Study Modifications
When changes are needed in a previously approved protocol, the investigator is responsible for requesting and receiving IRB approval for the changes before the changes are implemented. However, when changes are made to eliminate an immediate hazard or serious potential risk to participants, review of those changes may be requested after it occurs, provided the request is made within 10 days of occurrence. If non-emergency changes are introduced without advance approval, the investigator will be considered to be out of compliance with IRB regulations. This policy applies to all projects, regardless of funding source, and including those originally approved as Exempt.
Which Modifications Need Review
Changes or additions that require review and approval by the IRB are those that may affect the assessment of risks and benefits for participants from the research, including the potential legal, social, economic, health, and privacy risks.
Examples of modifications that need review include:
- any revisions to consent materials beyond minor editorial or grammatical changes;
- adding a new measure or instrument, or changing current measures or instruments;
- adding to or changing the sample(s) of participants;
- adding or changing the review of academic or medical records;
- involvement of participants for follow-up research that was not originally included in the protocol;
- adding a site for recruitment or data collection;
- changing key personnel on the study (individuals involved in decision-making, recruitment, or data collection);
- changing the procedures for how participants are invited/recruited into the study;
- changing the data collection procedures.
Examples of modifications that do NOT require review are:
- dropping a measure or instrument (unless it is used to screen or monitor the welfare of study participants);
- making minor editorial or grammatical revisions to approved documents that are unrelated to the sensitivity of the questions or the privacy of the participants;
- removing a research site from the study;
- changing the strategy or procedures for data analysis, as long as the changes do not affect the confidentiality of study data or potential for re-identification of participants.
If in doubt as to whether or not a proposed change requires review, the investigator should send an email describing the change to the IRB Administrator Lisa Ahern at lisa.ahern@uni.edu.
How to Request a Modification
Due to the transition to Cayuse IRB, modifications to protocols will be handled differently, depending on whether or not the protocol was approved within or outside of Cayuse IRB. Modifications to protocols approved using the earlier forms (pre-Cayuse) will be handled via email requests as described below. Modification to protocols approved within Cayuse IRB should be handled within the Cayuse system, by opening the study and creating a "Modification" submission. Ultimately, ALL active studies will migrate to Cayuse and all modifications will be handled through the system. Until that time, please follow the guidance below.
- Modifications to Protocols approved Pre-Cayuse: Please submit a modification request via email to the IRB Administrator Lisa Ahern at lisa.ahern@uni.edu (please CC karen.bass@uni.edu) describing the proposed changes and attaching any revised consent forms or other participant materials. The communication should include a reference to the original IRB protocol number, and changes should be highlighted to expedite the review. The IRB Administrator will review the modification request, unless the study is being monitored by the full board, in which case the request will be reviewed at the next regularly scheduled meeting of the IRB. In either case, the investigator will receive an email noting questions or concerns about the modification, or approving the changes as requested and allowing the study to continue with the modification. A formal letter of approval is not issued for modifications. Documentation of all modifications is entered into the study file.
- Modifications to Protocols approved in Cayuse-IRB: Open your submission in Cayuse IRB and follow the prompts to create a "Modification submission." Update the sections requiring changes and upload new documents if needed. Once finished, you will be asked to certify the Modification submission, and it will be routed to the IRB Administrator for review.
- If the study was originally reviewed by the full board, modifications may also require full board review. If the changes proposed are minor (e.g. changes to student personnel, minor revisions to participant materials, addition of study sites), regulations allow these to be approved under an expedited process.