Protocol Deviations, Adverse Events, and Amendments: What Researchers Need to Know

Conducting ethical research is more than designing a sound study—it means staying compliant every step of the way. That’s where IRBs come in. An Institutional Review Board (IRB) is responsible for reviewing research involving human subjects to ensure it meets regulatory and ethical standards.

But what happens when something changes after your protocol is approved?

Amendments Must Come First

Any changes to an approved study—such as modifying a survey, adding a new study site, or altering the consent process—must be submitted to the IRB as an amendment before implementation. The IRB must approve the revised protocol before those changes go into effect.

If changes are made without prior IRB approval, you could be dealing with a protocol deviation or even an adverse event.

Definitions: Protocol Deviations and Adverse Events

Protocol Deviation: Any instance where the approved research plan is not followed. This could be minor (e.g., missing a scheduled survey window) or major (e.g., enrolling ineligible participants).
Adverse Event (AE): Any unfavorable or unintended medical occurrence in a research participant, which may or may not be related to the research intervention.

Some deviations may lead to adverse events—but not all do. Understanding the difference helps ensure appropriate response and reporting.

How to Mitigate Protocol Deviations

Deviations happen, but the key is to minimize risk and prevent recurrence. Here are a few best practices:

Train your team thoroughly on the approved protocol.
Use checklists and tracking tools to stay on schedule and within compliance.
Communicate changes early—even anticipated changes should be discussed with the IRB in advance.

Why Timely Reporting Matters

IRBs need to know about deviations and adverse events promptly to assess potential risks to participants. Timely reporting helps:

Protect subjects’ safety and rights
Maintain study integrity
Meet federal and institutional compliance requirements

Delays in reporting could lead to additional corrective actions—or even study suspension.

How to Report a Deviation or Adverse Event

Reporting is simple: login to our online IRB application system to submit a report form. Include:

A clear description of what happened
The date and timeline of the event
Actions taken to resolve or prevent recurrence
Any impact on participant safety or data integrity

Our team reviews each submission carefully and will follow up if more information is needed.

Need Help?

Not sure whether your situation qualifies as a protocol deviation or adverse event? Wondering how to phrase an amendment?

The Solutions IRB team is here to help. Whether you need support with reporting, documentation, or planning your next amendment, we’ll guide you through it.