The US Food and Drug Administration (FDA) has published a new document consolidating its guidance for institutional review boards (IRBs) as they review the adequacy of biomedical research sites and clinical investigators.
While this oversight is generally the responsibility of the trial sponsor, the agency wants IRBs and investigators to have greater involvement “in order to protect the rights and welfare of study subjects”.
The recommendations also clarify the responsibilities of the IRB in determining whether an investigational new drug application (IND) or investigational device exemption (IDE) is required before starting a study.
Among the points raised in the document is that an IRB should review the qualifications of clinical investigators who conduct FDA-regulated research to make sure they have relevant training and experience.
This may be as simple as getting credentials from an administrator of the institution where the investigator works, but in some cases could require review and verification of their CV, training in Good Clinical Practice (GCP) and professional or medical licenses.
In the case of clinical sites, IRBs “must be able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice,” says the FDA. That could include a review to confirm whether a site is appropriately staffed and equipped to conduct the proposed research.
The FDA notes that many of the recommendations in this guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly, but until now there was no single document covering the topic.
The agency has been progressively updating its guidance to IRBs in recent years in order to bring the recommendations into line with changes in the clinical research sector, including a shift away from the single investigator-single site norm to multisite studies which require a greater level of oversight and a shift towards greater transparency in recording the design and results of trials.
