IRB Executive Committee Meeting
April 14, 2014 Members Present:
Susan Berry (chair), Joanne Billings, Robert Haight, Darlette Luke, Margaret MacMillan, June Nobbe, Michael Oakes (vice-chair), Don Quick, Sarah Jane Schwarzenberg (arrived at 1:55pm)
Ex Officio/Non-Voting Members:
Adrienne Baranauskas, Brian Herman, Barbara Shiels, Sarah Waldemar
: Debra Dykhuis
Cynthia McGill, Patrice Webster, Linnea Anderson, Andrew Allen, Christina Dobrovolny, Jeffery Perkey, Felicia Mroczkowski, Laura Conger
Scott Crow, Michael Steenson, Joyce Trost
Review of 2014.03.10 IRB Exec meeting recap (Berry) 2.
CMRR (Oakes, Mroczkowski) Michael Oakes met with Cheryl Olman, faculty representative for CMRR and IRB medical panel member, to discuss the outstanding issues detailed in correspondence between HRPP Post-
Approval Review staff and CMRR, following from the IRB Executive Committee’s discussion at
its March 10, 2014 meeting. These issues included: CMRR compliance with IRB tracking requirements for tesla levels above 3T and a second scientific opinion on the safety of repeat exposure to magnets at 3T and above. Response was received from a second scientific source regarding the safety of magnets 3T and above. The committee agreed that this response satisfies their concerns regarding that issue. Clarification was also provided during the meeting between Oakes and Olman regarding the outstanding requirements. Oakes clarified that the IRB requirement is for tracking subjects so that number of exposures can be documented. Oakes will continue working with Dr. Olman and other CMRR faculty/staff to develop a proposal on how CMRR will comply regarding tracking subjects for tesla levels 3T and above. This proposal will be brought back to the IRB Executive Committee for further discussion. 3.
Research concern raised by Leigh Turner (received March 4, 2014; discussion started March 10, 2014) (Berry/Dykhuis) This issue was initially brought to the committee on the March 10, 2014 meeting, but due to lack of quorum the committee was unable to make an official determination. The committee agreed, as a duly-convened IRB, that an investigation into the issues raised by Dr. Turner will not be opened