In a recent news release published by the Sacremento Bee, it appears that 2 neurosurgeons from the University of California at Davis, conducted experiments on humans without university consent. The 3 patients which underwent the experimental procedures were terminally ill patients with malignant brain cancer, and though the university was unaware, these patients granted written consent to the doctors.
The experimental procedure entailed introducing bacteria into open wounds in the head which the neurosurgeons theorized would prolong their survival by stimulating an immune response that would attack the cancer after fending off the infection. Unfortunately however, 2 of the 3 patients had died due to complications of widespread bacterial infection (sepsis). According to the Sacremento Bee in a later article, Muizelaar, one of the neurosurgeons, stated that "the other patient lived for months but has since died."
Conducting research on humans requires significant deliberation including ethical considerations, and generally, a proof of concept. Though there are always exceptions to everything, such decisions must be made by the appropriate authorities and while the intention of the neurosurgeons may have been in the right place, university officials claim to have been left in the dark. This prompted the university to notify the FDA about the situation.
Some may wonder what the big deal is? After all, the neurosurgeons got the approval from the patients which underwent the procedure. Though consent is certainly important, the regulatory steps have a purpose and are in place to protect humans.
The researchers have stated however that they were under the impression that they were not breaking any rules and according to the Sacromento Bee, Muizelaar even stated that "If I come down with a glioblastoma, I will demand that it be done on myself.\" This does not change the fact that both researchers have since been banned from conducting human research.
Regardless of whether there was intent or if this was just a serious error, this situation is certainly going to have an impact on the university's reputation and possibly affect research funding for the foreseeable future.