University Times

The University’s Institutional Review Board — the organization responsible for protecting human subjects in research conducted by Pitt investigators — is reaching out to faculty in light of recent changes in the IRB’s leadership and structure.

The message IRB staff are sending to faculty is “We’re here for you,” said Melissa Miklos, IRB associate director of education.

“It’s important to us that people don’t view us as an obstacle, that they view us as a resource. We want the research to go,” she said.

Lots of plans are in the works:

• The IRB is reactivating its advisory committee for social and behavioral research, which provided an avenue for input from faculty who conduct nonbiomedical research that typically does not require full IRB committee review.

• It’s planning to expand its educational curriculum and construct a learning center for on-site training and distance learning.

• In addition, IRB staff will mix and mingle and answer questions at an informal meet-and-greet session in the O’Hara Student Center ballroom set for noon-2 p.m. Oct. 14.

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The office itself has been restructured following the departure of IRB director Chris Ryan in 2014. The IRB staff has expanded to 22 to further assist researchers with their submissions.

Now, rather than being under the leadership of a single director, the IRB is managed in three divisions: a regulatory affairs division, headed by Jean Barone; an operations division, led by Nick Landolina; and an education and technology division, led by Patty Orndorf, manager of technology and instructional design, and Miklos as associate director of education. They all report to IRB chair Richard Guido, a faculty member in obstetrics and gynecology, who in turn reports to the head of the Research Conduct and Compliance Office (RCCO).

Since July 1, the IRB — along with the eight other offices overseen by the RCCO — has been reporting to the provost, with George Huber serving as interim in the new vice provost for research conduct and compliance position. (The RCCO previously was in the chancellor’s area, led by Vice Chancellor for Research Conduct and Compliance Randy Juhl, who retired this summer.)

The structural changes have little effect on the day-to-day process of reviewing human subjects research, said Barone.

“Our mission is protection of human subjects, but our secondary mission is assisting with getting good protocols through the office. We want people to remember that. Nothing’s changed in that regard,” she said.

“We’ve got office hours; we’ve got mailboxes where people can send questions. We are more than willing to go out and do presentations for various offices. We give courses on research topics.”

Connecting with faculty

The IRB staff includes new-faculty liaison Judith Navratil, whose goal is to help new investigators get off on the right foot. “Our staff people are very, very good in reaching out to new investigators if they need help writing protocols, or helping them understand the system,” said Barone.

In addition, psychiatry faculty member Sue Beers, one of four IRB vice chairs, serves as a liaison to faculty.

To further strengthen faculty outreach, the advisory committee for social and behavioral research is being re-established in response to faculty questions about changes in the IRB office.

In a report to Faculty Assembly this month, psychology faculty member Irene Frieze, who chaired the advisory committee, noted that it had been “quite active” after it was first established in 2004, but had met less and less often as fewer problems arose.

Since Ryan’s departure last year, “faculty have not had a clear understanding about what was happening with the IRB office, although the office appears to have been functioning well,” reported Frieze, who will continue to chair the advisory committee.

Educational programming

In addition to tailoring talks for a specific department or class, Pitt’s IRB has a regular schedule of recurring programs. Basic IRB seminars are held monthly at various locations across campus.
IRB 101 sessions are designed to help new investigators and research coordinators learn the ins and outs, including how to navigate the OSIRIS (Online Submission for Institutional Reviews) electronic submission system.

Larger quarterly programs typically feature a national speaker and focus on hot topics, such as data security or Internet research.

A calendar of events is posted at http://irb.pitt.edu.

Miklos added, “Because we are trying to be more education oriented, we want to be able to go to departments and speak to them individually, but we also want to be able to put together courses on general research topics, so that people can put together their own curriculum based on what their research needs are, or go through the program.”

The IRB learning center, currently in the planning and design phase, is expected to be in operation within 12-18 months, Miklos said.

The center will include a classroom equipped to accommodate about 25 students as well as a smaller meeting space where IRB staff can work one-on-one with investigators.

“We’ll have multifunction tables that we can arrange however we need. It will also be equipped with the technology to do distance learning. Anything that we can do now in a group learning setting can now be done in a larger center,” said Miklos.

“We’re also wanting to be able to reach out to the regional campuses,” said Miklos. “Our new learning center will be able to achieve all of that.”

By the numbers

The office is the IRB of record for faculty, staff and students regardless of where they do their research, as well as for UPMC’s domestic institutions, Barone said.

It’s a busy place. Last year, the IRB office reviewed a total of 10,056 submissions, most of which were modifications and continuing review.

The IRB approved 2,040 new protocols — 274 of which required full board review, in addition to 750 minimal-risk studies that met the criteria for expedited review and 1,016 that were determined to be exempt.

Turnaround times average around 51 days for protocols that must be reviewed by the full board, Miklos said. Submissions for minimal risk research are processed faster: expedited review takes around 21 days, while exempt submission turnarounds are approximately nine days.

Barone stressed the importance of making the connection with IRB staff in order to smooth the path for a protocol to pass review.

“There’s a set of regulations that we have to make decisions about so that the risks are minimized, that the subjects consent appropriately, the risks-to-benefits are in balance. If we can’t make those determinations, then it’s got to be reconsidered. Which means once the investigator responds, it’s got to go back to another meeting. That causes tremendous delay,” she said.

“Working with people up front and getting the information that we need in order to make decisions is really critical.”

Outright disapproval, “which means there is a scientific flaw that has to do with putting subjects at risk,” is rare — about 1 percent, Barone said. “When that happens, we’ve tried a couple of times to resolve that with the investigator and tried to give them suggestions on how they can change it, and they just don’t — it gets disapproved. Which means they’ve got to completely rethink the project,” she said.

“Breakdowns happen when people don’t realize they can call us. And then we get an application that doesn’t have the information we need in order to review it,” she said.

“That leads us to more rounds of comments than we would like to have. Ultimately, if there have to be any comments at all, we would like there to be one set of comments issued to the investigator,” she said. “Sometimes, though, the application we get is so lacking in information that it takes multiple sets of comments to get it into any shape where we can review it.

“I think that causes investigators to get upset,” she said.

Miklos urged faculty to take advantage of the IRB staff’s considerable expertise.

“Our staff come from a variety of backgrounds. Most of them have been research coordinators. About half were nurse coordinators — from a variety of backgrounds. So we have people from the psychosocial area on staff; we have people from the biomedical area on staff as well as lay people.” she said.

Miklos herself has 16 years of IRB experience, beginning at Children’s Hospital; Barone has been involved for 27 years. “Between us, we have loads of experience. We’ve done just about every job in the office over time,” Miklos said.

“We’re here to be a resource for the research community,” she said.

“There are a lot of rules and regulations out there. People get comfortable and familiar with the things they might deal with every day, but there are a lot of nuances, depending on the context of their research. So it’s our job to help them navigate that to make sure they’re compliant, and we’re compliant,” she said.

Added Barone, “There is lot of flexibility in the way the regulations are written. Part of our mission is to use those flexibilities when we can. And if an investigator comes to us with an idea, very rarely do we say ‘No, you can’t do that.’ We may say, ‘No you can’t do it the way you’re proposing, but consider these other options.’”

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“We don’t want to hold up anybody’s research. We want people to do research,” Barone said.

“What is really nice is when you see the protocol when it first comes in, and you see the newspaper article years later that talks about how a drug got approved, or you see a magazine article by one of our researchers.

“That’s thrilling. We want that.”

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If an investigator has had a difficult time dealing with the IRB office, Barone wants to know. “We can only fix things we know are problematic,” she said. “If they’re talking about it in the community and not talking to us about it, we can’t know there’s a problem.

“If there’s something in our policies that doesn’t make sense and it’s not regulatory based … we can change those things if there’s a good enough reason to do it.

“We’ve taken steps to address concerns. We’ve added more staff to get things through in a timely manner. We’d like to hear from people if there’s really something we should be doing differently,” she said, inviting investigators to submit comments online or call.

Federal changes on the way

Beyond the internal changes in the IRB office, new federal regulations that will change the way IRBs function are on their way, Barone said.

Comments are being accepted through Dec. 7 on the Notice of Proposed Rulemaking that was published Sept. 8.

Among the proposals are a move to a more centralized IRB review process for multi-institution studies, and clarification of the wording on consent forms.

Some types of studies that now require IRB review would be deemed exempt, and some that currently are categorized as exempt would be considered “excluded,” or excused from needing administrative or IRB review.

Details are posted at www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.

—Kimberly K. Barlow