Types of Submissions 

Initial Application
Any investigator intending to initiate a research study involving human subjects that is under IRB jurisdiction must submit an initial application for review and approval of the study.  No aspect of the study (including testing performed solely to determine eligibility for the study) may begin until the IRB has approved the application in writing.

The IRB process is initiated by the submission of an initial application via the eResearch on-line application process.   
To initiate a new study, log-in to www.eresearch.umich.edu and click on “New Study”.

Amendment Application
A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.
A change to the study, made without prior IRB approval, in order to avoid an immediate hazard to subjects, must be reported promptly to the IRB.

Changes to the study requiring IRB review include, but are not limited to:

• Changes to the study protocol, including changes to the eligibility criteria, recruiting materials and advertisements, questionnaires, surveys, and scripts.
• Changes to the investigator’s brochure or equivalent documentation.
• Changes to previously approved informed consent documents.
• Changes in investigators (including principal investigator, co-investigator) or performance site(s).
• Changes to any other aspect of the research.

To request an amendment to the approved study, the principal investigator must complete and submit an amendment application via eResearch.
To initiate an amendment, log-in to www.eresearch.umich.edu, go to the study you wish to amend and click on “New Amendment”.

Scheduled Continuing Renewal Application
The IRB conducts continuing review of any research study under its oversight at intervals appropriate to the magnitude of risk of the project and other considerations, but not less than once each year.

The principal investigator of an active project is responsible for submitting an application for scheduled continuing review sufficiently in advance of the expiration date of the current approval period so as to permit IRB review and approval before the expiration date. 
To initiate a scheduled continuing renewal, log in to www.eresearch.umich.edu, access the study you wish to renew and click on “New Continuing Review”.

Termination Application
The principal investigator is responsible for notifying the IRB of the completion and closure of a study.  Studies that are regulated by the Food and Drug Administration (FDA) must submit a termination application at the conclusion of the study.

To submit a termination application, log in to www.eresearch.umich.edu, access the study workspace for the study you wish to terminate, and click on “New Continuing Review”.  Select the termination option.

Adverse Events/Unanticipated Problems/ORIO (Other Reportable Information and Occurences
Adverse events, unanticipated problems (UAPs) and Other Reportable Information and Occurrences (ORIOS) must be reported to the IRB according to the standard IRBMED reporting guidelines (Adverse Event/ Unanticipated Problems Standard Reporting Guidelines).

To submit an AE/ORIO report log in to www.eresearch.umich.edu, access the study that requires the report, and click on “New Adverse Event/ORIO”.