Review Question - QID 214094

Of the above, the only study design that does not require IRB review is a quality improvement study using a patient database with INTERNAL implications only.

Originating in the 1970s, the modern IRB exists to protect the safety and welfare of human participants in research studies. The IRB committee usually consists of scientists, lay community members, physicians, and lawyers, and their roles include ethical consultations, education, and peer review. Quality improvement assessments that involve data collection and analysis with the goal of improving specific processes and systems internally, within organizations, is NOT be considered research and therefore does NOT require IRB approval. However, IRB review is required if the investigators seek publication of the data in a national journal or presentation at a national meeting and/or the results of the study will have application beyond the confines of the investigators’ local institution or practice.

Parvizi et al. reviewed the importance of the IRB process. They reported that IRBs exist to protect human subjects involved in research from any potential harm. The authors highlighted that the Belmont Report provided the ethical principles (respect for persons, beneficence, and justice) that should be observed while conducting research on human subjects.

Slover et al. reviewed the basic principles for conducting human research in orthopaedic surgery. The authors acknowledged that most orthopaedic surgeons do not have in-depth training in regulatory requirements and scientific research methods. They emphasized that researchers need to understand the regulations for compliance and proper data management, including the requirements of the Health Insurance Portability and Accountability Act, informed consent, use of the IRB, and data protection guidelines.

Incorrect Answers:
Answer 1: The medical record number is protected health information, and such a study would require IRB review.
Answer 2: A phase III clinical trial involving an investigational robotic device has the potential to exhibit greater than minimal risk and would require IRB review.
Answer 4: Even if the walking aid exhibits negligible risk, a prospective study involving this new device for GMFCS 2 cerebral palsy patients (a vulnerable patient population) would require IRB review.
Answer 5: Because of the potential difference in risk in the two cohorts, IRB review is required.