Submission Requirements

Objective

IRB members often rely solely on the documentation submitted by Investigators for initial and continuing review. Therefore this material must provide IRB members with enough information about a study to assess if it adequately meets the IRB's criteria for approval.

A submitted protocol will be scheduled for IRB review when it has been determined that the information and materials submitted present an adequate description of the proposed research.

Specific Procedures

1. Submission Requirements for Initial Review
1. Required: Investigators applying for initial approval of a proposed research protocol must submit:
• IRB Application with Parts A, B, C, & D completed
• Questionnaires & assessment instruments
• Proposed informed consent document
• Proposed subject instructions
• Any other supporting material, such as examples of recruitment advertising, etc.
• Research site approvals
• IRB Tutorial certificate
2. Submission Requirements for Continuing Review
1. During the approval period, Investigators must submit documentation to inform the IRB about changes in the status of the study including, but not necessarily limited to:
• Deviations from the protocol (protocol violations)
• Reports of serious or unexpected adverse events
• Changes to the status of Principal or Sub-investigators
2. Progress Report and/or Request to Renew IRB Approval. Within sixty days prior to IRB approval expiration date, Investigators requesting renewal of an approved research project must submit:
• Annual Review of Approved Research form
• All the required materials that are indicated on the form are also required prior to review.
3. Action Taken If Documentation is Not Adequate or Additional Information is Required
1. If the IRB or IRB staff determines that the submitted documents are not adequate, Investigators will be required to submit additional information. No incomplete submission will be reviewed by the IRB.