Guidance for Submission of Chart Reviews to the IRB (Revised 12/09)

Research based on reviews of patient records is subject to IRB review. The method for and the type of data to be collected will dictate the category of IRB review that is appropriate:

• Exempt [45 CFR 46.101], or
• Expedited [45 CFR 46.110 and 21 CFR 56.110].

See guidance on Case Reports.

Exempt Chart Review Studies:

Review of existing patient records may be considered exempt if the records are collected without identifiers or a link to identifiers; specifically, there is no possible way to go back to the records at a later date.

In most cases, a chart review that does not record identifiers falls under the following allowable exempt category:

"Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects."

In order to submit this type of anonymous chart review to the IRB for consideration, complete the following:

• IRB Form 1 – Proposal Cover Sheet
• IRB Form 1a - Study Personnel/Required Education Sheet
• IRB Form 2a – Chart Review Research Plan
• IRB Form 3 – Conflict of Interest Questionnaire
• IRB Form 4a – Application for Determination of Exempt Status
• IRB Form 4c - HIPAA Compliance

For research involving review of patient records for which it is necessary to collect identifying information or maintain a link to the data source, a protocol for expedited review must be submitted to the IRB.

Based upon the details being collected and the risks to the patient, a waiver of obtaining informed consent/authorization might be granted by the IRB.

In order to submit a proposal for this type of chart review to the IRB for consideration, the following is required:

• IRB Form 1 - Proposal Cover Sheet
  
• IRB Form 1a - Study Personnel/Required Education Sheet
  
• IRB Form 2a - Chart Review Research Plan
• IRB Form 3 - Conflict of Interest Questionnaire
• IRB Form 4b - Informed Consent: Request for Waiver, Documentation or Elements
• IRB Form 4c - HIPAA Compliance
• Research Consent Form (if appropriate)