Application Process
Any U-M investigator planning a research study involving human subjects must submit an application for IRB review and approval or determination of exemption before initiating any interaction with subjects or their identifiable data.
Initial IRB Application (New Study)
The IRB application is an online questionnaire/form that any member of the study team can initiate within U-M’s eResearch Regulatory Management (eRRM) system. It’s designed to gather all the information and materials necessary for the IRB-HSBS, along with applicable research review units, to evaluate and approve the research in accordance with federal regulations and U-M policies.
To facilitate data entry and committee review, the IRB application is organized into types which determine the review path and sections that describe the proposed research and identify subject protections. Based on the selected application type and your responses in the initial sections, eRRM activates additional relevant sections and questions within the form. A section may include functionality to upload related documentation (e.g., informed consent documents, protocol, recruitment material, etc.) into the application or to add/select information from the other eResearch systems (e.g., PAFs from Proposal Management).
Application Types
Application paths for projects reviewed by the IRB-HSBS include:
- Human Subjects Research Involving Interaction or Intervention – used for all research that will collect information or biospecimens from human subjects. Selecting this option with offer a series of additional questions to identify projects that might qualify for an exempt determination.
- Secondary Research Uses of Private Information or Biospecimens – for research involving only the analysis of previously collected information or biospecimens. Selecting this option will open the Scope of Secondary Use Research section that will elicit responses to route the application to the correct review path (comprehensive IRB review, exempt or not regulated).
- Activities Not Regulated as Human Subjects Research – for projects that involve people or their data that do not meet the definition of human subjects research requiring IRB oversight. The projects may require HIPAA or other institutional compliance and/or IRB confirmation of a “not regulated” determination. (See the Regulated/Not Regulated table in the HRPP Operations Manual, Part 4 for details)
- Projects lacking immediate plans for involvement of human subjects, their data and/or their specimens (a.k.a. “umbrella” or “dry” application) – for training grants, program projects, or studies that may not involve human subjects until later year
- Requesting Review by a Non-UM IRB – to track requests that U-M cede IRB oversight to an external IRB
Application Submission Policy
HRPP Operations Manual, Part 3, Section III, C 3 – outlines PI responsibility
Only the PI can submit an IRB application in eResearch, as the submission includes an attestation of responsibility for the ethical conduct of research. In cases where a student is the PI, the faculty advisor will also attest to their shared responsibility.
Using the U-M IRB System
To log on to eResearch Regulatory Management System (eRRM): www.eresearch.umich.edu
For eRRM information, see the Regulatory Management website
For system instructions to enter an IRB application, upload documentation, and more, see Resources below
Communications
After submitting an IRB application, all communications regarding that application are conducted within eRRM. The PI and/or study team members receive system email notifications when:
- An action is required in eRRM (e.g., changes requested)
- Information is posted
- An approval determination<< is made
Application Sections
The sections of an IRB application detail how the study team will interact with the research subjects and/or their data at each step of the project. The table below describes the key sections of the IRB application with links to resources, as applicable, to highlight the information expected by the IRB in an application.
| Section | Description |
| General Study Information | List the study team; briefly describe the project; select the IRB and application type |
| Sponsor Information | Indicate external or internal support; link to the grant application (PAF) or Award number |
| Performance Sites | List the locations where research activity is to be conducted and/or institutions collaborating in the research projectSee Authorization Agreements |
| Research Design | Enter protocol details; fully describe the study interactions with human subjects |
| Benefits & Risks | Detail the study’s benefits and the risks of harm to human subjects |
| Special Considerations | Routes you to specific sections of the IRB application, as indicated by “yes” answers, for those considerations that require additional information regarding their use in the research (e.g., surveys, interviews, tissue or specimens, subject compensation, deception, etc.) |
| Subject Information | Enter information about the study population, recruitment and screening method, vulnerable subjects |
| Informed Consent | Describe the informed consent process; upload consent documents |
| Confidentiality, Security & Privacy | Indicate the identifiability of data; privacy protections for subjects; data management and security; plans for future use |
To ensure the IRB can understand the details presented in the IRB application, enter information clearly, concisely, and consistently throughout the application sections and in the associated study documentation (e.g., protocol, informed consent, recruitment materials, interview/study instruments).
References and Resources
Website listing links to job aids and other reference materials to learn how to use the eRRM system to complete, update, and review an IRB application.
Questions?
For questions regarding IRB application requirements (e.g., policy, procedure, science), contact:
IRB Health Sciences and Behavioral Sciences
Phone: (734) 936-0933
Fax: (734) 936-1852
irbhsbs@umich.edu
For help using eResearch Regulatory Management, contact:
ITS Service Center
(734) 764-HELP (764-4357)
4HELP@umich.edu
online service request (login required)
Related Information
Minors in Research Policy Requirements (SPG 601.34) – effective 09/13/2021
Review the institutional requirements on the Children on Campus-Research webpage for study team members who interact with children participating in U-M human research studies, and for those who supervise study team members.
Questions? Email ResearchwithMinors@umich.edu.
IRB-HSBS Quick Links
- IRB-HSBS Website Directory
Access resources and guidance by alphabetical topic listing from the IRB-HSBS Directory & Guidance webpage. - IRB-HSBS Submission Deadlines & Meeting Dates
Blue board meeting dates 2024
Maize board meeting dates 2024
“IRB NextGen” Project
Multi-year project to revise & enhance the IRB application and review processes.
Visit the IRB NextGen webpage for volunteer opportunities, project status info, and more!