How to prepare for IRB Application

Initial Application to the IRB 

Within the eResearch Regulatory Management (eRRM) system at the University of Michigan, the IRB application is a web-based questionnaire or form that may be initiated by any member of the study team. It is intended to collect all of the information and materials that are necessary for the Institutional Review Board for Human Subjects (IRB-HSBS) and any other relevant research review units to evaluate and approve the research in accordance with federal regulations and University of Michigan policies.

 The IRB application is divided into different classes, which determine the review path, as well as parts that describe the proposed research and specify subject safeguards. This is done to make data entry and committee review more efficient. eRRM will activate further pertinent sections and questions inside the form based on the application type you have chosen and the replies you have provided in the initial sections of the form. It is possible for a section to contain functionality that allows users to add or select information from other eResearch systems, as well as upload associated documentation (such as documents pertaining to informed consent, protocols, recruitment materials, and so on) into the application (e.g., PAFs from Proposal Management).

 APPLICATION TYPES

The following application routes are available for projects that will be examined by the IRB-HSBS:

• Research Involving Human Beings :That Involves Interaction Or Intervention This protocol is utilized for any study that will collect data or biospecimens from human subjects. If you choose this option, you will be presented with a series of additional questions designed to help you locate projects that may be eligible for an exemption determination.
• Uses of Private Information or Biospecimens in Secondary Research : Secondary study uses of private information or biospecimens refers to research that only involves the examination of information or biospecimens that was gathered in the past. If you choose this option, the Scope of Secondary Use Research section will become visible and you will be prompted to provide comments so that the application can be directed down the appropriate review path (comprehensive IRB review, exempt or not regulated).
• Activities That Are Not Regulated As Being Carried Out On Human Subjects : This category is for projects that include individuals or their data but do not satisfy the definition of human subjects research that would require oversight from the Institutional Review Board (IRB). Compliance with HIPAA or another institutional standard may be necessary for the projects, as well as certification from the IRB that they are "not regulated." (For further information, please refer to table Regulated/Not Regulated located in Part 4 of the HRPP Operations Manual.)
• Projects that may not include immediate intentions for the involvement of human subjects, their data, and/or their specimens (also known as a "umbrella" or "dry" application) - for training grants, program projects, or research that may not involve human subjects until later in the year.
• Requesting Review by an IRB That Is Not Part of the University of Michigan – to keep track of requests that the University of Michigan hand over IRB monitoring to an external IRB

APPLICATION SECTIONS

An application to an IRB has parts that outline, at each stage of the project, how the research team will engage with the people who are the subjects of the study and/or their data. The information that the IRB anticipates finding in an application is highlighted in the following table, which provides a description of the most important elements of the application and links to relevant resources when available.

• Information Relating to the Study in General: Please introduce the research team. Please provide a synopsis of the project. IRB and application type should be selected.
• Information Regarding Sponsors: Indicate whether the support is coming from outside or inside the organization, and include a link to the grant application (PAF) or award number.
• Locations of Performances: Please include a list of the institutions that will be participating in the research project as well as the places where research activities will be undertaken. Plan for the Research : Enter the specifics of the protocol, and give a comprehensive account of the study's contacts with human participants.
• Benefits & Risks: Describe both the positive outcomes of the study as well as any potential adverse effects on the participants.
• Taking Into Account Particulars: Provides navigation to particular portions of the IRB application, as indicated by "yes" replies, for those factors that call for additional information concerning their application in the research (e.g., surveys, interviews, tissue or specimens, subject compensation, deception, etc.)
• Information Regarding the Subject: Input data regarding the research population, method of recruiting and screening, and susceptible subjects.
• Consent Provided After Being Educated: Describe the process of informed consent, and upload any documents required for consent.
• Maintaining Privacy, Confidentiality, and Physical Safety: Indicate the identifiability of the data, as well as the privacy safeguards afforded to people, the data management and security procedures, and the future applications planned for the data.