Research Roundtable: HRP-503R Retrospective Medical Chart Review Protocol Template

In order to address the specific details and regulatory requirements present in a retrospective medical chart review, the UB IRB recently created a new Protocol template: the HRP-503R. In the regular HRP-503 Protocol template, there are many sections that were irrelevant or not applicable for retrospective medical chart review studies, which led to some confusion about what answers the IRB was hoping to receive.

The HRP-503R is to be used in studies that are Retrospective Medical Chart Reviews ONLY. The document was released in October 2022, and the UB IRB will require its use for all Retrospective Medical Chart Reviews starting on April 1, 2023.

This version of “Research Roundtable” presents the new template by section and briefly details some of the highlights of the new template.

The first section of the HRP-503R template asks researchers to confirm that their study is a retrospective medical chart review only. The UB IRB defines “retrospective” as the data being already in existence at the time of IRB approval. So, for example, if a study team wants to extract data from January 1, 2017, to June 30, 2023, but they will not do so until August 1, 2023, and the study is submitted to the IRB on May 1, 2023, this will not qualify as a retrospective medical chart review. In this case, the regular HRP-503 Protocol Template must be used. Conversely, if the study team wanted to extract data from January 1, 2017, to January 1, 2023, and the study is submitted to the IRB on May 1, 2023, then the HRP-503R can be used.

All chart reviews with a prospective component must be submitted on the regular HRP-503 template. Any submission that uses the HRP-503R but contains a prospective component of the review will be asked to resubmit the Protocol on the HRP-503 template.

This section also asks if the researchers will obtain consent, which should be done whenever possible. If researchers plan to obtain consent, the regular HRP-503 must be used. The HRP-503R should only be used when the study team plans to request a waiver of consent.

This section has been reworded in the HRP-503R to specify the number of charts. In the past, researchers would sometimes leave out the number of charts reviewed on the HRP-503 because the question seemed to address recruiting participants instead of participant charts. 

If one of the vulnerable populations’ status listed above will be known to the research team through the chart review, then the appropriate population’s box should be checked. If children’s charts will be included, since the age of individuals is often included as a data point in a medical chart review, then the appropriate box should be checked, and the age range of the children specifically described.

It is certainly possible that the data being collected in a medical chart review will not include whether a participant is pregnant (for example), and the IRB does not expect researchers to account for all these cases when it is not necessary to collect that data as part of the research study.

The confidentiality section of the HRP-503R Protocol contains the most significant changes from the HRP-503 in order to showcase the specific information the IRB needs to know when reviewing a retrospective medical chart review study. Breach of confidentiality is the primary (and often only) risk for a retrospective medical chart review, so it is vital for confidentiality procedures to include detailed and appropriate information in order to limit the chances for a breach. One example of this is shown above, where some questions separate electronic and paper data where necessary.

The HRP-503R Confidentiality section includes more specific directions about coding the data, and providing a separate code key document in the overall Click IRB submission when doing so. If identifiable data will be collected or stored for any amount of time, the data should be coded as one measure to reduce the risk of a breach of confidentiality.

This is an example of a larger chart that shows all potential identifiers that could be collected as part of a data set during a retrospective medical chart review. The section asks researchers whether the particular identifier is not being recorded, whether it will be on the code key, or kept on the data collection form. It may be appropriate for some limited identifiers to remain on the data collection form instead of the code key if there is an appropriate justification, which is addressed below in Section 22.7.

The updated questions in this section ask investigators to directly answer why their study should qualify for a waiver of consent. The questions come from the HRP-410 Waiver or Alteration of Consent Checklist, which the IRB uses to determine whether consent can be waived.

The Data Banking section has been expanded and clarified to include more information about when this section should be completed. If data from the retrospective medical chart review could be used in potential future studies outside the scope of the project the Protocol is related to, then this section should be completed. If this is not happening, then this section may be skipped. Conducting future analyses related to the same study would not count as banking data for future use.

The end of the HRP-503R includes a checklist of documents that are commonly submitted with retrospective chart review studies. This is not an exhaustive list, but it could be helpful to researchers to ensure that certain documents are included in the Click IRB submission. 

If you have any questions about the HRP-503R Retrospective Medical Chart Review Protocol Template, call or email the UB IRB at 716-888-4888 or ub-irb@buffalo.edu.

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