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As a general rule, case reflections represent anecdotal observations and NOT research; therefore they would NOT require institutional Review Board (IRB) approval.
- An IRB is a committee within a university or other organization receiving federal funds to conduct research that reviews research proposals. The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove, or require modifications of these projects.
- When a series of patient observations is compiled in such a way as to allow possible "extrapolation" of the results from the reported cases to a much larger population, it probably does represent research.
- Anytime statistics are utilized to analyze the observations from patients in a report you probably have crossed the line into research
Regardless of whether or not IRB review/approval is required, care must be taken to protect the confidentiality of private information associated with the patient involved in the case reflection. A "safe" rule of thumb would be that anytime the report will deal with more than a single patient you should seriously consider that you may be "stepping across the line" into research and you should contact the IRB office for advice.
For additional guidance, please refer to the ABPTS website's information regarding the WCS.
ALL APPLICANTS - PLEASE NOTE THE FOLLOWING from the American Board of Physical Therapy Specialties:
The Certificate of Achievement in Pelvic Physical Therapy (CAPP-Pelvic) and the Certificate of Achievement in Pregnancy and Postpartum PT (CAPP-OB) are not part of the Clinical Specialist Program of the American Board of Physical Therapy Specialties (ABPTS), and a favorable review of the case reflection submitted by an applicant for the CAPP-Pelvic or CAPP-OB does not guarantee favorable action by the ABPTS in the event the case reflection is submitted in support of an application for specialist certification.
Final case reflection should be emailed to the SOWH executive officer. It will then be sent to 2 blinded reviewers for scoring. You will be notified in 8-16 weeks of score indicating pass or the need for revisions. Please contact the Director of Education, with questions.
When does a case reflection need to be submitted to the IRB?
- When it is a disease or condition that is so rare that by discussing the case and identifying yourself, you are identifying the subject
- When it is more than one in a series
- Things to consider
- How will you be using the information?
- Is it for Grand Rounds and teaching purposes or is it for publication and contributing to generalizable knowledge?
- Are you looking at rare cases to merely inform an audience, or do you attempt to draw some relationship or conclusion from these reports?
Patient Treatment
Do I need to obtain permission from the subject of a CAPP case reflection?
- No, not for the purposes of the CAPP requirements. However, if you are hoping to publish a case report that could be extended from the reflection, or if you think that you will need IRB approval, then you should probably obtain permission from the subject. The SOWH has created a release form for this purpose
Can treatment of a single patient constitute "research?"
- Yes, if 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 a case study. Treating with a research intent should be distinguished from the use of innovative treatment practices
Do all studies have to be submitted to the IRB?
- All research involving the collection of data from human subjects must be submitted to the Office for the Protection of Research Subjects (OPRS). Some research activities are exempt from full IRB review; the OPRS staff must confirm the type of review required and will issue a determination of exemption on the IRB's behalf.
What is "Research"?
- The key aspect of research is that there are systematic designs in advance, utilizing a scientific approach or protocol, for the definite purpose of contributing to the generalizable knowledge.
The Common Rule defines research as "...a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge."
Belmont Report "...the term 'research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or to contribute to generalizable knowledge.... Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective."
Please contact the Director of Education, or SOWH executive officer for further information.
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