Federal regulations define research as the systematic investigation, including development, testing and/or evaluation, designed to develop or contribute to generalizable knowledge.  Generalizable means that the knowledge gained from a study may be applied to populations outside of the specific study population.  Participants in a research project may or may not benefit directly from the study, but society may gain from the knowledge obtained in the study.  

Federal regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. 

Investigators must seek IRB review and approval for research projects involving human subjects, but they do not have to seek IRB approval for for quality improvement/quality assurance projects or for clinical practice that also may involve human subjects.  IRB approval must be obtained before any research activity is undertaken. Therefore, in determining whether a project is a quality assurance or improvement project, clinical care, or whether it is a research project subject to IRB review and approval investigators should consider whether there is the possibility that the resulting data will be worthy of publications or presentation and thereby contribute to generalizable knowledge. If so, IRB approval must be sought prior to initiating the project.  IRB approval cannot be given retroactively should a QA/QI provide interesting results that the investigator would like to publish. 

If an investigator is not sure whether an activity falls into clinical practice, QA/QI, or public health research, faculty should request an IRB opinion on whether an activity is research requiring IRB review.  The request for opinion should be sent by a letter to the IRB office.  An IRB Chair or designated reviewer will respond with the final determination. 

QI/QA Activity: As additional guidance the proposed description of quality improvement projects put forth by the National Bioethics Advisory Commission (NBAC) in their December 19, 2000 draft document is provided.  Activities that meet the terms explained in the following statements are considered quality improvement/quality assurance activities (QI/QA) and do not require IRB review.

“…some data collection and analysis activities in the health services area are not intended to generate scientific knowledge, but rather are used as a management tool to improve the provision of services to a specific health care population (IOM 2000).  These activities are not intended to have any application beyond the specific organization in which they are conducted.  These activities are generally referred to as program evaluation or quality improvement.  But, like public health, because populations are the targets of study and because the methods used in program evaluation or quality improvement are the same as those used in research, it is often difficult to determine whether or not the activity is research that falls under the oversight system.

When an activity is research involving human subjects, it is subject to review and approval of an Institutional Review Board (IRB) before the work may be undertaken.  Customarily faculty investigators must seek IRB review for research projects, but they do not have to seek IRB approval for clinical practice or quality improvement projects or public health interventions. 

When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information gained from the evaluation will be used to provide feedback to improve that program, the activity is not human participants research.  The evaluation is a management tool for monitoring and improving the program.  Information learned has immediate benefit for the program and/or clients receiving the program or services.*  When the quality improvement involving human participants is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is research.  The systematic comparison of standard or non-standard interventions involving human participants also is research.”

*Note from HSPO:  This is not considered research because the results are held within the confines of the specific program and do not contribute to generalizable knowledge.  Results could not be published without prior IRB review and approval. 

Public Health Research: Surveillance, emergency responses, and program evaluations do not meet the DHHS definition of human subjects research.  These activities constitute public health activities with the primary intent to prevent disease in a particular population, improve a public health program, or to provide emergency disaster relief and do not meet the DHHS definition of human subjects research.  Therefore, these activities do not have to be reviewed by an IRB.