University Safety and Assurances

Forms and Templates


Pre-Submission (OPTIONAL)


 

Determine If You Need to Submit to the UWM IRB: Not all research involving humans will require UWM IRB submission or approval. Only activities meeting the regulatory definitions of (a) “research” and (b) “human subjects” and where (c) UWM is “engaged” in the conduct of human subjects research require UWM IRB review and approval.

This form may be used as (1) a tool to help you determine whether you may need to submit a New Study to the UWM IRB, and/or (2) formal documentation that the UWM IRB is not "engaged" in human subjects research requiring UWM IRB review/approval. If you need a formal document from the IRB, please submit the completed form to the IRB (irbinfo@uwm.edu) and the IRB staff will review and reply to you with a final determination for your records. 


 

Request an IRB Deferral Agreement Between Aurora and UWM: Research projects involving multiple IRB's may qualify for an inter-institutional IRB Authorization Agreement (IAA). This will allow one IRB to defer review and oversight to another IRB. Use this form if your study involves Aurora Health Care and UWM (only). IMPORTANT, this form must be submitted to the IRB that will be accepting oversight (i.e., the IRB where the majority of the study activities are taking place).

 

Please note that Aurora has additional approvals for research projects that need to be obtained before a decision can be made on which IRB will be responsible for study oversight.  Please see the Aurora IRB website for more information.

 


 

Request an IRB Deferral Agreement Between CTSI Partners: Research projects involving multiple IRB's may qualify for an inter-institutional IRB Authorization Agreement (IAA). This will allow one IRB to defer review and oversight to another IRB. Use this form if your study involves Blood Center of Wisconsin, Children’s Hospital of Wisconsin, Marquette University, Medical College of Wisconsin/Froedtert Hospital, or Milwaukee School of Engineering and UWM.  Please submit the completed form to the UWM IRB at irbinfo@uwm.edu or contact us for more information.

IRB Deferral Request Form: Research projects involving multiple IRB's may qualify for an inter-institutional Authorization Agreement (IAA).  This will allow one IRB to defer review and oversight to another institution. If you are working with another institution and would like to explore the possibility of an IAA, please complete and submit this form to the UWM IRB at irbinfo@uwm.edu or contact us for more information.


 

External Institution Permission Letter: The UWM IRB may require research projects involving external sites (e.g., schools and businesses) to provide documentation/permission for the use of those facilities and/or subjects. Use this form if requested by the IRB or proactively.

 

 

Submitting a New Study


Instructions:

 

 

 

 

 

 

 

 

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All IRB Submissions must be submitted to the IRB through the online submission system, IRBManager.

For more details about IRBManager (including how to request a user account, how to use the system, and other frequently asked questions), please visit the IRBManager section of the website.

  1. After obtaining a user account, access the IRBManager web submission system.
  2. When logged in, click on "Start xForms" under "Actions" (on the left) to start the submission.
  3. The new study xform asks a few basic questions about the study (see a copy of the form here) and then requests you to upload the following more detailed documents:
  4. At the end of the form the submitter will be required to agree to several statements and enter his/her password to submit the study to the IRB.  If the submitter not the PI (i.e. is a student or study coordinator), the PI will automatically receive an email to notify him/her that the study also requires his/her "sign off" before the IRB will receive it for review.


Submitting a Continuing Review, Study Completions, or Study Closeouts
Instructions:


  • Studies approved by the IRB under Expedited or Full Board status require annual review and approval.
  • Data collected during lapsed or expired IRB approval is unapproved human subjects research. See the FAQ for further details.
  • Projects approved by the IRB under Exempt status do not require annual review and approval.
  • Access the IRBManager web submission system. After logging in, find the study you plan to submit the continuing review for. Then click "Start xForm" under "Actions" to begin the continuing review submission.
 
Submitting an Amendment
Instructions:

  • Once a study receives IRB approval, any changes or modifications to the approved Exempt, Expedited, or Full Board protocol (e.g., revised questionnaire, new recruitment strategy, change number of subjects, revised eligibility criteria, etc.), will require IRB submission and approval.
  • Access the IRBManager web submission system. After logging in, find the study you plan to submit the amendment request for. Then click "Start xForm" under "Actions" to begin the amendment submission.






Submitting a Reportable Event

Instructions:

  • Once a study receives IRB approval, any Adverse Events; Unanticipated Problems Involving Risks to Participants or Others; Protocol Deviations; and new information that may change the risks/benefits to subjects.Use the following form if you are reporting an adverse event, a deviation from the currently approved project, a participant complaint, or other unanticipated problem with the project must be reported to the IRB.
  • Access the IRBManager web submission system. After logging in, find the study you plan to submit the amendment request for. Then click "Start xForm" under "Actions" to begin the amendment submission.



Informed Consent and Assent Templates
Instructions:

Use the consent and/or assent template based on the appropriateness of your study. Multiple consent/assent forms may be required depending on your subject population.



Before you begin…
  1. Remember who your research subjects are and keep the reading level and font appropriate to the grade level of the participant. The average reading level should not exceed the 8th grade.
  2. Refrain from using technical words and if appropriate make the font-type larger.
  3. Subjects should not be pressured to sign. Do not include any statements stating, “Your [parent/partner/instructor/employer] has agreed to allow you to take part in the study”, or “Your parents said it was okay for you to be in this study.” This implies the possibility of pressure to participate. Instead use language like, “Your [parent/partner/instructor/employer] knows about this study”.
  4. Subjects should be allowed to ask questions and be given adequate time to read and sign the consent/assent form.
Do’s…
  1. Have someone else who is not involved in the research study read the consent/assent form when you are done. If they don’t understand it, then chances are the research subject and the IRB won’t either.
  2. Enter your own text and delete [IRB instructions contained in brackets like this].
  3. Check your spelling and grammar. Use the “readability statistics” function in MS Word to see the reading level.
  4. Use consistent pronouns.
  5. Arrange events in the procedures section in a chronological order.
  6. Group related risks together.
Don’ts…
  1. Delete or add statements that are not in brackets (e.g., IRB contact info) without notifying the IRB beforehand.
  2. Use long sentences.

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Standard Adult Informed Consent Template:
This template should be used for projects involving physical activities, multiple study visits, or complex study proecures. If your project is limited to surveys or interviews, consider using the online survey, letter, or short version templates.


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Standard Adult Informed Consent Example


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Combined Consent and Assent for Parent and Minor Template:
Use this template for children who are 12 years old or older. This template is similar to the Standard Adult Informed Consent with the addition of child's assent section.


    Parent Informed Consent Template

Use this template for parent consent when children are younger than 12 years old and only the parent will sign this form.  A separate child assent form may also be required.

 
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Minor Assent Template:
Use for children between the ages of 6-12.


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Online Survey Consent Template:
Use this template for online surveys. For clarification on the definitions of anonymous and confidential, please see the IRB guidance document. In addition, think about how the participant will provide consent. If participants are clicking on a "next" or "I agree" type button to continue, a request to waive documentation of consent should be applied for in the New Study Form. 

 


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Letter Format Consent Template:
Use this template for projects where the letterhead or format may be more appropriate due to the subject population (e.g., school letterhead for parent surveys). If signatures are not being sought, remember to request a waiver to document consent in the New Study Form.

 


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Short Version Consent Template:
Use for non-complex survey and interview projects.





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Waiver to Obtain/Document/Alter Informed Consent:

Use when requesting to not obtain informed consent (e.g., secondary data analysis); requesting to not obtain documentation (i.e., subject does not sign the consent form); or seeking to modify the consent document/process (e.g., verbal consent, eliminating required language in the consent).