“IS IT HUMAN SUBJECTS RESEARCH?”

The graphic at the bottom of the page has been developed by the Office for Human Research Protections (OHRP) as a guide for investigators to decide if an activity is research involving human subjects that must be reviewed by an IRB. In addition to the graphic, use these questions to help determine if your project meets the regulatory definition of human subjects and/or research.

  1. Does the study involve interaction or intervention with a living individual?                  Information/data must be collected from live individuals. Information from subjects now  deceased is not human subjects.
  2. Is the information/data obtained about the living individual?                                                  That is, does the research data being sought pertain to the individual subject, or is the data  merely being provided by the subject? For example, a quality improvement program may ask  teachers to provide information on how an educational program can be improved. This  information is not “about” the teacher but is information provided by the teacher about the  educational program.
  3. Will the information/data be obtained through intervention or interaction with the individual?                                                                                                                                           Do you plan to communicate with living individuals using surveys, questionnaires, or  interviews? Do you plan to manipulate a situation or environment in some way?
  4. Is the collected information/data identifiable private information?                                   Private information is that which the individual can reasonably assume will not be made public  or can reasonably expect that no observation is taking place, e.g., data provided for a health  care record. Identifiable information allows the identity of an individual to be associated with  the data, either directly by a name, ID#, etc. or indirectly, by containing one or more data  elements that can be combined with reasonably available information to identify an individual.
  5. Is your study designed to produce generalizable knowledge?                          Generalizable knowledge is when the intended use of the research is to draw general  conclusions so that the findings can be applied to populations or situations beyond the studied  unit.
  6. Is the study systematic?                                                                                                                     Do you have a methodical plan that includes collecting and analyzing data to answer a research question? Is your activity designed to test a hypothesis and allow conclusions to be  drawn?

Examples of Studies that are NOT Human Subjects Research

  1. Data Collection for internal University administrative purposes such as teaching evaluations and workshop evaluations.
  2. Service or program surveys designed with the intent of improving services or programs or developing new services or programs for students, employees, or alumni as long as the privacy of the subjects is protected, the confidentiality of individual responses is maintained, and survey participation is voluntary.
  3. Information-gathering interviews where questions focus on procedures, policies, or products rather than on people or their thoughts regarding themselves.
  4. Course-related activities designed specifically for educational or teaching purposes, such as instruction on research methods, where data is collected from and about human subjects as part of a class exercise or assignment but are NOT intended for use outside the classroom.

Requesting IRB Determination
If in doubt, potential investigators may consult the IRB about whether their study is human subjects research or not. This must be done before any research activity takes place. If you would like the IRB to review your project to determine whether it meets the regulatory definition of human subjects research, you may submit a “Not Human Subjects Research” application, available for download on the FORMS page. If the IRB determines your project does not meet the regulatory definitions, you will receive a determination letter which states IRB approval is not required. If the IRB determines that your project does meet the regulatory definitions, you must then submit the appropriate application for review (full, expedited, or exempt) before any research activity can occur.

Chart 1: Is an Activity Research Involving Human Subjects?

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