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QUICK LINKS

• Before You Submit
• New Study Submission
• Amending an Active IRB Approved Study
• Continuing Review
• 3-Year Renewal
• Final Report/Study Complete/ Study Closed
• Adverse Event & Non-Compliance
• Informed Consent & Assent Templates
• Electrical Safety Testing
• Health Insurance Portability & Accountability Act (HIPAA)

BEFORE YOU SUBMIT

A1. Determination of MU IRB Submission

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.

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.

A2. Coordinated IRB Request Form

Request MU IRB to rely on one of the following IRBs, or one or more of the following IRBs to rely on MU:

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

A3. Request for MU IRB to Rely on Another IRB

A4. Request for Another IRB to Rely on MU IRB

A5. Research Site Letter of Permission Template

NEW STUDY SUBMISSION

B1. Protocol Summary Form

Complete this form and attach any additional materials.

B2. Consent templates (see H1-H3)

AMENDENDING AN ACTIVE IRB APPROVED STUDY

C1. Protocol Amendment Form

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. NEW Protocol Amendment Form - Personnel Change

Complete this form if the only change(s) are adding, removing, or changing the role of research personnel for an approved protocol. To make changes in addition to modifying personnel, please complete the Protocol Amendment Form (above).

C3. 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).

CONTINUING REVIEW

D1. Continuing Review Form

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

• Enrolling new research subjects
• Intervening or interactive with research subjects
• Obtaining or accessing identifiable data
• Analyzing or writing on identifiable data

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

3 YEAR RENEWAL REVIEW

E1. 3 Year Renewal Form

The 3 year renewal is a continuation of previously approved research in which it is evaluated as if it were a new protocol. Any changes that might otherwise require an amendment can be made at this time.

FINAL REPORT/ STUDY COMPLETE/ STUDY CLOSED

F1. 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.

ADVERSE EVENT & NON-COMPLIANCE

G1. Adverse Event Form

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.

INFORMED CONSENT & ASSENT TEMPLATES

H1. Adult Informed Consent Form

Use this template for studies where the research subjects are 18 and older.

H2. Parent Permission Form

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.

H3. Assent Form

Use for children between the ages of 6-12.

Electrical safety testing

I1. Electrical Safety Testing Documentation Form

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. Battery powered devices and computers used for completion of surveys or other research activities do not require electrical safety testing.

• Standard equipment that has not been modified will require testing after three years from the manufacture date or date of purchase. Subsequent testing is required every three years thereafter.
• Custom equipment or standard equipment that has been modified (and no longer meets manufacturer specifications) must undergo testing prior to IRB approval. Subsequent testing is required as determined by the IRB thereafter.

health insurance portability & accountability act (hipaa)

J1. Request for Approval of Authorization

Complete this form if your protocol seeks to use or discluse PHI for research. Then complete J2, J3, or J4 below.

J2. Authorzation to Use or Disclose PHI in Research

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

J3. Data Use Agreement for Research

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.

J4. Request for Waiver of Authorization

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.

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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.