IRB Corner: Understanding Human Subjects Research

IRB Corner: Understanding Human Subjects Research

This month in the IRB Corner we will address a common question as to whether a project or activity requires an IRB review.  The University of Phoenix has assured federal agencies that the UOPX IRB will review all human subjects research. Therefore, any study that meets the federal definition of human subject research will undergo an IRB review. The federal regulations (45 CFR 46.102) define human subjects research and encourage researchers to consider 1) whether the project is considered research and 2) whether the project involves human subjects.  The federal guidelines indicate this determination is a two-step process of first considering whether the project or activities constitute “research” and next whether the research involves human subjects.

Is the project “research”? 

According to the federal regulations (45 CFR 46.102(d)), research is defined as:

…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A systematic investigation typically involves a method, or plan to collect and analyze data in an effort to answer a question or test a hypothesis.  Developing or contributing to generalizable knowledge means that the project is designed with the purpose of disseminating or sharing findings, typically through publication or presentations. Even if there is no intent to publish findings from the study, if the conclusions are meant to inform or generalize beyond the single case or program, then the activities are considered research. 

Does the project involve “human subjects”? 

According to the federal regulations (45 CFR 46.102(f)), a human subject is defined as:

a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

An intervention involves physical procedures that allow for the collection of data or manipulations of the subject or the subject’s environment that are performed for research purposes.  Interaction includes communication or interpersonal contact between an investigator and a subject.  Private information includes information about an individual’s behavior that occurs in such a way that the individual could reasonably expect that the information would not be made public. Identifiable information includes personal data, like names, addresses, social security numbers, etc…or data that can be combined to identify an individual, such as age, gender, job title and employer, for example.  

Educational Activities and IRB review 

Researchers must obtain an IRB review prior to conducting human subjects research. However, not all activity involving data collection from humans is considered “human subjects research”. For example, classroom exercises that require students to engage in activities to practice developing methodological or design skills generally are not designed as a component of research.  Educational activities designed to teach research are not designed with the intent to develop or contribute to “generalizable knowledge,” and thus these activities do not require an IRB review.

There are possible exceptions to the federal general guidance that educational activities are not human subjects research. For example, if a class activity may lead to a research project resulting in a formal academic presentation (such as at a conference) or publication, an instructor is encouraged to recommend the student submit the project for an IRB review prior to beginning the study.

Additional Questions About IRB Reviews

For more information on the definitions of research and human subjects, please see the federal policy for the protection of human subjects here: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102

For more on the University of Phoenix IRB, please see the UOPX Research Hub: https://research.phoenix.edu/content/institutional-review-board.  The UOPX IRB also maintains a library of guidance materials within IRBNet (http://irbnet.org) under the Forms and Templates tab from the left menu.  Additional questions about IRB reviews can be directed to the IRB Office at IRB@phoenix.edu.

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