stack of paper," Dubberly recalls. "And if the auditor found an error or a missing piece of paper, we could get dinged. Now nothing is lost."

One of the challenges facing software teams seeking to develop solutions for the field is that every IRB operates a little differently. "If you talk to three different academic medical centers, you will hear three different ways of doing business," says Diane Gromowski, senior department administrator in the Office of Research at the Medical College of Wisconsin in Milwaukee. Therefore, it is imperative that whatever solution you choose matches the culture of the organization, she adds.

"You have to incorporate stakeholder concerns into the design and put a lot of thought into training and how you roll it out," Gromowski says. "We feel like we did that with IRB and IACUC. We had a great communication plan, and still when it came time to roll out the grants and contracts module, we underestimated the change management challenges, and it took longer than we thought to get it done."

Eliminating siloed applications

The Medical College of Wisconsin has been using the Click Portal since 2005. One key gain is that researchers now have a single place to go to check the history of the project. Over the years, many academic medical centers bought or developed their own applications for specific needs and found they had programs for finance, grant tracking, conflict of interest, IRBs and IACUCs that couldn't share data.

Gromowski says the grant submission module of Click is integrated with the IRB module, and both can share data with the Oracle (oracle.com) financial system. "That speeds up the process of tracking grant status and setting up accounts," she explains, "so investigators can start spending their grant money faster."

An open source option

A consortium of university administrators is working on an open source system based on software developed at the Massachusetts Institute of Technology.

The Kuali Coeus project started as part of the open source Kuali Financial System and was broken out as a separate module about four years ago, says Dan Dwyer, director of research administration information services at Cornell University. The Kuali Foundation will soon take over development of the Coeus software from MIT, and it is expected that the 40 consortium members who worked with MIT will move over to support Kuali.