Research compliance office move to save $1 million

Published on March 9, 2016. 

The campus office that approves protocols for researchers whose projects deal with animal subjects, human participants and biomaterials will soon become part of the system.

The Board of Regents approved the move of the Office of Research Compliance on Feb. 25 in an effort to make it more efficient and save the system an estimated $1.1 million. However, not everyone is happy with this change.

“This is in line with their strategic vision, and so I understand that,” University of Hawaiʻi Professional Assembly (UHPA) Associate Executive Director Christian Fern said in a phone interview. “It’s just for us and the impact on our members, we need to better understand the details.”

The Mānoa Office of Research Compliance provides research compliance services — including education and the handling of misconduct — to all 10 system campuses. According to system Vice President for Research and Innovation (VPRI) Vassilis Syrmos, the move will have no effect on Mānoa researchers, faculty, staff and students, though he anticipates a positive effect on those at other campuses.

“As research has been growing at all campuses including community colleges, faculty and staff will be serviced at a central shared resource compliance office as an equal client irrespectively of campus,” he said.

Saving money 

The office is composed of 22 positions. In fiscal year 2015, the total operating cost was $2.5 million — $2.1 million was used for salaries and fringe benefits using appropriated funds — and Syrmos estimates it will cost $1.4 million annually to sustain the ORC under the system. Areas of saving include:

How the cost savings would be achieved were some of the biggest concerns for the Mānoa Faculty Senate, which passed a resolutionopposing the reorganization in January, and UHPA, which has two bargaining unit members that are affected.

Michael Angelo, chairman of the senate’s Committee on Administration and Budget (CAB), said the justifications provided by the OVPRI were increased organizational efficiencies and an already existing budget surplus, but they still left the committee wanting to know how the move would make the process more efficient and where the cost savings would come from.

In addition, the system is requesting an estimated $600,000 in general funds from the Mānoa Office of the Vice Chancellor for Research (OVCR) and $800,000 from the system’s RTRF fund to pay for the ORC’s operating costs. This was not made clear to CAB until the BOR meeting, according to Angelo, who described this as a transparency issue.

“To the Committee on Administration and Budget, that’s very significant because … the $600,000 in general funds is money that is being shifted from the Mānoa campus up to the system level, and there should be a clear justification for that and [it] should be transparent,” he said.

ORC infographic

Noelle Fujii/ Ka Leo. Freepik (4).

ORC services

The ORC is composed of multiple program areas, some with committees composed of researchers and community members that approve protocols before researchers can begin their projects.

Because microbiology Professor Tung Hoang’s research revolves around developing vaccines for bacteria and infectious diseases, he got his protocols approved by the Institutional Biosafety Committee (IBC) – a process that takes at least one month.

He and his lab staff of one post doctorate and seven graduate students also receive yearly training in areas like biosafety and blood borne pathogens. Researchers are also required to participate in yearly inspections and inventories, sometimes with a compliance officer, who communicates with the federal agencies, such as the Centers for Disease Control (CDC).

“If the CDC wants to make a surprise visit and they want to do a surprise inspection, then we have to be there with the compliance office to show them where everything’s kept, what volume, you know, whatever they want to see, we have to provide them,” Hoang said.

Research protocols

Brye Kobayashi/ Ka Leo

Improved efficiency

Part of the reorganization stems out of the Research Compliance Task Force’s (RCTF) recommendation to reorganize compliance structures to be more efficient, according to Syrmos’ memo to the Board.

BOR Chairman Randolph Moore said this reorganization was in response to the question of what the system does versus what the Mānoa campus does.

While the RTCF found that many of its survey respondents did not experience problems understanding compliance requirements for areas like ethics, lab and bio safety and the institutional review boards for the Human Studies program, it did find there was a need to improve communication and transparency.

“[In terms of research] protocols, a lot of times we don’t know, well I do now, but new researchers might come along or even established ones [who] don’t know what is needed in terms of compliance because there’s no help and they’re doing it themselves, and that causes serious delay because, you know, it comes back to them [with information that they don’t know is] missing,” Hoang said.

He sat on the IBC for about four years and added that better guidance from the office from the start would reduce the delay in getting protocols — some of which can be 50-100 pages long — approved.

For the biosafety program, task force survey respondents reported experiencing problems with filing applications to comply with state requirements for the use of microorganisms.

According to Hoang, researchers have to file applications through the Hawaiʻi Department of Health (HDOA) to import microorganisms and animals – a process that can take up to a year. Stephen Case, a biosafety professional, said the ORC tries to ease the burden by guiding researchers through this paperwork, though because the researchers are the ones responsible for the imported organisms, the office doesn’t do it for them.

Depending on the situation, approvals from the state and federal departments are needed before research protocols can be approved, Case said. Other times, the protocol has to be approved first.

“Most researchers who want to work on something, they wait six months to a year, whether it’s a HDOA import, whether it’s helping with applications to submit to the IBC, helping with the deficiency prior to the submission, you know all these things the compliance officers should help but they’re doing a poor job, and each researcher wastes and enormous amount of time waiting and doing the paperwork,” he said.

Research Compliance Task Force

Noelle Fujii/ Ka Leo. Freepik (2).

The next steps

The goal is to complete the research administration realignment by the end of the calendar year, though in the meantime the office will continue to function as it has in the past, according to Syrmos.

All staff, except those assigned to the Animal and Veterinary Services Program, will move from the Biomedical Sciences Building to Sinclair Library. In addition, the system will assess synergies amongst the Office of Research Services, Office of Export Controls and ORC within the next three to four months to achieve a structure that will serve the university as one research administration enterprise.

“At [the end of the calendar year] we plan to physically coexist under one roof as a one stop shop for research administration at UH,” Syrmos said.

————

UH President proposes a set of reorganizations

While the Office of Research Compliance reorganization will advance towards its next steps, others are on the way.

UH President David Lassner has been speaking with the Board of Regents since August about potential reorganizations in administrative activity areas where there used to only be one of each, instead of the current two.

“So if you go back in time to when the president and chancellor were one position, there was only one HR office, there was one communication office, there was one government relations office, all of the facilities and capital improvements were in one office,” he said. “So these are the things that sort of split off, so they were a very natural place to assess.”

According to Board of Regents (BOR) Chairman Randolph Moore, these proposed reorganizations are in response to the board’s question on how to clarify and make more transparent who does what and why.

In January 2015, the BOR asked the Western Interstate Committee for Higher Education (WICHE) to look into whether or not the UH president and Mānoa chancellor positions should once again merge. According to Lassner, the interest stems from the belief that a merged administration would create administrative savings and efficiencies.

Ultimately, the BOR approved the WICHE recommendation to keep the positions separate, in addition to the recommendation to look at administrative efficiencies.

The proposed reorganizations would consolidate the Manoa and system offices under the Office of the Vice President for Administration, where the system functions currently exist.

Right now, eyes are only on Mānoa as it is perceived to have the most duplication and potential savings.

“…Once we move forward in a new direction and fine tune it, then there will be opportunities for looking at whether greater economies of scale that may be achieved if we start the discussions with the other units. But I mean Mānoa is the biggest and most complicated single part of the system,” Lassner said.

http://www.kaleo.org/news/research-compliance-office-move-to-save-million/article_e3dde308-e63e-11e5-97e0-0350ea7eb8b4.html

 

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