Internal Review Boards & Patient Harm

Internal Review Boards & Patient Harm

During the COVID-19 Pandemic internal review boards (IRB) were scrutinized for delaying potential treatments and vaccines to fight the coronavirus that causes COVID. IRBs exist to ensure that scientific research doesn’t harm patients. Throughout the history of science, many dubious science experiments have been carried out by less than fully considerate scientists. An IRB is a useful tool to ensure that researchers have real reasons to conduct experiments that may cause some type of physical or psychological harm to participants, and to ensure that researchers do as much as possible to mitigate those harms and adequately address the safety and needs of subjects before, during, and after an experiment.
However, in recent years many researchers have argued that IRBs have become too risk averse and too restrictive. Rather than purely focusing on the safety and health of research participants, IRBs have been criticized as protecting the brand of the research institution, meaning that some valuable and worthy science is denied funding or approval because it sounds weird and if it doesn’t go well could reflect poorly on the academic standing of the institution that approved the study. Additionally, well meaning IRBs can cause extensive delays, as each study is reviewed, debated, and approved or denied. Studies that are denied may have to make adjustments to methodology and approaches, and re-deigning studies can add additional time to actually get the study up and running. For many research studies this may be more of an inconvenience for the researcher than anything else, but during the COVID-19 pandemic, these delays have been sharply criticized.
COVID moves fast, and a delay of one month for a study that could prove to be life saving means that more people would die than would have died if the study had not been delayed. This means that in the interest of promoting safety, an IRB can create a delay that harms life. Mary Roach wrote about these concerns years before the pandemic in her book Gulp, “rather than protecting patients, IRBs – with their delays and prodigious paperwork – can put them in harms way.” If checking the right boxes on the right forms and submitting the right paperwork at the right time is more important than the actual research, we could see delays that hold back treatments, preventative vaccinations, and cures for deadly diseases.
The Pandemic has shown us how serious these delays can be. IRBs may have to be rethought and restructured so that in times of emergency we can move quicker while still addressing patient safety. For science where time is important and risk is inherent in the study, we may have to develop a new review or oversight body beyond the traditional IRB structure to ensure that we don’t harm patients while trying to protect them.