EXAMPLES OF NON-RESEARCH ACTIVITIES

When in doubt about any activity involving human subjects, individuals should contact the IRB Coordinator to discuss whether formal IRB review is necessary. Furthermore, even though the IRB does not review non-research activities, individuals should nevertheless incorporate into the design of their activities the principles of respect, justice, and beneficence as described in this policy. Consistent with the social justice mission of Seattle University, considerations such as full disclosure, respect for privacy, fair treatment, risk-benefit ratio, and informed consent should apply even when the activity is not classified as research.

The following examples of non-research activities are not meant to be exhaustive.

Program Evaluations

Program evaluations involve the systematic collection and analysis of information about the effectiveness of an existing program to make judgments about the program, improve program effectiveness, inform decisions about future program development, or all of the above. Although program evaluations generally involve interactions among researchers and program participants (e.g., surveys, interviews and collection and analysis of background information) and are sometimes called “institutional research,” when the sole intent of these projects is to inform a specific entity (e.g., program providers) about the program’s effectiveness, such activities do not meet the federal definition for considered research.

NOTE:  Evaluation research that is conducted on a program that is expected to be published, as a model program to be used nationally should undergo IRB review

Student Projects

Frequently, University colleges and departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these courses is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods. If the information collected for these class projects is used solely within the classroom such activities, while they may involve human subjects, do not constitute “research” as defined in the federal regulations. Please contact the IRB office for assistance in making a determination if doubt arises regarding this topic.

NOTE:  A pilot study for a thesis or dissertation should be considered research.

Focus Groups

Use of techniques usually considered research methods might be applied for another purpose, such as to develop a clinical intervention or training program.  For example, focus groups are often used in research as the primary data collection method to interview large numbers of people.  However, focus groups are also widely used to understand the nature of a problem so that a training program or intervention can be developed for the target population.  The focus group might be conducted systematically, but there is no intent to generalize the results, simply to develop a program relevant to the population of interest.

NOTE: Use of focus groups to collect large-scale data sets across groups to develop model programs that might be used nationally are better classified as research and so should be reviewed by the IRB.  

Case Reports

A summary of clinical data, including medical history and other relevant information, collected initially for the purposes of analyzing and diagnosing an individual’s condition, for instructional purposes or for both is considered by the IRB to be a “case report” or “case study.” This information was not collected with any intent to test hypotheses or otherwise produce ‘generalizable’ knowledge. Consequently, the activity does not meet the criteria for “research” (45 CFR 46.102(d)), and ordinarily does not require IRB oversight.

NOTE: Investigators may compile information from case reports or utilize information from a single case report to make general conclusions about outcomes or formulate an hypothesis for the purpose of making their findings available to a broader audience than would normally be presented with case report information. In this situation, the activity has likely become “research” and such use of these data would require IRB approval.  

Innovative Practice

Innovative or newly‐introduced clinical procedures or therapies do not require IRB review and approval except when they meet the definition of ‘research.’ An innovative clinical practice is an intervention designed solely to enhance the well‐being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to particular individuals as opposed to providing a venue for testing an innovative procedure for the purpose of generating knowledge.  

Quality Assurance and Quality Improvement Projects

Quality assurance (QA) and quality improvement (QI) projects do not require IRB review and approval except when they involve “research” as defined by the Federal regulations. Precise definitions to permit the distinction between research studies and QA and QI projects have not been established. The purpose of QA and QI projects is to improve patient care within a given patient care environment (e.g., hospital or health care organization) and project outcomes are not likely to be generalizable to other patient care environments. Publication of a quality assurance project does not, per se, categorize that project as research.