EXAMPLES OF NON-RESEARCH
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
activities are not meant to be exhaustive.
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
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.
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.
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 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
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.