IRB Executive Committee Minutes

Meeting Date: 5/12/14

Agenda Item: Update on CMRR
Item Description:
Information was presented to the committee from the recent meeting between IRB and CMRR
representatives. Issues previously identified by the IRB Executive Committee regarding
in subject tracking and adverse event reporting were clarified as follows:
Subject Tracking CMRR must maintain a record of which subjects go into the magnets
and when. This record can be in a format chosen by CMRR. However, elements that must
be recorded are: subject name, date of birth, type of MRI machine/Tesla level, and date of
scan. Any issues of individual PI non-compliance with this requirement should be reported
to the IRB by CMRR.
Adverse Events Any adverse events that are subject/researcher-related should be
reported to the IRB by the PI and those that are machine-related should be reported to the
IRB by CMRR.
Discussion of Controverted Issues Summary:

The committee voted as a duly-convened IRB in favor of the following:

Based on risk assessment and outside expert consult, it is recommended that the subject tracking
requirement be waived for standard use of 3T magnets. All non-standard use of 3T and all use of
higher Tesla levels must still maintain a record to track subjects.

Implementation of subject tracking requirements will be confirmed over the next three months
and compliance will be monitored.

Vote

Yes: 8

No: 0

Abstain: 0

Members Present for Vote: Susan Berry, Joanne Billings, Robert Haight, Darlette Luke, June Nobbe,
Michael Oakes, Don Quick and Debra Dykhuis
Members Not Present: Scott Crow

IRB Executive Committee Minutes

Meeting Date: 5/12/14
Agenda Item: Request for extension on open investigations
Item Description:
Progress on both open investigations (bifeprunox and Fairview issues) was presented to the committee.
The panels for both investigations request an extension of the three month expected time limit for
completion, which is stated in HRPP Policy 408A.
Discussion of Controverted Issues Summary:

The IRB Executive Committee voted, as a duly-convened IRB, to extend the time for conduct of both
investigations, with the understanding that progress will be reported monthly to the committee until
investigations are completed and determinations made.
Vote

Yes: 8

No: 0

Abstain: 0

Members Present for Vote: Susan Berry, Joanne Billings, Robert Haight, Darlette Luke, June Nobbe,
Michael Oakes, Don Quick and Debra Dykhuis
Members Not Present: Scott Crow

IRB Executive Committee Minutes

Meeting Date: 8/11/14
Agenda Item: Preliminary Report for Bifeprunox
Investigation
Item Description:
Per IRB Policy 408A, the preliminary report on the Bifeprunox Investigation, prepared by the
Investigation Panel, is submitted for review and decision by the IRB Executive Committee.

Discussion of Controverted Issues Summary:

Members Present for Vote: Susan Berry, Darlette Luke (by phone), Margaret MacMillan, June Nobbe,
Michael Oakes, Don Quick, Sarah Jane Schwarzenberg, and Debra Dykhuis
Members Not Present: Joanne Billings, Scott Crow, Robert Haight and Michael Steenson

IRB Executive Committee Minutes

Meeting Date: 5/12/14
Agenda Item: Adverse Event Report reviewed by IRB
Medical Committee on May 7, 2014
IRB #: 0905M65804
PI: Shapiro, Elsa
Item Description:
An unanticipated problem report for IRB protocol #0905M65804 was reviewed by the IRB Medical
Committee on May 7, 2014, and approved with stipulations. This report involves events experienced by a
minor subject at the time of her 3T scan for the neuroimaging component of the study (popping sound,
sensation of being shocked, feeling of warmth) related to her programmable shunt. However, after
additional discussion of continuing concerns among several attending IRB members, the IRB Executive
Committee was requested to consult on and review this report.
Discussion of Controverted Issues Summary:

After review, the IRB Executive Committee voted as a duly-convened IRB to defer this report pending
receipt of additional information. Due to the fact that similar events were reported to the IRB in April
2013 and that concerns were expressed about the possibility of the problem occurring again during the
events of the current report, the IRB is concerned that decision was made to go ahead with the scan.
There is no direct benefit to the subject for participation in this study; therefore, the decision to continue
the scan in light of these events altered the risk/benefit balance of the research for this subject.
Additionally, the rationale provided for continuing with the scan (the possibility that the subject finds
herself in an emergent situation in the future) created a scenario in which CMRR and study staff were
engaging in device safety testing rather than the approved research activity.
As a result, the IRB determined that these events constitute an unanticipated problem that involves risks
to subjects or others and thereby suspended enrollment in this study of subjects with programmable
shunts pending resolution of the following issues to be addressed by the PI:

Confirm that these events will be reported to the device manufacturer (Medtronic). The IRB
requests that Medtronic comment on the safety of the shunt in this situation and what they
believe may have been the likely cause of these events. Confirm whether the first occurrence of
these events (as reported to the IRB April 2013) was also reported to Medtronic at that time.
The IRB believes a Medwatch report should be submitted to the FDA regarding these events in
this subject. Confirm a Medwatch report will be filed or provide rationale for not doing so.
Are the 10-second localizer and 4-minute FLAIR sequence part of this research study? That is,
would all subjects enrolled in this study undergo those scanning sequences?
Provide an explanation of the decision making process with regard to safety.
Explain how the determination was made (e.g. what procedures were followed) regarding
whether the continuation of the scan reflected clinical care or research.

Enrollment of subjects with programmable shunts may not be resumed in this study until/unless these issues are
resolved and the IRB has lifted this suspension.
Please confirm in writing within 10 business days of the date of this letter (June 6, 2014):
That no subjects with programmable shunts will be enrolled during this suspension.
That the study sponsor(s) has been notified of this suspension of enrollment.

We cannot conclude review of this report until you respond to this request. Please respond within 30 days of the
date of this letter.
Please note: According to federal regulations, when the IRB makes a determination of serious and/or continuing
noncompliance or when the IRB suspends any part of a study, we are required to report to regulatory
authorities, the study sponsor and institutional officials. You will be copied on these notifications.
The IRB was also concerned about the distinction between the operations of CMRR and the CCIR
(Center for Clinical Imaging Research) and the potential for a loss of distinction between the research
clinical use of MRIs in the CMRR and CCIR.

Vote

Yes: 8

No: 0

Abstain: 0

Members Present for Vote: Scott Crow, Joanne Billings, Robert Haight, Darlette Luke, June Nobbe,
Michael Oakes, Don Quick and Debra Dykhuis
Members Not Present: Susan Berry

IRB Executive Committee Minutes

Meeting Date: 10/13/14
Agenda Item: Review and Recommendation for determination/action on Bifeprunox Investigation
Report and PI Response
Item Description:
Per IRB Policy 408A, the revised report for the Bifeprunox Investigation, as accepted by the IRB
Executive Committee at its September 8, 2014 meeting

Discussion of Controverted Issues Summary:

Members Present for Vote: Joanne Billings, Debra Dykhuis, Darlette Luke, Margaret MacMillan, June
Nobbe, Michael Oakes, Don Quick, and Sarah Jane Schwarzenberg
Members Not Present: Susan Berry, Scott Crow, Robert Haight and Michael Steenson

IRB Executive Committee Minutes

Meeting Date: 9/8/14
Agenda Item: Proposed Amendments to the Preliminary Report for Bifeprunox Investigation
Item Description:
Per IRB Policy 408A, the preliminary report for the Bifeprunox Investigation, prepared by the
Investigation Panel, was submitted for review and decision by the IRB Executive Committee on August
11, 2014 and the committee voted to accept with proposed edits to be reviewed at the September 8, 2014
meeting.

Discussion of Controverted Issues Summary:

Members Present for Vote: Susan Berry, Joanne Billings, Robert Haight, Darlette Luke, Margaret
MacMillan, June Nobbe, Don Quick, Sarah Jane Schwarzenberg, and Debra Dykhuis
Members Not Present: Scott Crow, Michael Oakes and Michael Steenson

IRB Executive Committee Minutes

Meeting Date: 10/13/14
Agenda Item: Response to Deferral of Unanticipated Problem Report for 0905M65804, PI Elsa Shapiro
Item Description:
The PI has provided partial responses to the IRBs questions. She has said that there are difficulties in
getting the numbers needed to make a report to Medtronic; therefore, she has not responded to this
stipulation. The study is still on hold for subjects with shunts, and the PI says she does not plan to
resume with these subjects.
Dr. Whitley will be
taking over the study as principal investigator.
Discussion of Controverted Issues Summary:

The Executive Committee acted as a convened IRB in its review of the response to deferral of 0905M65804.

The IRB will schedule a face to face meeting with Drs Shapiro and Whitley to take place at the Executive
Committee meeting in November.

Members Present for Vote: Joanne Billings, Debra Dykhuis, Darlette Luke, Margaret MacMillan, June
Nobbe, Michael Oakes, Don Quick, and Sarah Jane Schwarzenberg
Members Not Present: Susan Berry, Scott Crow, Robert Haight and Michael Steenson

IRB Executive Committee Minutes

Meeting Date: 11/10/14
Agenda Item: Response to deferral and discussion of outstanding issues related to unanticipated problem
report for 0905M65804, PI Elsa Shapiro
Item Description:
Dr. Whitley has assumed the role of PI
. Previously requested
information has been provided and the PI confirms he will not resume enrollment (permanently) of
subjects with programmable shunts.
Discussion of Controverted Issues Summary:

On October 13, 2014, the Executive committee, acting as a convened IRB, requested that Dr. Elsa Shapiro and
Dr. Chet Whitley (as new PI) attend the November 10th Executive committee meeting to discuss in person the
outstanding issues related to this review. In response to this request the following people were in attendance at
the November 10, 2014 meeting: Dr. Shapiro (by phone), Dr. Whitley (now PI on the study), and study staff
Igor Nestrasil, Brenda Diethelm-Okita and Kathleen Delaney. The committee also reviewed materials provided
by study staff via emails of 10/16/14 and 11/9/14 in support of this discussion.
The IRB noted that a requested PI change has been made as of October 20, 2014 to reflect Dr. Whitley as PI and
Dr. Shapiro as co-investigator
Dr. Nestrasil noted that information had been obtained from Medtronic regarding the possible effects from MRI
on the programmable shunt device and provided an explanation of this for the committees review. Dr. Whitley
confirmed that, per the IRBs suspension on May 12, 2014, they have stopped enrollment of subjects with
programmable shunts, and will not resume enrollment of these subjects. He also noted that they had consulted
Dr. Jerry Froelich at CMRR regarding the actions surrounding the time of the event, confirming that the subject
was seen by a neurologist following the event and no reset of the shunt was needed.
The committee thanked the PI and study staff for attending before they left the room for deliberations. The
committee then discussed the issues and responses presented, and noted that the following is required: The
current PI should submit an updated application and protocol to reflect the exclusion of subjects with
programmable shunts and should document how it will be determined whether a subject has a programmable
shunt, which would affect the subjects eligibility for participation in the study. Once this information has been
reviewed and approved by the IRB, resolution of the suspension of enrollment of this subgroup of subjects can
be noted.

Vote

Yes: 8

No: 0

Abstain: 0

Members Present for Vote: Joanne Billings, Debra Dykhuis, Bob Haight, Keith Horvath, Darlette Luke,
Michael Oakes, Don Quick, Sarah Jane Schwarzenberg
Members Not Present: Susan Berry, Scott Crow, Margaret MacMillan, June Nobbe

IRB Executive Committee Minutes

Meeting Date: 11/10/14
Agenda Item: Allegations of

prompted by complaint IRB #1002M78216, PI: Verneris

Item Description:

Discussion of Controverted Issues Summary:

Members Present for Vote: Susan Berry, Joanne Billings, Debra Dykhuis, Robert Haight, Keith Horvath,
Darlette Luke, Michael Oakes, Don Quick, and Sarah Jane Schwarzenberg
Members Not Present: Scott Crow, Margaret MacMillan and June Nobbe

IRB Executive Committee Minutes

Meeting Date: 12/8/14
Agenda Item: Results of Post-Approval Review audit on allegations of
complaint IRB #1002M78216, PI: Verneris
Item Description:

Discussion of Controverted Issues Summary:

Members Present for Vote: Susan Berry, Joanne Billings, Debra Dykhuis, Keith Horvath, June Nobbe,
Michael Oakes, and Don Quick
Members Not Present: Scott Crow, Robert Haight, Darlette Luke, Margaret MacMillan and Sarah Jane
Schwarzenberg

prompted by

IRB Executive Committee Meeting

May 12, 2014, 1:30-3:00pm
Members Present: Susan Berry (chair), Joanne Billings, Robert Haight, Darlette Luke, June Nobbe, Michael
Oakes (vice-chair), Don Quick, Scott Crow (arrived at 2:20pm)
Members Absent: Sarah Jane Schwarzenberg, Michael Steenson
Ex Officio/Non-Voting Members Present: Adrienne Baranauskas, Brian Herman (arrived at 2:35pm)
Ex Officio/Non-Voting Members Absent: Joyce Trost, Barbara Shiels, Sarah Waldemar
Staff: Debra Dykhuis, Cynthia McGill, Linnea Anderson, Andrew Allen, Christina Dobrovolny, Jeffery
Perkey, Felicia Mroczkowski, Laura Conger, Molly Weistenberg

Discussion Items

1. Review of 2014.04.14 IRB Exec meeting recap (Berry)

An update to the version initially sent out to members was made, indicating a word change. Under
item 3 in the final sentence of the first paragraph the word may was changed to will.
2. CMRR Update (Oakes)
Information was presented to the committee from the recent meeting between IRB and CMRR
representatives. Issues previously identified by the IRB Executive Committee regarding noncompliance in subject tracking and adverse event reporting were clarified as follows:
Subject Tracking CMRR must maintain a record of which subjects go into the magnets
and when. This record can be in a format chosen by CMRR. However, elements that must
be recorded are: subject name, date of birth, type of MRI machine/Tesla level, and date of
scan. Any issues of individual PI non-compliance with this requirement should be
reported to the IRB by CMRR.
Adverse Events Any adverse events that are subject/researcher-related should be reported
to the IRB by the PI and those that are machine-related should be reported to the IRB by
CMRR.
The committee voted as a duly-convened IRB in favor of the following:
Based on risk assessment and outside expert consult, it is recommended that the subject
tracking requirement be waived for standard use of 3T magnets. All non-standard use of
3T and all use of higher Tesla levels must still maintain a record to track subjects.

The committee does not find CMRR to be in serious/continuing non-compliance at this

time. Implementation of subject tracking requirements will be confirmed over the next
three months and compliance will be monitored.
(Scott Crow was not present for this vote.)
3. Update on Investigations (Weistenberg)
Two IRB initiated investigations are currently open to look into issues raised regarding studies
associated with research being done by the Department of Psychiatry: one on selected studies
involving bifeprunox and the other on studies involving research activities conducted at Fairview
facilities. The two investigations are being conducted by separate investigation panels and address
separate issues.
Progress on both open investigations was presented to the committee. The panels for both
investigations request an extension of the three month expected time limit for completion, which is
stated in HRPP Policy 408A.
The IRB Executive Committee voted, as a duly-convened IRB, to extend the time for conduct of
both investigations, with the understanding that progress will be reported monthly to the
committee until investigations are completed and determinations made. (Scott Crow was not
present for this vote.)
4. Research at the State Fair (Anderson)
Based on information provided by Dr. Logan Spector, 30 slots have been set aside for research to
be conducted at the Minnesota State Fair. All submissions for research at the State Fair are
required to be submitted to HRPP for review by June 1, 2014. HRPP will hold and track these
submissions as they come in. All submissions will be reviewed by a full IRB committee
(constituted mostly from members of the IRB Executive Committee), specifically convened for
this purpose in a separate meeting. Scheduling of this meeting will be communicated to
committee members by HRPP staff as information is finalized.
Members of the IRB and HRPP staff also met with Dr. Spector and discussed issues of concern
that are specific to the research venue. Main issues discussed included: capacity to consent, use
of incentives, timing of informed consent, and collection of blood for DNA testing.
Dr. Spector provided responses that reasonably addressed the IRBs concerns. Any other issues
identified by the committee or HRPP staff at a future date will be communicated to Dr. Spector as
soon as possible.
A presence at the venue by the IRB, in the form of an informational poster and/or brochures, was
also discussed.
5. Item from May 7, 2014 IRB Medical Meeting (Crow)
IRB #0905M65804 PI: Shapiro, Elsa
Title: Longitudinal studies in MPS Disorders: A Multicenter Study of the Lysosomal Disease
Network
An unanticipated problem report for IRB protocol #0905M65804 was reviewed by the IRB
Medical Committee on May 7, 2014, and approved with stipulations. This report involves events

experienced by a minor subject at the time of her 3T scan for the neuroimaging component of the
study (popping sound, sensation of being shocked, feeling of warmth) related to her programmable
shunt. However, after additional discussion of continuing concerns among several attending IRB
members, the IRB Executive Committee was requested to consult on and review this report.
After review, the IRB Executive Committee voted as a duly-convened IRB to defer this report
pending receipt of additional information. Due to the fact that similar events were reported to the
IRB in April 2013 and that concerns were expressed about the possibility of the problem occurring
again during the events of the current report, the IRB is concerned that decision was made to go
ahead with the scan. There is no direct benefit to the subject for participation in this study;
therefore, the decision to continue the scan in light of these events altered the risk/benefit balance
of the research for this subject. Additionally, the rationale provided for continuing with the scan
(the possibility that the subject finds herself in an emergent situation in the future) created a
scenario in which CMRR and study staff were engaging in device safety testing rather than the
approved research activity.
As a result, the IRB determined that these events constitute an unanticipated problem that involves
risks to subjects or others and thereby suspended enrollment in this study of subjects with
programmable shunts pending resolution of the following issues to be addressed by the PI:

Confirm that these events will be reported to the device manufacturer (Medtronic). The
IRB requests that Medtronic comment on the safety of the shunt in this situation and what
they believe may have been the likely cause of these events. Confirm whether the first
occurrence of these events (as reported to the IRB April 2013) was also reported to
Medtronic at that time.
The IRB believes a Medwatch report should be submitted to the FDA regarding these
events in this subject. Confirm a Medwatch report will be filed or provide rationale for not
doing so.
Are the 10-second localizer and 4-minute FLAIR sequence part of this research study?
That is, would all subjects enrolled in this study undergo those scanning sequences?
Provide an explanation of the decision making process with regard to safety.
Explain how the determination was made (e.g. what procedures were followed) regarding
whether the continuation of the scan reflected clinical care or research.

6. Suspension of UMN IRB-approved protocol #0907M69523 by Allina IRB Provider (Dykhuis)

IRB #0907M69523 PI: Traverse, Jay
Title: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
A study that has been approved by the UMN IRB was recently determined not approvable by the
IRB reviewing for research activities conducted at the primary Allina site. This determination
may result in the need for a suspension of the UMN study, but will be discussed once further
information regarding this matter is obtained from the IRB provider serving the Allina site.
7. Information on Faculty Senate Mandate for independent review of HRPP (Herman)
Vice President Herman provided an update on the progress of the search for an independent group
to complete the review of HRPP, per the Faculty Senates mandate of December 2013. Multiple
groups were sent the RFP and two responses are currently still under consideration. One of these
groups is expected to be chosen based on their response.
Standing Agenda Items
8. PAR update (Mroczkowski)
Informal report was presented, stating that activities are progressing appropriately within HRPP
policy and procedure. A formal report, including volumes of items reviewed, will be brought
before the committee at a future date.
9. Subject Advocate Update (Mroczkowski/Baranauskas)
6 calls were received through the Research Subjects Advocate Line in April, with 8
issues/questions expressed.
Materials were also provided regarding volume and details of calls to the Fairview Helpline.
10. AAHRPP Reaccreditation Policy Review (HRPP Staff)
HRPP has a total of 113 IRB-related policies that require review as part of the AAHRPP Reaccreditation process. We have committed to provide all policies to our AAHRPP Accreditation
consultant, Western IRB, by June 1. All policies requiring substantial revisions will continue to
be brought before the committee for review and approval.
Progress as of 5/12/14:
Scheduled for HRPP Internal Review
Still in HRPP Internal Review process
HRPP Internal Review complete
Total
Already sent to Western IRB for consultation

88 policies
31 policies
60 policies
113 policies
40 policies

11. IRB Membership Update (Perkey)

Orientation was completed by new members, Deb Englehardt and Insoon Han. Deb will be joining
the Medical IRB roster and Insoon will be joining the Student Social Roster.
Next Meeting: June 9, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

June 9, 2014, 1:30-3:00pm
Members Present: Susan Berry (chair), Robert Haight, Darlette Luke, Michael Oakes (vice-chair), Don
Quick, Sarah Jane Schwarzenberg
Members Absent: Michael Steenson
Ex Officio/Non-Voting Members Present: Adrienne Baranauskas, Brian Herman, Barbara Shiels (arrived
2:15pm), Sarah Waldemar, Joyce Trost
Ex Officio/Non-Voting Members Absent:
Staff: Debra Dykhuis, Cynthia McGill, Linnea Anderson, Andrew Allen, Christina Dobrovolny, Jeffery
Perkey, Felicia Mroczkowski, Laura Conger, Molly Weistenberg

Discussion Items
1. Review of recap from May 12, 2014 meeting (Berry)
2. Bifeprunox/Stephen Olson Investigation Update (Schwarzenberg/Dykhuis)

The report of the investigation is expected to be presented for a vote at the next IRB Executive
Committee meeting.
3. Investigation Requested by Fairview Update (Oakes/Webster)
This investigation is concerned with the broader issues of complaints expressed by Fairview staff
regarding the culture and recruitment practices of psychiatric trials in the Fairview clinical setting.
Records have been reviewed on multiple trials identified as enrolling subjects from the bipolar/schizophrenia population. Interviews have also begun and will continue until sufficient
information for the panel to evaluate subject safety has been obtained.
The investigation process is going well so far, with excellent cooperation from all persons
involved. No issues which would cause delay have currently been identified as of now with

resources or cooperation. However, due to the large amount of information to be reviewed, this
investigation is projected to take longer than initially anticipated.
4. Evaluation of IRB policies and procedures by an external panel (Herman)
AAHRPP has been retained as the vendor for the management of the evaluation of IRB policies
and procedures by an external panel, prompted by the mandate from the Faculty Senate
Committee in December 2013. AAHRPP will be in charge of administratively managing
investigation conducted by the following team of experts: Dr. Melissa Frumin (Harvard Medical
School), Joan Rachlin (former executive director, Public Responsibility in Medicine and
Research), and Dr. Jeremy Sugarman (John Hopkins University). AAHRPP will play no role in
the substantive analysis, decision-making, conclusions or recommendations of the team.
Will Durfee will serve as the Universitys point of contact with AAHRPP. Experts will likely be
at the University in Fall 2014 to review HRPP, the Department of Psychiatry, Fairview, and other
units at the University as specified. All information requested by the evaluation team (beyond
identifiable patient/subject information) will be provided in a transparent manner, where possible.
Some of the information requested will likely intersect with current investigations conducted by
the IRB Executive Committee and with information compiled in preparation for AAHRPP Reaccreditation. A complete report on the evaluation, which will go to the faculty senate for review
and questions, is expected by the end of calendar year 2014.

Standing Agenda Items

1. PAR update (Mroczkowski)
A verbal summary of recent PAR activities was provided (i.e. risk based site reviews, random site
reviews, self-assessments, eligibility checks, etc.) Current metrics will be provided via report
form at subsequent Exec meeting. AAHRPP averages in comparison to PAR metrics will be
included.
2. Subject Advocate Update (Mroczkowski/Baranauskas)
The May 2014 Research Subject Advocate Line report was shared with members. Six calls were
received during this reporting period all of which were questions specific to one research study
and required forwarding to the PI. It was noted that the May 2014 reporting period included one
fewer call than the previous year (May 2013). IRB members were also given advance notice of a
recent (June 2014) report from a subject related to an injury sustained during participation (stress
fracture during an exercise intervention). The PI (Dr. Arendt) was required by PAR staff to send a
UPIRTSO report promptly.
3. AAHRPP Reaccreditation Policy Review (HRPP Staff)
HRPP has completed its initial review of all 113 IRB policies in preparation for AAHRPP reaccreditation. A small group of policies still require administrative and internal revisions through
both HRPP and other involved institutional entities. Substantive revisions, which will be brought
to the Executive Committee for review, are currently anticipated on only one policy at this time,
IRB Policy 506: Adults Lacking Capacity to Consent.

HRPP Director and staff will be meeting on June 10, 2014 with representatives from Western IRB
Copernicus Group (WIRB), who is contracted to assist with the AAHRPP re-accreditation
process, to discuss steps moving forward. Overall goals are to have a completed version of the
AAHRPP application prepared for WIRB by July 1 and the final version prepared for submission
to AAHRPP by September 1, 2014.
4. IRB Membership Update (Webster)
New member Deb Englehardt will begin serving as a reviewer for the Medical Committee at
meetings this month. Also, we may be adding a new community member to the Medical
Committee as well. Lastly, a grateful farewell to IRB Executive Committees ex-officio member
and Fairview representative, Adrienne Baranauskas. We thank her for her amazing service and
dedication to this group. She will be greatly missed.
5. Other (prompted by questions from Herman)
A. It was confirmed that going forward, the IRB will allow the PI to provide information and
answer questions in person at the meeting where their protocol is firstreviewed. The PI will
only be present in order to address direct questions put to them by the IRB and will not be
present for voting.
B. The IRB Executive Committee Chairs are in the process of developing a white paper on IRB
reliance agreements. This white paper will suggest the UMN HRPP/IRB position on this issue,
including background and rationale for the position.
Next Meeting: July 14, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

September 8, 2014, 1:30-4:20pm
Members Present: Susan Berry (chair), Joanne Billings, Robert Haight, Darlette Luke, Margaret MacMillan,
June Nobbe, Don Quick, Sarah Jane Schwarzenberg
Members Absent: Scott Crow, Michael Oakes (vice-chair), Michael Steenson
Ex Officio/Non-Voting Members Present: Jill Cordes, Brian Herman, Barbara Shiels, Sarah Waldemar,
Joyce Trost
Ex Officio/Non-Voting Members Absent: none
Staff Present: Debra Dykhuis, Patrice Webster, Cynthia McGill, Linnea Anderson, Felicia Mroczkowski,
Laura Conger
Discussion Items
1. Review of recap from August 11, 2014 meeting (Berry)
2. AHC/CTSI researcher feedback (Herman)
Brian Herman and Debra Dykhuis met with Brooks Jackson, Bruce Blazar, Tim Schacker and Beth
Nunally to discuss AHC researcher issues regarding the IRB. The biggest concern discussed was overall
IRB turnaround times for review of medical protocols. Several possible options were put forward. These
options include:

Addition of a new Medical IRB roster to be scheduled for meeting on a regular weekly basis
Ability to cede review of some protocols to an independent IRB(s)
Inclusion of a review timeline to stipulation letters, which would show all previous submission
review actions and provide the PI with a more comprehensive context for the current study
status
Request that concerned PIs keep track of the metrics on their own studies/submissions, in
order to identify where time lags occur. This data should then be brought to the IRB when
presenting request for more rapid turnaround times

It was suggested that a meeting with Brooks Jackson and members of the Executive Committee is needed
to further discuss these and other options.
Items requiring action by the convened IRB
9. Bifeprunox/Stephen Olson Investigation Report (Berry/Dykhuis)

Standing Agenda Items

4. Membership Update (Dyhuis)
We have one additional new HRPP staff member and two current staff in new positions at HRPP.
Welcome to Clinton Dietrich (Exempt/Social Expedited RCS), and congratulations to Rebecca Yoho
(Medical Expedited RCS) and Linnea Anderson (Chief of Staff).
Next Meeting: October 13, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

August 11, 2014, 1:30-4:20pm
Members Present: Susan Berry (chair), Darlette Luke (by phone), Margaret MacMillan, June Nobbe, Michael
Oakes (vice-chair), Don Quick, Sarah Jane Schwarzenberg
Members Absent: Joanne Billings, Scott Crow, Robert Haight, Michael Steenson
Ex Officio/Non-Voting Members Present: Jill Cordes, Brian Herman, Barbara Shiels (arrived 2:15 pm),
Sarah Waldemar, Joyce Trost
Ex Officio/Non-Voting Members Absent: none
Staff Present: Debra Dykhuis, Patrice Webster, Andrew Allen, Jeffery Perkey, Felicia Mroczkowski, Laura
Conger
Staff Absent: Linnea Anderson, Cynthia McGill

Discussion Items
1. Review of recap from June 9, 2014 meeting (Berry)
2. IRB Member Retreat October 2, 2014 (Dykhuis)
A retreat for IRB Members has been tentatively scheduled for the afternoon of Oct. 2, 2014. This retreat
is meant to serve as a chance to meet as a group for training and discussion of current issues. Western
Copernicus Group consultant, Jeff Cooper, has been asked to lead a seminar and discussion on criteria for
IRB approval.
It has been noted that scheduling conflicts with clinic hours and holidays may affect the availability of
some members to attend. For these reasons other dates will also be looked at as potential options. It is
desirable to schedule the retreat for a date prior to the upcoming AAHRPP re-accreditation site visit,
estimated to be in first calendar quarter 2015.
3. Update on AAHRPP External RFP and State Legislative Auditor (Dykhuis)
AAHRPP External RFP
As of the August 4, 2014 deadline, all documents currently requested for the AAHRPP External RFP
have been provided for the panel to review. The inquiry panel will be on site September 8-11, 2014.
Specifics on what will be requested during the site visit have not yet been received. The goal is to have
all reviews and the final report completed to supply to the Faculty Senate Committee for their meeting on
December 5, 2014. If this goal cannot be met, the completed report will be reviewed at the next Faculty
Senate meeting in March, 2015.

The panel was also recently expanded to include a fifth person.

State Legislative Audit

4. Changes to IRB Policy re: Adults Lacking Capacity to Consent (Dykhuis)

As part of preparation for AAHRPP Re-accreditation, IRB Policy 506 Adults Lacking Capacity to
Consent (previously titled Prospective Subjects and Capacity to Consent) has undergone substantive
revision in order to conform to current AAHRPP standards and better mirror current IRB/HRPP practices.
As a result of these changes, new tools and training will be developed to help ensure that IRB members
and HRPP staff will be able to stay consistent with the new policy/procedures.
5. Changes to IRB Policy re: Reporting Events (Dykhuis)
As part of preparation for AAHRPP Re-accreditation, IRB Policy 411 Reporting Events Including
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) (previously titled
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)) has undergone substantive
revision in order to conform to current AAHRPP standards and to better the procedures surrounding PI
reporting of events to the IRB. A new reporting form has also been crafted to help prompt the PI to
submit appropriate and consistent reporting of events and other items pertaining to the research.
6. White paper on ceding review (Dykhuis)
A white paper presenting the IRB/UMN position on ceding of review to external IRBs is in the process of
being drafted by Debra Dykhuis, with assistance from members of the IRB Executive Committee and
HRPP senior staff. The original deadline for this paper of August 2014 has now been extended to
October 1, 2014, due to the volume of urgent concerns currently being handled by HRPP and the IRB.
7. Eligibility for Expedited Review (Mroczkowski/Berry)
IRB#: 1206M16301 PI: Laguna, Terri
IRB study 1206M16301 was assessed by PAR as part of Expedited Review eligibility verification. As a
result of this review, PAR raised questions for IRB deliberation associated with the inclusion of healthy
children (control group) who will be required to undergo multiple (up to 9 times) Oral Glucose Tolerance
Testing (OGTT) and IV placement procedures which would not appear to fall within Expedited Review
criteria or guidance.
The IRB discussed whether the inclusion of healthy child subjects should be considered minimal risk
under 45 CFR 46.404. If not, the committee was challenged to identify the appropriate category of
Subpart D to consider inclusion of these subjects. Deliberation included discussion of study procedures,
PI response to IRB stipulations, and previous IRB review associated with inclusion of healthy children.

After lengthy discussion, the IRB confirmed that current procedures did not fall within minimal risk
criteria. That being said, study procedures were deemed slightly greater than minimal risk as the OGTT
procedure was compared to a child being given soda and use of an IV line, versus multiple needle
sticks, was considered to result in minimization of risks. The IRB also considered whether inclusion of
these children should fall under 45 CFR 46.407; however, it was understood that the research would not
practicably occur if approved in accord with this category.
The IRB concluded that healthy control children (biological siblings only) could be included in accord
with 45 CFR 406 as it was argued that the research seeks to assess genetic factors that influence glucose
tolerance and response in Cystic Fibrosis (CF), for which healthy siblings of CF patients could have a
predisposition.
8. Response from CMRR
of research subjects at CMRR

to IRB request for information regarding oversight

At the May 12th IRB Executive committee meeting, an unanticipated problem on IRB study #
0905M65804 involving an MRI scan of a subject with a programmable shunt was reviewed and
enrollment of this subject group was suspended.

Discussion was tabled until the September Executive Committee meeting.

Items requiring action by the convened IRB
9. Bifeprunox/Stephen Olson Investigation Update (Berry)
A brief review on the investigation and draft report was presented by Sarah Jane Schwarzenberg.)

By IRB Policy 408A, the panels findings and recommendations are advisory to the IRB and must be
acted upon by a duly constituted IRB committee to become effective.

Standing Agenda Items

10. Membership Update (Dykhuis/Berry)
Welcome to Jill Cordes as the new Fairview Representative for the IRB Executive Committee. This
position was previously held by Adrienne Baranauskas, who left the committee in June 2014.
Next Meeting: September 8, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

Note:
There was no meeting of the IRB Executive Committee held in July 2014.

IRB Executive Committee Meeting

November 10, 2014, 1:30-3:30pm
Members Present: Susan Berry (chair), Michael Oakes (vice-chair) (by phone), Joanne Billings, Debra
Dykhuis, Robert Haight, Keith Horvath, Darlette Luke, Don Quick, Sarah Jane Schwarzenberg (arrived at
2pm)
Members Absent: Scott Crow, Margaret MacMillan, June Nobbe
Ex Officio/Non-Voting Members Present: Jill Cordes, Brian Herman (by phone), Barbara Shiels
Ex Officio/Non-Voting Members Absent: Joyce Trost, Sarah Waldemar
Staff Present: Patrice Webster, Cynthia McGill, Linnea Anderson, Laura Conger, Clinton Dietrich, Felicia
Mroczkowski, Jeffery Perkey
Guests Present for item #6: Chester Whitley, M.D., Alice Shapiro, M.D., (by phone), Brenda DiethelmOkita, Igor Nestrasil, Kathleen Delaney
Informational Items and Notifications
1. Review of Recap from October 13, 2014 meeting (Berry/Dykhuis)
2. Update on current events affecting IRB/HRPP (Dykhuis)
The AAHRPP Inquiry has requested to independently gather feedback from current or former research
subjects and /or their family members. Discussions about how this will be accomplished will continue
with University and Fairview representatives.

3. Update on AAHRPP Reaccreditation status and form/process changes (Dykhuis/Anderson)

AAHRPPs response to our Step 1 Application has been received. All changes prompted by
AAHRPPs concerns will be addressed and HRPPs response, along with any revised documents, is to
be submitted by the deadline of December 11, 2014. Changes that directly affect the IRBs processes
will be communicated to the chairs at the December Exec meeting and to the wider IRB membership
through the monthly IRB Member Newsletter.
Items Requiring Action by the Convened IRB

4. Research Subject Advocate Line Report IRB #1002M78216, PI: Michael Verneris
(Mroczkowski)

Items for Discussion

5. Recruitment Methods for IRB #1303M29544, PI: Elizabeth Seaquist (Webster)
The Principal Investigator, Dr. Seaquist, submitted a request for reconsideration of the 7/17/2014 IRB
Medical Committee decision to not approve opt-out letters as a recruitment method on this study. In
support of this request for reconsideration Dr. Seaquist also provided notification of IRB approval of
these recruitment letters from other sites. Patrice Webster contacted the IRB at each of these sites for
more information on their practices regarding approvable recruitment methods. This information was
also presented to the committee for review.
The IRB Executive Committee discussed the above issues, both in reference to the study in question
and to the wider practices of the UMN IRB regarding approvable recruitment methods. The committee
is willing to consider opt-out recruitment methods but this will be considered on a case by case
based upon the following suggested criteria: permissible PI access to contact information for
recruitment, the nature of the study, level of risk, vulnerability of the population, and what type of
contact has previously been attempted with potential subjects. This will be communicated to the
broader IRB membership in the December IRB Member Newsletter.
6. Response to Deferral of IRB #0905M65804 Shapiro (Webster)
On October 13, 2014, the Executive committee, acting as a convened IRB, requested that Dr. Elsa
Shapiro and Dr. Chet Whitley (as new PI) attend the November 10th Executive committee meeting to
discuss in person the outstanding issues related to this review. In response to this request the following
people were in attendance at the November 10, 2014 meeting: Dr. Shapiro (by phone), Dr. Whitley
(now PI on the study), and study staff Igor Nestrasil, Brenda Diethelm-Okita and Kathleen Delaney.
Dr. Nestrasil noted that information had been obtained from Medtronic regarding the possible effects
from MRI on the programmable shunt device and provided an explanation of this for the committees
review. Dr. Whitley confirmed that, per the IRBs suspension on May 12, 2014, they have stopped
enrollment of subjects with programmable shunts, and will not resume enrollment of these subjects.
He also noted that they had consulted Dr. Jerry Froelich at CMRR regarding the actions surrounding
the time of the event, confirming that the subject was seen by a neurologist following the event and no
reset of the shunt was needed.
The committee thanked the PI and study staff for attending before they left the room for deliberations.
The committee then discussed the issues and responses presented, and noted that the following is
required: The current PI should submit an updated application and protocol to reflect the exclusion of

subjects with programmable shunts and should document how it will be determined whether a subject
has a programmable shunt, which would affect the subjects eligibility for participation in the study.
7. Policy and Procedure Related to Change in Protocol Submissions (Webster/Anderson)
This item was tabled, due to time constraints.
8. Referral for investigation by a convened IRB IRB #1303M29243, PI: Nelson Rhodus
(Webster/Berry)

Standing Items
9. Fairview Research Helpline Report (Mroczkowski)
The Fairview Research Helpline Report for October was included in the materials provided to the IRB
Executive Committee for review. No significant patient concerns were noted.
Next Meeting: December 8, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

October 13, 2014, 1:30-3:10pm
Members Present: Michael Oakes (vice-chair), Joanne Billings, Debra Dykhuis, Darlette Luke, Margaret
MacMillan, June Nobbe, Don Quick, Sarah Jane Schwarzenberg
Members Absent: Susan Berry (chair), Scott Crow, Robert Haight, Michael Steenson
Ex Officio/Non-Voting Members Present: Jill Cordes, Brian Herman, Barbara Shiels, Sarah Waldemar,
Ex Officio/Non-Voting Members Absent: Joyce Trost
Staff Present: Patrice Webster, Cynthia McGill, Linnea Anderson, Andrew Allen, Clinton Dietrich, Felicia
Mroczkowski, Betsy Swanson
Informational Items and Notifications
1. Review of Recap from September 8, 2014 meeting (Oakes)
2. Update on AAHRPP Inquiry (site visit) and Legislative Audit (Dykhuis)

3. Requiring updated Appendix I at Continuing Review (Dykhuis/Anderson)

At the last continuing review meeting the committee discussed requiring an updated Appendix I with
continuing review submission, when applicable. This would be required if the study includes
participants lacking or with diminished capacity to consent, continues to enroll or has active subjects
and the PI has not already submitted the newly revised Appendix I form. HRPP staff will monitor this
and determine at time of continuing review submission when an updated Appendix I is needed. The
Executive Committee agreed that the IRB should go forward with this requirement.
Items Requiring Action by the Convened IRB
4. Review and Recommendation for determination/action on Bifeprunox Investigation Report
and PI Response (Oakes)

5. Response to Deferral of 0905M65804 Shapiro (Webster)

The Executive Committee acted as a convened IRB in its review of the response to deferral of
0905M65804. Patrice Webster summarized the unanticipated problem involving the 3T MRI scan of a
subject with a programmable shunt and the background of IRB review and the PIs response. The PI
has provided partial responses to the IRBs questions. Dr. Shapiro has said that there are difficulties in
getting the numbers needed to make a report to Medtronic; therefore, they have not responded to this
stipulation. The study is still on hold for subjects with shunts, and the PI says she does not plan to
resume the study with these subjects.
and Dr.
Whitley will be taking over the study as principal investigator.

Items for Discussion

6. CMRR safety issues during research procedures

7. CMRR screening procedures for inclusion of metalworkers as research subjects

(Webster/Mroczkowski)
The CMRR requested guidance on allowable procedures for safe inclusion of subjects who are
considered metalworkers. The CMRR is unclear whether it can impose screening requirements to
confirm if it is safe to include subjects who are metalworkers. The committee confirmed that the IRB
relies on the CMRR to consider subjects risk and expects that they will screen and exclude subjects
for any safety concern.
Next Meeting: November 10, 2014 at 1:30 p.m. D-528 Mayo

IRB Executive Committee Meeting

December 8, 2014, 1:30-3:15pm
Members Present: Susan Berry (chair), Michael Oakes (vice-chair), Joanne Billings, Debra Dykhuis, Keith
Horvath, June Nobbe, Don Quick,
Members Absent: Scott Crow, Robert Haight, Darlette Luke, Margaret MacMillan, Sarah Jane
Schwarzenberg
Ex Officio/Non-Voting Members Present: Jill Cordes, Brian Herman, Barbara Shiels, Joyce Trost, Sarah
Waldemar
Ex Officio/Non-Voting Members Absent: none
Staff Present: Patrice Webster, Cynthia McGill, Andrew Allen, Laura Conger, Clinton Dietrich, Felicia
Mroczkowski, Melissa Nowicki, Jeffery Perkey
Informational Items and Notifications
1. Review of Recap from November 10, 2014 meeting (Berry/Dykhuis)
2. Update on current events affecting IRB/HRPP (Dykhuis)
The AAHRPP Inquiry has requested more information, including the Bifeprunox Investigation Report,
the Fairview Investigation Report (or draft that is available) and the report/communication(s) in IRB
records regarding the 2009 ORA Audit of the Department of Psychiatry. They also previously
requested to independently gather feedback from current or former research subjects and /or their
family members. Through discussion between AAHRPP, University of Minnesota and Fairview Health
Services representatives, the proposed plan for completing this request is to post fliers in common biomedical research areas giving contact information where subjects can provide their feedback if desired.

3. Update on AAHRPP Reaccreditation status and form/process changes (Dykhuis)

HRPPs response to AAHRPPs Review of the Step 1 Re-accreditation Application is in the process of
being submitted. Two of three parts have already been sent to AAHRPP, with no feedback as of yet,
and the final part is scheduled to be sent no later than the given deadline of December 11, 2014.
As the next step in this process, AAHRPP will have until December 29, 2014 to review these response
materials. Once they have accepted all HRPPs responses and revisions to the Step 1 Review, HRPP
will have 10 business days to submit the completed Step 2 Application materials. These will be

reviewed by AAHRPP and a site visit will be scheduled no less than 50-55 business days before the
assigned Council date, putting the site visit in late spring/early summer 2015.
4. Update on Fairview Investigation (Oakes)
Michael Oakes, a member of the Investigation Panel, gave a summary of the events which prompted
the investigation, the goal of the panel and the preliminary results of the investigation. The
Investigation Report will be focused on the culture and practices surrounding psychiatric research
within the University of Minnesota and Fairview Health Systems. A draft of the preliminary
investigation report has been completed, but is still circulating among the panel members for final
editing. It is estimated that a finalized version of the report will be presented to the IRB Executive
Committee for review at the January 12, 2015 meeting.
This report has been requested by the AAHRPP Inquiry panel as part of its investigation and a draft
will be provided once it has been finalized by the three members of the Investigation Panel.
Items Requiring Action by the Convened IRB
4. Update on PAR Audit resulting from complaint IRB #1002M78216, PI: Michael Verneris
(Mroczkowski)

Items for Discussion

6. General Committee Update (Webster/Mroczkowski)
HRPP has been implementing a more formalized search process and training program for increasing
and improving IRB membership. This initiative includes an application form for candidates, a formal
interview with the appropriate IRB committee chair and senior HRPP staff, as well as formal training
in the form of New Member Orientation presentations and the newly purchased Ethical Research
Oversight Course (EROC) training program.
As a result of this initiative, two new members will be joining the IRB Medical Committee roster:
Tom Krause (community member consultant/former Medtronic employee) and Sonya Brady (UMN
Epidemiology/Community Health). We are excited to add these new members to our ranks and hope
to include others in the near future.
7. OHRP Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating
Standards of Care (Dykhuis)
This OHRP draft guidance discusses research comparing standards of care and what information needs
to be communicated to subjects regarding risks involved. This guidance has prompted a national
discussion that will continue to be important moving forward, as research comparing standards of care
becomes more frequent. Committee members are asked to review and familiarize themselves with this
information so as to be more informed when participating in discussions surrounding this issue.
8. NIH Clinical Research Policy on Models of IRB Review (Dykhuis)
The use of a Centralized IRB Model for multi-site research is becoming more prominent. The
University of Minnesota has already been and will continue to be asked to participate in multiinstitutional agreements for ceding of IRB review, based on a centralized IRB model. Therefore,
committee members are asked to review and familiarize themselves with the information provided in
this new NIH policy so that our IRB may be better prepared to successfully navigate this complex
issue moving forward.
9. Policy and Procedure Related to Change in Protocol Submissions (Webster)
Many difficulties may arise when the IRB is asked to review multiple submissions for the same study
during an overlapping time period. In order to avoid some of these difficulties, such as confusion
regarding document version and approval control, HRPP is proposing to review submissions
(excepting reporting of events) in a serial fashion. The IRB Executive Committee discussed this

proposal and agreed that this action would help avoid confusion and make status transparent to the
parties involved.
This proposal will therefore be implemented once HRPP is more fully staffed and able to handle the
workflow in an efficient manner. More information on how this change will directly affect the IRB
and research community will be provided when it becomes available.
Standing Items
10. Fairview Research Helpline Report (Mroczkowski)
None.
Next Meeting: January 12, 2015 at 1:30 p.m. D-528 Mayo