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Application Submission Process

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Last update
01.09.08

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All campus based Behavioral and Social Sciences investigators conducting research involving humans or their data, should contact the Campus IRB to determine whether they must submit and application for IRB review.

Determining if Proposed Activities Meet the Criteria for IRB Review

1. How do you know IF proposed activities are human subject research? All research involving human subject participants (human subjects' research), regardless of sponsorship, must be reviewed by the Campus Institutional Review Board. The determination of whether the activities are subject to review MUST be made by the Campus IRB, NOT the investigator.
2. WHEN do you contact the Campus IRB? An investigator must submit an application to the Campus IRB when they propose to conduct research involving human subject participants. If an investigator has questions about whether proposed activities involving human participants are subject to review, they must contact the Campus IRB at (573) 882-9585. The determination of whether the activities are subject to review MUST be made by the Campus IRB, NOT the investigator.

Submission Requirements for EXEMPT Human Subject Research

Some activities involving human participants may meet the criteria for "exemption" from some of the IRB requirements. Federal guidance prohibits the investigator from making the determination of whether their activities meet the criteria for "exemption" and require the IRB to make such a decision.

Investigators applying for EXEMPT review status of proposed human subject research activities must submit an application to the Campus IRB and request which exemption category they believe describes the proposed research activities. The Campus IRB will review the "Exempt Application" and make a determination based upon the information provided. If the activities DO NOT qualify for exemption, the investigator must apply for the standard IRB review which will be determined at either the expedited or full board level.

Campus IRB Review Process (PDF, 224K)

The application shall include, but not limited to, the following information:

• Campus IRB Exempt Application
• Documentation of current Human Subjects Training
• Advisor Approval Form (if applicable)
• Description of the Study Population
• Description of the Recruitment Process
• Description of the Risks and Benefits
• Description of the Informed Consent/Parental Consent/ Youth Assent Process
• List of study tools, instruments, activities to collect data
• Disclosure of Conflicts of Interest Disclosure

NOTE: If the application fails to meet the criteria for EXEMPT review, the applicant must complete the application submission requirements for INITIAL REVIEW at the expedited or full board level. All reviews will be conducted in compliance with the "Campus IRB Review Process" policy.

Campus IRB Review Process (PDF, 224K)
REVIEWER CHECKLIST -Do your activities qualify for exemption? (PDF, 64K)
Login to eIRB (Opens in a new window)

Submission Requirements for INITIAL REVIEW (EXPEDITED OR FULLBOARD)

WHAT needs to be submitted to the Campus IRB? The investigator must submit all relevant information and supportive documents, or any requested supplemental documentation to assist the board's review of the proposed activities.

Required Information and Documentation: Investigators applying for approval of proposed human subject research activities must activities must comply with the "Campus IRB Review Process" policy and submit the following, if applicable to the proposal:

• Campus IRB Application
• Documentation of Current Human Subject Research Training Certification
• Advisor Approval Form
• Funding proposal, People Soft Signature Routing Sheet, and Letter of Award
• Office of Registrar's Approval Documentation
• Financial Conflict of Interest Disclosure
• Instruments/Inventories/Research Tools/Sample Interview Questions/Focus Group Protocol
• Description of the Recruitment Process
• Copy of the final recruitment materials and incentive plans
• Accounting Services Approval Documentation for relevant incentive plans
• Proposed and Final website access/information
• Proposed subject instructions
• Letters of Permission
• Certificate of Confidentiality
• Proposed Informed Consent/ Parental Consent/ Youth Assent Methods, Forms and Documentation
• Description of the Risks and Benefits
• Collaborative Institution or Multi-Center Supportive Documentation
• IRB Approval Documentation from Collaborative Institutions
• Data Safety Monitoring Plan (DSMP) or Data and Safety Monitoring Board Plan (DSMB), (If the research involves more than minimal risk, when appropriate, the Campus IRB will require the application (EXCEPT those qualifying as exempt) to include a Data Safety and Monitoring Plan (DSMP) to provide a description of the provisions for monitoring the data to ensure the safety of participants in compliance with the "Assessing the Level of Risk" policy.
• Memorandum(s) of Understanding
• Data Use Agreements
• Proposed Publication Plan
• HIPAA Documentation
• Debriefing Materials
• Any requested supplemental documentation to assist the board's review of the proposed activities.

All members are expected to review all materials and investigator responses in enough depth to be prepared to discuss the proposal and make a meaningful contribution to the convened meeting.

REVIEWER CHECKLIST -Do your activities qualify for expedited review? (PDF, 32K)
REVIEWER CHECKLIST -Do your activities qualify for full board review? (PDF, 16K)
Login to eIRB (Opens in a new window)

Submission Requirements for Proposed CHANGES to an Approved Project

Investigators must submit an Amendment application to the IRB requesting to implement proposed changes in compliance with the "Amendment Review Process" Policy, and receive PRIOR approval of those changes BEFORE initiation. The following information must be submitted, but not necessarily limited to:

• Amendment Application
• Advisor Approval Form
• Documentation of Current Human Subject Training Certification
• Proposed Consent Document(s)
• Proposed REVISED Instruments/Inventories
• Interim Data Results
• Total Subjects Enrolled
• Total Number of Complaints/Nature of Complaints/Action Plan
• Total Number of Subjects who Withdrew from Participation/Reason for Withdrawal /Action Plan
• Summary of Adverse Events or Unanticipated Problems
• Any other relevant documents to support the proposed changes
• Any requested supplemental documentation to assist the board's review of the proposed activities.

Amendment Review Process Policy (PDF, 64K)
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Submission Requirements for the CONTINUING REVIEW PROCESS

The Investigators must submit the Continuing Review Report (CRR) to the Campus IRB PRIOR to the expiration date and in compliance with the deadlines and requirements set forth in the Continuing Review Process policy. CRR shall not be reviewed before 30 days prior to the expiration date. All investigators shall submit the CRR by the required 45 day deadline to avoid risking a delay in the review process or expiration of IRB approval. The investigator should contact the Campus IRB if they have questions about whether a CRR is required.

If the investigator's activities are limited to analyzing data that is unidentifiable, a CRR report may not be required and a short form "Data Analysis" status form maybe all that is required.

Continuing Review Process (PDF, 80K)
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