FDA Wants IRBs to Write Better SOPs
​​​[Posted on: Friday, May 18, 2018]

In a joint announcement, FDA and Office of Human Research Protection (OHRP) at NIH released a new guidance document today to address several deficiencies observed in the SOPs and other policy and practices documents maintained by IRBs. In all, FDA and OHRP listed 55 SOPs or written policies covering 5 major areas of compliance that all IRBs should have. In the introduction to the guidance, the agencies stated that several written processes at IRBs are rewriting of the rules which does not provide adequate instructions to the users. Also several areas of compliance are unaddressed due to the lack of clear instructions from the regulators. This is the first list of this kind from the regulators to the IRBs and creates a very detailed list of regulatory responsibilities. There is no new requirement put forward for IRBs but a detailed description of regulatory expectations was needed. The regulations governing IRBs and human subject protection were written decades ago and contain few details. The guidance document tries to fill the gaps in the perception and interpretation of the regulatory requirements that should be welcome to the IRBs. Most importantly, the guidance document includes a detailed checklist that should be maintained by the IRBs listing if they have, do not have, or do not need a given SOP. One would expect the auditors from OHRP and FDA to expect this checklist at the next visit to a given IRB.  Many of the processes listed should already be covered in the existing SOPs so many IRBs will find this list easy to fill. For those that lack certain SOPs, this list will provide the justification to create one now. Creating an SOP is a resource-intensive work and some busy IRBs may have to identify additional resources to get the work done but at least now they have their marching orders.