Standard Informed Consent Template

The working version template containing blue and orange text boxes is updated with additional instructions and required language. IRBMED recommends using the working version template for creating the consent document. If using the outline version (without the blue-box instructions), always use the working version as a companion document for additional information and as-applicable required language.

Section 9.2

In the bulleted list of reasons participants’ personal information may be shared:

• The item regarding information collection for payment processing has been updated, consistent with the new HSIP threshold change.
• A new set of bullets has been added explaining in detail the sharing of PHI with external entities when another hospital may need the information to provide care/safety coordination

Sections 9 and 12

The introductory sentences in Section 9 have been expanded to clarify that while Section 9 describes storing and sharing of information during the study, Section 12 relates to retention and potential sharing after the study is complete.

Typographical corrections and minor updates

Minor changes such as typographical corrections, grammar in blue box instructions, and URL updates are sprinkled throughout the document.

Extensive revisions, including a new section

Change history available upon request.

• New Applications:  Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• Amendments: Per the IRBMED Document Revision Guidance, Naming Convention, and Version Control statement of practice, as part of an amendment modifying the consent(s)
  • Edit the most recent version of the CLEAN informed consent document found in 10-1.1.
  • Turn on “Track Changes” feature in Word.
  • Save “Track Changes” version in .docx or .doc format.
  • Upload ONLY “Track Changes” document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column.
  • Use the standard naming conventions for stacks from the Document Revision Guidance, Naming Convention, and Version Control statement of practice. 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 “X – Not in use” or “X – Out of Date” to the file name. Do not delete these documents from the eResearch application.