When should a researcher submit an IRB protocol modification to an approved study? Per federal regulations, once a human research study has received IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation.
Modifications are categorized into minor changes and significant changes. A minor modification may include:
- A proposed change in research-related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
A significant modification may include:
- A proposed change in research-related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
Researchers can use Five-Self-Checks to reflect on an IRB modification submission.
Self-Check #1:
Risks/Benefits:
- Have the risks or benefits changed since my original IRB protocol submission?
- Have I made any new discoveries that could impact the future risks or benefits of this study that are important to address immediately?
- Are there site or participant requirements that impact the risks or benefits of my study?
- Do I need to adjust my Data Security Plan to ensure I am fully protecting the confidentiality of my participants?
Self-Check #2:
Recruitment:
- Has recruitment become ineffective? In what ways can I improve my recruitment methods? For tips and insights, review our Notes on Recruitment Materials.
- Has recruitment become overly effective or overwhelming?
- Am I recruiting more participants than I originally anticipated?
- Do I need to add new recruitment materials to supplement my already approved protocol?
- Will adding an incentive (or participant payment) change my recruitment efforts?
Self-Check #3:
Informed Consent/Debriefing:
- Are participants expressing any confusion or misunderstanding with the informed consent process? if so, make sure to review our Be Informed about Consenting post.
- Is the debriefing process going as planned?
- Are participants raising questions or concerns about study activities or procedures?
- Can I revise my consent form (or other study related materials) to clarify the study activities?
- Are my study materials (e.g., consent form, flyer) too difficult to read and understand? Do I need to address the reading level of my study materials? If participants are struggling to understand your materials, review the Writing for an IRB Review page.
Self-Check #4:
Privacy and Confidentiality:
- Has storage of the digital or physical data raised any issues? For example, does my locked filing cabinet have limited space or does my digital data storage require a backup? If you are struggling with protecting data, please review our Data Sharing, Requests, & Encryption page.
- Do I fully understand the benefits and opportunities afforded by the software and hardware I am using for this study?
- Is the coding system I used to maintain participant confidentiality sufficient, effective, and efficient?
- Do I need to institute more strict confidentiality procedures to protect participant data?
Self-Check #5:
Monitoring communication/research assistants:
- Are there any issues or concerns with disseminating the information associated with this study?
- Are research assistants expressing any concerns about interacting with participants?
- Do I need to revamp the entire study structure because the procedures originally proposed do not reflect data collection procedures common to my field?
- Do I need to hire new research staff with specific data analysis expertise?
- Do I need to remove research staff who are no longer associated with the project?
In rare circumstances, researchers may modify a protocol to avoid an immediate, apparent hazard to a research participant (i.e., to avoid an adverse event). Researchers should alert TC IRB about any protocol changes to an approved study.
Researchers can visit TC IRB’s Modification page and search for specific instructions on how to submit a minor or significant modification to an already approved protocol.