Modification is required when an investigator wishes to implement a change to a project which constitutes a deviation from what was approved in the initial IRB Research Application and/or accompanying materials. Changes are classified as either major or minor.
Minor changes include those changes to the project that have no impact on the primary goals of the research or procedures detailed in the initial application and which do not significantly increase or change the risks associated with participation in the research. Such changes may include but are not limited to the following:
- Change of project name/title
- Change in principal investigator or addition of a co-investigator
- Changes to wording in a survey or other data collection instrument
- Expansion of data collection to additional participants drawn from the same sampling pool
- Changes in wording of consent forms or study documents as long as those changes do not alter the consent or study process (e.g., fixing grammatical errors)
- Addition of a new data collection instrument
- Addition of a new sample of participants
Major changes include those changes to the project that significantly alter the goals or protocols described in the initial research application or that pose potential harms to human participants beyond or different from what was originally approved. Such changes may include but are not limited to the following:
- Changing the purpose of the research
- Major changes in the informed consent process
- Changes in the treatment condition being administered by researchers
Form required for this review: IRB Modification Request Form
Forms must be submitted in paper copy to IRB secretary Jennifer Kozak, Building 6, Suite 750.
For additional information, contact Patricia Cahape Hammer, IRB chair, at extension 53005 or email@example.com.