Amending Previously Approved Research

Guidance on Amending Previously Approved Research

Amending an Existing Protocol
Determining Review Requirements
Amending a Protocol vs. Submitting a New Protocol
Amending Exempt Research
Amending Expedited Research
Amending Full Board Research

This guidance is intended to guide researchers when considering changes to previously approved research to determine review and submission requirements.

General Considerations

In general, changes to previously approved research require review by RCS and/or the IRB prior to implementation to determine whether the study continues to comply with regulatory requirements. The first section of this guidance helps an investigator determine whether a modification or a new study may be appropriate for the proposed changes. The second section of this guidance helps an investigator determine the submission and review requirements for  a modification based on the level of review.

If a change requires either a modification or a new study, approval for the changes must be secured prior to implementing changes.

If you must make a change to an approved protocol to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make changes to eliminate immediate potential hazards, contact RCS as soon as possible for further instructions.

If you are done with a portion of your study (e.g., phase 1) but other portions are still ongoing, please do not remove the completed portions from your research plan. Instead, please note within the research plan which portions of the study are complete (e.g., note COMPLETED next to the applicable sections). However, if you previously were planning to do certain study procedures and those procedures are changing, revise the content to reflect your revised procedures. If you are done using study materials such as recruitment or consent forms, please rename those documents in the RAP to include "RETIRED" in the name of the document. 

Application Submission

Applications to change previously approved research are submitted via the IRB module of the Research Administration Portal (RAP) by selecting the study from the system and completing a the "Create Modification/CR" activity.  NOTE: On May 12, 2021 all legacy studies were migrated into the RAP.  Going forward, legacy studies including modifications will be managed through the RAP.