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Common questions and answers.
Entire collection of data resources.
Log in to www.eresearch.umich.edu. Go to the expired study and click the title. Along the left margin of the screen will be some choices. Click on [Adverse Event/ORIO].
1-2.1 Other Reportable Information on Occurrences (ORIO) types:
Select [Report of study lapse].
1-2.2 Does this report include follow-up to previously reported information or occurences?
14. Report of Study Lapse
You need to answer several questions about the study lapse. You need to provide enough details for the IRB staff to conclude that no harm has occurred.
14.2 Briefly describe ay study activity conducted during the lapse of study approval
You should not have any study activity during the lapse. Once an IRB expires, e-research sends an e-mail that says:
After [date] all project activity must stop. This includes subject recruitment, experimental procedures or treatments, and data collection or data analysis, except as necessary to eliminate apparent immediate hazards to research subjects.
In addition, after [date], expenditure of federal research funds must stop, including salary support associated with human subject activities. For more information about this restriction please contact your Division of Research Development and Administration (DRDA) representative.
14.3 Has the sponsor or DRDA been notified of this lapse? If not, why?
It is fine to answer no. Explain that you have done no research, have had no contact with subjects, etc.; are responding immediately to fix the situation.
Depending on the length of the lapse, the activity that occurred during the lapse, etc. the IRB reviewer may suggest/require that DRDA and/or the sponsor be notified.
4.4 Briefly describe why the lapse occurred
Describe why your IRB expired, e.g., had started SCR (if true), but lost track of the deadline; did (or did not) receive 30 day warning; was in the hospital and no one else has access to my e-research space, etc.
14.5 What measures will be taken to prevent a recurrence of this event?
Be honest. What would help you? Do you need to add staff to your IRB to watch for reminders? Do you need someone to help you sift through your e-mail? Describe a solution that will prevent this problem from happening again and then follow through with it.
If you continue to have problems - multiple expired IRBs, this is a serious issue. It means that you are not taking IRB compliance seriously. The university will not look kindly upon second and third violations.
14.6.1 Does the event(s) or information being submitted suggest that the research places subjects or others at a greater riske of physical or psychological harm than was previously known or recognized?
Finish and submit the AE/ORIO report. There may be questions from IRB staff. Answer them and wait for your IRB to be restored to approved status. If you have not heard anything within a week be sure and check that you submitted the report and that it is not just sitting in limbo.
As always, come see us for help if the above is not clear.