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Institutional Review Board

October 10, 2022 @ 1:00 pm - 2:00 pm

Institutional Review Board10/10/202201:00 pmVideo Conference Call AGENDAUW Oshkosh Institutional Review Board (IRB)October 10, 2022- 1:00-2:30 PMVirtual: Microsoft TeamsJoin on your computer or mobile appClick here to join the meetingMeeting ID: 242 617 981 126Passcode: DtMWoiDownload Teams | Join on the webOr call in (audio only)+1 608-440-8168, PIN: 458174332#  Current IRB Membership: 14 voting, quorum=8 (*15 voting for prisoner research in which quorum=8) Anca Miron, IRB Chair, Psychology (scientist)Melissa Bublitz, Marketing (scientist)Kathleen Wren, Nursing (scientist)Kirsten Ihde, Music (nonscientist)Thomas Fischer, Special and Early Childhood Education (scientist)Christopher Rose, Criminal Justice (scientist)Michael Ford, Public Administration (scientist)Rev. Kevin Mundell, Community Representative (nonaffiliated, non-scientist)Kimberly Calvert, Kinesiology and Athletic Training (scientist)Kathy Phillippi-Immel, Psychology, UWO Fox Cities Campus (scientist)Evan Williams, Philosophy (non-scientist)Nenad Stojilovic, Physics (scientist)Nadia Louar, Foreign Language (non-scientist)Kristi Wilkum, Communication Studies, UWO Fond du Lac Campus (scientist)Prisoner Representative:*Carmen Heider, Communication, non-scientist (*only voting member for prisoner research)Alternates:Larry Herzberg, Philosophy (alternate non-scientist)Denise Robson, Economics (alternate scientist)Christopher Groves, Psychology (alternate scientist)Michael Lenza, Criminal Justice, (alternate prisoner representative)AgendaMeeting called to order at _________ by Chair Miron.Attendance and Confirmation of QuorumReview and approval of minutes from the IRB meeting held on May 25, 2022.Items from Chair (Miron):Introduction of new member Kimberly Calvert, Kinesiology and Athletic Training.Proposed updates to Faculty Handbook for IRB CompositionIRB Reviews/Approvals to report since last meeting: See IRB Tracking Sheet-Approvals TabOld Business (0)New BusinessNew IRB Protocols for Full Committee Review: (0)Modification Requests for Full Board Review: (0)Extension Requests/Continuing Review for Full Board Review: (0)IRB Standard Operating Procedures: (SOPs) (2)New SOPs (1)SOP 18: Online Research StudiesUpdated SOPs (1)SOP 2: IRB Review Process and Responsibilities of Researcher and IRBProposed updates (highlighted):Update of title from IRB Application and Review Process to IRB Review Process and Responsibilities of Researcher and IRBAddition of reference to SOP #1: Determining whether a project requires IRB reviewExperienced IRB staff or IRB members will make the determination on whether research activities meet the criteria for exempt statusDisapproval of a study: Typically is used following review of a protocol after substantive revisions request from the IRB have been made by the researcher and the IRB determines that the revised study does not meet the criteria for IRB approval.Updates to research personnel may be submitted using the IRB Research Personnel Change Form. Change in personnelThe IRB Office will send an annual status check-in email for exempt studies and expedited studies (determined by the IRB to not required continuing review).Added OHRP Guidance: Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse EventsCreated an IRB Review Process Flow Chart (see SOP #2 folder)IRB Administration Updates: (1)Updates from FDA:On September 28, 2022, FDA issued proposed rules for the harmonization of FDA regulations with the revised Common Rule. One proposed rule amends sections of 21 CFR 50 and 56 to harmonize language, requirements for informed consent, and provisions for continuing review and recordkeeping. The other amends 21 CFR 56 to adopt the 2018 Common Rule’s single IRB requirement for cooperative research in the US, with additional exceptions. The comment period for both proposed rules close 11/28/2022.The FDA issued a draft guidance on regulations for human subjects protections for children, stating the Additional Safeguards for Children in Clinical Investigations (21 CFR 50, subpart D), must be considered when children are enrolled in a clinical trial. The draft guidance provides guidance to industry, sponsors, and IRBs on considerations for enrolling children in clinical investigations of drugs, biological products, and medical devices.Items from IRB Committee Members:Items from IRB Guests:Upcoming IRB Meeting DatesMonday, November 7, 2022, from 11:30 AM- 1:00 PM via Microsoft TeamsTuesday, January 3, 2022, from 10:00 AM-11:30 AM via Microsoft TeamsMeeting Adjourned at ____________ by ____________.Kelly Schill10/07/2022


October 10, 2022
1:00 pm - 2:00 pm