October 4, 2007
Norman Fost, MD, MPH
Chair, Health Sciences IRB
Professor of Pediatrics and Bioethics
Director, Program in Bioethics
ncfost@facstaff.wisc.edu
Nichelle L. Cobb, PhD
IRB Office Director
Room B-3065
nlc@medicine.wisc.edu
Dear Norm and Nichelle,
This letter serves as a summary of adventitious findings on fMRI research studies
conducted at the Waisman Brain Imaging Laboratory from the inception date, September
1, 2005, of the HS IRB required radiological reads through April 29, 2007.
The following are data supplied by Dr. Howard Rowley, who leads the team of
radiologists reading all of our research scans:
Total scan reading forms in the radiology main database = 756
PI or MRI Technician-initiated queries = 9
Abnormal, but no follow up necessary = 15
Abnormal, follow up recommended = 15
Normal variant, CSF collection (arachnoid cyst, mega cisterna magna, etc.) = 17
Normal variant, prominent perivascular spaces = 57
Normal variant, other (vascular variants, borderline Chiari I, etc.) = 76
No tally of sinus inflammatory disease, but it was over 100 cases.
As the numbers above indicate, the mandatory scan readings are picking up
abnormalities that we clearly missed (although the percentage of abnormal,
recommended follow up cases is below 2%). We want to thank the HS IRB for putting
this policy into place as it has proven to be very effective and it is one that I now very
strongly endorse. We know among the cases read so far there have been two proven
brain tumors (one from Waisman, one from VA) and several other substantial lesions.
The overall frequency of potentially serious findings requiring follow-up (1.9%) is in line
with the expectations from the literature.
Howard also raised the issue of adopting generic wordage in the consent forms that all
PIs send to the HS IRB for approval.
Howard’s suggestion is this:
“This research scan is not intended to be clinical in any way. All scans will be read by a
radiologist to detect major abnormalities, but the scan is limited and no formal MRI report
will be available to you.”
We have had a few instances where research subjects attempted to “bully” research
coordinators into obtaining copies from the radiologists. Howard feels that this additional
language will address this particular issue.
If you need any additional information, please contact me or the lab’s Assistant Director,
Donna Cole, at dmcole@wisc.edu or 265-8107.
Sincerely,
Richard J. Davidson
.