How to Submit a Chart Review

Research “involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)” is subject to IRB review. This type of study can either be retrospective or prospective in nature. Make sure you detail this in your application.

  • Retrospective All materials must already be in existence at the time of IRB submission
  • Prospective – Some or all of the materials may not be in existence at the time of IRB submission

The method for and the type of data to be collected will dictate the category of IRB review that is appropriate. For more information you can review the exempt and expedited categories at the links below:

If you feel that your study qualifies as an exempt chart review please follow the directions for How to Submit Exempt Research. If it does not, please follow the instructions below.

Step 1: Complete the following form: Application for a Chart Review, located on our IRB Forms page
As appropriate, submit the following appendices/forms:

  • Appendix – Children: Submit if you plan to collect data about children (including infants) in your study.
  • Appendix – Pregnant Women, Fetuses and Neonates:   Submit this form when you plan to collect data about any of the following: pregnant women, fetuses, non-viable or uncertain viability neonates
  • Appendix – Prisoners: Submit this form when you plan to collect data about prisoners in your study.
  • Appendix- Cognitively Impaired: Submit this form when you plan to collect data about cognitively impaired persons in your study.
  • Application for Waiver of Informed Consent and/or HIPAA authorization: Submit this form to request any type of waiver for consent or HIPAA authorization
  • For lists of who to obtain signatures from, please click here.
    • Note: If study personnel are from multiple departments, approval must be obtained from all departments represented
Step 2: The following items must be completed by all study personnel.
Step 3: Assemble your submission packet. A submission packet must include all of the above completed and signed items as well as the following:
  • Research Protocol in MS Word format or (if sponsored study) searchable PDF format
    • This should be a detailed plan describing the objectives, design, methodology, statistical considerations, etc. of the study. Click here for a template with guidance on required elements
  • Data Collection Information- This can be a list or code book of all of the health information that you are collecting. It should not contain identifiers (MR#, name, dates, etc.).
  • Master Link Sheet– This should contain only the random study ID code assigned to each participant/record linked to any identifiers you are collecting (MR#, dates, name, etc.). It should not contain any health information. For a template, click here.
  • Any of the following as applicable to the study:
    • Consent Form (if data collection is prospective) in MS Word format
    • Any other written information to be provided to subjects