Common IRB Comments, Questions, and Suggestions

GENERAL OVERVIEW

This guidance document is designed to help investigators prepare an IRB application by providing insight into common mistakes.  

COMMONLY REQUESTED REVISIONS

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  • Consent forms need to be written in the second person. Second person is also known as the "you" perspective; for example, "you will be asked to..." 
  • Description of observation procedures are incomplete and sometimes omitted from consent forms. 
    • The application, and typically the consent form, must describe w​​​​​​hat is being observed, when the observations are occurring, and how and what data is being collected. How will participants know when they are being observed and how you will avoid collecting data from bystanders?
    • Public behavior exception: exempt category 2 allows for observation of public behavior without consent, but the the application needs to clearly describe what is being observed. 
• Privacy and Confidentiality – Responses are incomplete in describing provisions of privacy and confidentiality.
  • Privacy is control over the extent, timing and circumstances of sharing oneself with others. Issues such as physical space, proximity to others, and participant preferences should be considered.
  • Confidentiality is how subject information and study data will be kept secure and confidential. Confidential means maintaining subject identities in a manner that prevents inadvertent disclosure of their identity or participation in the study.
• Anonymous, confidential, coded, de-identified – Materials do not correctly describe the study as either anonymous or confidential.
  • Anonymous – Anonymous means there is no way for anyone, including study personnel, to ascertain an individual's identity. Studies using online interactions of any type are not anonymous.
  • Confidential – Subject identities are maintained in a manner that prevents inadvertent disclosure of their identity or participation in the study even if data cannot be linked to them. Coded information is considered confidential.
  • Coded - refers to data linked to individuals subjects' identifiers using a code. Generally, the data is collected with a "Study ID" and a linkage file is maintained where the Study ID is associated with the subject's identifiers. 
  • De-identified refers to data that are not associated with any direct or indirect identifiers or codes linking the data to the individual subject's identity. Data are de-identified when the linkage file has been destroyed or the code has been removed from the dataset and no data can be linked back to an individual.  
• CITI is not current or incomplete – The IRB cannot approve a new or continuing review request if PI or Co-I CITI training is incomplete or expired. CITI training is valid for three years. 
• Consent materials are difficult to understand – Consent forms should be simple to understand to the lay person, free from scientific jargon and written at an 8^th grade reading level or lower.
• Failure to describe all study procedures including:
  • Interactions – Interactions are data collection methods such as surveys and interviews. Interactions must be described in the application and consent form.
  • Interventions –An intervention can be broadly defined as an activity that is designed to manipulate a behavior. Interventions include cognitive activities, environmental manipulations, learning tasks, and physical manipulations. Interventions must be described in the application and consent form.  
• Incomplete responses – Ensure responses are complete and fully address the question’s required content.
• Lack of congruency across materials – MOST COMMON - All materials should consistently describe the study. Make sure the application and consent and recruitment materials consistently describe all elements of the study including time of participation, risks, compensation, and interventions. Ensure the study is consistently and correctly describe as either anonymous or confidential.    
• Missing materials – Submit all recruitment and consent materials, appendices, and any other documents relevant to IRB review.

OTHER SUGGESTIONS

• Prior to submitting your application, consider the following:
  • Thoroughly proofread your application, ensuring clarity and coherence for readers unfamiliar with your research.
  • Use complete sentences, proper spelling, punctuation, grammar, and cohesive writing structure.
  • Provide a comprehensive description of the research procedures, leaving no ambiguity.
  • Consistently describe the study – ask yourself, does the consent form match the rest of the application?
  • Familiarize yourself with the IRB help resources.
  • It is assumed that faculty PIs have been involved in this process and have ensured that applications are of the highest possible caliber prior to submitting.
• Proof Read:
  • Ask a friend or family member to read your materials prior to submitting them to the IRB. They should be able to easily understand your research.
  • Use complete sentences and proper spelling, punctuation, and grammar. Applications that are difficult to understand take longer to review. 
• Plan Ahead
  • If your study involves multiple compliance processes (external IRB agreements, HIPAA, FERPA, IBC, Radiation Safety) plan ahead. These processes may complement IRB processes, but are separate. 
  • International research, complex studies, and applications that are not well written take longer to review.
  • If you plan to start a study on a specific date or time period, such as at the beginning of a semester, you should submit the application at least 8 weeks in advance as to allow the IRB ample review time. Complex studies, including studies occurring outside of the US take longer to review.  

Kuali Technical

• Addressing IRB comments - when addressing IRB comments you must update the application. Using the reply feature alone is rarely accepted. Please see the help documentation - Responding to IRB Comments.   
• Please see the Kuali help documentation and FAQs on the IRB forms webpage.