Division of Research
Creating Modifications to Approved Research
Definitions
- Modification (Amendment): Any change to an IRB-approved study protocol, informed consent documents, recruitment materials, personnel, study sites, or other supporting documents.
- Minor Modification: A change that does not materially affect risk/benefit, participant safety, or the integrity of the study.
- Major (Substantive) Modification: A change that may increase risk, significantly alter study design, or impact participants' willingness to participate.
When to Submit a Modification
| Type of Change | Examples |
|---|---|
| Study Design or Procedures | Changes to research methods, interventions, data collection tools (e.g., survey updates, additional visits) |
| Informed Consent Documents | Updates to procedures, risks, compensation, or language |
| Study Population or Sites | Adding new sites, altering inclusion/exclusion criteria |
| Research Personnel | Adding/removing investigators or staff who interact with participants or data |
| Recruitment Materials | Revising ads, emails, flyers, or social media language |
| Funding or Conflict of Interest | Adding new funding sources or disclosures |
Do not implement any change until the modification has been reviewed and approved by the IRB (unless necessary to eliminate immediate hazards to participants.
Required Documents
To request a modification, submit the following through the eIRB system or your institution’s Huron IRB platform:
| Type of Change | Examples |
|---|---|
| HRP-213 – Modification Request Form | Details the type and rationale for the change |
| Revised Protocol | Use tracked changes on the original protocol (e.g., HRP‑503, HRP‑503a, HRP‑503b) |
| Updated Consent Form | Include tracked changes and a clean copy (e.g., HRP‑502 series) |
| Updated Recruitment Materials | Include new or revised flyers, scripts, ads |
| Other Affected Documents | Questionnaires, data use agreements, safety monitoring plans, etc. |
IRB Review of Modifications
- Modifications to exempt research do not require IRB review if the change does not impact the exempt determination.
- Minor modifications may be eligible for expedited review under 45 CFR 46.110.
- Major modifications will be reviewed by the full IRB at a convened meeting, if required.
- The IRB will assess:
- Risk/benefit balance
- Continued consent adequacy
- Participant safety
- Impact on scientific validity and ethical conduct
Best Practices
- Use tracked changes in all revised documents.
- Clearly justify each change in the modification submission form within Huron
- If modifying consent language, consider whether re-consent is required for currently enrolled participants.
- Coordinate with your sponsor (if applicable) before submitting site-level changes.
- If you are part of a multi-site study, notify the lead PI or coordinating center as required.
Related HRPP Toolkit Resources
Modifications to Exempt Research
Minor modifications do not require review and approval if the research remains within the exemption category(ies) determined to be applicable to the research.
Examples
- Changes to eligibility criteria that fall within the scope of the approved research and do not increase risk
- Adding non-sensitive questions to a survey or interview or revising current measures within the scope of the approved aims
- Adding recruitment material that follows IRB guidelines
- Increasing or decreasing the approved enrollment number
- Administrative revisions to study documents (i.e. clarity, grammatical corrections) that do not alter the approved purpose of the material
- Revisions to study timelines
- Change of study team members
- Certain specific or significant changes that impact the review category or increase the risk profile must be submitted to the HRPP/IRB for review and approval.
Specific Examples
- Studies that received a Limited IRB Review
- Change of principal investigator
- Adding a new funding source
Significant Examples
- Changing the study purpose or aims
- Addition of a vulnerable population
- Addition or change to physiological data collection outside of the current review category
- Adding sensitive questions about participants’ health or behavior (i.e., diagnosis for illness or disease, illegal conduct or traumatic events)
- Changes to sources or identifiability of data outside of the current review category
- Adding external collaborators or sites (each site must obtain their own exempt determination from their home institution)
For further assistance, use the self-assessment tool to evaluate if the modification requires a submission for review and approval.