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  Research using Humans as Subjects:
  Application Forms and Templates


General Application Procedures

Types of Applications Described: Level 1 v. Level 2

Applications Download Links

Consent and Other Useful Templates

Post-Approval Forms:

Annual Report;
Personnel Update;
Modification Application;
Adverse Events Reporting.



 
 

General Procedures

1. Prior to completing an application, you will need to satisfy training requirements. The orientation session 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 MREI (Miami Research Ethics and Integrity Office) where they are processed to be administratively reviewed (Level 1 research) or distributed to the IRB for 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 MREI.

Application documents include:

  • The completed cover-page and personnel form;
  • The research description for Level 2 applications.
  • Appendices that can include recruitment flyers, consent forms, survey questions, interview questions, 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)

If possible, please send the coverpage, research description, and personnel form in the original format (.docx).

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 attache the files to an email message and send them to humansubjects@MiamiOH.edu.

No physical signatures are required if using your MiamiOH email account to submit applications. Use of Miami email account for submission stands in place of a physical signature.

 

Types of Applications: Level 1 v. Level 2

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 - Collecting new data *
(formerly "exemption screening")

Click below for a video describing Level 1 Research

Link to video Audio decription of research that qualifies for Level or exemption review

  • 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.

Level 1 Research - 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).

Level 1 Applications are reviewed and approved by a representative of the MREI 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.


Level 2 Research - Review by the IRB*
(formerly 'General Research or IRB review)
      • Minimal risk research involving a vulnerable population or manipulated subjects.
      • Research that does not qualify for Level 1 status or has been deemed to require periodic reports to the IRB.
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.

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.
  • 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.

* 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 where review is conducted by a sub-committee of the IRB. Level 3 Research actvities require review through a convened meeting and a majority vote of approval by the IRB.

 



Application Download Links

Level 1 Application Forms
(Formerly "Exemption Screening Application")


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

 

Level 1 Research -
Use of pre-existing data Zip File

e.g. research using data that is publicly available; data collected by non-Miami personnel,
research collected at another institution by current Miami personnel under IRB approval at that institution (i.e.. transferring de-identified data), or data collected under other justifiable circumstances prior to IRB approval or exemption


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


Level 2 Application Zip File

File Contents

- Application Cover Page - MS-Word Form Version - Revised July 2016
- Rese
arch description form
- Personnel Form
- Guidance Document: Information on what to include in the research description

 

Templates and Forms:

Consent Templates
(templates may include consent, assent, and parental consent formats and all need to be customized for your application and research).
Consent Form/Information Characteristics

 A document listing desirable content and issues that delay approval

Consent/Assent

Possible additional requirement/Option Description
Interview - Formal Parental Consent - Inter Meeting a subject at an agreed upon location for an in depth interview.
Interview - Informal Parent for child - Informal Recruiting and interviewing in a public place (street, zoo) 
Interview - Zoom/phone Parent for child - Zoom Calling persons on a members list or respondents to an online invitation  
Focus Groups   Convening a group to discuss an issue 
Survey - Online Parent for child - Survey Recruitment via email, online invitation, or accessing aninstrument in a computer lab
Survey - Paper Parent for child Distributing a survey card to patrons or program participants
Classroom Observation

Classroom Minor Assent

Presence of a researcher in the classroom to observe and collect data
Long Form Consent Example   A longer example for more complicated projects.
Use of Classroom Materials - FERPA   For paper based requests to use class assignments or grades for use in pedagogy research
Online Google Form FERPA Release Online Version A word document with information/content that can be used to create an online form like this
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.
Research Team Ethics Agreement Template   For research team leaders to instill a sense of accountability among team members.

Post-Approval Forms
Annual Report Form Page There is an online Google Form (new in 2020 beta testing) or a word template that would be submitted by email attachement. It would be wise to have a personnel roster updated and available before beginning the form. Forms are available below. The 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
Lab Personnel Form Potential form for when members of one lab group are approved to work on multiple protocols.
Personnel Commitment Potential form for establishing a commitment of personnel to the project manager regarding basic research integrity issues.

Adverse Event Report

This form is used for reporting adverse events associated with protocols approved by the Miami IRB or Level 1 research approved by the Research Ethics and Integrity office. 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.

 




Please contact the Research and Innovation Office 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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