ORSP Enhancement Task Force Meeting Minutes
Wednesday, October 10, 2012
Members Present: Cathy Christie, Jeff Will, Cheresa Hamilton, Carolyn Stone, Alex Schonning, Mark
Tumeo, Mike Toglia, Andres Gallo and Rick Buck.
Absent: Newton Jackson
1. Call to Order:
The meeting was called to order at 9:07 a.m.
2. Review/Approval of Minutes:
Minutes from the October 3rd meeting were deferred until the next meeting.
3. Organization for Discussing the Recommendations
Dr. Kathe Kasten joined us for discussion of the issues and recommendations under the IRB section of
the SRA report. Dr. Kasten presented some background information about the IRB situation when she
became chair and then discussed six recommendations for the task force to consider.
1- The IRB should reexamine the protocol for exempt protocols. It is currently the same as for
expedited protocols with the exception that expedited protocols are approved for one year and
then must be reapproved for continuation while exempt protocols are approved once with no
reexamination unless risk to human subjects is significantly changed.
2- The procedure which involves ORSP staff suggesting language to PIs for protocol change was an
issue. It may be possible to include suggested language in IRBnet for PIs to select up front rather
than as feedback for proposals submitted which delays approval.
3- The IRB should look seriously at cooperative agreements with major entities who also have an
active IRB such as hospitals, clinics, and school boards, to facilitate approval and reduce time
spent submitting and waiting for two IRB approvals.
4- The IRB has made changes to facilitate student project approval and to work with the
5- IRB staff and board members should be more involved in education and outreach to faculty and
6- Guidelines should be established for when faculty use their own students’ work such as
reflection papers for transformational learning and community based projects as research.
She also reported that the Standard Operating Procedures were revised and submitted for approval in
November 2010. They were approved in January 2011. There was a companion document submitted as
well that was never approved.
Following the discussion with Dr. Kasten, the following issues and recommendations were discussed.
Animal Care and Use
The humane care and use of animals should be of utmost concern to the University of North Florida.
The reviewers were charged with conducting a high level review of the research enterprise at UNF. A
comprehensive review of the Animal Care and Use program was not part of this engagement. We were
not charged to ensure compliance with federal regulations. As such, a review of policies, procedures,
practices, training records, and other materials that are generally maintained by the Research Integrity
Office were not reviewed. However, during our review and discussions, we identified a few issues that
should be addressed. We do make some general recommendations on issues that we observed.
Issue: The reviewers observed that there is detailed information about the animal care and use
program on UNF’s Research Integrity website, including the names of the members of the IACUC, names
of the faculty doing research, and minutes of IACUC meetings.
Recommendation: There have been many issues related to animal rights groups who obtained
information about IACUC committee members and faculty who have conducted animal research. These
groups have held protests at universities, and have used the information to harass, intimidate, threaten,
and disrupt the research of faculty. UNF needs to maintain a well-run animal care and use program, but
it does not need to have all that information on the university website. It is recommended that the
current information be removed as soon as possible. It also is recommended that the website and any
related websites only contain the following information: A statement that UNF follows federal animal
care and use regulations, the Animal Welfare Assurance Number, the phone number for the Research
Integrity Office, and references to federal regulations related to care and use of animals. This having
been said, we recognize that Florida laws and regulations about public disclosure of information related
to state institutions may require certain disclosures. Therefore, it is recommended that UNF consult
with its sister institutions about what should be disclosed.
Issue: Research Integrity Office staff review award documents and budgets to determine if animals
will be ordered on a project.
Recommendation: Staff of Research Integrity Office should know if animals are to be involved in a
project. If a question about animal usage is not listed on the internal clearance form it should be. This
should be easily tracked through their database or they should be alerted when an award is issued when
animals are indicated. This appears to be a waste of Research Integrity Office staff time. Furthermore, if
there is only one central person who is responsible for authorizing animal purchases (for example, a
designated purchasing agent) this should provide an appropriate check and balance.
Issue: UNF has just had new animal facilities constructed. At present this facility is in pristine
condition. UNF should consider if it wants its animal facility accredited by AAALAC.
Recommendation: AAALAC is considered the gold standard for accreditation of animal facilities.
Obtaining AAALAC accreditation creates research opportunities for UNF. This may be attractive to hiring
new faculty who conduct animal research. Some research funders will provide support for animal
research only if the facility is AAALAC accredited. In addition, UNF can allow researchers from other
institutions to use UNF’s facility on a cost plus reimbursable basis to offset the cost of operation. Others
may decide to teach elsewhere, but hold a dual appointment and conduct their research at UNF.
Issue: UNF needs to obtain adequate IACUC membership and ensure attendance at meetings.
Recommendation: IACUC membership requires a minimum of five members including a scientist,
veterinarian, a non-scientist, and a non-affiliated member. The non-affiliated member and non-scientist
can be the same individual. UNF has had a difficult time getting individuals to participate in the
Committee. It is recommended that UNF seek out non-affiliated and non-scientists from the
community. They can be teachers, retired individuals, members of the clergy. The non-affiliated
member is crucial because this person is required for a quorum. We also recommend that the ex-officio
member from ORSP be the Assistant Vice President for Research to allow the individual to become more
aware of the research being conducted at UNF. A representative from the Research Integrity Office
should be responsible for staffing the Committee. If the IACUC has trouble getting people to attend
meetings, they should consider the use of alternate members.
Issue: We were informed that the IACUC meets only twice a year, at the beginning of each semester.
Recommendation: It is uncertain if there are protocols submitted between meetings and how
their reviews are handled so as not to delay research. It is recommended that the Committee consider
meeting more frequently to maintain continuity of the members, engage in training of Committee
members, and review of protocols, amendments and final reports.
Issue: The IACUC uses only the CITI online animal training program for members of the Committee
and investigators. The Chair of the IACUC has gone to a national IACUC training program.
Recommendation: We commend the AVP Research for providing support for the IACUC Chair to
attend a national meeting on animal care and use. Training of IACUC members should be an ongoing
endeavor. We recommend that at each meeting of the IACUC, the veterinarian present some type of
training related to animal research to the Committee and/or that the Research Integrity Office subscribe
to on-line or other publications about animal care and use issues.
Issue: The IACUC application that faculty complete for submission to the IACUC for approval is shorter
than what has been used by members of the review team and does not contain what we consider to be
the elements of other applications we have seen. For example, the current IACUC application does not
request the number of animals that are required to be used and how this number was determined.
There also was no description of statistical methods.
Recommendation: It is recommended the IACUC consider revising its IACUC application and
request additional information about animal protocols. An IACUC application that can be considered for
use by the IACUC is in Appendix D.
Issue: From discussions, it was not easily determined what occurs after the end of a protocol. In
addition, we did not identify from the website if there was a final report form to be used following
completion of an animal protocol.
Recommendation: It needs to be determined if there is a final report form, if such forms are
required to be submitted by researchers, if they are reviewed by the IACUC, and if they are maintained
by the RI Office. A new version of the “Guide for Animal Welfare” was published in 2011 and can provide
guidance on this topic. The IACUC and the Research Integrity Office staff should ensure that UNF’s
animal care and use program conforms to the Guide.
Issue: It appears that there is more than one individual who can order animals from Purchasing and
more than one individual handles the ordering in Purchasing. There appears to be no check and balance
to ensure that IACUC ordering of animals has been approved by the IACUC and that there is room in the
animal facility to house the animals when they arrive.
Recommendation: There should be a procedure for ordering animals through Purchasing. No
faculty members should be allowed to order animals on their own, and no animals should be housed in
a faculty member’s laboratory. There should only be one individual who is authorized to contact
Purchasing and place an order for animals, with possibly a back-up. In many cases this is the person in
charge of the day-to-day management of the animal facility. This person knows the amount of animals
that can be accommodated in the facility at any one time, and the species of animals that have
approved protocols. Similarly, there should be only one person, with an alternate, who does the actual
purchasing of animals from a vendor. Any purchase order for animals must contain the date of the
IACUC approval and the IACUC approval number.
Issue: Not all animal projects are processed through the IACUC, especially field work.
Recommendation: The AVP Research and IACUC Committee need to communicate the need for
all research involving animals conducted by UNF researchers to be reviewed and approved by the
IACUC. The negative implications of such projects not being processed through the University should an
adverse event occur could have detrimental effects on the reputation of the University and the faculty
member. This calls for increased communication between the AVP Research, IACUC, colleges,
departments, and faculty. One means of verifying that protocols have been approved by the IACUC are
a review of faculty member’s publications. However, this is an after-the-fact event, and not a proactive
Issue: There does not appear to be a description of the roles and responsibilities of the IACUC
members and Chair.
Recommendation: There needs to be written description on the roles and responsibilities of the
IACUC Chair and members. If such a document exists, it needs to be communicated to them, and
members should undergo more specific training.
Issue: The IACUC may be paralyzed by detail. The Committee needs to understand the difference
between attention to detail versus what are really big problems that should be addressed.
Recommendation: One way for the Committee to do this is to engage an IACUC Chair or member
from another institution to review specific troublesome protocols and make a written report to UNF’s
IACUC. The researcher’s application and the external reviewer’s comments are considered by UNF’s
IACUC in reaching its decision. This also provides a learning experience for UNF’s IACUC.
Issue: There are federal regulations related to marine mammals.
Recommendation: Both the IACUC and ORSP need to be aware of the federal regulations as they
pertain to marine mammal research being conducted. If the IACUC and/or ORSP are uncertain about
specific regulations it is advisable that they contact other institutions who do similar research to
determine how they undertake such activities.
The committee discussed the issues related to animal care and use and concluded that if the market
justifies, it makes sense to pursue accreditation by AAALAC.
5. The meeting was adjourned at 11:00 am.
The next meeting is scheduled for Tuesday October 16, 2012 from 9:00 - 11:00 a.m. in
building 39, conference room 3031.