ORSP Enhancement Task Force Meeting Minutes
Wednesday, October 3, 2012
Members Present: Cathy Christie, Newton Jackson, Jeff Will, Cheresa Hamilton, Carolyn Stone, Rick
Buck, Alex Schonning, and Mark Tumeo.
Absent: Andres Gallo, Mike Toglia and Newton Jackson.
1. Call to Order:
The meeting was called to order at 8:34 a.m.
2. Review/Approval of Minutes:
Minutes from the September 11th were reviewed and approved.
3. The following issues and recommendations were discussed.
Issue: IRB Membership.
Recommendation: The amount of research being conducted at UNF is small compared to other
institutions. We recommend that the ex-officio member from ORSP be the AVP Research to allow the
individual to become more aware of the research being conducted at UNF. Staff of the Research
Integrity Office should be responsible for providing administrative support to the Committee only.
Issue: The reviewers met with many faculty members who conduct human subjects research. The
reviewers consistently heard from the faculty members that it takes several weeks to get approval of an
Exempt project. Subsequently, after meeting with Research Integrity staff and informing them that it
appears that their process takes too long, Research Integrity Office provided us with the report in
Recommendation: The fact that we had heard from so many faculty that there is an issue with the
IRB is of concern to the reviewers. We were told and it was stated in the minutes of February 22, 2011
IRB meeting that it generally takes 4-6 weeks to be on the safe side, but it can take less time if the
protocol is well-organized. In our collective experience in overseeing human subjects projects at various
size institutions, an Exempt project should generally take 3 to 5 days for review. A full protocol review is
not a requirement. In our opinion and based on federal guidelines, the full Board should not review
Exempt protocols. This is very efficient. The determination should be based on the federal guidelines
and can be done by the IRB Chair or his or her designee. A member from each college for most types of
exempt applications is not required, as the principles of exemption are very clear. The review should
NOT be done by a staff person. Federal regulations also require that the IRB be provided with a list of
exempt protocols that have been reviewed. The Research Integrity staff should provide the reviewer
with the human subjects decision chart to use as a tool.
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html. If the criteria are met, then it should
be allowed to proceed as an Exempt project.
Issue: There was discussion about pushing the approval of Exempt protocols down to the college level.
Recommendation: The decision if a protocol is considered exempt or not is a decision for the IRB.
We do not recommend allowing non-IRB members to make decisions about research protocols involving
Issue: The reviewers heard that the Research Integrity Office reviews all human subject protocols
submitted by students as part of their class projects. The Director of Research Integrity makes written
comments and returns them to the student. It is uncertain if the IRB Chair or other members of the IRB
see the comments.
Recommendation: This activity is beyond the scope of the Research Integrity Director’s
responsibilities. The reviewers have heard that faculty are telling their students to follow the federal
guidelines and submit their protocols to the IRB with little or no faculty advisor review. This also
indicates to us that the faculty members may not be doing their jobs. It is the faculty member’s
responsibility to teach the students the appropriate way to write human subjects protocols and to have
them reviewed in advance of sending them to the IRB. This can reduce some of the IRB’s workload.
There appears to be time for staff in the Research Integrity Office to provide occasional lectures to
students about human subject research requirements. Students can also be invited to sit in on a review
of a protocol as a learning experience. As described to the reviewers, the amount of time spent on
student projects creates unnecessary delays for faculty research projects, which limits their productivity,
publications, and advancement of their career. It is recommend returning incomplete or unacceptable
student protocols to the advisor, as overseeing student research is the advisor’s responsibility.
Issue: It is uncertain whether students are required to participate in IRB training before undertaking a
Recommendation: Students and faculty who oversee student research should be required to
take the UNF-designated IRB training prior to submitting a protocol. In addition, the faculty members
should see that students get project-specific training where applicable.
Issue: The reviewers were told that amendments to approved protocols were not reviewed.
Recommendation: All amendment are to be reviewed by the IRB Chair or designee and reported
to the full IRB.
Issue: The Research Integrity Office staff reviews all protocols and makes detailed comments on them
before sending them to the IRB members for review.
Recommendation: The Research Integrity Office staff are not scientists, engineers or researchers.
In our opinion and from experience, it is not within their authority, and they should not be commenting
on protocols. They should only review proposal for completeness based on its type to ensure that all
parts of the project description, depending on the type of project, are complete and that the consent
forms are complete. Once the protocol is complete, staff discuss it with the IRB Chair to determine who
should review the protocol and send it to the IRB member for review. Commenting on the protocol,
science, and the informed consent document description is NOT the role of Research Integrity Office
Issue: Faculty have described issues where they have received comments back from the IRB and they
have made the recommended changes and resubmitted their protocols only to have requests for more
changes made because of a different reviewer.
Recommendation: The review of a human subjects protocol is not like reviewing a grant proposal.
Issues are identified upfront and painstakingly discussed. When a faculty member makes appropriate
changes, the IRB Chair or designee should verify that the changes are made, and that the protocol is
approved. It should be a rare instance when additional issues are identified.
Issue: The IRB members are only required to take CITI training and occasionally a member is allowed
to attend the PRIM&R annual meeting.
Recommendation: The Research Integrity Office should subscribe to some type of online
subscription service or newsletter that deals with human subjects protections. Topics of interest should
be discussed at every IRB meeting and documented in the minutes as continuing education.
Issue: The Chair of the IRB indicated not knowing what her responsibilities were in terms of
supervising Research Integrity Office staff.
Recommendation: While RI staff report directly to the AVP Research, the Chair of the IRB should
be able to direct activities of the RI staff in relation to the IRB. Personnel in RI are staff to the IRB and
are there to support it, but to not manage it. If issues arise, the Chair of the IRB should convey those
issues directly to the AVP Research.
Issue: The IRB Chair does not receive additional compensation for performing these duties.
Recommendation: At some institutions, the IRB Chair receives additional compensation for their
services. Based on the workload, UNF should consider a modest compensation for the IRB Chair. For
small to medium institutions this can be equivalent to partial summer salary of, for example, $1,500.
The IRB Chair has the option of accepting it or not. Similar compensation should also be offered to the
faculty Chair of the Institutional Animal Care and Use Committee.
Issue: There was some discussion about how to handle protocols that involve children and deception.
Recommendation: While the issue of deception does not require full Board review, it does require
that the institution have a policy on deception, which we understand UNF has. UNF should consider
adjusting it to limit full Board review to those cases where there is more than minimal risk, as assessed
by the IRB Chair or designee. USF has an excellent policy that UNF should consider retrofitting for their
IRB. It can be found at:
Issue: The reviewers heard that it takes too long for Expedited and Full Board review.
Recommendation: It is the reviewers’ opinion that an Expedited protocol should take about 7 to
10 working days for a review to take place. For Full Board reviews where the Committee meets only
once a month and has scheduled meetings each month, then the review should take in most cases no
more than a month plus a day or two to get comments back to the researcher.
Issue: Staff of the Research Integrity Office tell investigators what language to use in their protocols
and consent forms.
Recommendation: In reviewing comments, it was noted that we were not certain whether RIO
staff made language comments about a researcher’s protocols and/or informed consent documents.
Staff making comments about protocol language appears inappropriate to us as they are not
investigators or voting members of the IRB. It is not unusual for the IRB to have standard language and
alternate language for certain components of an informed consent document, but beyond that staff that
support the IRB should not be responsible for making those types of comments in our collective opinion.
Issue: The review team heard about several instances where UNF was collaborating with other
institutions where there either was a nationally developed human subjects protocol or a protocol
developed at a consulting institution and approved by the primary institution. The Research Integrity
Office reportedly independently or with the IRB concurrence reviewed the protocol and wanted changes
made to the protocol. The IRB also conducted a Full Board Review.
Recommendation: While an IRB has the authority to do this, it is surprising to learn of the
frequency that this happens. The reviewers recommend that UNF consider entering into Affiliation
Agreements with other institutions to allow for approval of the other IRB’s approval. This requires the
approval of the IRB Chair and notification to the IRB Committee of the action.
Issue: The reviewers were told that in the past there was a time when there was no staff in the
Research Integrity Office and that no IRB protocols were reviewed for several months.
Recommendation: If the University of North Florida sees itself in this position again, whether
because of no staff in the Research Integrity Office, or that it cannot achieve the appropriate
membership on the IRB, ORSP should contract with a for-profit third party for the reviews as opposed to
holding up reviews and delaying teaching or research projects.
Issue: The reviewers heard from interviewees that the IRB did not collect final reports on IRB
approved projects, and that reports were not reviewed by the IRB. The reviewers did not have an
opportunity to verify this assertion since to do so would require an audit of IRB records which was
outside the scope of this project.
Recommendation: The IRB is required to receive and review all final reports and continuing
reviews for full and expedited protocols. This information should be listed in the IRB minutes. UNF
should undertake an audit of its IRB to ensure that its reporting standards are aligned to and in
compliance with federal regulations.
Issue: The reviewers heard that IRB protocols and related materials were not locked up in an
appropriately safe and secure manner, but allowed to lie out in the office.
Recommendation: All IRB reports should be kept in files in a locked cabinet.
Issue: The question was raised about whose job is it to develop standard operating procedures
related to the IRB.
Recommendation: The Federal Wide Assurance requires the development and adoption of
policies and procedures for conducting human subject research and the appointment of an institutional
official to oversee the University’s compliance with federal regulations pertinent to human participants
in research. The institutional official at the University of North Florida, as designated by the Provost and
Vice President for Academic Affairs of the University, is the Assistant Vice President for Research, who
should headed up the committee, with the IRB chair, IRB staff and a researcher versed in human
subjects research to develop the standard operating procedures. The responsibility falls squarely on the
AVP Research’s shoulders.
Issue: ORSP needs additional staffing in the Research Integrity Office to handle the large number of
human subjects protocols.
Recommendation: There does not appear to be a need for additional staff. Their workload is far
below what similar staff do at other institutions.
Issue: In our opinion the Research Integrity Office staff and the IRB want to do a good job, but they do
not appear to know what or how they are doing in respect to other institutions.
Recommendation: It is recommended that a comprehensive IRB audit be conducted by individuals
external to UNF. That is beyond the scope of this engagement and should take about 2 days on site.
Issue: ORSP purchased IRBNet to expedite the process for protocol submission and review.
Recommendation: It is uncertain what impact the IRBNet will have on IRB process. The Research
Integrity Office staff should keep track of timelines and whether or not their process improves. It is
uncertain if IRBNet will help with the communication issue between researchers and Research Integrity
The committee had a general discussion about the role of the IRB and the specific issues listed above.
We came up with several questions further discussion points and decided to invite Dr. Kathe Kasten to
our next meeting to discuss this entire section of the report with us. Dr. Christie will issue the invitation
for the next meeting.
5. The meeting was adjourned at 10:45 am.
The next meeting is scheduled for Wednesday October 10th from 9:00 – 11:00 a.m. in
conference room 3031, building 39.