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Further IRB approval is required to make any changes to your research design or procedures.
Changes that require IRB approval include, but are not limited to:
- participant recruitment
- number of participants
- research instrument modifications
- changes to the consent form
- changes in research assistants
Until September 2018, you may submit modifications using Form K (Continuation/Modification Form). Include all supporting documents that have been modified (surveys, recruitment flyers, consent forms, etc.).
Beginning in September 2018, Form K will no longer be used. Modifications and continuations will be submitted via PACS. This includes projects originally submitted via e-mail that now require modifications or continuation. All researchers and research advisers will need to create an account to access the PACS system. The IRB will be providing online and in-person training to help the transition go as smoothly as possible. You can also contact the IRB Office for assistance.
Be sure to allow at least two weeks for review. You cannot implement any changes until you receive written approval from the IRB. Please note that a modification does not change the approval/termination dates; the modification approval is effective within the approval period of the entire project and does automatically grant a continuation of the project.
Proposals that have been approved at all levels of review (exempt, expedited and full-board) are open to modifications.
The Continuation/Modification Form (Form K) is available in the Forms section of the IRB website. General information about the PACS system can be accessed here. Specific guidance about how to submit a modification via PACS can be found here.