Any research that involves human subjects requires an Institutional Research Board (IRB) review. It is important to first clear up some gray areas on what might constitute “research” and a “human subject.” If it involves both, it needs IRB oversight.
Learning Objectives
After taking this course, learners will be able to:
Research definition
Research is a term defined by research ethics legislation as “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
We will outline three major criteria for something to be considered research.
By these criteria, the following can be ruled out as research: journalism, biographies, literary criticism, customer satisfaction surveys, historical review, court ordered gathering of information for criminal justice concerns or intelligence at the behest of the military. Even if the results of these are categorized and published, they are not considered research and do not require IRB review.
Human research
Research is considered involving human subjects if there are any “interventions or interactions” with a human being, in person or not. Examples of interventions would be testing new therapy modalities, reading brainwaves or testing the subject in a social scenario with actors. Examples of an interaction would be interviewing the subject, giving them a survey (even if its digital and anonymous) and observing individuals for research.
Exceptions to the above include deceased individuals and information provided by an individual that is not about an individual. For instance, calling a manager of a bank and asking how many clients they have is not considered research on human subjects, as the information was not pertaining to an individual human being.
Secondary research of data collected for human research does count as human research.
Private Personal Information
Information is considered private (and therefore ethically required to be kept so) when it meets the following definition: “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public”
Therefore, anything that the subject does not have any reasonable suspicion to believe shall be made public and anything about the subject’s actions in a private setting is considered private. Special attention should be given that just because the subject is in a “public space” does not mean they have any reason to believe their conversations or actions will be recorded or monitored and therefore, actions like filming a couple getting dinner in a public diner without their knowledge or consent can be considered a breach of privacy.
It is also important to note that FERPA (the Family Education Rights and Privacy Act) makes school records legally protected and only able to be disclosed with express written consent. HIPAA (the Health Insurance Portability and Accountability Act) protects an individual’s private health information in the same manner.