"For example, faculty and staff in Psychiatry repeatedly characterized the climate of work as a 'culture of fear.' They provided stories of intimidation by researchers and fear of retaliation should staff voice opposition to practices that were of concern."
"The review team found little evidence that the University’s IRB engaged in a meaningful process of evaluating research risk."
"Investigators have failed to address issues of vulnerability to coercion or undue influence."
“It was clear to the external review team that the membership of the Medical IRBs did not include sufficient members with the scientific expertise necessary to adequately address the research being reviewed at corresponding meetings.”
“The failure to have either adequate number of IRB members, or adequate expertise, during IRB deliberations raises profound questions about the IRB’s ability to conduct a robust and reliable protocol review.”
“Of the 30 protocols examined for scientific review, five cases were identified where the scientific review was completed by a subordinate faculty member for research in which a department chair was the principal investigator. In these cases, a conflict of interest exists and the risk of bias in the review is significant.”
“Accordingly, the minutes did not completely or accurately appear to represent what occurred during the IRB meetings. “
“The review process, as documented in the minutes, does not reflect a meaningful discussion of the risks and benefits of research protocols and the necessary steps taken to protect human subjects in the face of scientific or ethical concerns. “