The investigator and the IRB: a survey of depression and schizophrenia researchers

Abstract

Despite the integral part Institutional Review Boards (IRBs) play in U.S. research, research on IRBs is lacking. This is especially true in the area of mental health investigator-IRB interactions. It was hypothesized that schizophrenia researchers would have a different experience with IRBs as compared to depression researchers. This would include longer turn-around time and fewer protocols approved on first submission. It was also thought that schizophrenia researchers would be more hesitant to submit ethically complex protocols for IRB review. 396 NIH-funded schizophrenia and depression investigators were invited to participate in a survey study on IRBs. 108 usable responses were returned, 45 of which were from schizophrenia researchers. Schizophrenia researchers were significantly less likely to submit ethically complex protocols for IRB review than depression researchers even when controlling for academic rank, years of research experience, type of research done, and the need to submit to multiple IRBs. However, there was no significant difference between researcher groups in IRB review turn-around time or initial approval rates. As a group, respondents found IRB submission paperwork burdensome but necessary and were almost evenly split as to whether IRB comments were helpful (54.8%) or not (45.2%). Time to initial review was 3 weeks or longer for most respondents. 94.4% agreed IRBs should enforce subject privacy and 68.2% agreed they should monitor conflict of interest, but only 37.% agreed IRBs should review study design. Conclusions are that 1. the population studied may have profound impacts on the type of protocols submitted to IRBs even within the field of mental health, 2. IRBs may not draw as large a distinction between depression and schizophrenia protocols as researchers believe, and 3. facilitating IRB review by eliminating evaluation of design may be possible if the protocol has already been vetted by a credible funding agency (such as the U.S. National Institutes of Health).