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Non-Human Subjects Research

IRB Forms

Some projects that are commonly called research are not defined as human subjects research by federal definition and do not require IRB approval.  It can be challenging to determine what constitutes human subjects research. Unfortunately there is no definitive list.  The definitions are intentionally broad to capture a wide range of research needs from the biomedical to social and behavioral.   You will need to look at 2 federal definitions:  Research and Human Subjects.

If you believe your project is does not meet one or both of these definitions you may submit a non-human subjects determination form to the IRB.

Is my project Research?

DHHS Definitions:

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

A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Examples of systematic investigations include:

  • surveys and questionnaires
  • interviews
  • focus groups
  • photovoice studies
  • analyses of existing data or biological specimens
  • epidemiological studies
  • evaluations of social or educational programs
  • cognitive and perceptual experiments
  • evaluation of business process effectiveness
  • medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (like a class assignment).

Research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

Examples of activities that typically are not generalizable include:

  • biographies
  • oral histories that are designed solely to create a record of specific historical events
  • service or course evaluations used only for the purpose of improving the service by the collector without presentation of application to outside entities.
  • classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
  • quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the GS community.
Is my research Human Subjects Research?

DHHS definitions:

human subject is as a living individual or a biospecimen about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

  • Intervention includes both physical procedures by which data are gathered (e.g., blood draw) 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 or opinion poll).

Is GS engaged in the Research?

Investigators conducting human subjects research must satisfy DHHS (OHRP) regulations [45 CFR Part 46] known as the Common Rule and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.  Find a comparison of FDA and DHHS regulations here

Form Name Additional Form Information
Non-human subjects determination formNEW Use the form for assistance in determining if your project meets the definition of human subjects research.  To minimize time and effort in review, please read the definitions on the first tab before completing this form.
These Items may apply to your project – even if the determination is non-human subjects
Georgia Southern Survey Policy Georgia Southern’s Policy on the distribution of surveys to faculty, staff, and students. – Not limited to Human Subjects Research

Sample Letter of Cooperation (LOC)

Not a required format – full content required.

If subjects are students or employees of another institution, include a written letter of cooperation from the subjects. This may be a letter or email from the institutional official’s professional address with the institutional officer and title identified in the email body. All letters of cooperation must clearly identify the investigator and project by title. (See the FAQ for additional information.)  Note: If using education data obtained from school records you must include documentation of parental permission for the release of such data under the Family Educational Privacy Act (FERPA). This may be a copy of the release form, informed consent, or an assurance from the institutional official that such permission has been obtained prior to data release.
CITI Human Subjects Training  CITI Program training provides social/behavioral content training. Online certificate will be provided to you once the course is completed. Attach certificate or transcript to each protocol submitted. Certificates are not maintained by the IRB.  Training certificates from previous submissions are not readily available.  Click here for instructions. REQUIRED EACH TIME YOU APPLY.
Non-human subjects research self determinations

Print the self determination you are claiming to maintain with your project records until data is destroyed.  Use the HS number for the self determination you are claiming in recruiting information.

  Standard Determination-NEW Scenario
Non-human subjects research

Self Determination HS1001 – Literature Review

– does not constitute human subjects research or require IRB review

Research that only collects data from published books, journals, or public facing websites that do not require a password or a data use agreement or other permission to access and where the posters have the authority to legally post the information.
Non-human subjects research –

Self Determination HS1002 – Oral History

– does not constitute human subjects research or require IRB review

“Oral history interviews seek an in-depth account of personal experience and reflection, with sufficient time allowed for the narrators to give their story the fullness they desire. The content of oral history interviews is grounded in reflections on the past as opposed to commentary on purely contemporary events.” (Oral History Association – 2018)

To claim the oral history self-determination, the interview must allow the subject (narrator) to tell their story without analysis, manipulation or content editing and be collected with fully informed consent to include consent for archiving, presentation or publication of the collected story.  Oral history projects must adhere to the principles and best practices established by the Oral History Association.

Oral History Association Principles and Best Practice,

Non-human subjects research –

Self Determination HS1003 – Publicly Available Data Sets Cleared as Nonhuman Subjects Research

– does not constitute human subjects research or require IRB review

Generally researchers should submit a non-human subjects determination form or Exempt 4 IRB application for use of secondary data, however the listed data sets do not contain identifiable private information and have been granted a standing non-human subjects determination provided that the researcher does not merge any of the data sets in such a way that individuals might be identified or enhance the publicly available data set with restricted, identifiable or potentially identifiable data.

Restricted data sets will require individual IRB determination or exemption and a data security plan.

Data Site Data Set
American Hospital Association AHA Annual Survey Database
Center for Disease Control (CDC)
  • Behavioral Risk Factor Surveillance System  (BRFSS) Public Data Only
National Center for Health Statistics
  • NHANES: National Health and Nutrition Examination Survey
  • Vital Statistics: National Vital Statistics System
Non-human subjects research –

Self Determination HS1004 – Market Research

– does not constitute human subjects research or require IRB review

Gathering information about customer or client needs and preferences for the purpose of improving the service provided.  This information is not generalizable beyond the market.

This self determination also applies to data gathered for the  purposes of accreditation documentation.

Last updated: 3/5/2020