Is my project research?

Many projects qualify as research, such as those with investigational drugs or devices being tested in humans. But there are other situations where it may be more difficult to tell whether an activity qualifies as research.

Please review the following information prior to submitting your application to the Children's Hospital of Wisconsin IRB:

Activities that do not qualify as research

• Medical practice. Designed to enhance the well-being of a patient or others. Includes innovative therapy, which still is designed to benefit an individual patient but "the desired outcome is to some degree unproven."
• Medical practice for the benefit of others. Donating blood, for example, in which the goal "is to benefit a well-defined group of people in a predictable way."
• Public health practice. Such as surveillance (monitoring of diseases) and program evaluation (immunization coverage or clinical preventive services such as mammography).
• Case report or case series. A retrospective report on a treatment, including innovative treatment.
• Quality assessment. Activities that determine whether aspects of medical practice conform to established standards.
• Outcome analysis. "Projects in which medical records are reviewed to evaluate the outcome of medical treatment or the course of patients with a specific medical condition." Results are not compared to an established standard.
• Resource utilization review. "Medical record review conducted to evaluate the use of resources in a specific health care activity."
• Education. Transferring information from one group of people to another, such as teaching somebody something.

Activities that do qualify as research

• According to the U.S. Department of Health and Human Services: A systematic investigation (including research development, testing and evaluation) designed to contribute to generalized knowledge.
• According to the Food and Drug Administration: An experiment involving a test article (drug, biologic, device, food or color additive, electronic product) and people who either receive the test article or serve as controls.

Based on these definitions, there are two key elements necessary for a project to qualify as research:

• Some form of study design is necessary (typically a written protocol or study plan). A report of an interesting case or occurrence is not research because there was no study plan. However, a retrospective review of records looking for patterns is research because it would have a study plan. The study plan (protocol) may be written by industry sponsors, a cooperative study group or the investigator. The Children's Hospital investigator is responsible for following the protocol as approved by the IRB.
• Research is designed to contribute new knowledge to science and society, such as generalized knowledge. The new knowledge may be proving a hypothesis, showing that a drug or device works, reporting on results of certain activities (controlled or naturally occurring), etc. The knowledge that results from research often drives other research projects, further contributing to science and benefiting society. Activities such as quality assurance and service provision, intended only to benefit a defined group (such as a hospital system, a business or a student class) or an individual (such as patient care or student instruction), even if innovative or unconventional, are not designed to contribute to generalized knowledge, and thus don't meet this part of the definition of research.

Remember that the IRB oversees only research involving living human beings. If your project involves no living humans or identifiable data on human subjects, it does not require HRRB review. Consider your intent of the entire project, not just if you wish to publish.

If you have questions about whether your project qualifies as research, contact the IRB Office at (414) 266-7454. We can review your proposal either over the phone or in a face-to-face meeting.

References
Amdur RJ, Speers M, Bankert E. (2006). Identifying intent: Is this project research? In RJ Amdur and EA Bankert (eds.), Institutional Review Board Management and Function (pp. 101-105). Sudbury, MA: Jones and Bartlett Publishers.