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Forms and Templates
|Determination of UWM IRB Submission: 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) documentation of formal notice that the UWM IRB is not "engaged" in human subjects research requiring UWM IRB review/approval.
|IAA Request 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).
|IAA Request 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.
|Institutional 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.
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.
|Submitting a Continuing Review, Study Completions, or Study Closeouts|
|Continuing Review Form: If your study is NOT listed in IRBManager, use this form and email to email@example.com with "Continuing Review Submission for IRB#____" in the subject line. Remember to also submit any required documents (e.g., Consent Form and Protocol Form).|
|Submitting an Amendment|
|Amendment Form: If your study is NOT listed in IRBManager, use this form and email to firstname.lastname@example.org with "Amendment for IRB#____" in the subject line. Remember to also submit any forms that are being modified and highlight, bold or underline the requested modifications.|
|Submitting a Reportable Event
|Reportable Event Form: If your study is NOT listed in IRBManager, use this form and email to email@example.com with "Reportable Event for IRB#____" in the subject line. Remember to also submit an Amendment to modify the approved protocol if warranted by the reportable event (e.g., inclusion of new risk in the Consent Form and Protocol Form).|
|Informed Consent and Assent Templates|
||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…
|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.
|Standard Adult Informed Consent Example
|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.
|Minor Assent Template:
Use for children between the ages of 6-12.
|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.
|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.
|Short Version Consent Template:
Use for non-complex survey and interview projects.
|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).