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Research using Humans as Subjects: Application Forms and Templates

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.


Level 1 Research*
(formerly "exemption screening")
  • minimal risk surveys, interviews or observations of public behavior with subjects over 18 years old
  • If subjects are under 18, the research has to occur in a normal classroom setting using materials collected as part of the normal curriculum
  • research with anoymous data or biospecimens that have already been collected, however, Miami researchers can not have been involved with the design of the project or collection of data;
  • food taste testing;

Level 2 Research*
  • Minimal risk research involving a vulnerable population or manipulated subjects.

    Pending Forms
    - Level 2: General Activities - individual study
    - Level 2: Umbrella Protocol -

    Multiple studies with the same basic risk, subject population, and methods. Typically activities will qualify for Level 1 approval, but with minimal risk, may include Level 2 subject populations. Initially, individual study materials are attached as appendices or later submitted as ammendments. Later, Faculty may be authorized to determine if an activity fits the umbrella and procede with the research but register the activity.


Level 3 Research
  • Research subject to full IRB review and majority approval. Level 3 review occurs when, at the Level 2 stage, a member of the IRB has called for Level 3 review.

* Level 1 Research correlates to activities listed in one of the "exempt" categories in the federal regulations (45 CFR 46). Level 2 Research correlates to activites qualifying for what is commonly referred to as "Expedited Review" per the regulations and review is conducted by a sub-committee of the IRB. Level 3 Research actvities require review through a convened meeting and vote of approval by the IRB.

 


Level 1 Application Forms
(formerly "Exemption")


Level 1 Application Zip File



File Contents

- Application Form - MS-Word Form Version - Revised July 2016
- Personnel Form
- Guidance Document: Information on what to include in the research description (Rich Text Version)

 


Consent Templates
(each may include consent, assent, and parental consent formats and all need to be customized for your application and research)
Consent Form Characteristics A document listing desirable content and issues that delay approval
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 - Skype/phone Calling persons on a members list or respondents to an online invitation
Survey - Online Recruitment via email, online invitation, or accessing aninstrument in a computer lab
Survey - Paper Distributing a survey card to patrons or program participants
Use of Classroom Materials - FERPA Requesting to use class assignments or grades for use in pedagogy research
Classroom Observation Minor assent text and parental consent
Courtesy/Debriefing Card/Message Thank you and contact information to send nominal gift offer or share summary results , etc.
Image/Video 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 for accessing a location and conducting research.
 

 

Other Forms and Templates: Documents unpacked from zip files and post-approval materials
Level 1 Application  
Level 1 Guidance Web Page Downloadable RTF Version
Personnel Form For use if more than one person (other than a faculty advisor) is working on a project. Use as an attachment for the initial application and later to update the study personnel list
Protocol Modification or Ammendment Application  For changing previously approved methods or the type of research subject or adding additional locations, procedures etc.  
Consent Form Characteristics A document listing desirable content and issues that delay approval
 


 

Level 2 Application Forms
(Formerly "General/Students are Subjects IRB Applications")

 

Link to Webpage being replaced

Post-Approval Forms
(Protocol modification or amendments, personnel changes, annual continuing research review)
Protocol Ammendment or Modification Application For changing previously approved methods or the type of research subject or adding additional locations, procedures etc.  
Other Personnel Form For use if more than one person (other than faculty advisor) is working on a project. Use as an attachment for the initial application and later to update the study personnel list  

 




Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site: 513-529-3600
    or email Neal Sullivan at sullivnh@miamioh.edu or Jennifer Sutton at suttonja@miamioh.edu

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