Research Integrity and Assurance

Human subjects

Human subjects 

All ASU research projects involving humans as subjects must be reviewed and approved by ASU’s Institutional Review Board (IRB) prior to implementing studies, including recruitment and screening activities. The role of the IRB is to review all proposed research involving human subjects to ensure that subjects are treated ethically and that their rights and welfare are adequately protected.

All institutions engaged in human subjects research that is not exempt from 45CFR46, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections(OHRP)-approved assurance of compliance. The Federalwide Assurance (FWA) is the only type of assurance accepted and approved by OHRP. The Assurance is a formal declaration to HHS that it will comply with the requirements set forth in 45CFR46, as well as the terms of Assurance.

ASU FWA 00009102

What activities require IRB review?

IRB review is required if the study involves human subjects and meets the definition of research.

A human subject is defined as “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.” This definition can include online surveys, collection of data from Twitter, analysis of coursework, interviews, etc.

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

If you are unsure whether your project meets this definition and requires review, e-mail us with a brief description of the study and specific direction will be provided.

Special case: Research as part of coursework

Some student classroom projects may not be considered research (and might not require IRB review) if they meet all three of the following criteria:

  • procedures are low-risk or no-risk
  • the objective is to provide students with training about and experience with research methods
  • the data will not be used, published or otherwise disseminated outside of the classroom

For more information, review the Guidance: Classroom research

Special case: Collaborating with other universities or institutions

See Collaborating with other institutions: Affiliation agreements and review procedures

Special case: ASU as a study site

If ASU is serving as a study site and no ASU students, faculty, staff or employees will be members of the research team (or will be collaborating with the research team besides being subjects of the research), then formal review by the ASU IRB is not required. Email a copy of the study to us for informal review.

Submitting for review

Submit your application through ERA, ASU’s online submission system. See the Protocol Submission page for more information.

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