Application Submission Process

Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

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. The Campus IRB has developed a new exempt review process whereby an investigator can complete an abbreviated IRB application and checklist, and receive immediate IRB approval.

NEW EXEMPT PROCESS!

The Campus IRB has a new EXEMPT application. The new process permits the investigator to submit the exempt application, identify the category of exemption for their proposed activities, complete a checklist, and receive approval immediately without waiting for a prior review of the filing. The investigator may begin their research immediately upon receipt of the approval notice. http://www.hhs.gov/ohrp/faq.html

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.

The Campus IRB released a new revised Expedited/Full Board Application. The application is now more tailored to your study. We now have a main form that requires each investigator to submit general information about their study. Most of this information applies to each protocol submitted to the IRB. Depending on the information checked in the application, sub-forms will automatically be generated for completion at the end of the form. For example, investigators conducting research with prisoners will be given a sub-form to complete for prisoner research. This will no longer be part of the main form.

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 Expedited/Full Board 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
• 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
• Informed Consent Documents
• Collaborative Institution or Multi-Center Supportive Documentation
• IRB Approval Documentation from Collaborative Institutions
• Data Safety Monitoring Plan (DSMP)
• Memorandum(s) of Understanding
• Data Use Agreements
• 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.

• 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)
• Login to eIRB (Opens in a new window)

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)
• Login to eIRB (Opens in a new window)