AddtoAny All new protocols must use the electronic submission process in the eIRB module of eResearch. Investigators benefit from the elimination of all paper documents, the automatic routing of protocols to ancillary committees,
the ability to follow the status of each submission as it moves through the approval process and the storage and tracking of all documents. The IRB does not accept paper applications or materials that are emailed outside of the eIRB system. All applications and supplemental materials to accompany new protocols, amendments, continuing reviews and reportable events must be submitted via the
eIRB electronic IRB management system. For information on the criteria the IRB uses to determine if a study is approvable, please read more about
requirements for approval. The investigator must determine which review pathway they believe their research should follow. Human subjects research can either meet the criteria for Exemption, it can be eligible for review using Expedited procedures, or it can require review by the Full Board.
When the meeting agenda is full, additional submissions go to the next available convened meeting. The IRB Committees are constituted as general biomedical committees capable of reviewing any protocol. Review Types
What are the different types of IRB review?There are three types of IRB review: Expedited, Exempt and Full Board. Expedited Expedited review is only allowed for research projects that are no more than minimal risk and will be reviewed by an IRB Chair or Chair Designee (IRB Member). Expedited review does NOT mean that the research project will be reviewed quickly – projects are reviewed in the order that they are received in HawkIRB. The IRB Chair (or his/her IRB member designee) retains discretionary right to require full board review of any project, even when the project appears to meet the criteria for expedited review. Exempt An IRB Chair may determine that a research project meets criteria for Exempt status. When exempt status is granted, the PI will be excused from complying with certain regulations: documentation of informed consent and continuing review on an annual basis. However, if changes are made to the project, a modification MUST be submitted through HawkIRB for review. Full Board Human subjects research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. These meetings are closed meetings that are not open to the public. Full board review is required in the following instances:
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How will the IRB communicate with me if they have questions about my application?The HawkIRB workflow is used to track correspondence between the IRB/HSO and the Investigator. Questions and requests for clarification are sent to the Investigator via HawkIRB workflow. Links are provided to make changes in the application or attached documents and the investigator returns the response to the IRB/HSO via workflow. When an application is returned to the Investigator through workflow, the application will appear in the Inbox section after the PI (or delegate) logs into HawkIRB. Click on the wkflw link (on the right side of the screen) to view the workflow page and respond to requests from the IRB/HSO. Instructions are provided for making changes in the application and using the Edit function to revise attached documents. On the workflow page, you will see the contact information of the HSO staff member or IRB Chair who sent the request. When an application is being processed, the PI, delegates, and research team contacts will receive an email notification each time the study application returns to her/him in workflow. The PI is then directed to HawkIRB to continue application revision. Are there any other entities that will need to review my research proposal?There are several other committees within the UI that may need to review your application, depending on your procedures. Other committees that review human subjects research applications include:
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What other documents should I expect to submit with my HawkIRB application?The HawkIRB application opens attachment categories for the required attachments based on the response to questions in the application. For example, if the application indicates that subjects will be recruited via advertisements, a category for the advertisement will be opened on the attachment page. In general, a complete HawkIRB application contains the following attachments (where applicable):
Follow the instructions on the attachments page in HawkIRB to upload these documents to your application. There are also some templates that can be generated from the attachments page. Contact the HSO with any questions - 319/335-6564 or . ADDITIONAL RESOURCES:
How long will it take for my IRB application to be reviewed?The time to process an application depends on the complexity of the research study and the quality and completeness of the application submitted to the IRB. Other variables include whether the application can be approved by the IRB Chair or Chair Designee (expedited review) or by the full board. The most common problem with New Project applications is that not enough detail is provided for the IRB chair or full board to evaluate the study's purpose and/or procedures. The more complete the initial description is, the less likely that your application will be routed back and forth between you and HSO staff or IRB chairs to fill in the details. Read each question in the application carefully. Provide a complete and accurate answer to each question, and make sure that details throughout the application are consistent. What are the possible determinations that the IRB can make about my application?
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What type of research requires IRB approval?FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
Which type of IRB review does not require an IRB approval but does?“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
What is a convened IRB review?A convened meeting is one at which a majority of members must be present, including a member whose primary concern is in a non-scientific area, before official actions may be taken. In order for the research application to be approved, it must receive approval of a majority of those members present at the meeting.
What are the 3 types of IRB reviews?IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects' research review: Exempt, Expedited, and Full.
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