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When is IRB Review Required?
Lunch and Learn April 22, 2015
Office of Human Research
Making a Determination: Is IRB review Required?
Question 1: Is it Research? A systematic investigation designed
to develop or contribute to generalizable knowledge (including research development, testing and evaluation) 45 CFR 46.102(d)o Systematized - Having or involving a
system, method, or plano 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 Publishing or presenting the results at
a conference
Question 2: Does the Research Involve Human Subjects?
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
Generalizable Knowledge
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.
Generalizable Knowledge
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 non-peer reviewed format with the intent of sharing data/outcomes/analyses that may influences others behaviors, theory generation, experimental design, etc.
Examples of research that does NOT contribute to generalizable knowledge and is NOT subject to IRB review: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).
o Work for an organization that generates a report specific to that organization (and which again cannot be generalized to similar organizations).
o Work on aspects of quality assurance or quality control for GWU that provide data specific to GWU and are not generalizable.
o 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.)
o In house program evaluations (e.g., faculty benefit evaluations, departmental course evaluations)
o Accreditation studies (e.g., APA accreditation of counseling psychology)
What is and What is Not Human Subjects Research (HSR)?
Not HSR
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
HSR Qualitative research Quantitative research Comparative case
studies Projects involving
experimental design and/or randomization
Surveys, interviews asking about thoughts, opinions, feelings, etc.
Quality Improvement/ Quality Assurance Projects and Program
Evaluations 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.
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. 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.
QA/QI Checklist
Examples 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.
Examples 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.
Examples 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: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.”
