Kuali is 探花视频鈥檚 new web-based system for data entry and management of IRB applications. All IRB submissions (new, amendments, continuing reviews and reportable events) are submitted in Kuali.
DETERMINING IF IRB REVIEW IS REQUIRED
Not all research involving humans will require 探花视频 IRB submission or approval. Only activities meeting the regulatory definitions of (a) 鈥渞esearch,鈥� (b) 鈥渉uman subjects鈥� and where (c) 探花视频 is 鈥渆ngaged鈥� in the conduct of human subjects research require IRB review and approval.
If you are unsure if 探花视频 IRB is required and want the IRB to make a formal determination, you must submit a determination request in Kuali. Start a "New Protocol" in Kuali and select:
You will then be guided through a series of questions to help determine whether 探花视频 IRB submission and review is needed and then will submit this to the IRB for a final determination.
Form A1 is a Word version of the same form found in Kuali. Use the Word version only if you do not intend to submit it to the 探花视频 IRB for a formal determination.
A1 Determination of 探花视频 IRB Submission Form
WORKING WITH 探花视频LTIPLE IRBS (SINGLE IRB AND RELIANCE AGREEMENTS)
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:
A3 Investigator Reliance Request Form for any other institution.
探花视频 faculty interested in obtaining adjunct appointments through the Clinical Translational Science Institute at the Medical College of Wisconsin, visit ORSP.
EXTERNAL SITE PERMISSION LETTERS
A4 Research Site Letter of Permission Template
When research is conducted at a school or institution other than 探花视频, 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.
NEW STUDY SUBMISSION
All new study submissions must be completed through Kuali using the 
function.
AMENDING AN IRB APPROVED STUDY
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 if instructed to do so in Kuali.
Legacy protocols created before/outside Kuali will still need to be submitted through Kuali and may require attaching the word version of the (amended) Protocol Form when submitting. When legacy protocols were entered into Kuali, research assistants may not have been listed. If you need to have a student who is working on the project added to the protocol so that they can create an amendment submission please contact Jessica.
C1 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 / RENEWAL / CHECK-INS
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.
FINAL REPORT / STUDY COMPLETE/ STUDY CLOSED
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.
REPORTABLE EVENTS
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.
INFORMED CONSENT, ASSENT AND PERMISSION LETTER TEMPLATES
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.
ELECTRICAL SAFETY TESTING
If a research study involves human subjects coming into contact with electrical equipment owned by 探花视频 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.
