irb minutes (redacted) for markingson death may and june 2004

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  • 7/27/2019 IRB Minutes (Redacted) for Markingson Death May and June 2004

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    Twin Clues Campusesearch Sthjects Pr lioi Programsayo Mail Code 820Institutional Review Board: Human S ubjects Committee (IRD)Institutional Animal Care and Use Committee f 1ACUC)

    May 13, 2004O fficial N otification:

    1)528 Mayo Memorial Building420 Delaware Street S.E.Minneapolis, MN 55455-0392612-626-5654Fax: [email protected]@umti.eduhttp://www.research.wnn.edu/sukkels lum

    Serious Adverse Event involving a Research SubjectTO : Food and Drug Adm inistration: M inneapolis District OfficeSharon M attson, Investigations Division FAX: 612 334-4134

    Office for Human Research Protections (OH BP )Assurance Officer H arold Blatt :WmL:00 3 JTA 301 402-0527FROM: Richard W. BiancoInstitutional Official for k1ux uat1 Std t ProtectionsRE: "Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of

    First Episode Psychosis: ARnndomized Double Blind 52-Week C omparison - The CafeStudy" Human Subjects Code Number: 0202M1 7441Stephen C. Olson, MD, Principal InvestigatorThe University of Minnesota is reporting an unanticipated serious adverse event in an InstitutionalReview Board approved research project. A subject enrolled in the referenced study committedsuicide on May 8, 2004. The principal investigator has reported this event and will continue toprovide us with information. The investigator has made reports to the commercial sponsor who inturn is making reports to the FDA.The study completed enrollment in March 2004 at this site, therefore, no additional subjects w ill berecruited. When a complete report is available, the IRB w ill review the incident and determine ifadditional safeguards are necessary for currently enrolled subjects. We will continue to keep youinformed.This is a tragic event, unfortunately not uncommon in this study population. The U niversity ofMinnesota continues its comm itment to protection of human subjects and will continue to assurethat every prec aution is in place to limit potential for such even ts.If there are any que stions, please contact me or Moira Keane, Director of Research SubjectsProtection Programs.

    CC: Stephen, C. O lson, Jean K enney, S Charles Schulz, John Vuchetich

    Page 24

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    UNIVERSITY OF MINNESOTAResearch Subjects Protection Programs Mayo Mail Code 820Institutional Review Board: Human Subjects Committee (IRS) D-528 Mayo M emorial Building420 Delaware Street S.E.Institutional Animal Care and Use Committee (IACUC) Minneapolis, MN 55455

    612-626-5654Fax: [email protected]@umn.eduwww.irb.umn.eduwww.iacuc. umn,eduInstitutional Review Board: Human Subjects Committee

    MinutesHealth and Biological Sciences Panel 05WednesdayMay 26, 2004Meeting Convened at: 1:00 pmMeeting Adjourned at : 3:45 pm

    Chairperson: David AdsonMem bers in Attendance: David Adson, Matt Bower, Nancy Flenimons, Robert Haight, KathrynJohnson, Elizabeth Kipp-Campbell, Jill Klingner, Jan McNeIly, Michael Schwartz, Scott VeldersNon-Scientific Member: Carol SiegelCommunity Member: Elizabeth Kipp-Campbell

    Mem bers Absent: noneQuorum R equirement: 7Quorum Established at: 1:00 pmConflict of Interest Declaration Request: None DeclaredMinutes Ratified: April 28, 2004

    The follow ing M inutes were reviewed and approved by the chairperson in attendance at themeeting.

    David Adson,hairate

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    Committee Meeting MinutesMay 26, 2004Page 9

    Olson, Stephen C.Efficacy and Tolerability of Olaisznpine, Quetiapine and Rlspsidone in theTreatment of First Episode Psychosis. , A Randomized Double Blind 52-WeekComparison The Cafe Study" 0202M17441At its meeting on May 26, 2004 the IRB: Human Subjects Committee reviewed and approved the change in protocol, for theabove referenced study, described in your letter of May 10, 2004. The approved change involves a new version of the adultconsent form that now includes diabetes as a risk for patients taking atypical antipeychotic agents, including CAFE studymedications. The consent form dated March 24, 2004 was included in this review and has been approved. In other business,the IPJI: Human Subjects Committee reviewed and noted the unanticipated problem and adverse event report for the referencedstudy received on May 12, 2004, involving subject 00100013. As noted in the IRBs correspondence of May 13, 2004, thisevent was reported to appropriate regulatory agencies and on May 17th, the FDA acknowledged receipt of the report, The WBfurther notes receipt of requested follow-up information on this event from the P1. This information (P1s letter of May 17, 2004and accompanying attachments) will be forwarded for review by the committee at its next meeting on June 23, 2004. Thankyou for keeping the IRB Informed of the status of your research, As Principal Investigator for this study, you are required byfederal regulations to inform the IRB of any proposed changes to your study that will affect human subjects. Changes should bereviewed and approved by the iRS before they are initiated. Unanticipated problems and adverse events should be reported tothe IRB as they occur. Research projects are subject to continuing review and approval.11/0/0

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    UNIVERSITY OF MINNESOTAResearch Subjects Protection Programs Mayo Mail Code 820Institutional Review Board: Human Subjects Committee (IRE) D-528 Mayo Memorial BuildingInstitutional Animal Care and Use C omm ittee (IACIJC) 420 Delaware Street S.E.Minneapolis, MN 55455

    612-626-5654Fax: [email protected]@umn.eduwww.irb.umn.eduwww.iacuc.umn.edu

    Institutional Review Board: H uman Subjects Comm itteeMinutesHealth and Biological Sciences Panel 05June 23, 2004Meeting Convened at: 1:00pmMeeting Adjourned at: 3:57pm

    Chair: David AdsonM embers in Attendance: David A dson, JoanneBill ings, Matt Bower, Nancy F lemmons,Bob Haight, Kathryn Johnson, Elizabeth Kipp-Campbell, Jill Klingner, Morry Rothstein,Michael Schwartz, Scott VeldersNonscientist Member: Carol SiegelMembers A bsent: Jan McN ellyComm unity Member: Elizabeth Kipp-CampbellQuorum Requirement: 8Quorum Established at: 1:00pmConflict of Interest Declaration Request: None DeclaredM inutes Ratified: May 26, 2004The following Minutes were reviewed and approved by the chairperson in attendance atthe meeting.

    f l 4David Adson,hairate

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    Committee Meeting MinutesJune23, 2004Page 10

    Olson, Stephen C.Efficacy and Tolerability of Ohsnzapine, Quetiapirse and Riaperidone In theTreatment of First Episode Psychosis: A Randomized Double Blind 52-WeekComparison The Cafe Study" 0202M17441The MB; Human Subjects Committee received your response to its stipulations of May 13, 2004. Since this informationsatisfies the requirements set by the IRB, review of the recent unanticipated problem and serious adverse event report involvingSubject 00100013 is concluded. The committee reviewed and noted the additional information regarding the consent processand interim clinic visits for study Subject 00100013. For your records and for grant certification purposes, the approval date forthe referenced project is January 2, 2004, and the Assurance of Compliance number is FWA000003I2 (Fairview HealthSystems Research FWA00000325). Thank you for keeping the lR.B informed of the status of your research.12/0/0