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Application Process and Forms

General Procedures

  1. Prior to completing an application, you will need to satisfy training requirements. The Human Subject Research Orientation on Canvas will ultimately save you time in preparing your applications.
  2. Application packets (zip files) can be downloaded from the links below. Each application packet contains documents needed for that type of research. The zip files will often include a guidance document that provides information on how to address the questions posed on the application.
  3. The completed applications are submitted to the Research Ethics and Integrity Program (REI) where they are processed to be administratively reviewed for an Exempt determination (level 1) or distributed to the IRB for Expedited or Full Board review (levels 2 and 3). Each template is in a generic word-processing format and must be completed using a computer and submitted electronically.

Applications are not accepted directly from students for any student-led project. Completed forms should be sent electronically to a faculty advisor for the project who will review, approve and forward the application to the REI Program.

Submission documents include:

  • The completed Application Form.
  • Appendices that can include recruitment flyers, consent forms, survey questions, interview questions, personnel form, etc.

Please include your last name in the filenames. It is helpful if the files are named and ordered in a logical manner (e.g. 1_smith_coverpage.docx, 2_smith_research description.docx, 3_smith_appendices, etc).

Appendices materials (survey and interview questions, consent forms) can be combined into compilations of documents. Please title the inclusions and arrange them in a logical order (e.g. Consent Form:, Survey Questions, Interview Questions, etc.).

If the project is a student-led activity, the students should send the application to their faculty advisor for their consideration and the faculty advisor/PI will attach the files to an email message and send them to humansubjects@MiamiOH.edu. 

REI can only accept pdf and Word formatted documents.

IRB Meeting Dates 

TBD

 

Applications for Full Board (level 3) review must be submitted 10 days prior to the next meeting to ensure placement on the agenda.

Types of Applications

The category of review and the forms to be used are dependent on the nature of the research. The subject population, risk level, and degree of confidentiality are factored in determining the review type.

 

How do I select the appropriate review category -- Exempt (level 1) or Expedited (level 2)?

Select the review category that best fits the research design. Use the Human Subject Decision Charts from the Department of Health and Human Services website for guidance related to determination of Exempt (level 1) and Expedited (levels 2) review categories.

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

Exempt (level 1) Research

Exempt (level 1) Research correlates to activities listed in one of the "exempt" categories in the federal regulations (45 CFR 46). Exempt (level 1) Applications are reviewed and approved 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.
Request Exempt (level 1) Application

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).
Request Exempt (level 1) Application with use of pre-existing data

Expedited (level 2) and Full Board Review (level 3) Research

Expedited (level 2) - Review by the IRB

Expedited (level 2) research correlates to activities per the regulations where review is conducted by a sub committee of the IRB.

  • Minimal risk research involving a vulnerable population or manipulated subjects.
  • Research that does not qualify for Exempt (level 1) status or has been deemed to require periodic reports to the IRB.

Expedited (level 2) Applications are typically reviewed by 2 IRB members and the IRB chair guided by the requirements for expedited review under the federal regulations.

Request Expedited (level 2) Application Form

Full Board (level 3)

Full Board (level 3) reviewed research activities require review through a convened meeting and a majority vote of approval by the IRB.

  • Occurs during Expedited (level 2) review, an IRB member calls for a Full Board (level 3) 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 (Zoom/Phone) - Calling persons on a members list or respondents to an online invitation.
  • Focus Groups - 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 Example - A longer example for more complicated projects.
  • FERPA Release - Template from the General Counsel.
  • Courtesy/Debriefing/Card/Message - Thank you and contact information to send nominal gift offer or share summary results, etc.
  • Media Release Template - A template for specific release of an image or video when not included in the consent form.
  • 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.
Request consent templates

Post-Approval Forms

Request post-approval forms

Annual Report Form Page

There is an online Google Form Human Subject Research Annual Status Report or a word template that would be submitted by email attachment. It would be wise to have a personnel roster updated and available before beginning the form. The original submitted with the protocol or most recent update may be used as a more efficient starting point.

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 (level 1) 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

Jennifer Sutton

Director of Research Ethics and Integrity

102 Roudebush Hall
suttonja@MiamiOH.edu 
513-529-0454

Amy Balk

Assistant Director of Research Ethics and Integrity

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