Chart Review Protocol

Chart reviews are conducted for research purposes and to improve patient care. There are two primary types of data reviews:

  • A retrospective chart review evaluates patient data that is existing at the time the project is submitted to the Institutional Review Board (IRB) for initial review.
  • A prospective chart review evaluates patient data that does not yet exist at the time the project is submitted to the IRB for initial review.

Final Evaluation Types

There are three types of evaluations:

  • Exempt: An exempt review should only be requested if the information to be collected already exists and is publicly available or data will be recorded in such a manner that subjects cannot be identified, either directly or indirectly. As data must exist at the time the project is submitted to the IRB, this limits exempt review to retrospective chart reviews. In the majority of cases, chart reviews do not qualify for exempt status because most investigators need to retain identifiers at least through the data collection process. Even if an investigator plans to eventually discard all identifiers once data collection is complete, this is not sufficient for the project to qualify for exempt review.
  • Expedited: Expedited review can be granted for retrospective and prospective chart reviews when the research involves 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). Most chart reviews fall into this category.
  • Full Board: While rare, full board reviews may be required for both retrospective and prospective chart reviews. Some circumstances under which this occurs is if the investigator plans to collect sensitive data or if the chart review results in a change in care for the patients whose data is being collected.

Types of Consent

You must use one of three types of consents:

Waiver of Consent: In order for the IRB to approve a waiver of consent, the IRB must be satisfied that the following criteria are met:

  • The research involves no more than minimal risk to the subjects.
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  • The research could not practicably be carried out without the waiver or alteration.
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The waiver of consent is the most frequently requested type of consent for both retrospective and prospective chart reviews.

Waiver of Documentation of Consent: Under a waiver of documentation of consent, an investigator must still obtain consent from the subject. This type of consent is not usually requested for a chart review. However, the investigator does not need to obtain a signed consent form from subjects if the IRB agrees that the following criteria are met:

  • The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject is asked whether the subject wants documentation linking the subject to the research, and the subject's wishes will govern.
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Written Consent: In certain instances, the IRB may determine that written consent is required if the investigator is unable to justify why it is impracticable to conduct the research without a waiver. This is more often the case for prospective chart review studies, but sometimes occurs in retrospective chart review studies. For example, an investigator wants to review the charts of all his patients who he refers for a colonoscopy to collect outcome measures. The IRB may determine that the investigator should obtain written consent since he or she will have the chance to obtain consent from the patients during their clinic visit with him or her.

Sample Chart Review Protocol

Principal Investigator:

Address:

IRB Project Title:

Site(s) Where Study will be Performed:

Protocol Version Date:

  1. Introduction: background and rationale (include references):
  2. Hypothesis/key questions (the hypothesis being evaluated; the key questions being asked in the research):
  3. Objectives (primary endpoints of study, listed and numbered individually):
  4. Selection of patients:
    • Inclusion criteria:
    • Exclusion criteria:

    • Age range:

      Note: Regarding research involving pregnant women, prisoners, or minors, the IRB must review the study in accordance with Subparts B, C, or D of the federal regulations. If it can be presumed that the subjects are not pregnant, incarcerated, or under the age of 18 during the conduct of the chart review, the Subparts do not apply. If, however, during the course of the chart review, the investigator becomes aware that the subjects meet one or more of these conditions, the principal investigator must either exclude such subjects from the data set, or the IRB must promptly re-review the proposal in accordance with the requirements of Subparts B, C, and D.

  5. Indicate if this is a retrospective and/or prospective chart review:
    • _____ Retrospective Chart Review: Retrospective means the data is already in existence when the project is submitted to the IRB for initial review.
    • _____ Prospective Chart Review: Prospective means the data is not in existence when the project is submitted to the IRB for initial review.
    • Provide the date range of the chart review: If this is a retrospective chart review, the end date must come before the IRB submission date: mm/dd/yyyy to mm/dd/yyyy.
  6. Study methods:
    1. Provide the source (location) of the records to be reviewed:
    2. Describe how the charts to be reviewed will be identified:
    3. Describe who will identify charts to be reviewed:
  7. Confidentiality of data:
    1. Describe how data (both paper and electronic) will be stored to safe-guard confidentiality (e.g., in a locked cabinet, on a password-protected computer):
    2. Specify who will have access to harvested patient data:
    3. Clarify how long harvested patient data will be stored and how it will be destroyed when no longer needed:

  8. Consent: Describe the type of consent to be obtained and justification for the choice (written, waiver, or verbal). For additional information, please see the Guidance and Instructions at the end of the protocol.

    Note: Illinois state law requires written consent for research which collects data related to HIV/AIDS, genetic information, mental health information, and substance abuse information.

  9. Risks and benefits (modify as needed):
    1. Risks: A confidentiality breach is a risk associated with chart review research.
    2. Benefits: The subjects whose charts are reviewed are not likely to receive any benefit from the proposed research, but society and investigators will benefit from the knowledge gained.
  10. Statistical considerations:
    1. Proposed sample size (number of records to be reviewed):
    2. Proposed time period to be evaluated:
    3. How data will be analyzed and by whom:
  11. Appendices: The following appendices must be attached to the protocol:
    • Appendix A: This form should list the data elements that will be collected from the medical record. It should not contain any direct or indirect identifiers, except for a unique subject code.
    • Appendix B: This form should serve as the link between the unique subject code and any identifiers you will need to conduct this chart review study (e.g., name, medical record number, date of birth, address, telephone number, Social Security number).

APPENDIX A: DATA COLLECTION FORM

  1. Unique subject code:
  2. List all elements to be collected during the chart review:

APPENDIX B: CODED IDENTIFIER LIST

  1. Unique subject code:
  2. List all identifiers to be collected or used in this study (e.g., name, medical record number, date of birth, address, telephone number, Social Security number):