There are several types of IRB review under the Federal regulations the IRB may use to approve a new project or post approval form. These are described in detail in Types of IRB Review. These include Exempt, Expedited, or Full Board Review.

The IRB may approve several types of waivers of informed consent for your project if the project meets the regulatory requirements for one of these waivers. These are discussed in detail in Types of waivers of consent. 

After the review of your project by HSO staff, the project will be routed for IRB review based on the type of project and the overall risk level of the project. The IRB Chairperson or convened Board will make their determination. The type of determination is discussed in detail in IRB determinations and include:

  • Approved
  • Approved Pending
  • Tabled
  • Disapproved
  • Withdrawn 

It is the responsibility of the Principal Investigator to be aware of all University of Iowa policies and procedures that may affect the conduct of their research.  It is the Principal Investigator's responsibility to adhere to these policies.  This includes any Human Research Protection Program Committee policies, reviews and approvals as well as all post IRB approval requirements. These post approval requirements are discussed in detail in After IRB approval and include the following:

HawkIRB Workflow

If the IRB/HSO has feedback about your application, questions and requests for clarification are sent to the Investigator via HawkIRB workflow.  HawkIRB workflow satisfies a regulatory requirement to track correspondence between the IRB/HSO and the investigator. Workflow questions will contain links to make changes in the application or attached documents. Be sure to click one of the save buttons at the top or bottom of the page to save any changes in the form. The investigator or their HawkIRB Delegate returns the form to the IRB/HSO via workflow to continue the IRB review process. 

When an form is with the Investigator, it will appear in the Inbox section of the PI’s HawkIRB inbox. It will be visible when the PI or their HawkIRB delegate logs in to HawkIRB. Click the ‘wkflw’ link on the right side of the screen to view the workflow page and respond to requests from the IRB/HSO. Use the instructions provided for making changes in attachments using the Edit function.  The workflow page will include contact information for the HSO staff member or IRB Chair who sent the request.

When a form is routed back, the HawkIRB system sends an email to the PI, their HawkIRB Delegates, and contact persons on the research team. 

Review by Other Committees

There are several other committees within the UI that may need to review your application, depending on your procedures. For a list of other committees and more information about their approval process please see Additional Approvals.

Other documents that may be expected with 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)
  • Screenshots of e-consent documents
  • 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. 

ADDITIONAL RESOURCES:

HawkIRB application processing time

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. Applications are reviewed by IRB/HSO staff in the order that they are received.

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.