Policy Regarding 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 determined to be Exempt from ongoing review.
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 or changing the sample(s) of participants;
- adding or changing the review of academic or medical records;
- involvement with participants again 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.
If in doubt whether or not a proposed change requires review, the investigator should simply send in an email describing the change to the IRB Administrator.
- Modifications are typically reviewed fairly quickly without the use of a special form. The investigator should simply send an email to the IRB Administrator describing the proposed changes and attach any revised consent forms or other participant materials. The communication should include a reference to the original IRB protocol number. 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.
- 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 sties), regulations allow these to be approved under an expedited process.