An IRB revised its board meeting minutes process from a clunky system of writing everything into an electronic document to one in which the minutes are automatically populated through the IRB’s electronic system, saving staff time and work. The old way of creating board meeting minutes sometimes took as long as a month for IRB staff to generate. Since the IRB revised its process, the staff can generate board meeting minutes within a week.
Increased mortality rate in some hospitals led to new IRB monitoring and oversight
February 18, 2021
A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.
The COVID-19 pandemic has created more uncertainty in human research protections in 2021. One issue IRBs will face is whether the benefits continue to outweigh the risks for people who enroll in COVID-19 vaccine studies.
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools. When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
If an IRB sets a goal of greater efficiency, then giving researchers self-assessment tools and using self-auditing tools on IRB operations is a method that can work. These tools can help study coordinators and investigators turn their study protocol submissions from a hot mess into a submission that is mostly compliant and easier to pre-review.
Finding ways to evaluate IRB ethical quality and effectiveness has been an elusive ideal. Two research professionals are advocating for directly measuring quality of board oversight, rather than relying on the structure of the IRB. An upcoming U.S. Government Accountability Office evaluation of commercial IRBs also may promote the conversation.
Expectations and communication issues are the two biggest challenges between principal investigators and the IRB community. IRBs set expectations through their websites and response letters, but they might not have articulated those expectations to themselves and investigators. From the principal investigator perspective, researchers might not fully appreciate that IRBs can be advocates and not merely a clearing house or impediment to putting research in the field.