Modifications to Approved Projects & Research
The ACIRB must review and approve changes to previously approved projects or research to ensure the regulatory criteria for approval continues to be met and the risk/benefit ratio remains appropriate considering the proposed changes. Researchers are responsible for proposing any changes for review and approval prior to implementation, except when the changes are necessary to avoid immediate hazards to subjects.
Any change in study procedures or personnel must be submitted and approved by the ACIRB before being implemented. Researchers notify the ACIRB of proposed changes by completing a modification submission in Cayuse. A modification submission opens the approved ACIRB submission for editing the application or other attachments. Exceptions to this process can only be made when there are concerns for subject safety. If there are subject safety concerns, immediately contact the ACIRB.
Modification Information
Modifications may be categorized as a minor revision that involves no more than minimal risk to participants or a major revision that involves increased risk to subjects or significantly affects the design of the study. All changes to full board and expedited studies must be reviewed and approved by the ACIRB before the changes are implemented. Examples of proposed changes that require a modification submission include:
- Increased risk to subjects – a new risk is identified; serious adverse event has occurred
- Eligibility changes – inclusion or exclusion criteria is changed
- Recruitment of subjects – recruitment procedures are modified (number of subjects increased or decreased); recruitment materials are revised or new materials are used
- Scientific changes – study objectives are changed, statistical analyses are modified
- Data, data collection, and data collection materials – Study diaries, questionnaires, or surveys given to subjects are revised
- Editorial and administrative changes – changes made to contact information; changes to study staff; typographical revisions to recruitment materials
For exempt studies, only certain changes must be reviewed and approved by the ACIRB prior to implementation:
- All personnel changes
- All funding changes
- If protected health information is being collected, all changes to data collection procedures
- Substantive changes
o A change that results in the study no longer qualifying to be exempt
o Addition of participants from a vulnerable population (i.e., children, prisoners, cognitive impairment, etc.)
o Change in sensitivity level of study by adding sensitive questions or changing to identifiable data collection procedures
o Addition of physical or biomedical procedures
o Addition of use of deception or incomplete disclosure
o Removing consent process
Please note the examples provided are intended to be used for guidance only and are not all inclusive of changes that need to be approved prior to implementation. If you have questions about determining if a proposed change requires a modification submission, contact the ACIRB.
Modifications to any documents or communications (i.e., advertisements, introductory or reminder emails, questionnaires, etc.) must include both a tracked changes and clean version as attachments to the modification submission.
How do I complete a modification submission?
- Log into Cayuse
- On the Researcher Dashboard, select the Studies tab.
- Select the study requiring a modification submission (study must be approved before a modification submission may be completed).
- In the top right-hand corner of the Study Details page, click on the New Submission drop-down menu, and select Modification.
- Follow the instructions in Cayuse to complete the submission.
For additional assistance, access the Cayuse Help Center and search for “modification” to access detailed instructions.