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IRB Application Process

Application Submission Policy

HRPP Operations Manual, Part 3, Section III, C 1 - 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

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 types reviewed by the IRB-HSBS include:

  • Standard - general application used for most research that will collect data from/about human subjects
  • Secondary Use of Existing Identifiable Data/Records/Specimens - for research involving only the analysis of previously collected data/specimens including direct or indirect subject identifiers
  • Exempt Human Subject Research - for human subjects research that falls within the federal exemption categories or U-M exemption categories
  • Activities Not Regulated - for projects that involve people or their data that do not require IRB oversight but require HIPAA or other institutional compliance and/or require 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 years
  • Requesting Review by a Non-UM IRB - to track requests that U-M cede IRB oversight to an external IRB

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 required initial sections of a Standard 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; enter the grant application (PAF) number

Performance Sites

List the locations where research activity is to be conducted and/or the collaborating institutions

See Authorization Agreements

Research Design

Enter protocol details; fully describe the study interactions with human subjects

Benefits & Risks

Detail the study's benefits and the risk 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 methods, 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

  • eResearch Regulatory Management (eRRM) Training Website that contains job aids and other resources to learn how to use the eRRM system.  See the PI & Study Team menu for step-by-step system instructions.  See the Application questions spreadsheet to view all the questions by section and any related questions/sections based on "yes" answers.

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)