Human Subjects

Contents

  1. Working with Data from Human Subjects
  2. Are you conducting a study with human subjects data?

Working with Data from Human Subjects

If you’re working with data from human subjects, there are specific, additional considerations that you’ll need to take into account at all stages of research. Princeton’s primary resource for information related to working with human subjects is the website for human subjects research provided by the Office for Research Integrity and Assurance (RIA):

https://ria.princeton.edu/human-research/policies-and-guidelines

Princeton has a number of policies in place that govern the use of human subjects in research and if you work with human subjects it’s important that you know these policies. 

The federal regulations that govern human subjects research were revised effective January 2019. Please see https://ria.princeton.edu/human-research/the-final-rule for more information about these changes. 

Are you conducting a study with human subjects data?

A human subject means a living individual about whom an investigator (whether professional or student) who is 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.

NB! If your proposed study involves a drug, device, or biologic, other regulations and definitions may apply. 

Not sure if you’re planning a project that will have data that are classified as human subjects data? You can email a synopsis of the proposed activity (2-3 paragraphs) to the IRB at IRB@princeton.edu that includes the following information:

  • Study funding
  • Purpose
  • Study procedures
  • Any draft study measurements (survey, questionnaire, and interview guide)