IRB Recordkeeping & Reporting

The Office for Research Protections (ORP) is responsible for ensuring that IRB records are being maintained appropriately and that the records are accessible, upon request, to authorized Federal officials. For institutions relying on another IRB, records may be retained at the IRB site.

ORP must ensure prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary, to eliminate apparent, immediate hazards to the subject.

ORP is also responsible for ensuring the prompt reporting to the IRB, appropriate institutional officials, Office for Human Research Protections, and any sponsoring Federal department or agency head:

1. any unanticipated injuries or problems involving risks to subjects or others;
2. any serious or continuing noncompliance with the regulations or requirements of the IRB, and;
3. any suspension or termination of IRB approval for research.

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