Studies are submitted to the IRB for review via e-mail. Please see the Electronic Submissions page for details.


A1. Determination of MU IRB Submissionword

Not all research involving humans will require MU IRB submission or approval. Only activities meeting the regulatory definitions of (a) “research,” (b) “human subjects” and where (c) MU is “engaged” in the conduct of human subjects research require MU IRB review and approval. This form may be used as (1) a tool to help you determine whether IRB submission needed, and/or (2) documentation from MU IRB acknowledging your project does not meet the criteria for IRB review/approval.


Working with a colleague at another institution?

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 and minimize the effort needed to obtain IRB approvals from multiple institutions. Please complete a reliance request form and submit it to the Office of Research Compliance ( before beginning any IRB paperwork.

A2. Investigator Reliance Request Formword

If you are partnering with any of the following institutions, please complete and submit the Investigator Reliance Request Form:

MU faculty interested in obtaining adjunct appointments through the Clinical Translational Science Institute at the Medical College of Wisconsin, click here.

A3. Investigator Reliance Request Formword

If you are partnering with any other institution, and would like MU to defer IRB oversight or act as the single IRB, please completed and submit the Investigator Reliance Request Form.

A4. Research Site Letter of Permission Template word

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.


Studies are submitted to the IRB for review via e-mail. Please see the Electronic Submissions page for details.

B1. NEW Study Protocol Form word

Complete this form and attach any additional materials (e.g., data collection instruments, recruitment materials, consent forms, etc.). Use this form for all types of review (exempt, expedited or full board). Note: Final determination regarding level of review is made by the ORC/IRB.

B2. Consent Templates (see G1-G3) and Exempt information sheet template (see G4). If conducting an online survey please use the online survey consent template (G5)


C1. NEW Amendment Form word

Once a study receives IRB approval, any changes or modifications to 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.

C2. Waiver to Obtain/Document/Alter Informed Consentpdf

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).


D1. NEW Continuing Review Formword

Studies approved by the IRB under Expedited or Full Board status require annual review and approval if any of the following apply:

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


E1. Final Report, Study Complete or Study Closed Formword

Use this form if the study is no longer enrolling new participants and all participants have completed research-related activities and:

E2. Exempt Final Report Formpdf

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.


F1. Reportable Event Form word

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.

F2. Reportable Event Definitions and Flow Chart word

Use this document to understand what the IRB defines as "Unanticipated problems involving risks to subjects or others," "Serious Adverse Events," "Protocol Deviations," etc. and how the IRB will process the reportable event.


G1. Adult Informed Consent Formword

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 Formword

Use this template to obtain parent permission for the participation of minors in research.

G4. Assent Formword

Use for children between the ages of 6-12.

G5. Exempt Information Sheetword

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, e-mail, 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 Studiesword

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

Electrical safety testing

H1. Electrical Safety Testing Documentation Formword

If a research study involves human subjects coming into contact with electrical equipment owned by MU 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.

health insurance portability & accountability act (hipaa)

I1. Request for Approval of Authorizationword

Complete this form if your protocol seeks to use or disclose PHI for research. Then complete I2, I3, or I4 below.

I2. Authorization to Use or Disclose PHI in Researchword

Use this form when subjects are giving direct authorization to release and use PHI. Most often used in conjunction with an Informed Consent Form.

I3. Data Use Agreement for Researchword

A covered entity may use and disclose a limited data set for research activities conducted by itself, another covered entity, or a researcher who is not a covered entity if the disclosing covered entity and the limited data set recipient enter into a data use agreement.

I4. Request for Waiver of Authorization word

For research where obtaining direct authorization is not feasible, the IRB/Privacy Board may approve a waiver or an alteration of the Authorization requirement in whole or in part. Use this form to request a waiver or alteration.



Schroeder Complex

Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.