Chart Review Guidelines and Instructions
1. What is the difference between a retrospective and prospective chart review?
A Retrospective Chart Review evaluates patient data that already exists in the subject's medical record at the time the project is submitted for initial REB review. The patient data does not result from the research activity.
A Prospective Chart Review evaluates patient data that does not yet exist in the subject's medical record at the time the project is submitted for initial REB review.
2. What do I need to do before conducting a chart review?
A chart review is generally considered to be human participant research and therefore REB review and approval is required PRIOR to commencing chart review activities. Depending on the custodian of the medical records you wish to access, additional administrative, operational or research agreements must be in place prior to accessing the data.
3. Is REB review required?
The use of health information in the conduct of research-related activities requires the review and approval of the REB. Use of the health information for quality assurance/improvement activities may not require REB review. The determination that the project is indeed QA/QI should be sought from the REB prior to accessing the data. In most cases, chart reviews are dealt with via a delegated ethic review process. On rare occasions, such as the collection of sensitive data, the study may have to be reviewed at the full board.
4. Do I need to obtain informed consent when conducting a chart review?
Waiver of Consent
It is a common misconception that consent is not required for chart reviews. While in most cases this may be true, the researcher must first request a waiver of consent from the REB. Under the Alberta Health Information Act (HIA) the HREB is mandated to determine the requirement for individual consent. The researcher must provide a sufficient and detailed rationale for why it would not be reasonable, feasible or practical to obtain individual consent.
At minimum, the researcher should address the following when requesting a waiver of consent:
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the research involves no more than minimal risk to the subjects, and
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the waiver or alteration will not adversely affect the rights and welfare of the subjects, and
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the research could not practicably (feasibly) be carried out without the waiver or alteration, and
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whenever appropriate, the subjects will be provided with additional pertinent information after participation.
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the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions.
A common error that researchers make is to restate the above criteria in their waiver request. In order to ensure a waiver is granted it is necessary to demonstrate how the above apply to the research, particularly the third point above.
Researchers should consider the following when outlining their rationale:
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Sample size. Is the sample size too large to contact all individuals or is it small enough that contacting individuals is feasible?
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The dates on the medical records. Many individuals may be lost to follow up from older medical files whereas it may be possible to contact individuals who recently received medical care.
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The impact of contact for consent. Depending on the nature of the medical condition under study, will contact from the research team cause undue stress to the individual?
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Consent may introduce bias. Where the population is small and requiring consent may put the scientific integrity at risk.
Consent is Required
Where the above criteria cannot be sufficiently demonstrated, the REB may determine that written informed consent is required. This is almost always the case in prospective chart reviews where an investigator intends to review the charts of all of patients within his/her practice. In this situation, the REB will likely determine that the investigator should obtain written informed consent since there will be an opportunity for patients to be consented during a scheduled clinic visit (consent is feasible and practical).
5. Tips for the Successful Completion of a Chart Review Application
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All relevant sections up to Section 4.1 of the application should be completed. In particular, Section 2.1 should contain a detailed description of the research including the plan for analysis.
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Section 2.2: Select Chart Review/Review of Health Data, which will branch to Section 2.15.
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Section 2.15: Question 4.0 asks about the date range of the medical records. This question is designed to determine if the project is retrospective or prospective. The question is NOT asking about when the study team will physically be accessing the charts but rather, what are the dates on the medical records that will be reviewed.
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Section 2.15 Question 5.0 if you select NO - a detailed rationale for why you believe it is not reasonable, feasible or practical to obtain informed consent. It is NOT acceptable to state - "retrospective chart review." See Question 4 above for guidance.
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Both a research proposal/protocol and a data collection sheet containing all variables to be extracted from the charts must be appended in the Documentation Section.