IRB Submission Forms and Templates

Research projects involving multiple IRBs may qualify for an interinstitutional IRB Authorization Agreement (IAA). This will allow one IRB to defer review and oversight to another IRB and minimize the effort needed to obtain IRB approvals from multiple institutions. Please complete a reliance request form A2 and submit it to the Office of Research Compliance (orc@marquette.edu) before starting a New Protocol in Kuali.

A2 Frequent Partner Investigator Reliance Request Form for use with a partner from the following institutions:

• Children's Wisconsin
• Medical College of Wisconsin/Froedtert Hospital
• Milwaukee School of Engineering
• University of Wisconsin-Milwaukee
  
• Versiti Blood Center of Wisconsin

A3 Investigator Reliance Request Form for any other institution.

Marquette faculty interested in obtaining adjunct appointments through the Clinical Translational Science Institute at the Medical College of Wisconsin, visit ORSP.

A4 Research Site Letter of Permission Template

When research is conducted at a school or institution other than Marquette University, a letter of permission and/or IRB approval letter from the site is required. The optional template can be completed by research sites to give the investigator permission to conduct the study. In most cases it is expected that researchers obtain permission from the site(s) prior to submitting a protocol to the IRB for approval.

All new study submissions must be completed through Kuali using the  function.

Once a study receives IRB approval, any changes or modifications to an Exempt study, or the approved Expedited or Full Board study (e.g., revising a questionnaire, adding a new data collection instrument, modifying the recruitment strategy, changing the number of research subjects, revising eligibility criteria, changing the study principal investigator, etc.), will require IRB submission and approval PRIOR to that change/modification.

All amendments must be completed through Kuali using the  function within the protocol. Only use C1 and C2 if instructed to do so in Kuali.

C1 Amendment Form Complete and attach this form to the Kuali amendment. Only complete this form if your protocol was not initially submitted in Kuali.

C2 Waiver to Obtain/Document/Alter Informed Consent Complete this form if you are 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).

Protocols approved by the IRB under Expedited or Full Board status will need to complete either a check-in or a full continuing review submission annually.  Reminder notifications will tell you which one to complete, or contact the IRB manager if you are unsure.

All renewals and check-ins must be completed through Kuali using the  function within the protocol. Only use D1 if instructed to do so in Kuali.

D1 Continuing Review Form

NOTE: Data collected during lapsed or expired IRB approval is unapproved human subjects research.

All final reports/completions/closures must be completed through Kuali using the  function within the protocol. Only use E1 and E2 if instructed to do so in Kuali.

E1 Final Report, Study Complete or Study Closed Form Use this form if the study is no longer enrolling new participants and all participants have completed research-related activities and:
• Data analysis or report writing is complete; OR
• All data has been de-identified; OR
• Individually identifiable private information is being stored without using, studying or analyzing such information.

E2 Exempt Final Report Form Use this form to close an Exempt research study. Exempt studies may be closed if all contact with participants has concluded and/or if researchers are no longer using any identifiable data or specimens.

Once a study receives IRB approval, any Adverse Events; Unanticipated Problems Involving Risks to Participants or Others; Protocol Deviations; Non-Compliance and new information that may change the risks/benefits to subjects may need to be reported to the IRB per SOP IRB-600.

All Reportable Events must be completed through Kuali using the  function within top-middle the protocol. Only use F1 if instructed to do so in Kuali.

F1 Reportable Event Form

G1 Adult Informed Consent Form Use this template for studies where the research subjects are 18 and older.

G2 Adult Informed Consent Form for NIH funded studies Use this template if the study is receiving funding from NIH. This template includes NIH-specific required language.

G3 Parent Permission Form Use this template to obtain parent permission for the participation of minors in research.

G4 Assent Form Use for children between the ages of 6-12.

G5 Exempt Information Sheet For research that qualifies for exempt status, this information sheet template may be used for basic research procedures such as surveys, interviews or focus groups. Additional information may need to be added based on individual study details. Template language may be modified as needed; similar language may be used for in-person, email or online consent. Please note that this template does not contain the required elements of consent that are necessary for Expedited or Full Review research studies.

G6 Informational Letter for Online Studies Use this template for studies involving online survey/questionnaire tools. This template has been approved by the Versiti Blood Center of Wisconsin, Children's Wisconsin, Medical College of Wisconsin/Froedtert Hospital, Milwaukee School of Engineering and University of Wisconsin-Milwaukee.

If a research study involves human subjects coming into contact with electrical equipment owned by Marquette that plugs into the wall, the equipment may require electrical safety testing. Battery-powered devices and computers used for completion of surveys or other research activities do not require electrical safety testing. Review SOP IRB-600.

H1 Electrical Safety Testing Documentation Form