Is IRB Approval Necessary to Build a Registry?

Answer

There are many scenarios in which a database or registry is created or used. Generally:

• Building and maintaining a registry or database for current research purposes needs IRB approval.
• Building and maintaining a registry or database for future research purposes needs IRB approval.
• Creating and maintaining a registry or database for quality improvement purposes does not need IRB approval. However, if an investigator later wants to access that registry or database for research, IRB approval should be sought.
• Using identifiable data from any database or registry for research purposes needs IRB approval. See Use of Collected Data or Biospecimens.

The IRB considers each project on a case-by-case basis and will apply the appropriate human research protection regulations and HIPAA regulations, as applicable. Some projects may not be considered human subjects research but still be subject to HIPAA privacy regulations.

Investigators who collect data and biospecimens to be entered into a repository must:

1. Create a management plan
2. Obtain IRB approval, as applicable.

Investigators receiving data and/or biospecimens from the repository must also agree in writing to specific conditions required by the repository’s IRB.