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Application Process and Forms

Launching July 1, 2026 - IRB Protocol Submissions in Cayuse Human Ethics

Researchers working with human subjects are required to submit their studies for review and approval by the Institutional Review Board (IRB). To streamline this process, our institution transitioned to the Cayuse Human Ethics electronic system for protocol development, submission, and management. Creating and maintaining IRB protocols within Cayuse HE ensures accurate, organized, and accessible documentation throughout the life of your study. Researchers can prepare submissions, track revisions, respond to reviewer comments, and access previously approved materials in one location. Guidance materials are provided for support. If you need assistance, contact (humansubjects@miamioh.edu).

  • Required Training NEW: All faculty, staff and students are only required to complete CITI training, Humans as Subjects Basic Course. CITI training completions will import automatically to Cayuse if your primary CITI email address is your Miami email address. You may upload CITI training certification as an attachment to your study, if needed. Please utilize the Humans as Subjects CITI Completion Guidance for support.
  • Application Process NEW: Separate Application Forms are no longer required. All submission types will be completed within Cayuse, accessed using SSO. The IRB Initial Submission Guidance using Cayuse Human Ethics can assist with preparing the details you may need to provide for the Initial Submission. This document is an OPTIONAL tool and is not required to be uploaded as part of your study materials. Please utilize the IRB Step-by-Step using Cayuse Human Ethics for support. 
  • Submission Process NEW: For student-led projects, students may initiate Initial Submissions as a Primary Contact (PC). Faculty Advisors must serve as the Principal Investigator (PI). Students must route their submission to their advisor for review, or they may send the submission back to the student for edits within Cayuse. Documentation of Faculty Advisor approval will be obtained through the certification process upon study submission in Cayuse. The certification will confirm that the student's Faculty Advisor reviewed the IRB application and approves of the proposed research. 

General Procedures

  1. Prior to completing an application, you will need to satisfy training requirements. 
  2. Informed Consent templates can be downloaded from the links below for the applicable type of research. 
  3. The completed applications are routed to the Research Ethics and Integrity Program (REI) where they are processed to be administratively reviewed for an Exempt determination or distributed to the IRB for Expedited or Full Board review. 

Submission documents include:

  • Appendices that may include consent forms, survey questions, interview questions, personnel form, etc.
  • The submission should be comprehensive to include all recruitment materials including anything participant-facing researchers might be using (e.g., scripts for in person and email recruitment, in addition to flyers and social media posts).

Appendices materials should be labeled accordingly, with version history and dates preferred (e.g., Consent Form_v1.0_2026_7_1:, Survey Questions_v1.0_2026_7_1, Interview Questions_v1.0_2026_7_1, etc.).


If the project is a student-led activity, the students may initiate the application and route to their faculty advisor for their consideration for submission within Cayuse HE.

Please include only pdf and Word formatted document attachments with your IRB submissions.

IRB Meeting Dates 

The IRB accepts applications on a rolling basis. Plan to submit at least 4-6 weeks prior to project implementation. Projects involving special populations, international research, or multisite collaborations for example may require further review at a convened meeting or require additional documentation that extend the length of review. The IRB meets regularly to discuss protocols under review and handle routine business.

Types of Review

There is a single Initial Submission entry. The category of review is dependent on the nature of the research. The subject population, risk level, and degree of confidentiality are factored in determining the review type.

Use the Human Subject Decision Charts from the Department of Health and Human Services website for insight related to determination of review categories.

Please note that the Miami University IRB has final authority to determine the review level assignment in accordance with local considerations.

Exempt Research

Exempt Research correlates to activities listed in one of the "exempt" categories in the federal regulations (45 CFR 46). Exemptions are reviewed by a representative of the REI staff: either an IRB administrator or an IRB member. Ethical principles such as voluntary participation, adequate consent, and appropriate confidentiality are assessed for adherence to the Belmont Principles during the reviews. Modifications and amendments must be reviewed before implementation.

Collecting New Data

  • Minimal risk surveys, interviews or observations of public behavior with subjects age 18 or over.
  • If subjects are under 18, the research must pertain to a normal classroom setting with the research being the use of materials collected as part of the normal curriculum.
  • Commercially available food taste testing.

Access Cayuse HE Guidance Materials

Access Cayuse Human Ethics

Use of Pre-existing Data

  • Research using data that is publicly available.
  • Data collected by non-Miami personnel and transferred to Miami personnel for research.
  • Research previously collected at another institution by current Miami personnel under IRB approval at that institution (e.g. transferring de-identified data).

 

Access Cayuse HE Guidance Materials

Access Cayuse Human Ethics

Expedited and Full Board Review Research

Expedited - Review by the IRB

Expedited research correlates to activities per the regulations (45 CFR 46) where review is conducted by a subcommittee of the IRB.

  • Minimal risk research involving a vulnerable population or manipulated subjects.
  • Research that does not qualify for Exempt status or has been deemed to require periodic reports to the IRB.

Expedited Applications are reviewed by IRB members and the IRB chair.

Access Cayuse HE Guidance Materials

Access Cayuse Human Ethics

Full Board

Full Board reviewed research activities require review through a convened meeting and a majority vote of approval by the IRB.

  • Occurs during Expedited review, an IRB member calls for a Full Board review, subject to majority approval.
  • Researchers will be notified that a convened meeting has been required and will be given the opportunity to attend the meeting and provide information.
  • A new application is not required, but the IRB may request additional information.

Consent Templates

Templates may include consent, assent, and parental consent forms and all need to be customized for your application and research.

  • Interview (formal) - Meeting a subject at an agreed-upon location for an in-depth interview.
  • Interview (informal) - Recruiting and interviewing in a public place (street, zoo).
  • Interview (online/phone) - Calling persons on a members list or respondents to an online invitation.
  • Focus Group - Convening a group to discuss an issue.
  • Survey (online) - Recruitment via email, online invitation, or accessing an instrument in a computer lab.
  • Survey (paper) - Distributing a survey card to patrons or program participants.
  • Classroom observation - Presence of a researcher in the classroom to observe and collect data.
  • Long Form Consent Template - A longer example for more complicated projects.
  • Courtesy/Debriefing/Card/Message - Thank you and contact information to send nominal gift offer or share summary results, etc.
  • Location Permission Template - Basic information for obtaining permission from a property owner/manager to access a location and conduct research.
  • Research Team Ethics Agreement Template - For research team leaders to instill a sense of accountability among team members.
Access Consent Templates

Post-Approval Forms

Access Post-Approval Forms

Annual Report Form Page

There is an online Google Form Human Subject Research Annual Status Report for Expedited projects underway. It would be wise to have a personnel roster updated and available before beginning the form. 

Protocol Modification Application

For changing previously approved methods or the type of research subject or adding additional locations, procedures etc.

Protocol Personnel Form

For use if more than the Primary Contact and Faculty Advisor is working on a project. Use as an attachment for the initial application and later to update the study personnel list.

Adverse Event Report

This form is used for reporting adverse events associated with protocols approved by the Miami IRB or received an Exempt determination. Adverse events can include, for example: data being compromised (or lost) contrary to the approved elements of subject consent; an injury or harm to a subject or researcher; or a subject withdrawing from the study under duress.

Paying Human Subjects with Gift Cards

This form is used for paying human subjects with gift cards. This form must be completed prior to the purchase of gift cards or gift certificates by Miami University employees.

Contact Us

Amy Balk

Assistant Director of Research Ethics and Integrity

102 Roudebush Hall
balka@MiamiOH.edu 
513-529-2061