Amendments are only necessary for exempt studies when the proposed modification are substantive or change the study procedure such that the study no longer qualifies for exempt review.
Examples of minor modifications to exempt studies that can be implemented without review include:
- Addition or removal of study personnel other than the PI
- Minor revisions to recruitment materials and methods. For example, a change to the phone number, or the addition of a newspaper ad when using similar language as an already approved flyer.
- Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the original approved instruments. For example, wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions.
Examples of substantive modifications that require review:
- Change in PI
- Change in funding source
- Change to study purpose or procedures. For example, adding a survey on a different topic than previously approved or collection of data falling outside the parameters of the data collection previously approved.
- Changes to study population targeted for recruitment. For example, adding a new population or substantively revising the inclusion/exclusion criteria for the current population.
- Changes to the identifiability of the research data you will receive or record. For example, your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset
- Changes to the risks involved in the study
- Substantive modifications must be submitted to for review prior to their implementation. To request review, submit an amendment to the existing protocol