university of minnesota irb executive committee minutes may to december 2014

8/9/2019 University of Minnesota IRB Executive Committee Minutes May to December 2014

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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 regardingin 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 monthsand compliance will be monitored.

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

Vote Yes: 8 No: 0 Abstain: 0


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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 forcompletion, 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 untilinvestigations are completed and determinations made.

Members Present for Vote: Susan Berry, Joanne Billings, Robert Haight, Darlette Luke, June Nobbe,


Members Not Present: Scott Crow



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Agenda Item: Preliminary Report for Bifeprunox

Investigation

Item Description:

Per IRB Policy 408A, the preliminary report on the Bifeprunox Investigation, prepared by theInvestigation Panel, is submitted for review and decision by the IRB Executive Committee.


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


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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 MedicalCommittee 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, afteradditional 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 April2013 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 IRBrequests that Medtronic comment on the safety of the shunt in this situation and what theybelieve 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 inthis 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) regardingwhether 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.


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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 researchclinical use of MRIs in the CMRR and CCIR.

Members Present for Vote: Scott Crow, Joanne Billings, Robert Haight, Darlette Luke, June Nobbe,


Members Not Present: Susan Berry



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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 IRBExecutive Committee at its September 8, 2014 meeting


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


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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 August11, 2014 and the committee voted to accept with proposed edits to be reviewed at the September 8, 2014

meeting.



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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


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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 thisstipulation. 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.


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, JuneNobbe, Michael Oakes, Don Quick, and Sarah Jane Schwarzenberg

Members Not Present: Susan Berry, Scott Crow, Robert Haight and Michael Steenson


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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 requestedinformation has been provided and the PI confirms he will not resume enrollment (permanently) of

subjects with programmable shunts.


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 staffIgor 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 MRIon 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 consultedDr. 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. Thecommittee 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 programmableshunt, 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.

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



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Agenda Item: Allegations of prompted by complaint IRB #1002M78216, PI: Verneris

Item Description:


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


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Agenda Item: Results of Post-Approval Review audit on allegations of prompted by

complaint IRB #1002M78216, PI: Verneris

Item Descri tion:


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


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IRB Executive Committee MeetingMay 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 non-compliance in subject tracking and adverse event reporting were clarified as follows:

Subject TrackingCMRR must maintain a record of which subjects go into the magnetsand 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 ofscan. Any issues of individual PI non-compliance with this requirement should be

reported to the IRB by CMRR.

Adverse EventsAny adverse events that are subject/researcher-related should be reportedto the IRB by the PI and those that are machine-related should be reported to the IRB byCMRR.

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 of3T and all use of higher Tesla levels must still maintain a record to track subjects.


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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 IRBmembers, 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 reportpending 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 occurringagain during the events of the current report, the IRB is concerned that decision was made to goahead 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 ascenario 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 involvesrisks 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). TheIRB 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 toMedtronic at that time.

The IRB believes a Medwatch report should be submitted to the FDA regarding theseevents 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.


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

IRB #0907M69523 PI: Traverse, JayTitle: 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 theIRB 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. Multiplegroups 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 Re-

accreditation 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 88 policies

Still in HRPP Internal Review process 31 policies

HRPP Internal Review complete 60 policies

Total 113 policies

Already sent to Western IRB for consultation 40 policies


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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


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IRB Executive Committee MeetingJune 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 ExecutiveCommittee 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 bi-polar/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 personsinvolved. No issues which would cause delay have currently been identified as of now with


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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 policiesand procedures by an external panel, prompted by the mandate from the Faculty Senate

Committee in December 2013. AAHRPP will be in charge of administratively managinginvestigation conducted by the following team of experts: Dr. Melissa Frumin (Harvard MedicalSchool), 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 Re-accreditation. A complete report on the evaluation, which will go to the faculty senate for reviewand questions, is expected by the end of calendar year 2014.


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 beincluded.

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 onefewer 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 re-

accreditation. A small group of policies still require administrative and internal revisions through

both HRPP and other involved institutional entities. Substantive revisions, which will be broughtto the Executive Committee for review, are currently anticipated on only one policy at this time,

IRB Policy 506: Adults Lacking Capacity to Consent.


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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 theAAHRPP 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 atmeetings 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 andanswer 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 bepresent 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


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IRB Executive Committee MeetingSeptember 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 overallIRB 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, inorder 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 neededto further discuss these and other options.

Items requiring action by the convened IRB

9. Bifeprunox/Stephen Olson Investigation Report (Berry/Dykhuis)


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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


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IRB Executive Committee MeetingAugust 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


Staff Present: Debra Dykhuis,Patrice Webster, Andrew Allen, Jeffery Perkey, Felicia Mroczkowski, LauraConger

Staff Absent: Linnea Anderson, Cynthia McGill

Discussion Items

1.Review of recap from June 9, 2014 meeting (Berry)

2. IRB Member RetreatOctober 2, 2014 (Dykhuis)

A retreat for IRB Members has been tentatively scheduled for the afternoon of Oct. 2, 2014. This retreatis 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 ofsome 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 onDecember 5, 2014. If this goal cannot be met, the completed report will be reviewed at the next Faculty

Senate meeting in March, 2015.


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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 substantiverevision 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 andHRPP 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 aresult 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 riskunder 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.


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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 needlesticks, 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 accordwith 45 CFR 406 as it was argued that the research seeks to assess genetic factors that influence glucosetolerance and response in Cystic Fibrosis (CF), for which healthy siblings of CF patients could have a

predisposition.

8. Response from CMRR to IRB request for information regarding oversight

of research subjects at CMRR

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 andenrollment 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.


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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


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IRB Executive Committee Meeting

Note:

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


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IRB Executive Committee MeetingNovember 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 at2pm)

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, FeliciaMroczkowski, Jeffery Perkey

Guests Present for item #6: Chester Whitley, M.D., Alice Shapiro, M.D., (by phone), Brenda Diethelm-Okita, 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 byAAHRPPs 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 membershipthrough the monthly IRB Member Newsletter.

Items Requiring Action by the Convened IRB


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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-outletters as a recruitment method on this study. In

support of this request for reconsideration Dr. Seaquist also provided notification of IRB approval ofthese 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 committeeis willing to consider opt-out recruitment methodsbut 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 thebroader 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 followingpeople 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


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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


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IRB Executive Committee MeetingOctober 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


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 includesparticipants 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. TheExecutive Committee agreed that the IRB should go forward with this requirement.


4. Review and Recommendation for determination/action on Bifeprunox Investigation Report

and PI Response (Oakes)


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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 asubject 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 thisstipulation. 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.


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 toconfirm 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


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IRB Executive Committee MeetingDecember 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, SarahWaldemar


Staff Present: Patrice Webster, Cynthia McGill, Andrew Allen, Laura Conger, Clinton Dietrich, Felicia

Mroczkowski, Melissa Nowicki, Jeffery Perkey


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 IRBrecords 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 HealthServices representatives, the proposed plan for completing this request is to post fliers in common bio-

medical 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, HRPPwill have 10 business days to submit the completed Step 2 Application materials. These will be


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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. TheInvestigation 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 finalediting. 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.


4. Update on PAR Audit resulting from complaint IRB #1002M78216, PI: Michael Verneris

(Mroczkowski)


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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 ResearchOversight 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 thisinformation 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 multi-institutional 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


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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

university of minnesota irb executive committee minutes may to december 2014

Documents