Institutional Review Board (IRB) for the Protection of Human Subjects (Procedure #731.A)

The University of Wisconsin-Whitewater encourages and supports free and responsible investigation by faculty, staff, and students, and adheres to the policies and procedures set forth by: CODE OF FEDERAL REGULATIONS; Title 45 Public Welfare; Department of Health and Human Services; Part 46 Protection of Human Subjects.

Before undertaking a research project, investigators must determine if the planned activity is human subjects research because specific regulations govern the conduct of human subjects research.

Research projects that involve human subjects will require review by the University of Wisconsin-Whitewater Institutional Review Board (IRB) for the Protection of Human Subjects to determine if a researcher has employed adequate measures to protect the participants involved in the research of study. Only the IRB is allowed to decide if a project is exempt. The IRB exists to protect the rights and welfare of participants in research.

This procedure contains guidelines and instructions to assist investigators in the preparation of a protocol for submission, identifying which parts of the protocol to complete, and understanding the review process.

Institutional Research Compliance Specialist, Office of Research and Sponsored Programs (ORSP)

Assent: An affirmative agreement of a child or an individual with impaired consent capacity to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Common Rule: Common Rule is a United States government's Federal Policy for the Protection of Human Subjects, regulations 45 CFR §46, which sets ethical guidelines for research involving people, including outlining requirements for Institutional Review Boards (IRBs), informed consent, Assurances of Compliance, and other protections, and to govern human subjects research they fund or conduct.

CITI training: A required training for all Principal Investigators and Student Principal Investigators on the rules, regulations, and ethical principles governing research involving human subjects. Renewal is required every 3 years.

Deception: Deception occurs when an investigator intentionally gives research participants misleading or false information about some aspects of the research.

Human Subject: Per regulations 45 CFR §46.102, it is a “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

Incomplete Disclosure: Incomplete Disclosure occurs when an investigator intentionally withheld information from participants about the true purpose or nature of the research.

Informed Consent: An ongoing educational process that takes place between the investigator and prospective subject, allowing the investigator and the participant to exchange information and ask questions.

Institutional Review Board for the Protection of Human Subjects (IRB): A group that has been formally designated to review and monitor research involving human subjects to protect the rights and welfare of human research subjects, with the authority to approve, require modifications in (to secure approval), or disapprove research.

Research: Per regulations 45 CFR §46.102, it is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

Institutional Research Compliance Specialist: The person who conducts compliance activities related to research within the Office of Research and Sponsored Programs.

A. NEW: Steps to obtain Institutional Review Board (IRB) Approval of a Research Study

1. STEP 1: Confirm if you need an IRB review.
   1. Is this activity considered research according to the federal definition?
   2. Does the Research Involve Human Subjects?
   3. If NO, activity does not meet the federal definition of research and IRB review is not required.
   4. If YES, does the activity involve obtaining information about living individuals?
   5. If NO, activity does not meet the federal definition of research involving human subjects and IRB review is not required.
   6. If YES, does the activity involve intervention or interaction with the individuals?
   7. If YES, activity is research involving human subjects. IRB REVIEW IS REQUIRED.
2. STEP 2. Whether proposed research that requires IRB is exempt is determined by IRB or ORSP.
   1. The investigator must not make any determination as to whether the research is exempt and start the activities of the research.
   2. If the research is determined exempt by IRB or ORSP, the investigator will be informed of the determination including which of the eight exemption criteria are met.
3. STEP 3. Complete an IRB review determination form and email to ORSP@uww.edu. ORSP will review the form and decide for you to submit an application. Please refer to the Office for Human Research Protections (OHRP) E-Learning Program.
4. STEP 4: Consult the IRB webpage for meeting dates of the IRB and when protocol packages must be submitted for consideration at those meetings. Note that if it is determined that your study requires a Full Convened board Review, your study will be placed on the agenda for the next monthly meeting of the Board.
5. STEP 5: Collaborative Institutional Training Initiative (CITI) Training
   1. All PIs must complete CITI Human Subject training, specifically Social, Behavioral, & Education (SBE) Sciences – All Researchers (Basic Stage) before you submit your protocol to the IRB. Log in to CITI Program by registering (Create an Account) or login under your current login information.
      
      During setup, you will be asked if you are interested in the option of receiving Continuing Education Unit (CEU) Credit for completed CITI Program Courses. You may select 'YES' for this option; however, you will be responsible for any fees associated with CEU credit (purchase options are offered at the end of course completion). If you select 'No' at this time, you can change this setting later.
      
      If you have been awarded a federal grant, additional modules or one-on-one training may be required. Please review the grant requirements or contact ORSP to help determine the educational requirements for grant compliance. The first course for Responsible Conduct of Research (RCR) is available on the CITI Program site at any time.
   2. Once you have completed the training, a certificate will be issued, which you should save for your records. Notification of completion will automatically be sent by CITI to the ORSP Office.
   3. NOTE: All members of the research team must complete training, including co-investigators, research assistants, and/or faculty advisors.
6. STEP 6: Prepare for submission to CAYUSE your protocol package, which should include the following as applicable to your research:
   1. IRB Application Form for review of research involving human subjects.
   2. Informed Consent, Parental Permission, and/or Subject Assent forms.
   3. Investigative Certificate Statement.
   4. Copies of recruitment materials, including emails, flyers, letters, etc.
   5. Copies of surveys to be used in the study.
   6. Copies of interview questions to be used in the study.
   7. Copies of all other materials to be used in the study, such as pictures, videos, and website URLs, etc.
   8. List of variables that will be observed if biospecimens/biomarkers are to be collected.
   9. Debriefing Form (Required for studies involving deception or incomplete disclosure research methodologies).
   10. NOTE: The IRB Application Form and templates for Informed Consent, Parental Permission, Subject Assent and Debriefing forms are available on the ORSP website.
7. STEP 7: ORSP sets up your CAYUSE account after you complete CITI Training. Please log in to CAYUSE under your current UW-Whitewater login credentials and complete your IRB Application Form. Follow step-by-step instructions in CAYUSE.
8. STEP 8: Submit Application
   1. Please submit your complete protocol package to CAYUSE.
   2. Once you have “confirmed” your study, you will be taken to the Submission details page, and the status is now changed to “awaiting certification.”
   3. Please inform the ORSP Institutional Research Compliance Officer via email of your submission.
   4. Please certify that you agree to the “Investigator’s Certification Statement.”
9. STEP 9: IRB Communications
   1. Application. You will receive a “receipt” via email once your protocol package is received. If everything is complete, the receipt will state that your protocol has been forwarded to the IRB Chair for review.
   2. IRB Decision. You will be notified via email of the IRB action on your protocol as either Approved, Exempted, Declined or if additional information is needed.

B. WITHDRAWAL: Steps to withdraw Institutional Review Board (IRB) application

Only IRB protocols that have NOT been submitted to the IRB for review can be withdrawn.

The investigator who began the entry of the IRB submission that is being considered for withdrawal is the ONLY person who has access to it. However, all investigators that have been listed on the protocol MUST certify its withdrawal.

1. STEP 1: Please log in to CAYUSE and choose the study number you wish to withdraw.
2. STEP 2: From the drop-down options, choose [+New Submission] then [Withdraw]. You will receive a WARNING screen notifying you that if you withdraw the submission, you must reenter the protocol.
3. STEP 3: You will be taken to the “Withdrawal Page”, where you will need to submit a reason for withdrawing the submission.
4. STEP 4: Complete submission, confirm and certify.
5. STEP 5: Once all investigators have completed the certification process, they will receive an email notification that the protocol withdrawal has been completed.

C. MODIFICATION: Steps to obtain Institutional Review Board (IRB) Approval of a Research Study

After a study has been approved by the UWW IRB, the only way to make changes is through a protocol modification.

No protocol modification review applications will be accepted if any added researchers have not completed the required CITI training.

1. STEP 1: Please log in to CAYUSE and choose the study number you wish to modify.
2. STEP 2: From the drop-down options, choose [+New Submission] then [Modify]. Follow step-by-step instructions in CAYUSE and complete the IRB Protocol Modification Summary. Save and complete submission.
3. STEP 3: An email will be sent to the PI, co-PI(s), and Student investigators (as appropriate) for Certification. Each investigator must log in to CAYUSE IRB and certify that they agree to the Investigator’s Certification Statement.
4. STEP 4: Once all investigators have completed the certification process, they will receive an email notification that the protocol modification has been certified and sent to the IRB for review.
5. STEP 5: IRB Decision and Communications. You will be notified via email of the IRB action on your protocol as either Approved, Exempted, Disapproved or if additional information is needed.

D. RENEWAL: Steps to Renew Institutional Review Board (IRB) of a Research Study

Investigator(s) will be sent an email at 90, 60 and 30 days before an existing IRB protocol is up for renewal/continuation review.

If you INTEND TO CONTINUE your research, you must submit and receive approval to continue the study before the IRB protocol has expired. You must CEASE all study activities (unless doing so will adversely affect the study participants), unless you receive an approval to continue or renew.

No protocol renewal/continuation review applications will be accepted if any added researchers have not completed the required CITI training.

1. STEP 1: Please log in to CAYUSE and choose the study number you wish to renew.
2. STEP 2: From the drop-down options, choose [+New Submission] then [Renewal]. Follow step-by-step instructions in CAYUSE and complete the IRB Protocol Renewal/Continuing Review Summary. Save and complete submission.
3. STEP 3: An email will be sent to the PI, co-PI(s), and Student investigators (as appropriate) for Certification. Each investigator must log in to CAYUSE IRB and certify that they agree to the Investigator’s Certification Statement.
4. STEP 4: Once all investigators have completed the certification process, they will receive an email notification that the protocol renewal/continuation has been certified and sent to the IRB for review.
5. STEP 5: IRB Decision and Communications. You will be notified via email of the IRB action on your protocol as either Approved, Exempted, Disapproved or if additional information is needed.

E. CLOSURE: Steps to Close Institutional Review Board (IRB) of a Research Study

Investigator(s) will be sent an email at 90, 60 and 30 days before an existing IRB protocol is up for renewal/continuation review.

If you DO NOT INTEND TO CONTINUE your research, you must submit a closure report to inform the IRB of the status and any unanticipated results and/or findings from the completed study.

Closure reports are REQUIRED as part of the IRB process. Failure to provide a closure report may have adverse effects or may create delays in the approval of any new studies by the investigator(s) in the future.

1. STEP 1: Please log in to CAYUSE and choose the study number you wish to close.
2. STEP 2: From the drop-down options, choose [+New Submission] then [Closure]. Follow step-by-step instructions in CAYUSE and complete submission.
3. STEP 3: You will receive an email notification that the protocol has been submitted to the Institutional Research Compliance Officer for closure. Once it has been closed, you will also receive a notification indicating the process is complete.

F. INCIDENT REPORTING: Institutional Review Board (IRB) of a Research Study

The procedures outline instructions for reporting incidents, adverse effects and unanticipated problems involving risks to subjects or others during a research study.

1. SERIOUS INCIDENTS: If incidents such as a life-threatening illness, injury, or death occur during the course of the study,
   1. The investigator(s) MUST IMMEDIATELY seek the appropriate medical treatment for the participants, and cease all study activities, unless stopping activities will be life-threatening to participants.
   2. The incident MUST be reported within three (3) days. Follow step-by-step procedures in CAYUSE.
   3. The IRB will assign an investigator to the incident who may contact the PI for additional information. A determination will be made on the proper procedure for next steps. Federal guidelines require that serious incidents may need to be reported to the Office of Human Research Protections (OHRP) and any research sponsors.
   4. Research activities MAY NOT RESUME until notified by the UWW IRB and may be terminated or suspended indefinitely because of the incident.
2. NON-SERIOUS INCIDENTS: In case of non-serious incident(s), the study may continue but
   1. The investigator(s) MUST be reported to UWW IRB via CAYUSE incident report.
   2. The IRB Chair and the Institutional Research Compliance Officer will review the incident report and depending upon the incident and severity, determine if the entire IRB needs to be consulted and if an investigator needs to be assigned to the incident for further review.
   3. IRB Chair and the Institutional Research Compliance Officer may determine if the study needs to be suspended until an investigation has been completed.
   4. No studies will be suspended if suspension creates further complications for participants.
   5. The investigator(s) will be instructed on how to proceed and given deadlines as appropriate for changes and corrections.
      1. STEP 1: Please log in to CAYUSE and choose the study number you wish to report an incident on.
      2. STEP 2: From the drop-down options, choose [+New Submission] then [Incident]. Follow step-by-step instructions in CAYUSE and complete submission.
      3. STEP 3: Your submission will be reviewed by the IRB Chair, and the Institutional Research Compliance Officer, and you will be contacted with any further instructions.

Policy Number: IRB101; December 21, 2017.

U.S. Department of Health and Human Services Office for Human Research Protections 

UWW IRB Forms

• IRB Consent for Online Data Collection - Fillable Form(Typically used for online surveys, where obtaining a signature is not practical.)
• IRB Informed Consent with Participant Signature - Fillable Form(Typically used for paper surveys or in-person consent where confidentiality is not necessary.)
• IRB Consent without Participant Signature - Fillable Form (Typically used for in person confidential research.)
• IRB Informed Consent for Minors or Persons with Diminished Decision Making Capabilities - Fillable Form(Parental/Legal Guardian approval form, used in addition to Child/Participant approval.)
• IRB Assent/Consent for Participation in Research - Fillable Form(Child/Participant Approval, used in addition to Parental/Legal Guardian approval.)
• IRB Sample Institutional Affiliation Letter - Fillable Form
• IRB Single Authorization - Fillable Form
• IRB Closure- Fillable Form
• IRB Annual Progress Report - Fillable Form

First approved: April 16, 2026

June 30, 2030

Questions regarding the interpretation of this procedure should be directed to:

Institutional Research Compliance Specialist, Office of Research and Sponsored Programs (ORSP)
800 West Main Street; Whitewater, WI 53190-1791
orsp@uww.edu
p 262-472-5212 | f 262-472-5214