HawkIRB requires the investigator to respond to all applicable items on the New Project Application in order to submit the project to the HSO. The most common problem with New Project applications is that not enough detail is provided for the IRB Chair or members to evaluate the study's purpose and/or procedures.

In particular, investigators are required to provide detailed information regarding how potential subjects are initially identified, and how consent is obtained. The Principal Investigator must accurately and completely describe the study procedures in the HawkIRB application. The more complete the initial description is, the less likely that time will be spent with correspondence back and forth between the investigator and Human Subjects Office staff and/or IRB chairs to fill in the details. The New Project application in HawkIRB will indicate what is required with regard to supporting documentation.

Starting a ​new project application

All IRB applications are submitted through HawkIRB.  The HawkIRB system is accessible from the Human Subjects Office web site.  The link is at the top of the yellow bar on the left side of the page.  

The first time you log into the system, you will be prompted to review your user profile.  Make any necessary changes and click Save and Continue.  Once in your HawkIRB inbox, select New Project Application. Note that you cannot link to every part of the application initially - HawkIRB is a smart application, meaning certain sections of the application will open and close based on how you answer previous questions.

Note: The HawkIRB system considers the person who creates the new project form to be the Principal Investigator. If you are completing the application for someone else, you should log in as a delegate of the PI.

As you work through the application, be sure to click on "Back/Save", "Index/Save", or "Continue/Save" at the top and bottom of the HawkIRB screen to save your answers.  Do not navigate through the application using your web browser buttons.  You can access your application at any time under "Draft Forms" in your HawkIRB inbox - it does not need to be completed at once.

The HSO/IRB will not see your application until you submit it.  Feel free to start an application to get a feel for the form and the questions; it does not have to be submitted to the IRB.

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 (link sends e-mail).

Incomplete HawkIRB Applications 

In order to perform a thorough and timely review of research protocols, the IRB must have complete, accurate, and understandable information about the proposed study. Applications that lack sufficient detail to address regulatory requirements, are missing attachments, or whose language is too technical for reviewers of various backgrounds to understand, require disproportionate IRB resources and slow down the review of all projects. Submitting complete, accurate, and compliant applications through HawkIRB helps streamline the IRB review process for everyone. 

There are five reasons HawkIRB applications will be returned without review:

  1. They do not meet federal requirements for protocol approval. HawkIRB forms prompt the PI to provide information so the IRB can verify that the project satisfies the federal regulatory criteria for IRB approval (45 CFR 46.111 and 21 CFR 56.111). As the expert on the study design and procedures, it is the PI’s responsibility to provide a detailed, plain-language description of the study in the HawkIRB application, even if they assign the task of preparing the form to a HawkIRB Delegate. It is essential that the PI provides the information requested in each question of the HawkIRB application so the IRB can review the form.
  2. The descriptions of the study design and/or the study procedures are incomplete. Be sure to include details about all aspects of the study procedures, including the recruitment and consent processes and confidentiality protections.
  3. Only partial answers are provided in response to IRB questions.  Be sure to read each question carefully and provide the information that is requested. Also, address both parts of a two-part question.
  4. There are multiple inconsistencies in the description of the study. These may be inconsistencies between responses in the application or between the application and the attached documents.
  5. Missing, incorrect or incomplete attachments. This includes incorrect or missing signatures on the Assurance Document, attaching a template document rather than a study-specific consent document, or just missing documents related to the conduct of the study.

PIs should make sure their HawkIRB Delegate(s) are fully trained to use the HawkIRB system and are knowledgeable about their role preparing forms on behalf of the PI.  The HSO/IRB strongly encourages PIs to use the resources available within their college or department for assistance.