Investigators must seek IRB approval before making any changes to the approved research project even though the changes are planned to occur during the current approval time frame. Changes to the project may not be implemented until approved by the IRB.
However, a change may be implemented WITHOUT IRB approval when the change is necessary to eliminate immediate hazard to the subject. If this happens, the IRB must be notified at once.
Amendments may include:
- Addition of a subject population even if the original study procedures, rationale and aims have not changed;
- Increase in the number of subjects to be enrolled;
- Changes to study instruments/questionnaires, deletions and/or additions;
- Change in study site location or addition/deletion of a study site;
- Change in methods and procedures;
- Change in consent form language;
- Addition of a consent/ an assent form; etc.;
- Changes to the research team, additions, replacements or deletions.
Expedited or Full Board Review Necessary
The IRB may use an expedited review procedure to review either or both of the following: (A) some or all of the research appearing on the expedited review categories list and found by the reviewer(s) to involve no more than minimal risk, and/or (B) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
A minor change is defined as the change to the project makes no substantial alterations to: (1) level of risks to the subjects; (2) the research design or methodology; (3) the number of subjects enrolled in the research (e.g. increases of greater than 10% for projects that are greater than minimal risk); (4) the qualifications of the research team are changed; (5) the facilities available to support the safe conduct of the research; or (6) any other change in the research that would otherwise warrant review of the proposed changes by the convened IRB. Project changes that do meet these criteria will be placed on the agenda for full board review at a convened meeting.
Documents to be submitted for both types of review:
- Completed Application for Amendment/Proposed Changes
- All revised documents with changes underlined
- CLEAN electronic copies of all revised consent/assent forms, recruitment flyers, advertisements, etc. that require an IRB approval stamp
- All information is e-mailed to email@example.com