Why Do I Need to Understand the IRB Process

As a doctoral-granting institution, Aspen University values both original research and the application of research in an effort contribute to knowledge in a field of study. The doctoral programs at Aspen University teach skills commiserate with a doctoral degree, which include understanding issues related to human participants in research. Thus, experience with the IRB process is built into every doctoral program and every doctoral candidate is required to submit an IRB application and receive formal approval prior to conducting any dissertation research or implementing any doctoral project.

Candidates in the DNP program with experience conducting Quality Improvement (QI) or Quality Assurance (QA) projects where IRB approval is not standard because the activity is not deemed “research” may logically question the need for the IRB to review their DNP Project.

It is true that not all work that we would colloquially call “research” is considered to be research under the Common Rule (the Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991 and revised in 2018). The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” To decide if a certain activity meets the regulatory definition of research, two factors are assessed: 1) whether the activity involves a systematic investigation, and 2) whether the activity is designed to develop or contribute to generalizable knowledge. Whether or how an investigator shares results with the scientific community is not the deciding factor for whether the activity was designed to develop or contribute to generalizable knowledge.

For example, information is published that comes from activities that do not meet the Common Rule’s definition of research. And sometimes results from activities that meet the Common Rule definition for research never get published. Publication of results is sometimes used, incorrectly, as an indicator that a project meets the definition of research. It is not publication, nor the intent to publish that matter, it is the intent of the project that matters.

Distinguishing between QI/QA and research can be difficult. If the intent of the data collection is to contribute to "generalizable" knowledge, or if the results are applicable outside of the project setting or population,the activity isusually classified as research.If the QI/QA results stay entirely in-house and are used for administrative purposes only, many organizations do not consider this research. There is no regulatory guidance on the meaning of generalizability. The essential consideration is whether it was the principal investigator’s intent to contribute to a body of knowledge.