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.
Request MU IRB to rely on one of the following IRBs, or one or more of the following IRBs to rely on MU:
MU faculty interested in obtaining adjunct appointments through the Clinical Translational Science Institute at the Medical College of Wisconsin, click here.
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.
Complete this form if you are submitting your project for either Expedited or Full Board review and attach any additional materials (e.g., data collection instruments, recruitment materials, consent forms, etc.). If you are unsure of the type of review to request, see the MU ORC/IRB Flowsheet for guidance on the appropriate level of review (Exempt, Expedited, Full Review) and specific category of review based on the type of research and subject population. Note: Final determination regarding level of review is made by the ORC/IRB.
B2. NEW Exempt Review Form
Complete this form if you are submitting your project for Exempt review and attach any additional materials (e.g., data collection instruments, recruitment materials, consent forms, etc.). If you are unsure of the type of review to request, see the MU ORC/IRB Flowsheet for guidance on the appropriate level of review (Exempt, Expedited, Full Review) and specific category of review based on the type of research and subject population. Note: Final determination regarding level of review is made by the ORC/IRB.
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 Personnel Amendment Form
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).
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).
Complete this form if the list of research personnel exceeds the available space on a new protocol, amendment, or continuing review form. This form must be submitted concurrently with another IRB form.
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.
Use this form if the study is no longer enrolling new participants and all participants have completed research-related activities and:
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; 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.
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.
Use this template for studies where the research subjects are 18 and older.
Use this template to obtain parent permission for the participation of minors in research.
G3. Assent Form
Use for children between the ages of 6-12.
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.
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.
Complete this form if your protocol seeks to use or discluse PHI for research. Then complete J2, J3, or J4 below.
Use this form when subjects are giving direct authorization to release and use PHI. Most often used in conjunction with an Informed Consent Form.
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.
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.