Guidelines for Retrospective Chart Reviews & Case Reports

Guidelines for Retrospective Chart Review

Retrospective chart/record reviews necessarily involve the use of secondary data, where data contained in charts/records that was collected for a specific purpose(s) is later examined for a purpose other than the reason it was initially collected. The major risk associated with such reviews revolves around the potential that an individuals’ identity contained in the charts/records reviewed may be inadvertently revealed in reports, presentations, and/or publications derived from the retrospective review.

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans requires ethics committee approval for projects involving the use of secondary data whenever the data contains personal identifying information. Ethics committees are guided in their consideration for approval of such retrospective chart/record review submissions by the following principles (additional conditions to the four guidelines stated below may also be required at the discretion of the committee):

1. Identifying information must be essential to the retrospective research that is proposed.
2. Researchers must take appropriate measures to protect the privacy of all individuals whose charts/records are being reviewed in order to maximize the maintenance of confidentiality and to minimize potential harms to the individuals.
3. Individuals to whom the data refers must not have objected to their data being subjected to secondary use.
4. Researchers must not contact individuals to whom the data refers without prior written authorization from the Research Ethics Board.

Additional CHIPER considerations in considering Retrospective Chart/Record Reviews:

1. The proposed review poses no more than minimal risk to participants.
2. The questions/objectives of the review have scientific merit.
3. The data being collected and reviewed are being done so without the intention of contacting the individuals in the future.
4. The data being reviewed have been collected as a part of routine procedure and/or normal standard of care.

Please review the RITHIM Informed Consent Guidelines for guidance on requesting a waiver of consent for secondary use of data/retrospective chart reviews.  Your submission in RITHIM Harmony must include a detailed rationale for requesting a waiver of consent.

Guidelines for Case Reports

There is no requirement to submit individual case reports for ethics review. However, if you are required to provide ethics approval to your publisher, RITHIM will accept your submission.

Individual case reports may not meet the definition of research, depending upon the intent of the report.  Individual (single) or at most, five case reports may be considered a medical / educational activity, with no research intent, provided that they are not intended to be generalizable beyond the few incidents. It is expected that patients will provide consent for  the author / investigator to create a report about their case which may be published. Ideally a written consent to publish will be obtained. Case reports for REB purposes are a retrospective analysis of up to five clinical cases.

This does not imply that there are no ethical issues, as there are confidentiality and privacy matters that need to be addressed. There should be a process in place to ensure that the patient consents to the plan to publish a report about their case. It would be prudent to obtain written consent from the individual.  This may also be verbal and documented in the medical records.If more than five cases are involved in the analytical activity, the activity will normally constitute “research” and be subject to ethics review.

The general approach to case reports is to request that authors obtain the patient’s consent whenever possible, write up the case report and then submit it through RITHIM Harmony before sending it for publication. The case reports are reviewed largely to assess the risk that patient or individual identity may be inadvertently revealed by the author(s) in the write-up. If the probability of inadvertent identification of an individual based on the write-up is judged to be low, it is generally approved. If the probability of individual’s identification is unacceptably high — for example, if the individual has a very rare condition, or a lot of demographic data is provided in the write-up — changes will be requested (that should not result in the loss of critical information), designed to lower the risk of inadvertent individual identification from the publication of the case report.

In cases in which patient or individual or family consent is either impossible or extremely difficult (and thus quite impractical to obtain) as well as cases in which attempting to obtain consent from a living or from the family of a deceased individual would be too traumatic for those involved, CHIPER may waive the requirement for consent on a case-by-case basis.

Please contact CHIPER at CHIPER@researchmb.ca for a consultation and discussion if you are planning to conduct a case report and have further questions.

Case Report Submission Instructions

1. Register in Harmony, if you are not a registered user.

View detailed instructions here: https://rithim.ca/harmony/system-access/

2. Log into Harmony
3. From your Work Area, click on Create Project. In the popup window, enter your case report title, select Get Started form from the drop-down menu, click Create.
4. On the first (General) page of Get Started form, select “This project is a Case Report or Case Series (<5 cases) and a new Case Report/Series Application is required”, confirm and sign. Return back to project.
5. Click on Create Sub Form, select Case Report/Series Application from the drop-down menu, click Create.
6. Complete Case Report Application form, upload required documents, sign (or request PI/Advisor signature) and submit.

After submission, you can log into Harmony at any time to view the status of your project. You will be also notified about the review outcome via email.