In research, as in life, bad things sometimes happen. Federal regulations about what and when to report to the IRB can be confusing, so our advice is contact the IRB Office as soon as something worrisome happens. The staff will help you sort things out. (We have a form for reporting these things, but feel free to call). Here are some specifics:
Report to the IRB within
5 working days:
- Any local event determined initially by the investigator to be unexpected, serious, and has implications for the conduct of the study. (In reg-speak, this is called a UPIRSO). UPIRSOs don't happen very often in Social, Behavioral, and Educational (SBE) research and you'll know it when you see it.
- Any local event determined initially by the investigator to meet criteria for non-compliance that is either serious or continuing.
Non-compliance means failure to comply with any of the regulations and policies described in this document and failure to follow the determinations of the IRB.
Serious non-compliance means failure to follow any of the regulations and policies described in this document or failure to follow the determinations of the IRB, and which, in the judgment of either the IRB Chair or the convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of the Human Research Protection Program (HRPP).
Continuing non-compliance means a pattern of non-compliance that, in the judgement of the IRB Chair or convened IRB, suggests a likelihood that instances of non-compliance will continue without intervention.
- Any change in a protocol made to eliminate apparent harm to a research subject but not approved by the IRB. (The safety of research subjects must be the primary concern!)
- Any notice from a sponsor of suspension or termination of the protocol. (Our portfolio of externally sponsored is increasing, so this kind of thing will become more common!)
- Any local event that an investigator thinks should be brought to the attention of the IRB.
Feel free to err on the side of caution in reporting something, even though it may not appear to meet any of the above criteria.
Report a Research Concern