Guide to Human Subjects Research and IRB Review

Below is a brief overview of IRB policies and procedures; for complete information, see the Institutional Review Regarding Human Subjects Research page.

How do I know if my project requires Institutional Review Board (IRB) review?

IRB review is required whenever an investigator (whether professional or student) who is affiliated with the institution conducts research with human subjects, or when research involving human subjects is conducted on the Morningside or Lamont campuses. The latter requires consultation with the Columbia Human Research Protection Office (HRPO) to determine if a submission in Rascal is required.

IRB review and approval is required before research activities may begin.

How is research defined?

Research is defined in the federal regulations (at 45 CFR 46) as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

How is a human subject defined?

A human subject is defined in the federal regulations (at 45 CFR 46) as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

How does this relate to social science or humanities projects?

This means that social science, ethnographic, humanities projects, or any research project, regardless of the subject matter or department in which it originates, will require IRB review if the project meets the definitions of both research and human subjects provided above.

If you are conducting interviews, surveys, focus groups, or otherwise interacting with people and collecting data “about” them, you may need IRB review. This includes surveys or data collection conducted on the internet or on social media (e.g., SurveyMonkey, Mechanical Turk, Qualtrics, Facebook).

Secondary Data Analysis/Data Sets: If you are obtaining a dataset(s) that contains direct (e.g., name, address, birthdate, Social Security number, email address) or indirect (e.g., data that may be combined to readily identify an individual) identifiers, you need to obtain IRB approval before conducting the research.

What if my project is exempt?

The federal regulations define certain categories of research with human subjects that are exempt from the requirements of the federal regulations. However, CU policy requires CU IRB review and approval of exempt research. It is the CU IRB that makes the exempt determination.

Questions?

If you need guidance to determine whether or not you are conducting research involving human subjects, you may: 1) consult the information provided by the US Office of Human Research Protections (OHRP); 2) and/or you may contact the CU HRPO at (212) 851-7040 or email askirb [at] columbia.edu.

For more information, see the CU HRPO/IRB website.