Step 2: Does the activity
involve Human Subjects?
Please notice that the definition of human subject focuses on what
information or material is obtained from people.
If EITHER of the following is true, your research activity
involves human subjects and you should proceed to Step
3:
The activity involves a living individual about whom an investigator
(professional or
student) conducting research obtains data through intervention or interaction
with the individual;
Intervention = both physical procedures (e.g. venipuncture) and manipulations
of living individuals or the living individuals’ environments.
Interaction = communication or interpersonal contact between the investigator
(or research team) and the living individual. Examples: interviews,
questionnaires, surveys, observations, manipulations of subject behavior,
diet, or environment, physical measurements, specimen collection (e.g.
blood tissue), administration of experimental drugs or devices.
- OR-
The activity involves a living individual about whom an
investigator (professional or
student) conducting research obtains identifiable private information.
Identifiable = if 1) the identity of the individual from whom the information
was obtained is ascertained or may be readily ascertained by the investigator;
or 2) the identity of the individual from whom the information was obtained
is associated or may be readily associated with the information
Private Information = information about behavior that occurs in a context
in which the individual can reasonably expect that no observation or
recording is taking place or information that has been provided for
specific purposes that the individual can reasonably expect will not
be made public (e.g. medical record, employee or student records).
Examples of individual identifiers include the subject’s name,
address, phone number, social security number, medical record number,
student or employee identification number, or in some cases, the combination
of data such that they can identify a single individual through deductive
reasoning. For example, data about employer, job title, age and gender
may not individually identify a subject, but when combined, could in
certain cases, identify a specific individual.
If the information cannot be linked to a living individual, or is considered
public or is given with the expectation that it will be made public
and that it will be linked to the individual (e.g. biography or news
story), then it would not be considered private identifiable information.
For example, use of a publicly available data set that does not contain
identifiers or codes linked to individuals does not involve human subjects
research.
- If you are using specimens and/or data and neither you nor your collaborators can identify the subjects from whom the speciments and/or data were obtained either directly or indirectly through coding systems, the activity is not research involving human subjexts and does not require reivew by the IRB.
If your activity is research but does not involve human subjects, as
defined in the regulations, your activity does not fall under the purview
of the IRB. You DO NOT need to submit an application. If you have questions
about this please contact the RSPP office: 612-626-5654.
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