Complete the HSR Determination Worksheet if a) you are uncertain whether your project requires IRB approval or b) you believe that your project does not require IRB review and you want official determination documentation from the IRB. Send completed form to [email protected].

Download HSR Determination Worksheet

Key Definitions & Examples – Common Rule Guide

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Means a living individual about whom an investigator (whether professional or student) conducting research:

    • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

The information is expected to expand the knowledge base of a scientific discipline or other scholarly field or study and yield one or both of the following:

    • results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
    • results that are intended to be used to develop, test, or support theories, principles, and statements of relationships or to inform policy beyond the study.

Deceased individuals do not meet the definition of human subject. For specimens, data, and other information gathered without direct interaction with the individual, it is assumed that the individuals are alive unless the researcher specifically knows otherwise.

The data or information you seek must be about the person. Researchers may be asking for opinions, thoughts, or something about the subjects. This is different than asking for facts or factual information not related to the person. Biospecimens are always considered to be about the person.

Examples:

    • Not about the person. A survey of elementary school teachers that asks them factual questions about class size, classroom features, and availability of classroom materials.
    • About the person. The same scenario above but the researcher also asks the teachers how long they’ve been teaching and/or asks their opinions about the standard curriculum.
    • Not about the person. An interview with Montana farmers asking questions only about the land and farming - acreage, prior year yields, or tilling methods.
    • About the person. Same scenario as above but opinion and personal, ranking, or perception questions are added. What was the biggest challenge you personally faced last year while farming, and how did that affect your mental health?
    • About the person. A researcher is developing a new user interface for a computer program. Their research uses the “think aloud” method, asking college students to verbally express their thought processes as they use the interface. Though the object of the researcher’s interest is the interface, not the students, they are collecting data about the students.

Record in any way (writing, video, email, voice recording, photography, etc.) for research purposes and retained for any length of time.

Physical procedures or manipulations of the individual or individual’s environment that are performed for research purposes.

  • Manipulations may be physical, social, psychological, or emotional.
  • Environment includes an individual’s social and virtual environments as well as physical environment.

Examples:

  • Games, puzzles, or decision making activities
  • Collection of biospecimens
  • Imaging, scanning
  • Diet or nutrition studies
  • Use of instruments or devices to collect data or to monitor/influence behavior
  • Clinical studies of drugs and medical devices

Communication or interpersonal contact between a member of the research team and the subject. Interactions can occur in person, by mail, email, phone, online/virtual mediums, or via social media, etc. 

Examples:

  • Surveys
  • Questionnaires
  • Educational tests (cognitive, diagnostic, aptitude, achievement)
  • Focus groups
  • Interviews
  • Observation of behavior (inlcuding visual or auditory recording)

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

  • Means Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • The Common Rule speaks of “readily ascertained” but does not specifically define terms often used by investigators such as coded, de-identified, or anonymized. Such strategies must be clearly laid out by the investigator with enough information for the IRB to consider whether a subject’s identity is readily ascertainable.
  • Facial images and voice recordings of individuals are generally considered identifiable.
  • Unique identifiers alone may not necessarily be identifiable – Example: random fingerprints.

A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.