Guidelines for Institutional Review Board (IRB) projects
According to federal regulations (specifically, 45 CFR 46),
Institutional Review Boards have the responsibility of overseeing the ethical
standards in research involving human subjects. This responsibility is broken
down in more detail below to clarify what projects should and what projects should
not be reviewed by the IRB.
What is research?
Research, in the federal regulatory sense, is “a
systematic investigation that is designed to develop or contribute to
generalizable knowledge.” This includes research development, testing, and
evaluation that contributes to generalizable knowledge.Read more
In order to determine if a proposed project qualifies as research,
the IRB must know the intent of the researcher. Will findings be published or
presented to external audiences? Will any outcome of the study, whether in the
form of data analysis or methodological advances or anything else, be reported
as a means to disseminate knowledge and advance the field? These possibilities
should be considered when deciding if your project needs to be reviewed by the
- Projects done in fulfillment of a course or “class
project” and that will be presented to the class are not considered to
contribute to generalizable knowledge.
- Program evaluation projects in which the
findings are reported to an oversight agency or other interested party or used
to develop a quality improvement plan also are not considered to contribute to
If a researcher is unsure about whether or not a project
qualifies as research under the authority of the IRB, the researcher should
contact the IRB office.
What are human subjects?
The federal regulations define a human subject as a “living
individual about whom an investigator conducting research obtains:
- data through intervention or interaction with
- identifiable private information”
Research involving records from deceased individuals, such
as in historical studies, does not need to be reviewed by the IRB. Projects in
which information about a thing, such as a process, is collected from
individuals, but personal identifiers or any information about the informant is
not collected, also do not need to be reviewed by the IRB. Research collecting
private information must be reviewed by the IRB. Private information is
information that can cause the identity of the participant to be associated
with the information provided or allow the participant’s identity to be readily
ascertained by the researcher. Researchers unsure about whether or not a
project involves living human subjects should contact the IRB office.
Projects must meet the criteria described under both of the
questions above to require review by the IRB. That is, the project must both:
- be research, as defined above
- involve living human subjects