Protocols approved under the Expedited or Full review procedure require a continuing review. The IRB establishes the intervals of review at the time of approval. The intervals between reviews are commensurate with the level of risk involved to participants. However, continuing review must occur at a minimum of every 12 months from the original approval date, except as described in [46.109(f)]. Under new regulations, effective after Jan 19,2019, in regards to research eligible for expedited review in accordance with [46.110], continuing review of research is not required.
OPRR mandates that all continuing reviews must be substantive and meaningful. Continuing reviews will include the following:
- The number of subjects accrued;
- A description of any adverse events or unanticipated problems involving risks to subjects or others, withdrawal of subjects from the research, or complaints about the research;
- A summary of any recent literature, findings, or other relevant information, especially information about risks associated with the research; and
- A copy of the current informed consent document.
In addition to IRB initiated reviews, investigators are required to submit any changes to the original protocol for IRB approval prior to enacting these changes. Again, it is important to consider the IRB approval as a process rather than an isolated event.