Research & Economic Development

Office of the Vice Chancellor

If you are looking for how to submit an application for a Human Subjects Research Determination - Applications for Human Subjects Research Determinations are made through the eCompliance system.
  1. Log in
  2. Under All Modules
  3. Click on Institutional Review Board
  4. Under Submission to IRB
    1. Click on IRB Forms
  5. Click on Human subjects research determination


Activities that do not constitute "Research"

The Research Compliance Office and Institutional Review Board (IRB) are responsible for oversight of all research activities involving human subjects. Under the federal Common Rule, “research”, "means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

In addition, the FDA has separate definitions for what constitutes research and therefore, if your project includes use of a drug, device or biologic, it may be subject to FDA regulations and require IRB review.

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

If you believe your project does not constitute human subjects research, but are required by policy or a publisher to obtain a determination, this application type is appropriate. If the project includes a research question/hypothesis, an intent to publish, present or contribute to generalizable knowledge, or the project would not be conducted in the same way or at all if there was no potential for publication/presentation, the project is most likely considered research and another application type required.

2018 Common Rule Regulations - Activities determined to NOT be research.

Activities that do not constitute "Human Subjects"

Some projects may be "research" but do not involve human subjects as defined by the Common Rule.

A Human Subject "means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(2)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.

(3)Interaction includes communication or interpersonal contact between investigator and subject.

(4)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 (e.g.,a medical record).

(5)Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

(6)An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen."

It is the institutions role is to oversee "research" involving "human subjects". As a result, studies that do not involve human subjects do not require oversight. Some examples of this type of research are straightforward and easy to determine, e.g. analyzing de-identified tissue samples obtained from a commercial source, or analyzing data from deceased individuals. However, it is often difficult to determine whether a study involves human subjects or not. For assistance with this, please see the NIH decision tree.

If you are required by policy, a funding agency, or a publisher to obtain an Institutional determination, please submit an application for this type of research.

Please contact the IRB Office with questions about whether your project involves human subjects and subsequently requires IRB review at or 816 235-5927.