Decision Charts for Research Staff

We recognize that determining when to report a research circumstance to the IRB can be unclear. The NMDP IRB has developed 3 decision charts to help teams answer the following questions:

  • Do I need to report this adverse event or unanticipated problem to the NMDP IRB?
  • Do I need to report this non-compliance or deviation to the NMDP IRB?
  • Will my submission be reviewed by the full IRB or can it be expedited?

These decision charts are intended to be used by research staff to help quickly identify if an event or incident needs to be reported to the NMDP IRB in real time, removing added delay from the process of reporting an incident.

Instructions

  • Begin at the top of the decision chart, answer the yes or no questions, and follow the corresponding arrows until you reach a decision.
  • If the decision reached indicates the incident must be reported to NMDP IRB, submit the Reportable Event Form via the IRBManager online platform.

Assessing a Potential Unanticipated Problem

Chart available for download here

Assessing a potential unanticipated problem

Assessing Potential, Serious, and/or Continuing Non-Compliance

Chart available for download here

Assessing Potential Non-Compliance
Assessing Serious Non-Compliance
Assessing Continuing Non-Compliance
Full IRB vs. Expedited for Initial Review and Amendment
Full IRB vs. Expedited for Major Protocol Exception, NMDP sIRB Study-Specific Local Context Worksheet and Site Principal Investigator Change
Full IRB vs Expedited for Consent Form Revisions and Consent Form Translations
Full IRB vs. Expedited for Reportable Event Form and Major Protocol Exception
Full IRB vs. Expedited for Continuing Review of Research Previously Approved by The Convened IRB and Reportable Event Form

If there are further questions please reach out to the NMDP IRB team via email at IRBstaff@nmdp.org.

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