Defining Research

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It is recommended that you let the IRB decide the category your project fits into. The IRB is an experienced resource to determine the level of review (if any) that your project requires in order to protect you and the institution.

Federal regulations define "research" as:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

This definition would include but is not limited to studies or projects that involve patient interviews, follow-up contact of patients to determine the effectiveness of a program or a treatment, chart review, analysis of computer-stored clinical and administrative data, and mailed questionnaires. Additionally, randomized trials of experimental drugs, devices, and procedures must be reviewed and approved by the IRB because there is contribution to generalizable knowledge. Any project that involves randomization of members to different intervention risks must be reviewed by the IRB since random assignment is part of an experiment (by definition) and thus research.

In some cases, publication or presentation implies intent to contribute to generalizable knowledge. Additionally, many medical journals require documentation of IRB review as a condition of publication. However, planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.

The NHRMC IRB does review applications in order to determine NHRMC's engagement with research studies. This is for research studies that are being conducted by other institutions that request NHRMC's involvement by the use of NHRMC medical records, facilities, or NHRMC staff notifying potential subjects about the research study. If it is determined that NHRMC is not engaged in the research, IRB review and approval is not required and a formal letter of determination from the IRB will be issued. The guidance document for this determination can be found here: 

Other Helpful Links

OHRP Guidance on research determination and decision trees:

OHRP Quality Improvement Activities FAQ: