IRBs and IECs Have Ongoing Requirements

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All relevant IRBs and IECs must review the protocol and analysis plans at intervals appropriate to the degree of risk, at least once a year and whenever changes occur in your procedures. In addition, report any changes in informed consent or IRB or IEC approval status to NIAID. For this reporting, send your program officer a copy of the following:

• IRB or IEC letter of renewal.
• Latest IRB- or IEC-approved protocol identified by version number or date.
• Latest IRB- or IEC-approved informed consent document identified by version number or date and dates it is valid.

To learn more about requirements for continuing IRB and IEC review, see the following:

• Office for Human Research Protections' Guidance on Continuing Review.
• HHS regulations at 45 CFR 46.103(b)(4).
• Your institution's OHRP-approved Federalwide Assurance.

Additional Resources

• Human Subjects Certifications: IRB or IEC SOP
• Human Subjects Reporting Requirements: IRB and IEC checklist

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