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Lunch and Learn
April 22, 2015
Office of Human Research
Question 1: Is it Research?
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A systematic investigation designed to
develop or contribute to generalizable
knowledge (including research
development, testing and evaluation)
45 CFR 46.102(d)
o
o
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Systematized - Having or involving a
system, method, or plan
Investigation - Testing an hypothesis and
permitting conclusions to be drawn (i.e.,
detailed, careful examination)
Intended to develop or contribute to
generalizable knowledge (expressed,
for example, in theories, principles,
and statements of relationships)
o
Question 2: Does the Research Involve
Human Subjects?
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Publishing or presenting the results at a
conference
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A human subject is a living
individual about whom an
investigator conducting
research obtains 45 CFR
46.102(f):
data through intervention
or interaction with the
individual;
OR
identifiable private
information
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What is “generalizable knowledge”?
The vast majority of scholarly work in academia is intended
to be shared, published, presented to colleagues, and is
intended to have an impact (theoretical or practical) on
others within one’s discipline.
Activities that are disseminated with the intent to influence
behavior, practice, theory, future research designs, etc. are
contributing to generalizable knowledge.
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Examples of research t hat
contributes to generalizable
knowledge and may be subject to
IRB review:
o Work that is to be presented at
regional, national, or
international meetings.
o Work that is published in an
academic (peer reviewed)
journal.
o Work that is published in a nonpeer reviewed format with the
intent of sharing
data/outcomes/analyses that
may influences others
behaviors, theory generation,
experimental design, etc.
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Examples of research that does NOT
contribute to generalizable knowledge and is
NOT subject to IRB review:
o
o
o
o
o
o
Work for a private or public entity that generates
a report to the same entity which cannot
conceivably apply to another like entity (i.e., the
data are UNIQUE/SPECIFIC, not generalizable).
Work for an organization that generates a report
specific to that organization (and which again
cannot be generalized to similar organizations).
Work on aspects of quality assurance or quality
control for GWU that provide data specific to
GWU and are not generalizable.
Classroom projects in a research methods class
or laboratory class where the findings will only
be reported to the class and/or instructor. (The
instructor is responsible for the ethical conduct
of this study.)
In house program evaluations (e.g., faculty
benefit evaluations, departmental course
evaluations)
Accreditation studies (e.g., APA accreditation of
counseling psychology)
Not HSR
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Quality Assurance Project
Project for Program
Evaluation
Oral history/Life Stories
A Case Study
Secondary/Aggregate data
analysis only
Class assignment/project
only
Research with deceased
persons data
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HSR
Qualitative research
Quantitative research
Comparative case studies
Projects involving
experimental design
and/or randomization
Surveys, interviews asking
about thoughts, opinions,
feelings, etc.
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Quality assurance/quality improvement initiatives:
o Are only intended to assess or improve internal practices, programs,
or systems AND
o Are not designed to contribute to generalizable knowledge.
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Does a quality improvement project that involves research
need to be reviewed by an IRB?
o Yes, in some cases. IRB review is needed if the project meets the
definition of human subjects research.
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If your project involves research and a QA/QI component,
submit for review.
If you are uncertain if your project qualifies as a QA/QI
project, please contact OHR.
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A Physical Therapy class at GW has introduced a new electronic
component to the curriculum involving weekly webinars, followed by
online quizzes about the students’ knowledge. The researcher wants to
compare scores on these quizzes to scores from last semester, when
the students took the same quizzes in class following a lecture. If the
scores are better following the webinar, the researcher may recommend
keeping this component in the curriculum. No identifying information
about the students will be recorded.
Determination: Not Human Subjects Research
Rationale:
o 1.The goal of this research is to determine something about a teaching
mechanism, not something about an individual.
o 2.The researcher is not collecting information about the participants involved.
o 3.The researcher is not intending to contribute her findings to generalizable
knowledge; the findings will be used solely within GW to inform decisions about
a class curriculum.
o 4.The students are participating in this activity independent of the researcher’s
involvement.
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A researcher wants to see the number, age and gender of patients who
underwent knee surgery at GW Hospital between 2010 and 2012. The
GW Hospital IT Department is accessing the medical records and
providing the data to the research team stripped of identifying
information. The researcher’s aim is to see if more surgeries took place
after 2011, which was when they expanded their orthopedic practice.
He may publish his findings, to show if/how their practice expansion
was successful.
Determination: Not Human Subjects Research
Rationale:
o 1.The researcher is not collecting data through interaction or intervention with
any of the individuals.
o 2.The researcher is not accessing any medical records himself; the IT
department is.
o 3.The researcher will never view, record or have access to protected health
information (PHI).
o 4.The researcher may publish the results to inform others, but these results
would not be considered generalizable to any other individual or institution.
In an introductory Anatomy class, the students are divided into two
sections for the semester. The researcher, who is also the professor, is
trying to decide which primary textbook to use for her class. She gives
the one she’s used in the past to the first group, and a new one to the
second group and gives them comparable assignments throughout the
semester. At the end, she gives the students anonymous surveys asking
for their feedback on the reading material they were given. The survey
also includes a few questions about gender, # of semesters at GW, and
typical study habits.
Determination: IRB Exempt Research Category #1/ May be reviewed under
Expedited due to randomization.
 Rationale:
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o 1.The researcher is manipulating elements of the participants’ environment for
research purposes.
o 2.The researcher may draw conclusions about the participants.
o 3.The participants are being separated into two groups and receiving different
“treatments.”
Office of Human Research
ohrirb@gwu.edu
202-994-2715
Humanresearch.gwu.edu