When Should You Submit an Application to Amend Your Study?
Investigators with approved projects must submit an Amendment Application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team. The administrator and chair of IRB review all amendment applications, and assign them to either expedited or full committee review.
You must submit an amendment application for any of the following situations and changes to your approved study:
- Changes in the content of a previously-approved personal interview, telephone interview, or self-administered questionnaire – new or substantially rewritten questions (you do not need to report typos and minor wording changes)
- Review of the final interview or questionnaire for a previously approved study
- Addition of new consent or assent forms
- Changes to any of the consent forms or scripts – may require full committee review
- Changes to the aspect of the informed consent process, including oral consent – may require full committee review
- Changes in the population studied, e.g. including minors as well as adults – may require full committee review
- Changes in study recruitment procedures, e.g. changing from telephone to email recruitment – may require full committee review
- For focus groups, major changes in recruitment procedures or aims
- Changes in the mode of administration of a study, e.g. from mail or telephone to web or Internet access – may require full committee review
- Changes in the leadership of a research project, e.g. change in the principal investigator, adding a co-investigator, changing faculty adviser
- Data set enhancements, such as merging community, company, or neighborhood level data into survey records
- Any changes in research design
- Any other change in protocol that affects treatment of human subjects