Documents and Attachments
The IRB reviews and approves supporting documents to the IRB application for the following purposes:
- Information included in the document is necessary for the IRB to determine if the study meets the Criteria for IRB Approval of Research, as well as other applicable federal regulations.
- The document will be provided to the research participants and will assist them in making an informed choice about participation in the study.
Most IRB applications have accompanying documents that must be submitted to the IRB for review and approval.
What Should I Attach to My IRB Application?
The Documents and Attachments Page of the IRB application includes sections for each type of document. Consent documents, recruitment materials, and any other documents the IRB needs to assess the Criteria for IRB Approval of Research should be attached. Click on the help guide titled "Required Documents & Forms for IRB Applications" on this page for more information.
How to Prepare Your Documents for Processing
ERICA processes two types of documents with the approval stamp:
1) Word documents with a clean, unstamped watermark footer, or
2) Adobe PDF documents with 2” of blank space in the footer.
As you prepare your documents, please choose one of the following:
Word Document: Cut and paste all the text from your current document into the IRB template Word document. Use the template found on the IRB website. This will enable the ERICA system to use the mail merge field in the footer of the template to stamp the document(s) with an approval stamp during final processing. Please do not alter or enter any information in the footer of the document(s).
PDF: Convert your Word document to a PDF and ensure there is at least 2” of white space at the bottom of each page. Do NOT insert the watermark footer. ERICA will add an image of the approval stamp to the footer of each page of the document.
What Do the Documents Look Like After They've Been Stamped by the IRB?
The ERICA system locks the documents to further editing and adds an approval stamp to the footer of each page of the document.
MS Word Example
Adobe PDF Example
Click on image to view larger
Click on image to view larger
If your documents are MS Word documents, this usually has something to do with the internal formatting of the document. There are a couple of things that can prevent ERICA from stamping Word Documents:
- The watermark footer is a mail merge field. If the footer is altered in any way (e.g. an image is pasted in the footer instead of the mail merge field, text is added, the field is pasted from another document, etc.), ERICA won’t recognize the footer and won’t stamp the document.
- Section breaks are added in the document. Section breaks signal to ERICA that different rules should apply to the footers on
different pages. This can lead to some pages being stamped and some not.
To ensure your Word document is processed correctly:
- Every time you attach a clean document you intend to be processed and stamped by the IRB, cut and paste all of your text into a clean watermark template with an unaltered mail merge footer. Do not alter any of the information in the footer.
- Avoid using section breaks in the body of the document.
Contact us if you need help determining what went wrong with your documents. We will help you prepare them so they can be re-submitted for processing.
Submit an amendment to your IRB application with your clean, corrected document(s) attached.
Note in the amendment application that the purpose of the amendment is to re-process previously approved documents that did not stamp correctly and that there have been no changes to the content of the document(s).
Consent Documents of any kind are the most common type of document that requires an IRB stamp. If you have another document type that you believe needs to be stamped by the IRB, please contact us for guidance.
The following sections of the ERICA Documents & Attachments page will process MS Word and Adobe PDF documents with the IRB approval stamp:
- Consent Documents
- Parental Permission Documents
- Assent Documents
- VA Consent Documents
- Other Stamped Documents
This tutorial will walk you through the process of attaching updated documents to your Continuing Review or Amendment application:
The University of Utah IRB has thousands of active protocols, each with several documents that require review, and each application is reviewed on its own timeline. This means that at any given time, the IRB staff is reviewing documents for hundreds of different studies.
Each application often has multiple versions of documents, different revision requests in process, etc. Tracking changes made to documents previously reviewed by the IRB can help the IRB staff streamline and speed up the review process.
Learn more about how to help the IRB staff by providing helpful tracked documents with your application: Tracking Documents for IRB Review [PDF].
Attaching Revised Documents
If you are attaching a document the IRB has previously reviewed or approved, attach:
- A tracked copy of the document showing the changes you've made, and
- A clean copy of the document the IRB can process with your approval.
Learn more about tracking documents for IRB review: tracking documents