Informed Consent Templates: What's New
Click on the date to review changes made at that time.
- September 15, 2007
- March 18, 2007
- October 3, 2006
- January 4, 2006
- August 1, 2005
- June 13, 2005
- January 17, 2005
- August 20, 2004
- April 22, 2004
- February 12, 2004
- June 19, 2003
September 15, 2007
The standard template has been updated to facilitate the University of Michigan 's compliance with the 'National Coverage Decision for Routine Costs in Clinical Trials' (NCD) which concerns payments by the Center for Medicare & Medicaid Services (CMS). For full details on which studies must update to the new template, click here to review the Update Memo.
- Marked up copy of the pre-9-15-07 template with all the changes (PDF)(note, the version date on this information form is not the final 9-15-07 date)
- New standard template (MS Word)
- PDF with all instructions
Common Mistakes Encountered in the Update to the New Template
- MISTAKE #1-- SECTION 5.2 "What happens if I get hurt, become sick, or have other problems as a result of this research?"In section 5.2 these or similar words are mistakenly included in the text, "The cost of emergency care will be billed to your insurance. If not covered, the University of Michigan will pay for emergency care if it is determined to be related to the study."
You cannot, in any place in the informed consent document, make a promise of payment for treatment/medical care by the University of Michigan. If the study has funds from an internal or external sponsor to cover such care, then in section 8 you can state that the "study" or the "sponsor" will pay (but not the University of Michigan). - MISTAKE #2--"Who will pay for the costs of the study? Will I or my health plan be billed for any costs of the study?"
In section 8.1 study teams are deleting the last paragraph. The instructions state, "If there is no cost for the study, delete all of the language under 8.1 EXCEPT FOR THE LAST PARAGRAPH and state 'There are no costs or billing for this study.' "
Make certain section 8.1 includes the sentence,"By signing this form, you do not give up your right to seek payment if you are harmed as a result of being in this study."
March 18, 2007
The Arabic language short form was found to have errors and was replaced. In addition a new version of the Arabic-English translation was added.
October 3, 2006
Change in Practice--Study Team Actions Required at SCR Approval in Legacy (Paper Application System)
- Change the expiration date on the ICD to match the study's new expiration (same practice as in the past).
- Change the consent approval date to match the SCR approval date (new practice).
If no revisions to the consent were made at the time of continuing review, it is not required for you to modify the version number or version date of the consent document (but it is allowed if required by a sponsor).
eResearch
For studies in the eResearch system the IRBMED updates the informed consent documents. We place the 'water-marked' electronic copy in eResearch, in the Approved Application Workspace ('Parent' workspace) under the 'Currently Approved Documents' header in the 'Documents' tab. This practice was implemented in the eResearch system with the SCR renewal (July 2006).
- Notification of Change in Practice, Guidance--Consent Document Approval Date (PDF)
- Announcement faxed with Legacy Approval Notices (PDF)
- Global email announcement (PDF)
January 4, 2006
In section 9.2, the FDA was added to one of the bullets regarding who may see subjects' records such that it now reads:
-
University, Food and Drug Administration [FDA], and other government officials may need the information to make sure that the study is done properly.
Compared to the previous version:
- University and government officials may need the information to make sure that the study is done properly.
Please note: Previously approved Informed Consent Documents (ICD) need not be updated to make this change until the next scheduled continuation review or ICD change made for other purposes.
Also note, from January 4 to January 11 the Version in the footer was posted incorrectly. It said 1-4-05 when it should have been 1-4-06. This has now been corrected.
August 1, 2005
One template, for use in both eResearch and Legacy (the paper system), has replaced the previously posted templates. The primary change is that the template is now file type '.DOC' rather than '.RTF.' (The only other change is to the first instruction in the template.) This is to accommodate the eResearch system which uses merge fields. Legacy users will still need to fill in the header information as they did in the past. Legacy users are not required to switch to this template or to the '.DOC' format unless required for reasons other than this template change ( for example , see the January 17, 2005 or August 20, 2004 changes noted below-if these changes have not yet been incorporated into a study's informed consent document then update using the 8-1-05 template).
June 13, 2005
A template for use in eResearch was added. The difference between the eResearch and the legacy template is that the header in the eResearch version enables the watermarking function when informed consent documents are approved in eResearch. The footers differ by their version dates.
January 17, 2005
IRBMED Address, page 6
FROM:
4673 Kresge I
Ann Arbor, MI 48109-0570
TO:
Argus I
517 W. William
Ann Arbor, MI 48103-4943
Please note: Informed Consent Documents and other study related forms that include the IRBMED address should not be updated to the new IRBMED address until the next scheduled continuation review or ICD change made for other purposes . When updating the IRBMED address on the ICD submit section 11 with the previously approved project application. Submit section 8 for other documents.
August 20, 2004
Introductory Section "INFORMATION ABOUT THIS FORM"
An instruction has been added that refers to the first paragraph of the informed consent template. The suggested text on the template states:
You may be eligible to take part in a research study. This form gives you important information about the study. It describes the purpose of the study, and the risks and possible benefits of participating in the study.
The new instruction provides alternate text for that paragraph. The new instruction is:
For studies that use the same informed consent document for both adult and pediatric subjects, the following text may be substituted for the first paragraph:
You, or your child, may be eligible to take part in a research study. This form gives you important information about the study. It describes the purpose of the study, and the risks and possible benefits of participating in the study. Parents or legal guardians who are giving permission for a child, please note: in the sections that follow the word 'you' refers to 'your child.'
While this alternate text has been endorsed by the IRBMED, it may not be appropriate for all studies. As appropriate, on an individual basis, the IRBMED may require a different approach. Investigators may also propose a different approach, subject to IRBMED approval.
Implementation of the change at time of scheduled continuation review (renewal) of previously approved informed consent documents will be at the discretion of the reviewing IRB when the change would represent an important improvement.
April 22, 2004
Wording in the instructions for using the template were changed.
Excerpt from the Consent Template Instructions—changes in blue:
Submission Instructions:
To submit a new or revised informed consent document (ICD) to IRBMED for review, send the ICD with one of the following:
- New Project Application (always use the most recent submissions not utilizing the IRBMED version of the ICD template posted on the IRBMED Web site at the time a New Project Application is submitted will be rejected for review.)
- Previously Approved Project Application and a copy of the previously approved consent document (ICD revisions cannot be made on a template version dated April 2002 or earlier if the study involves PHI).
February 12, 2004
Section 12: Formatting in the signature box for a subject's legal representative (for a subject who cannot consent for herself/himself) was changed to mirror the formatting in the other signature blocks (see below). The requested information was delineated on each line. Because this was a minor formatting update, the IRBMED Consent Template Version Number was changed from 6-19-03 to 6-19-03-a.
June 19, 2003
In response to feedback from our users-investigators, reviewers, and coordinators-changes have been made to nearly every section of the HIPAA-compliant informed consent document template and the instructions that are embedded in the template (seen as 'pop-up' bubbles). Changes address readability and clarity. As always, we encourage researchers to download the latest template.
Investigators are encouraged to transition informed consent documents that are based on the Pre-HIPAA template ("Version April 2002" or earlier) to the HIPAA-compliant template (Version 2-14-03 or later) at their earliest convenience, but no later than with the next significant amendment to the informed consent document or at the project's next Scheduled Continuation Review. New project applications submitted to the IRBMED after July 1, 2003, are required to utilize the Version 6-19-03 or later template.
