Office of Human Research Ethics SOP 2501: Case Reports Requiring IRB Review

Title

Office of Human Research Ethics SOP 2501: Case Reports Requiring IRB Review

1. Case Reports Requiring IRB Review

In general, an anecdotal report on one or a series of patients seen in one’s own practice and a comparison of these patients to existing reports in the literature is not research and does not require IRB approval. Going beyond one’s own practice to seek out and report cases seen by other clinicians creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and would require IRB approval.

1.1 Definitions

Single Case Report. The external reporting (e.g., publication, poster or oral presentation) of an interesting clinical situation or medical condition of a single patient. Case reports normally contain detailed information about an individual patient and may include demographic information and information on diagnosis, treatment, response to treatment, follow-up after treatment, as well as a discussion of existing relevant literature. The patient information used in the report must have been originally collected solely for non-research purposes as the result of a clinical experience.

Case Series. The external reporting (e.g., publication, poster or oral presentation) of an interesting clinical situation or medical condition in a series of patients (i.e., more than one patient). Case series usually contain detailed information about each patient and may include demographic information and information on diagnosis, treatment, response to treatment, follow-up after treatment, as well as a discussion of existing relevant literature. The information used in the report must have been originally collected solely for non-research purposes as the result of a clinical experience.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879

Details

Article ID: 132243
Created
Thu 4/8/21 9:27 PM
Modified
Fri 3/18/22 4:57 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
06/02/2017 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor
Last Review
Date on which the most recent document review was completed.
06/02/2017 12:00 AM
Last Revised
Date on which the most recent changes to this document were approved.
06/02/2017 12:00 AM
Next Review
Date on which the next document review is due.
06/02/2019 12:00 AM
Origination
Date on which the original version of this document was first made official.
06/02/2017 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-IRB and Human Research Ethics