Institutional Review Board Manual
Research that Requires Approval
Although case studies usually do not meet the Common Rule definition of research (a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge) and as such do not require IRB review and approval all case studies must be reviewed by the applicable supervisor(s).
Case Studies and Protected Health Information
- Case studies that do not involve the receipt, disclosure or use of Protected Health Information, “PHI” (i.e., health information paired with identifiers such as name, SS#, DOB, address, etc.) do not require a signed “AUTHORIZATION TO DISCLOSE SCDMH PROTECTED HEALTH INFORMATION” or other privacy authorization to receive, disclose or use the non-PHI.
- All case studies that involve the receipt, disclosure or use of PHI must be reviewed by the local Privacy Officer (and if the use involves computer PHI, it must also be reviewed by the local Security Officer) for applicable Privacy Practices and other requirements (see Privacy Practices Directive 837-03 and applicable Security Policies.)
Case Studies Requiring IRB Approval
Regardless of the number study participants, the activity is considered research and requires IRB approval if any of the following is present,
- Investigational drug(s) or device(s) are involved (off-label use of an approved drug or device for the sake of an individual patient does not constitute research).
- There is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing the case study.
- There is a plan to perform the treatment on some individuals but not on others.
- There is intent to manipulate medications (even approved ones) to determine maximum effectiveness, or to test if they work consistently well.
- Extra tests are conducted for the sake of reportability.
- There is a protocol/study plan.
- Records or data sheets are maintained separate from clinical records (particularly with identifiers).
- The primary purpose is to answer a research question, not to provide care.
- There is a possibility that the treatment might yield a case series if it is effective in others (e.g., testing a hypothesis).
- There is intent to publish a report that is analytical not descriptive.