Last Revised: 10.2015
Prior Version: 7.2007
Research Involving Chart Reviews
Introduction
The CWRU SBER IRB will review and approve studies involving chart reviews; however, the
CWRU SBER IRB does not review and approve protocols involving specimens and tissues.
Investigators must submit specimen/tissue studies to a hospital IRB such as University Hospitals
Case Medical Center (UHCMC). All applicable federal regulations for the protections of human
participants (DHHS) must be met. In addition, for chart reviews involving vulnerable
population(s), 45 CFR 46 Subparts B, C and D may also apply.
Definitions
Chart review may include a patient medical and/or dental record (e.g. from a hospital or clinic),
employee records, student record, etc. Collected data may be on paper or electronic.
Policy
The CWRU SBER IRB requires a protocol to be submitted for review for all Chart Review
Studies. The IRB's main concern with chart reviews for research is the possible invasion of
privacy and the use of confidential and privileged data or information. For any study to qualify
as a chart review, all the data accessed must have been collected (or will be collected) as part of
routine clinical care or institutional operations (e.g. student records, employee records etc.).
Informed Consent
Informed consent must be obtained unless a waiver can be fully justified and meets the
regulatory requirements. If an investigator has the opportunity to obtain consent from a subject,
they must do so as usual under the human subject protection regulations. The consent process
and all requests for waivers must be addressed in the protocol/research plan.
Minimal Risk vs. Greater Than Minimal Risk
Although most chart reviews are minimal risk, it is possible that a study may be greater than
minimal risk depending on the type of information collected. In either case, a research study that
only includes chart reviews must be submitted using the IRB Initial Protocol online application
via the iRIS Electronic System. For continuing review submission, investigators must complete
and submit the Continuing Review Form via the iRIS Electronic System.
Greater than minimal risk chart review studies must include a fully completed Initial Protocol
Submission Form via iRIS. In addition, informed consent must be sought unless the regulatory
criteria for waiving the consent process are met.
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CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
If children are involved, parental permission and age-appropriate assent must also be obtained
unless the criteria for waiving parental permission and waiving assent are met. Written
justification for all waiver(s) is required and must be approved by the IRB.
If charts/medical records are obtained from another institution, then the investigator may have
additional regulatory requirements (e.g., FERPA, PPRA, etc.) that must be met.
Exempt Research
Certain chart review studies may qualify for an IRB exemption; however, an investigator can
request an exemption but cannot make that determination. An exemption, if eligible, can only be
made by the CWRU SBER IRB after a formal exemption application has been submitted and
reviewed.
Access to an Investigator’s Own Records for Research
Investigators in clinical practice (i.e., physicians, dentists, social workers, nurses) may access
their own patients’/clients’ existing records (or those of their group practice) for research;
however, the IRB requires additional documentation. Such documentation includes IRB
approvals, letters of cooperation, and/or requests for appropriate waivers or consents/parental
permissions. As part of the protocol application, the investigator must ensure that all collected
data will be kept confidential and private, and any study results will be presented in a way that
preserves subject anonymity.
Access to Another Investigator’s or Another Organization’s Records for Research
Investigators may access data from another source; however, the protocol application submitted
to the IRB must describe how patient privacy will be protected and how the confidentiality of the
information will be maintained. The best way is for the investigator to receive completely deidentified and unlinkable data from the data source. If this is not possible and a member of the
research team must review the charts/electronic records, then investigators reviewing the
charts/records must agree to keep all identifying data confidential. If identified data leaves a data
source, then consent from participants is usually required before they (or their data) are included
in the study.
Contact with Potential Participants from Chart Reviews
Any investigational or research project involving use or review of charts/records where contact
will be made with subjects or subjects’ families as a result of chart review requires approval by
the IRB. No one can be contacted to participate in research without approval from the data
source. If seeking approval from a data source, the lack of reply can never be construed as
approval. The investigator is required to submit a protocol application to the IRB indicating:

Justification for contacting subjects;

Method of contact; and

Indication that prior approval will be obtained from the data source

Supporting documentation that indicates permission to access data and/or actual subjects.
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CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
References and/or Regulatory Citations:
45 CFR 46
OHRP Guidance on Coded Private Information or Biological Specimens
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CWRU SBER IRB Policies and Procedures