Pre-submission Investigator Requirements

Upon reviewing the Checklist for IRB Review and determining that the IRB needs to review your activity, Principal Investigators and Co-investigators must complete each of the following three tasks before approval of a research study can be granted:

  1. Complete the required Collaborative Institutional Training Initiative (CITI)
    All principal investigators, co-investigators, (anyone involved in the design, conduct, or reporting of the research, or having significant interaction with subjects) including personnel obtaining informed consent listed on the IU Health Bloomington IRB application will need to complete CITI training or a comparable human subjects tutorial. CITI is a web-based tutorial and testing site that is frequently updated to reflect changes in human subject law and regulation. Additionally, CITI meets the Federal Requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants.
  2. Complete the Research-Related Financial Interest Disclosure Form
  3. Provide “Letter of Support” to conduct research
    As applicable, the investigator must provide written acknowledgement by the Department Manager, Director or Administrator that the study can be conducted on their unit(s)/hospital. This requirement can be fulfilled by an email or letter.