Frequently Asked Questions
Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The IRB interprets the phrase “Ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” to refer to normal healthy individuals in general and exclude the risks that certain subcategories of individuals face in their everyday life. For example, the IRB does not evaluate the risks imposed in research focused on a special population against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).
For research involving Children as subjects, minimal risk is further defined as the level of risk that a normal, average, healthy child may be exposed to in the course of that child's everyday life, or those risks encountered by normal, average, healthy children living in safe environments in daily life or during the performance of routine physical or psychological examinations or tests.
For research involving Prisoners as subjects, minimal risk is further defined as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
For research subject to Canadian oversight: The probability and magnitude of possible harms implied by participation in the research that is no greater than those encountered by subjects in those aspects of their everyday life that relate to the research.
More information about assessing risk is available under "IRB Guidance", "Assessing Risk Level Using Magnitude of Harm": https://research.cc.lehigh.edu/irb
Yes, if you are obtaining private identifiable information about individuals for research purposes. Definitions of these key terms are as follows:
- “Obtains” means obtaining, using, studying, analyzing, collecting, gathering, or viewing.
- “Private” can refer to data or behavior. "Private" data means that individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will not be made public, e.g., tax record, medical record, or educational record. "Private” behavior means that the information is about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place.
- “Identifiable” means that the investigator can readily ascertain or associate the information with the individuals’ identities. Examples of identifiers include names, social security numbers, medical record numbers, or a code that permits the data to be linked to individually identifiable living individuals.
If the activity is limited to data analysis (i.e. does not involve interactions, such as data collection, or interventions), then the data being analyzed must be neither private nor identifiable in order for the activity to be considered NOT human subjects research. In other words, if you are analyzing private and identifiable information, you need IRB approval. If you are analyzing data that is neither private nor identifiable, you do not need IRB approval.
If you’re obtaining data through intervention or interaction with an individual for research purposes, the activity is human subjects research, even when the data is not private and identifiable.