Effective March 9, 2018, IRBMED has revised its standard informed consent template. The working version containing blue and orange text boxes has been updated with additional instructions and required language. The version formerly referred to as the ‘clean’ version is now titled as the ‘outline’ version. IRBMED’s recommendation is to use the working version as the template for creating the consent document. If using the outline version, always use the blue-box working version as a companion document for additional instructions and required language.
You must now begin using the revised template if you have not already started creating your consent document in the prior version. IRBMED will continue to review consent documents created in the previous template if submitted prior to Monday, April 2, 2018. Consent documents submitted on or after April 2 must be created in this revised template. IRBMED-approved consent documents using the previous template do not need to be amended to update to the revised template.
The revised template includes changes to the following sections:
- Section 1:
- Study teams are instructed to list only a study’s principal investigator and study coordinator in the consent document.
- Key information about study participation has been reformatted.
- Section 4:
- The genomic data sharing language has been updated.
- Box C is now divided into Boxes C and D to distinguish “substudies” and “unspecified future use”
- The following statements are now required:
- With appropriate permissions, your samples and collected information may also be shared with other researchers, here, around the world, and with companies.
- Your identifiable private information or identifiable biospecimens may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.
- Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.
- Section 9:
- Certificate of Confidentiality language has been updated to be in accordance with new NIH policy.
- ClinicalTrials.gov language has been updated.
- Section 11:
- Addition of State of Michigan HIV testing language has been included (this will eliminate the need to use the separate State of Michigan pamphlet).
- Section 12
- Signature boxes have had minor updates.
When uploading your informed consent form in eResearch:
- 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 Version Control of Informed Consent Documents 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.
- Use the Upload Revision button to stack the new tracked-changes document on top of the tracked-changes stack.
- Use the standard naming conventions for stacks from the Version Control of Informed Consent Documents 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 “Not in use” to the file name. Do not delete these documents from the eResearch application.
Page created 1-13-2014