When completing a new submission form in CLARA, please pay close attention to the questions related to HIPAA and respond individually to each one. We understand that some of the questions may seem like forehead-slappers, such as a request to explain why access to the protected health information is necessary in a chart review study. However, each of these questions addresses a specific requirement in the HIPAA regulation, and the IRB needs these specific issues addressed to document that we are making the correct determinations regarding HIPAA. Each of these questions should be answered individually rather than responded to with a single cut-and-paste answer that’s repeated for several questions.