Frequently Asked Questions
General Information
- What is eResearch?
- When will eResearch be available?
- Who is developing eResearch?
- What are the benefits of the system?
- Have there been any communications to faculty and staff about eResearch?
Using eResearch
- What does a PI need to do?
- What does the eResearch interface look like?
- How do I get started?
- How do I add a new Study Team Member?
- What questions are in the new study application?
- What is the study review process?
- What about adverse events, amendments, continuing reviews?
- I'm a Co-Investigator or Faculty Advisor. How do I accept my role?
- Why isn't my PEERRS certification showing up in eResearch?
Converting from other systems
Support
- Where can I get help with eResearch?
- Where can I get training for using eResearch?
- What browser/operating system do we need for using eResearch?
- How do I fix broken links in eResearch email notifications?
- How do I change my UMICH Kerberos password?
What is eResearch?
eResearch is a Web-based system for submission, routing, approval and management of research information. Initially, the system will be used for research involving human volunteers.
The system will help the University better ensure that it is meeting its obligation to conduct research in an ethical manner and in accord with regulations governing research conduct.
When will it be available?
eResearch for human subject studies is currently available across all University of Michigan campuses.
Who is developing eResearch?
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.
What are the benefits of the system?
- PIs submit a single application for multiple reviews. That single application will be automatically routed to required committees. The IRB will review the application last in those cases where other committees are also involved.
- Principal Investigators can be assisted by others in preparing applications. However, the PI must:
- Review information entered by the study team (can print full application to review)
- Submit application electronically
- Re-submit if changes are required by review committees.
- Electronically submit any adverse events, amendments, scheduled continuing reviews, and terminations.
- The application guides a research team step-by-step through the information required for approval. The team fills out online a "smart form." Logic built into the system will guide PIs, Study Coordinators, and other study staff to relevant questions, based on their responses.
- Detailed questions and their answers will provide more clarity and less ambiguity during the review process.
- Validation of entered data will improve quality and may reduce number of changes required after submission.
- All reviewing committees will see the same version of the application.
- Review and approval will be conducted online.
- Email notifications will include hyperlinks to specific applications
- Correspondence content will be maintained on the database for future reference.
- Changes will be logged and time stamped.
Have there been any communications to faculty and staff about eResearch?
The eResearch team has sent email messages to targeted groups, such as IT staff, as well as global communications to the University community. Click here to read these messages.
You may also have received email notifications from your IRB. Contact your IRB office for more information about messages from those offices.
What does the eResearch interface look like?
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.
How do I get started?
Before starting a new application in eResearch, there a few things you should do:
- Verify that your computer meets the minimum requirements
- Have or obtain a uniqname and UMICH (or Kerberos) password
- Log into eResearch and complete an Access Request
- Review the Pre-application Checklist
How do I add a new Study Team Member?
You can add Study Team Members in question 1.3 of the application.
You can see a Show Me demonstration of this process (Flash player required). Click here to open a new window with the demonstration
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.
Other Show Me demonstrations are available on the Training page.
What questions are asked in the new study application?
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What is the study review process?
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.
What happens to existing studies when the new system is operational?
Data from previously approved studies will be converted from the existing IRB systems (used by IRBMED and IRB BehavSci/Health) into eResearch, to the extent feasible.
Data relating to previously approved studies that cannot be converted from the existing IRB systems will have to be entered into eResearch at the time continuing review or amendment. If your study is expiring or is no longer using human subjects, contact your IRB office for more information.
What about adverse events, amendments, continuing reviews?
Once the study is approved, activities are available in the eResearch Study Workspace to submit:
- Adverse Events (AEs)
- Other Reportable Information and Occurrences (ORIOs)
- Scheduled Continuing Reviews
- Amendments
I'm a Co-Investigator or Faculty Advisor. How do I accept my role?
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.
You can see a Show Me demonstration of this process (Flash player required). Click here to open a new window with the demonstration
Other Show Me demonstrations are available on the Training page.
Also, see the Downloads page for Step-by-Step Guides and other materials.
Why isn't my PEERRS certification showing up in eResearch?
eResearch displays your PEERRS certification based on three modules in PEERRS:
- Human Subjects - Biomedical Sciences
- Human Subjects - Behavioral Science
- Human Subjects - Health Sciences
eResearch only checks if you have completed one of these three modules. If you have not completed any 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.
If you have a valid certification that pre-dates PEERRS, please contact the PEERRS team or your IRB.
If you have an issue not addressed here, contact the Help Desk.
Where can I get help with eResearch?
See the Support page for more information.
Where can I get training for using eResearch?
See the Training page for Show Me Demonstrations or the How To page for Step-by-Step Guides and other materials.
What browser/operating system do we need for using eResearch?
See the System Requirements page for more information.
How do I fix broken links in eResearch email notifications?
If the notifications you receive from the eResearch system contain broken links, you may need to reconfigure your email client to display HTML-formatted email. See the Configuring Your Email Client page for more information.
How do I change my UMICH Kerberos password?
See the ITCS Choosing and Changing a Secure UMICH password page for information on changing your UMICH Kerberos password.
