Frequently Asked Questions

General Information

Using eResearch

Support

What is eResearch Regulatory Management?

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.

When was it implemented?

eResearch Regulatory Management was implemented across all University of Michigan campuses in July 2005.

Who develops and maintains 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.

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 are a few things you should do:

How do I add a new Study Team Member?

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.

What questions are asked in the new study application?

Spreadsheet of all questions on the Application, AE/ORIO, SCR, and Amendment cover Sheet forms as of Release 1.7

Required Information
1. General Project Info
2.  Sponsor Information
3. Performance Sites
4. Study Abstract
5. Research Design
6. Benefits & Risk to Subjects
7. Special Considerations
8. Subject Description
9. Survey/Subject Populations
10. Informed Consent
11. Security
12. Exemption
Special Consideration Details
13. Subject Payments and Other Incentives
14. Health Care Treatments and Procedures
15. Drugs, Biologics, etc.
16. Devices
17. Placebo
18. Biological Specimens
19. Stem Cells
20. Genetic Analysis
21. Ionizing Radiation
22. Organ/Tissue/Cell Transfer
23. Gene Transfer
24. Secondary Data Analysis
25. Protected Health Information (HIPAA)
26. Epidemiology
27. Deception Research
28. Internet/Email
29. Survey Research
30. International
31. Watching/Listening to Audiovisual Materials
32. Data Safety Monitoring Plan
Vulnerable Subjects Details
33. Children
34. Neonates
35. Pregnant Women and/or Fetuses
36. Lactating Women
37. Women of Child Bearing Potential
38. Prisoners
39. Cognitively Impaired Adults
40. College Students
41. Subjects Vulnerable to Coercion
GCRC and PRC
42. GCRC Resources
43. MADRC Information
44. Supporting Documents
45. End of Application Activities

What is the human subjects research 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 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 Occurences (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.

Additional system and training informationis available on the Training page.

What is PEERRS Human Subjects Certification?

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:

  • Human Subjects - Biomedical & Health Sciences
  • Human Subjects - Social & Behavioral Sciences

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.

Where can I get help with eResearch?

See the Contact Us page for more information.

Where can I get training for using eResearch?

See the Training page for Training Sessions, 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 you 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.