1. HOW TO CREATE AND SUBMIT AN IRB AMENDMENT 1 Institutional Review Board Health Sciences & Behavioral Sciences 2009-2010 Nancy Adair Birk, Ph.D. IRB Education Coordinator

2. OBJECTIVES Understand: Completing the cover sheet in a way that easily guides the IRB through the changes How to enter new information in eResearch application in a way that is easy to understand Document naming conventions for new and revised documents How to “stack” documents when uploading revised documents into eResearch How to help the IRB understand what is changed in revised documents 2

3. WHAT’S THE PROBLEM WITH AMENDMENTS? In the eResearch system, amendments are challenging, both for investigators and for reviewers Not always easy for the IRB to understand what has been changed Confusion about what has been modified can result in delays in approval and sometimes in requests for updates to material that may not be part of the amendment Remember, the changes you are proposing must be reviewed in the context of the study as a whole 3

4. GETTING STARTED Go to your home workspace in eResearch Click on the Approved tab Open the study you wish to modify In the lower left corner of the screen, under “Create New,” select Amendment You can create a title for your amendment (recommended) or the eResearch system will create a title that includes the study number Good idea to keep the original study number in title You may get a message telling you the system is creating a copy of the application. The system will notify you by email when the copy is complete. 4

5. THE COVER SHEET This guides the IRB through the changes you are proposing to your research Question 1.3: Select the relevant items, such as “informed consent process” or “change in accrual” Question 1.4: For each proposed change, provide a description and a justification Tell the IRB what you are going to modify Tell the IRB why you need the modification Indicate where in the application the change(s) will be made (and provide document titles, if appropriate) Go to the bottom of the cover sheet and click the link to the application to make the changes Describing the changes in the cover sheet isn’t sufficient! 5

6. SAMPLE COVER SHEET 6

7. MAKING CHANGES IN THE APPLICATION Be sure the change is described clearly, consistently, and completely Example: A change in procedures might mean a change to the informed consent document, description of risks in 6.4 You might need to re-read the entire application! If entering new text, separate new information from existing information by a header: AMENDMENT OCTOBER 2009 ADD NEW SURVEY If you make additional changes to the application that are not described in the cover sheet, update the cover sheet before you submit the amendment Because eResearch is upgraded regularly, you may have to respond to some additional questions to submit your amendment 7

8. SAMPLE VIEW OF MODIFIED 5-1.5 8

9. DOCUMENT NAMING CONVENTIONS It is helpful to the IRB if you can include a date and some descriptive information in document titles This is especially important if you have multiple documents and/or multiple study phases Multiple documents labeled “Informed Consent” may produce considerable confusion for the IRB and may result in the amendment being returned for clarification Some examples: Informed Consent AME12147 10-09.doc Recruitment Letter Amended Oct 2009.doc Child Assent –New Arm – Oct 09.doc 9

10. “STACKING” DOCUMENTS When you are revising an existing document, you can “stack” a revised document on top of an already-approved document—please do not delete an approved document! Open 10-1 of the application in an amendment Click “edit” next to the document name You’ll have the option to upload the new document – remember the importance of naming! When you hit “OK,” you’ll see the document name and will note that the version number is now 0.02, rather than 0.01. 10

11. STACKING PROCEDURES 11

12. STACKING PROCEDURES 12

13. STACKING PROCEDURES 13

14. ANOTHER DOCUMENT ISSUE The “audit trail” in eResearch displays changes made in the body of the application, but does not display changes made to uploaded documents It is burdensome for the IRB to do a side-by-side comparison of a new document to an old document to see what exactly was changed Help the IRB help you: Submit two versions of a revised document For one version, turn on the “track changes” feature in Word to display changes OR highlight the changes Upload a “clean” version of the revised document (track changes off), and name them clearly so the IRB knows which is which. 14

15. DON’T FORGET….. Submit your amendment to the IRB! If you haven’t submitted the amendment, the IRB does not know it’s there and no review will occur Look at the “stoplight” system in the amendment workspace If the light is yellow and it says “IRB Review-Core Committee Staff Review,” then you’ve submitted the amendment If the light is red and it says “Pre-Submission,” the amendment has not yet been submitted 15

16. QUESTIONS? Ask them now! Call or email 936-0933 or nbirk@umich.edu 16

17. RESOURCES IRB Health Sciences & Behavioral Sciences irbhsbs@umich.edu 936-0933 www.research.umich.edu/irb/index.html eResearch www.eresearch.umich.edu HELP features, tutorial, Sandbox in eResearch Informed consent templates & samples www.research.umich.edu/irb/consent.html Office for Human Research Protections (OHRP) www.hhs.gov/ohrp www.hhs.gov/ohrp 17