Definition of a Human Subject Research

If you are conducting research on humans directly or indirectly (using human data or tissue), you must obtain IRB approval prior to starting your research.

What is a Human Subject?

According to the federal regulations (45 CFR 46 102.f) a Human Subject means a living individual about whom an investigator conducting research obtains:

  1. Data through intervention or interaction with individual
  2. Identifiable private information
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.
Interaction
Includes communication or interpersonal contact between investigator and subject.
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). 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.

Some examples of human subjects:

  • A person who becomes a participant in research – either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient.
  • data obtained from medical records – even if the data is recorded without identifiers.
  • tissue used in research that possesses or is linked* to any kind of identifiable information.
  • data obtained from surveys – even if the data is recorded without identifiers.
  • data obtained from observation – even if the data is recorded without identifiers.
  • data obtained from third parties – collecting information about family members makes them subjects.

For more information about what consititutes identifiable information, please review our HIPAA web pages.

Some examples of what does not meet the federal definition of a human subject:

  • tissue obtained from another source (not directly from the patient) that is either:
    • totally anonymous and unlinkable to the person who it was obtained from, or
    • is coded such that the researcher obtaining the sample does not know who it belongs to, AND a confidentiality agreement assures the researcher cannot learn the identity of the person who the sample was obtained from.
  • data obtained from another source (not directly from the patient or their records) that is either:
    • totally anonymous and unlinkable to the person who it was obtained from, or
    • is coded such that the researcher obtaining the datadoes not know who it belongs to, AND a confidentiality agreement assures the researcher cannot learn the identity of the person who the data was obtained from.
  • data or tissue collected about/from individuals after they are deceased
    • federal regulations governing research define a human as a “living individual”
    • Using deceased tissue subsequently in humans for research purposes (e.g. transplanting organs/tissue from a deceased individual into a living individual as part of a research protocol) does equal human subjects research (because of the person who is receiving the tissue).
    • NOTE: HIPAA requires you to obtain a Certificate for Research with Decedents Info

NOTE: research involving tissue and/or data, even if it does not meet the federal definition of human subject, must still be submitted to the IRB for review and approval.

What is Research?

According to the federal regulations (45 CFR 46 102.d) RESEARCH means a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge.

There are two significant points to consider:

What is a systematic investigation?
The dictionary defines systematic as having a method or plan, possibly concerned with classification. Definitions of investigation include a detailed or careful examination, exploration, or to learn the facts about something complex or hidden. Attempting to answer a question or prove/disprove a hypothesis are clear indications that an activity is a systematic investigation. (Note: the absence of a hypothesis does not automatically mean an activity is not a systematic investigation.)
What is developing or contributing to generalizable knowledge?
You are developing/contributing to generalizable knowledge if you intend on sharing the information you produce with others, be it at a poster presentation, at a conference, or in a publication.

Some examples of what is not research:

  • Case reports – are not considered research in that although they contribute to generalizable knowledge, they are not systematic investigations. The clinician is simply sharing information about interesting cases for educational purposes.
    Where people go wrong
    If you attempt to answer a question, or prove/disprove a hypothesis, you are no longer dealing with a case report and instead are now dealing with research. in addition, case reports are usually limited to no more than a few patients. Once you start to exceed three subjects it appears that you are doing something systematic (attempting to prove a point or answer a question) and IRB approval is required.
  • Quality Assurance / Continuous Quality Improvement (QA / CQI) – is not considered research in that although it is a systematic investigation, there is no intent to share the information with others (contribute to generalizable knowledge). For example, the pharmacy can conduct quality assurance and compare the use of a medication PO vs IV administration and not require IRB approval provided they do not publish the results. The results of QA can only be published if IRB approval is obtained prior to publication.
    Where people go wrong
    If you know you are likely to publish your work provided the results are worthwhile, then the project does not meet QA guidelines and should be submitted as research prior to initiation. To meet quality assurance criteria there must be no intent to publish at the onset of your investigation.For more information, review the IRB’s position paper on CQI at: /docs/op-cqi.docx