Comments to the Faculty Senate on January 20, 2016
Presentation notes submitted by
John Galland Ph.D., Assistant VC, Office of Research Compliance
To be the best University, we must have the best researchers, students, and staff.
The primary mission of the Office of Research Compliance (ORC) is to help our
researchers, students, and staff to become the best—to help them build their
knowledge, abilities, and reputations so that the University’s reputation is enhanced.
Thus, ORC is more than policepersons and paper pushers. As members of the
Academy, ORC provides scholarship in service that promotes research excellence
and mitigates risk to the University and to the individuals employed by the
University. These essential services of scholarship, faculty development,
infrastructure development, and enhancing the reliability of research results must
not be lost if ORC is to become administered by the University System rather than
the University’s flagship. These essential services must transcend where the office is
housed and who is in charge of it.
Regulatory burden has increased over the last 20-years and ORC in the last 3-years
has worked hard to lessen the burden on UH faculty, students, and staff by 1)
educating them about the ever-increasing and complex regulations, 2) helping them
complete the required additional paperwork necessary to comply with the new
regulations, 3) speeding the process by which they meet the requirements so they
can proceed with their work, and 4) providing for them the documentation the
regulators require that assures that UH personnel adhere vigilantly to all regulatory
requirements. These important functions of the ORC are the most basic and meet
the minimum requirements (the floor) for a compliance office. However, our office
aspires to exceed minimal requirement and reach for the ceiling to help UH faculty,
students, and staff pursue and achieve excellence.
Here are but four of the ways our office not only has lessened the burden on faculty,
students, and staff, but has protected their ability to continue to research and teach;
has mitigated the risk to their reputations; and has protected their health and
safety:
1. Our office or the federal government could have shut down all aquatic
research at UH for non-compliance, we chose instead to help aquatic facility
managers learn how to improve their operations cost effectively in order to
comply with regulations. We accomplished this, in part, by creating and
validating an assessment instrument, inspecting 13 aquatic facilities using
the instrument, holding workshops, and establishing the Aquatic Animal
Diagnostic Laboratory (AADL).
2. Our office or the federal government could have shut down research on
select agents at UH for non-compliance, but instead, we chose to help
researchers and staff members make changes to comply with the regulations
and entered into a performance improvement plan. Our office lessened the
burden on SAP faculty by preparing more than 12,000 pages of original
writing to the regulators to restore our federal authorization to conduct
research important to Hawaii.
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3. Our office or the federal government could have shut down more than 30
research facilities in the University System for non-compliance, including the
Honolulu Aquarium, but instead chose to work with the facility managers to
come into compliance with federal regulations.
4. Rather than increase the vivaria per diem rate by 27% that was necessary
two years ago to breakeven, we increased the rate incrementally 6% per
annum and ORC covered the shortfall by using funds from our other
programs as a loan. Had we not bailed out the program or had increased the
per diem rate, research using mice would have diminished and the burden
on researchers would have been immense.
These illustrations, support ORCs continued efforts not just to become more
efficient and reduce cost, which has been done well, but about making the University
better by helping researchers become better. To help them establish and maintain
responsible and productive research programs— to help them thrive in the research
enterprise.
Members of the ORC are not concerned about whether the office is housed at system
or even who they report to; however, they are concerned that they were not
consulted before the decision was made and that the primary argument for the
transition is unsubstantiated claims of “inefficiencies in the UH compliance system…
and …longstanding issues with research compliance procedures and processes...”
that were contained in a task force survey. Unfortunately, a report from this task
force unfairly promulgates these unsubstantiated claims. Members of ORC and
members, mostly faculty, of the five compliance committees are critical of this
report issued by the Research Compliance Task Force. They believe the report is
unfair because 1) the questionnaire used as a basis for the report asked respondents
to answer based on their last 15-years of experience with compliance, and
substantial improvements have been made within the last 4-years, 2) the criteria
used for selecting task force members may not have included impartiality, 3) the
instrument used to assess the perception of respondents was flawed, 4) the
sampling method was inappropriate, 5) few statistical tests were performed, 6)
interpretations were made that not only were beyond what can be supported by the
data, but were outright incorrect, and 7) The report seemed to emphasize negative
“results” and deemphasize or exclude positive “results”; while overall, 80% of the
respondents viewed ORC positively.
One respondent noticed these concerns in his or her written response to the
questionnaire:
“Have you noticed—these survey questions have a negative bias—really
inviting the person taking the survey to come up with negative things to
say. This is not a well-written, non-bias survey. You would think the
researchers behind this survey would know better!”
Members of the ORC and compliance committees believe, in spite of the report’s
apparent skewed perspective, that there is value in the report, especially in the
suggestions offered by the respondents.
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Members of the ORC and compliance committees understand that the job
description of the Vice President of Research and Innovation includes responsibility
for compliance and that the Vice President necessarily will want to excel in meeting
this responsibility. What is being defined is the scope of that compliance oversight,
which can be large: human research, animal research, recombinant molecule
research, research integrity, underwater and on-water research, chemical research,
radiation research, Title IX, financial conflicts of interest, export control, DURC,
intellectual property protections, biological and information repositories, HIPPA.
Whether each of these areas of compliance is administered at the campus or system
level remains to be resolved completely and may have to be reexamined periodically
as the University system and individual campuses grow and change.
Members of the ORC and compliance understand that the upper leadership of the
University must make decisions and their decision to administer ORC at the system
level may have certain advantages. Administration’s decision, however, should be
based on these advantages and not on a flawed report that comes at the expensive
of the hard working people of the ORC. Unlike the previous administration’s
decision, which was made informally, to form the ORC and have it administered by
UHM, members of the ORC and compliance committees applaud that this new
administration has elected to follow a more formal process to help arrive at a
decision about moving ORC to system but only if that process is fair, open, and
considerate of all parties that will be affected by the change. Such a process
mitigates potential bias and promotes collegiality, essential elements of the
Academy.
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