Where to Begin

What is the Institutional Review Board (IRB) and what is its role?

The IRB is designated to protect the rights and welfare of human subjects participating in research conducted at or sponsored by an institution.

The Syracuse University (SU) IRB is comprised of 10 members from relevant and diverse academic backgrounds including two non-affiliated community members, one IRB chair and two IRB co-chairs.

SU receives federal funds and therefore is obligated to have a Federal Wide Agreement (FWA) with the government. As part of the FWA, SU pledges to follow the ethical principles outlined in the Belmont Report and the Federal Regulations 45 CFR 46-Part A (also known as the Common Rule) when reviewing research that involves human subjects.

The IRB at SU reviews all research studies involving human subjects for compliance with federal, state, and local laws as well as institutional policy whether they are funded and is responsible for reviewing, approving, requiring modifications, or withholding approval of research involving human subjects.

What requires IRB review? Do I need to submit?

The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human research.

How do we define Human Research?
In accordance with federal regulations, any research activity that meets the Department of Health and Human Services (DHHS) definition of both “research” and “human subjects” be reviewed by the IRB prior to initiation.

The definitions of research and human subject as defined by DHHS regulations:

Research: The revised Common Rule adds a provision that identifies four types of activities as not being “research” as defined in the Rule:

  • Certain scholarly and journalistic activities,
  • Certain public health surveillance activities,
  • Collection and analysis of information, specimens, or records, by or for a criminal justice agency for certain criminal justice or investigative purposes, and
  • Certain authorized operational activities for national security purposes.

45CFR46.102(I): Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject: The regulatory definition of human subject remains substantively the same but in the revised Common Rule “data” is replaced with “information or biospecimens” for clarity.

45CFR46.102(I): 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.

What do I do if I am unsure whether my proposed research constitutes ‘human research’ requiring IRB review?

Contact the Office of Research Integrity and Protections for guidance.

Training Requirements (Collaborative Institutional Training Initiative, CITI)

Learn more about CITI Training.