Not Human Subjects Research (NHSR) Guidance

Why is the determination needed?

The Fordham IRB is responsible for all research activities involving human subjects research. Under the federal Common Rule there are specific activities that do not meet the definition of research and therefore do not require IRB review and oversight.  

A study may not require IRB review and oversight if it does not meet the definition of research or involve human subjects. Therefore, in those situations, an application does not need to be submitted to the Fordham IRB for a formal review.

However, there are instances when verification or documentation is needed stating that it was officially determined your research does not require IRB review and oversight. If you believe your project does not constitute human subjects research, but you are required by policy or a publisher to obtain a determination, submitting the form attached below is appropriate.

Is it research?

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Some activities are typically outside the realm of research. Examples are operational activities (such as defined practice activities in public health and medicine) and internal management activities (such as quality improvement, quality assessment and program evaluation). However, some of these activities may indeed constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge.

Determining whether a project constitutes research under federal and institutional regulations can be a complex process that involves assessing the project intent, design, mandates, expected outcomes, and dissemination of results. For further information please read the Office of Human Research Protection’s Human Subject Regulations Decision Charts and scroll down to Chart 01.

The project is most likely research if the project includes a research question/hypothesis, an intent to publish, present or contribute to generalizable knowledge, or if the project would not be conducted in the same way - or at all - if there was no potential for publication or presentation. In this situation an Exempt or Expedited/Full Board application is required to be submitted to the IRB. 

Does it involve human subjects?

The Common Rule identifies human subjects as living individuals about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, OR  through identifiable private information. 

Although a seemingly straightforward question, whether or not an activity involves human subjects can actually be somewhat confusing, especially when using coded private information or specimens. For more clarity here are further definitions:

Intervention  includes both physical procedures by which information or biospecimens are gathered (e.g., 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example a medical record).

Individually Identifiable Private Information: private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information in order to obtain the information that constitutes research involving human subjects.

*Please complete the form available on the Mentor IRB App for official written determination from the IRB that your research does not require IRB review and oversight.*