Amending A Project
Any changes to an approved research protocol or a consent document must be approved by the IRB prior to implementation. This includes changes in:
- the participant population
- recruitment or consent procedures
- intervention or assessment procedures
- data recording or management procedures
- changes in the consent documents or consent scripts
It is the investigator’s responsibility to ensure that all anticipated changes or modifications affecting human participants are reviewed and approved by the IRB. In most instances, minor changes to minimal risk research may be reviewed via expedited procedures. However, substantive changes that might alter risk assessment or changes to research that involves more than minimal risk may require full IRB review. Amendments which require full IRB review are subject to submission deadlines and meeting dates, thus investigators are encouraged to contact the IRB chair or Compliance Manager to discuss the nature of the proposed changes and for guidance on how to proceed.
Investigators requesting an amendment to a previously approved protocol should submit an original plus 12 copies (13 total) of the completed Application for Amendment to Research Protocol and any supporting materials that are also being amended (e.g., consent documents, recruitment materials, instruments, letters from cooperating institutions, etc.) to the IRB Chair, c/o Research Services. Investigators must submit changes to any cooperating institutions that are involved, and documentation of approval from these institutions must be submitted to Loyola’s IRB before final approval can be granted.