- What is a modification? What kinds of changes to my study would require a modification to be submitted?
- How do I start the modification?
- How do I modify an attachment for my study?
What is a modification? What kinds of changes to my study would require a modification to be submitted?
Any change in study procedures or personnel must be submitted and approved by the IRB before being implemented. A modification application is the vehicle to make those changes. By starting a modification, your currently approved IRB application is opened up for editing, allowing you to alter, delete, or add to anything in your application and/or attachments. Exceptions to the process can only be made when there are concerns for subject safety. If there are subject safety concerns, contact an IRB Chair immediately.
- Office for Human Research Protections guidance
- IRB Standard Operating Procedures
- Section II, Part 19 PI Responsibilities after initial IRB Approval, Section B- Reportable Events
- Log into HawkIRB. If you are logging in as a delegate for the PI, click on delegate login and select the PI.
- Under Projects, click on the IRB number of the study you wish to modify.
- Under Create Form, click on Modification/Update Form. If you wish to submit a Continuing Review at the same time, click on Modification/Update + Continuing Review Form.
- After starting the modification, you are routed to the Modification Index, and more specifically, the Frequent Mods tab. This section provides links to areas of the application that are frequently modified by investigators. You can select the Project Index tab to view links to the entire application by section.
- The Attachment Changes tab will show all of the currently approved documents for the study and provide links/instructions to modify attachments and attach new documents.
To alter study documents, such as a consent document, recruitment material, questionnaire, etc, you must first start a modification. Please review the ‘Modifying Attachments in HawkIRB’ webpage for step-by-step instructions on this process.
By following these directions, you are creating a historical account of the documents being altered. To view past versions of these documents, you can click on the + sign to the left of the attachment name, which will allow previous versions to unfold.
If you are using a Mac:
Macs do not always open RTF documents in Microsoft Word by default. This causes the "IRB Stamp" to be lost, which will hinder the upload of your consent and recruitment materials. In order to configure your Mac to open RTF files in Microsoft word, please follow the instructions provided here.