Relevant Guidance
Click on the title to be directed to Guidance regarding:
Informed Consent Template
- Informed Consent Template Instructions - Required Reading
This document provides detailed instructions for completing the template including required language, alternate text and information about sections that may be altered. These instructions are to guide and assist you in completing the Informed Consent Template prior to being submitted to the IRBMED for review. Investigators are responsible for understanding and following all instructions. - Informed Consent Template (Clean) (version 8-9-11)
This document is to be used to complete the Informed Consent Template that is to be submitted to the IRBMED for review.
- When uploading your informed consent form in eResearch:
- New Applications: Please make sure to delete all instruction boxes, comments, and headers from the original template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
- Amendments: Please upload a "tracked changes" version as well as a “clean” version of the informed consent. For each consent and child assent document, there should be two documents uploaded: 1 labeled as the "tracked" changes version with all changes highlighted, and 1 labeled as the "clean" version that has all of the tracked changes accepted. This will be essential for the document review and finalization process. Otherwise, the IRB will not be able to provide you with finalized documents for the study. Also be sure to proofread the document for spelling, grammar, and formatting errors.
- For informed consent documents that are uploaded in eResearch but are no longer in use, please simply change the document file name by adding the phrase “Not in use” to the file name. Do not delete these documents from the eResearch application.
Assent Template (Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.)
- Assent Template Instructions - Required Reading
This document provides detailed instructions for completing the template including required language, alternate text and information about sections that may be altered. These instructions are to guide and assist you in completing the Assent Template prior to being submitted to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
- Assent Template (Clean) (version 7-11-11)
This document is to be used to complete the Assent Template that is to be submitted to the IRBMED for review.
Additional Information
- Foreign Language Short Form Consents (version 10-4-10)
- See the New Releases and Updates page for changes and requirements to amend
Page Updated: 8/30/2011
