So you have confirmed that you are doing human subjects’ research after listening to the first podcast in our human subject mini-series. And you have a clear human subjects’ protection and monitoring plan developed for your application after tuning in to the second episode in the series. What should you keep in mind after the award is made? Tune in to this NIH All About Grants podcast episode for tips about important post-award requirements, annual progress reporting, engaging your IRB and NIH when a protocol change is needed, and more.
Reminder of NIH Requirement to Adhere to the Revised Common Rule and Use a Single IRB for Multi-Site Studies
As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards.
Research involving human participants is key to improving public health and advancing medicine. Oversight of such research by institutional review boards (IRBs) both protects research participants and promotes ethical science. IRB review and approval is a critical step in initiating the start of a research project and for multi-site studies, NIH is taking an important step to help streamline the process. Today, NIH is issuing the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy) ….
For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. ….