1. What are the different types of IRB review? 
2. How will the IRB communicate with me if they have questions about my application?
3. Are there any other entities that will need to review my research proposal?
4. What other documents should I expect to submit with my HawkIRB application?
5. How long will it take for my IRB application to be reviewed?
6. What are the possible determinations that the IRB can make about my application?

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:

• The study involves investigational drugs, devices or biologics that require an Investigational New Drug (IND) or Investigational Drug Exemption (IDE) from the FDA
• The study involves prisoners as subjects (except retrospective review of records or minor modifications to an existing study)
• Continuing review for studies that were initially reviewed by the full board (except when the board has determined that there is no more than minimal risk and no additional risks have been identified)
• When there is risk of criminal or civil liability to subjects
• When participation in the research may be damaging to subjects financial standing employability, insurability, reputation or be stigmatizing (unless appropriate protections are implemented)
• Classified research involving human subjects

ADDITIONAL RESOURCES:

• UI Investigator’s Guide
  • - Chapter 4. Categories of Review, Section A. Exempt Human Subjects Research, Section B. Expedited Review, and Section C. Full Board Review. 

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:

• Conflict of Interest in Research Committee (CIRC, eCOI)
• Division of Sponsored Programs 
• Holden Comprehensive Cancer Center Protocol Review & Monitoring Committee (PRMC)
• Institutional Biosafety Committee (IBC)
• Institute for Clinical and Translational Science – Clinical Research Unit (CRU) Advisory Committee
• Medical Radiation Protection Committee (MRPC)
• Nursing Research Committee (NRC)
• Pharmacy and Therapeutics Committee (P&T)
• VAMC Research and Development Committee (VAMC)

ADDITIONAL RESOURCES:

• Guide for Human Subjects Research at The University of Iowa
• HRPP Committee Relationships

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):

• Written protocol (This is only required if a protocol already exists at the time of submission.  It is not necessary to create a protocol to attach to the HawkIRB application.)
• Reports of prior investigations that provide relevant information to the review 
• Assurance Document
• Informed Consent Document(s) or other consenting materials (based on the template available in the HawkIRB application)
• Sample Informed Consent Document(s) (for example, the DHHS or other sponsor sample consent, if available)
• Recruitment materials (including all content and graphic design elements to be used in the materials available for potential subjects)
• Surveys, interviews, or questionnaires
• Grant application (the full grant application is required)
• Letter of Agreement (to conduct the research in a facility or with an organization outside the University, and/or to use data from an outside entity)
• HIPAA Letter (if obtaining private health information from a non-UI entity without patient authorization)
• Investigator’s Brochure (for studies of an investigational drug)
• Other materials specific to the proposed study (e.g. sponsor correspondence with a regulatory agency such as the FDA regarding test article risk, etc.) 

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 irb@uiowa.edu.

ADDITIONAL RESOURCES:

• UI Investigator’s Guide
  • - Chapter 6. New Project Applications and IRB Review and Approval, Section B. General Guidance

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?

• Approved - the IRB Chair or full board has approved your application with no required changes.  You can start your research as soon as the approval memo is released to you.
• Approved Pending - the IRB full board has approved your application, pending the completion of specified required actions.  You will receive notification of and access to the meeting minutes in HawkIRB, which will state the required actions.  The IRB Chair can approve the project once the required actions have been completed successfully.
• Tabled - the IRB full board has tabled your application and has specified required actions.  Following completion of the required actions, the full board must review your application at another meeting.
• Disapproved - the IRB full board has disapproved your research application.  You must start a new project application if you wish to pursue this application further.
• Withdrawn - the application has been withdrawn, either at the request of the PI, or by the IRB if the PI failed to respond in a timely manner to requests for more information.

ADDITIONAL RESOURCES:

• UI Investigator’s Guide
  • - Chapter 6. New Project Applications and IRB Review and Approval, Section G. Revisions Prior to Final Approval