IRB review is required for regulated non-exempt HUMAN SUBJECT research
QUESTION 3 – Does this research involve “human subjects”?

What is the definition of a Human Subject?

Human subject means “a living individual about whom an investigator (whether professional or student) conducting research obtains” information via one of several means.  The definition has 5 elements.

1.  Is the donor or participant or subject living?

A study involving death records, for example, does not have human subjects.

2.  Is the information about the person involved?

Seeking a policy statement or institutional data from agency directors is not about them.  Seeking opinions about the policy or asking for demographics about the respondent is about them.

3.  Is the data obtained through intervention with the individual?

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.  Intervention might include changing a work environment or curriculum.

4.  Is the data obtained through interaction with the individual?

Interaction includes communication or interpersonal contact between investigator and subject.  Interviews and surveys definitely meet this criterion.  There was been some debate about internet surveys but most IRBs have decided that they constitute interaction, albeit virtual.

5.  Are you obtaining identifiable private information.

Private information includes 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

What constitutes private is changing rapidly.  Most IRBs take a conservative approach to considerations of privacy to take into account the part of the intended population that is more privacy conscious.  Decisions would take into account the media used and the demographics.

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.  Aggregated data sets that have no small cells would likely not be individually identifiable.  

The question is what identifiers the investigator can find, whether the individuals can be identified with that information and if these individuals would consider the information to have been private.  

FDA – A human subject is a person in a clinical trial (generally not SBER or minimal risk) or a specimen being used for device research.

Have you decided you have no research or you have research without any human subjects?  You may document that yourself and have someone other than the investigator agree, preferably in writing.  If you want external documentation of this determination, submit E&I form 11 to  [email protected]

CONTINUE if you have research with “Human Subjects”