1. IRB Application Process Deb Schneider IRB Administrator Office of Research & Sponsored Programs 1055 AB (313) 593-5468 dschnei@umd.umich.edu

2. Application Review Process Researcher begins the process with the submission of an IRB Application. IRB Administrator will review the application to be sure it is complete, correct, and that all relevant documents are attached. If IRB Administrator finds problems a list will be sent to the PI along with application for revisions. PI revises application and resubmits it. If everything looks good IRB Administrator forwards the application to the reviewer who will determine if adequate human subjects protections are in place.

3. Reviewer Decisions The Reviewer will look at the application to make sure that all subject protections are in place and then the reviewer makes a decision. Possible decisions can include: – Approve the application as it is. – Return the application to the PI for further changes. – Schedule the Application for Full Board Review

4. After the Review Depending on the outcome of the review you may receive the following: – An Approval Letter – A list of issues that must be addressed before approval can be given. – A notification of the date for full board review.

5. What happens if you need to make changes to your study after it is approved? You will login to eResearch; open your study and create an “Application Amendment” which will go through a similar process as submitting the original application. The Amendment is much shorter than the original application. Changes can be as simple as adding new Study Team Members or as complex as changing the protocol or consent form. Approval must be obtained before any change to the study is implemented.

6. It is the responsibility of the research team to protect the rights of the research subjects.

7. What happens if something goes wrong during your study? Contact the Research Office immediately if any of your subjects have a complaint or a problem. Once we have been notified you will access your original IRB application and create an Adverse Event report or an Unanticipated Problem report. An Adverse Event is an incident where the research subject experiences adverse effect or side effect that occurs as a result of participating in the research study. This usually refers to clinical trials but is not limited to them. An Unanticipated Problem is one that is unexpected in terms of participation in the research study and could possibly be experienced by others who are participating in the research study.

8. Scheduled Continuing Reviews Studies are approved for one year. If the research is not complete at the end of the year the researcher must login to eResearch and submit an SCR Scheduled Continuing Review. – This will have the same review process as applications and amendments; it is probably the easiest to submit.

9. Pre-application Process Collect all documents – CV – Protocol – Site Approval Letters – Survey Instruments – Consent Forms Complete relevant PEERRS Human Subjects module.

10. PEERRS Complete the relevant Human Subjects module(s) of PEERRS. – Go to my.research.umich.edu/peerrs/my.research.umich.edu/peerrs/ – Click the Yellow “Start PEERRS” button NOTE: PEERRS will ask you to complete a short survey and respond with a list of required and recommended modules. For IRB purposes you must complete the Human Subject module that corresponds to your research.

11. Begin the Application Login to eResearch Regulatory ManagementeResearch Regulatory Management – The login button is under the Block M Click the Create New “Study” button. Answer the questions marked with a red asterisk. Work you way through the application from front to back. eResearch will open or delete application sections based on your answers to questions in the first part of the application. Note: You may exit the study at any time but it is best to finish a page. Be sure to click Save and then Exit.

12. Before Submitting the Application Check to be sure all study team members have completed PEERRS and accepted their role. Check that all documents are uploaded to application. Click the “error check” button Click on the link in each error message to go directly to the application error and make the correction. Click the “Submit Application” button Keep a watch on your email for notices from eResearch

13. Contacts Dr. Drew Buchanan, Director Office of Research & Sponsored Programs 1055 AB (313) 593-5468 dbn-research@umd.umich.edu Deb Schneider, IRB Administrator Office of Research & Sponsored Programs 1055 AB (313) 593-5468 dschnei@umd.umich.edu