eResearch Regulatory Management is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
The system helps the University better ensure that it is meeting its obligation to conduct research in an ethical manner and in accord with regulations governing research.
eResearch Regulatory Management was implemented across all University of Michigan campuses in July 2005.
eResearch is being developed under the leadership of the Office of the Vice President for Research and Michigan Administrative Information Services (MAIS), with input from faculty and staff from all three U-M campuses, the institutional review boards, and other review committees.
Content is being developed in consultation with faculty and staff across the University, including the Flint and Dearborn campuses.
To become familiarized with the eResearch interface, you can complete some of the training materials available on eResearch Info, or you can work in the Sandbox.
Before starting a new application in eResearch, there are a few things you should do:
You can add Study Team Members in question 1.3 of the application.
Tip: If you have already submitted your study to the IRB and need to add a Study Team Member, you can use the Post Correspondence activity to ask the IRB to request changes. This will allow you to edit the application and add the team members.
Additional system and training informationis available on the Training page.
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When a study application is submitted, the same application is reviewed first by any necessary Cancer Center personnel, then any necessary Ancillary Committees, and then by the IRB. Click the image below to open a larger version of the review process.
Once the study is approved, activities are available in the eResearch Study Workspace to submit:
Once you log into eResearch, click the name of the study in your Home Workspace to open the Study Workspace. In the Study Workspace, click the Accept Role activity. Complete the activity and click OK.
Additional system and training informationis available on the Training page.
Investigators, Co-Investigators, Faculty Advisors and Study Coordinators/Project Managers are required to complete PEERRS Human Subjects Training.
eResearch displays your PEERRS certification based on successful completion of one of two modules in PEERRS:
If you have not completed either of the Human Subjects modules in PEERRS, you are not displayed as certified in eResearch. If you have recently completed your PEERRS certification, please allow up to 48 hours for your certification to appear in eResearch. If you were recently added as a new user to eResearch, also please allow up to 48 hours for a previous PEERRS certification to appear in eResearch.
Non-University of Michigan collaborators who are listed as study team members on a research project initiated at the University of Michigan and listed on the eResearch application are required to demonstrate completion of human subject training in one of two ways:
1. Register in PEERRS using the same email address as you use in eResearch and pass either the Human Subjects - Biomedical & Health Sciences module test or the Human Subjects - Social & Behavioral Sciences test with 100%.
OR
2. Send a request for a certification waiver to peerrs@umich.edu with:
a. proof of equivalent training completed within the last three years, or
b. proof that the study team member(s) collaborating on the U-M project will have their protocol reviewed and supervised by the local IRB.
IMPORTANT: when requesting a waiver, you must include the Friend account (email address the investigator/co-investigator uses to login to eResearch). A waiver cannot be granted without the Friend account.
After reviewing the waiver request per (2a) or (2b) above, the PEERRS staff will notify the parties as to whether a waiver will be granted.
See the Contact Us page for more information.
See the Training page for Training Sessions, Step-by-Step Guides, and other materials.
See the System Requirements page for more information.
If the notifications you receive from the eResearch system contain broken links, you may need to reconfigure you email client to display HTML-formatted email. See the Configuring Your Email Client page for more information.
See the ITCS Choosing and Changing a Secure UMICH password page for information on changing your UMICH Kerberos password.