This information is for applications that have already been approved by the WWU IRB.
Researchers may want to make changes or modifications to an approved protocol.
Changes Requiring Approval
Full board and expedited applications: All changes require IRB approval. Assume that if the IRB approved it originally, that we will need to re-approve it when changed.
- This includes changes to any of the following:
- The subject population
- The maximum number of approved subjects
- The recruitment plan or materials
- Consent forms or consent methods
- Study instruments
- The Lead Investigator
- Any investigator working with human subjects or their identifiable data
Exempt applications: Any changes that will change the risk level (changes in subject group, compensation, consent form or consent procedures, or a significant change in the time burden) to the subjects or fundamentally change what your research was approved to do.
- Changes that do not require IRB review include:
- Edits in spelling, punctuation, and grammar on your recruitment or study materials (excluding consent forms)
- Minor wording changes to your recruitment materials that do not change the overall content and resulting comprehension
- Adding or editing questions in questionnaires that are not outside of the scope of the questions are currently approved to ask
How to request a modification
To request a change, please submit a Modification form.
Timeline for modification approvals
The timeline for approval will vary based on the risk level of the research, the complexity of the modification, how complete your paperwork is, and the workload of the IRB. Modifications for exempt and expedited studies can be reviewed by a single reviewer. Modifications to full-board studies will require two reviewers or full board review.
Reporting a problem or issue with your study...
Our office is here to help guide you through adverse events, discoveries of non-compliance, or any breach in the responsible conduct of research framework.
Please report any adverse events, non-compliance, or issues that arise in your research and soon as possible, so that we can help you navigate the situation.
This includes issues such as:
- A breach of confidentiality
- An adverse event occuring during a study task
- An injury occuring as result of your research
- Discovering you used unapproved materials
- Any issue of non-compliance
Please submit a Problem Report within 7 days of when the event was discovered.
For additional information on non-compliance, please see our Human Subjects Research Compliance Manual.
Extending your study after approval...
Extending Your Project
When a full board application is approved the IRB assigns an expiration date. If the Principal Investigator would like to continue the research beyond the expiration, they must apply to extend the project. This is known as a "status report."
Studies Requiring Extensions
Full board applications need to be reviewed on a yearly basis for re-approval. Exempt and expedited applications do not expire.
Extension Application Process
Applying to extend your project is a separate process from a modification. While a modification can be submitted whenever a change is necessary in your research, the status report process occurs on a timed basis.
Please be sure to submit a Status Report report at least 6 weeks before the expiration of your project. It is considered non-compliance to continue recruitment, study procedures, or use of identifiable data on a study if the project has expired, so it is better to allow more time for your review.
Timeline for Extension Review
The timeline for approval of an extension will vary based on how complete your paperwork is, and the workload of the IRB. Status Report forms for full-board studies will require full board review.
Closing your study...
Closing Your Project
Please close expedited or full board applications if any of the below apply:
- You have completed all recruitment and interaction with subjects and identifiable data
- You are leaving Western Washington University
To close your application, complete a Status Report form and select the option to close the application.