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Do you need approval for Case Reports?
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In an academic medical center it is not unusual for unique and interesting clinical cases to be written up as case reports for publication in medical journals or presentation at medical or scientific meetings. Do you need IRB approval for case reports, and what is the difference between a case report and human research?

Collecting information from a medical record for the purposes of publishing the information in a journal or presenting at a meeting may meet the federal definition of research.

Please read the IRB Position Paper on Case Reports for more detailed information.

 

  CASE REPORT (IRB approval NOT needed) RESEARCH (IRB approval needed)
Record Review: Three of fewer patients Reviewing four or more patient records appears to meet the federal definition of research (systematic investigation intended to contribute to generalizable knowledge). See NOTE 1 below.
Clinical treatment: Each patient is treated as clinically indicated - treatment is not directed by a research protocol nor are specific research interventions/interactions required. If clinical trial: research protocol dictates how all patient/subjects are treated. Specific research interventions/interactions scheduled. Other research (e.g. retrospective review of clinical records): treatment occurs clinically or as part as part of IRB approved protocol.
HIPAA No HIPAA review/approval required provided patient confidentiality is protected (see NOTE 2 below). Need either: (1) subject signs IRB approved Informed Consent with HIPAA Authorization OR (2) IRB approved Waivers of (a) Informed Consent AND (b) HIPAA Authorization .
Generalizable? NOT GENERALIZABLE or scientifically rigorous. Information is educationaly solely by sharing a very limited number of interesting cases (3 or less) and how they were treated. No statistical analysis. GENERALIZABLE. Hypotheses can be proved/disproved. Data is collected and analyzed in a rigorous manner (may included statistics).

 

NOTE 1: Review of more than 3 patients usually occurs when the the clinician/investigator starts asking specific research questions which leads to formal systematic collection of data, moving these activities closer to prospectively designed research. The boundaries between case reporting and formal medical records research may be unclear for a series of one's own patients. Researchers are advised to consult with the IRB or submit larger case series reports for IRB review when uncertainty exists about whether formal and systematic collection of human subjects research is occurring.

NOTE 2: HIPAA regulations permit case reports provided patient confidentiality is protected. This means that your case report cannot contain any information that would identify the patient, including but not necessarily limited to:

  • Names, dates of birth, social security numbers, and other "codes" or combinations of identifiers, which might easily allow someone to identify a subject, should never be used in publications or external presentations.
  • Unique family trees or pedigrees should be masked or disguised when such information could identify individuals or kindreds.
  • Photographs should be appropriately masked to preclude identification of subjects.
  • It is strongly recommended (and required at Shands HealthCare and the VA Medical Center) that patients provide written consent to allow publication or electronic dissemination of pictures or other information (e.g. videos, voice recordings, transcripts), which might in any way identify them. Contact the Public Affairs office at UF, Shands HealthCare, or the VA Medical Center, as appropriate, for sample non-research consent forms for use of identifiable material. When photographs will ONLY be used in confidential medical records or as part of direct clinical care of the patient (for example, photograph of a characteristic rash which would be retained in a record for documentation or shown to colleagues in the provision of clinical care), it is appropriate and acceptable to obtain and document verbal consent.
Clinicians should be sensitive to the "small cell problem": the existence of individuals with such unique or unusual diagnoses or illnesses, that it might be possible for others (or patients and families themselves) to identify the individuals in case reports or medical text books based upon limited information, such as state or city of residence, age and diagnosis.

 

 



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