Do You Need IRB Review... and Why?


Why do IRBs exist?

Simply stated, egregious human experimentation such as that conducted by Nazis during World War II and during the Tuskegee Syphilis Study resulted in the creation of regulatory and ethical safeguards designed to protect the rights and dignity of participants in clinical trials and research studies. IRBs were the ultimate result and are in place to ensure research is conducted ethically and in accordance with various sets of regulations.

Where do regulations around human subjects research come from?

At the highest level, they are governed by the United States Department of Health & Human Services' Office of Human Research Protections (OHRP) at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56. The Belmont Report sets forth guidelines to be followed by researchers, based on three fundamental ethical principles:

  1. Respect for persons: Protect autonomy, ensure respect, and allow for informed consent without deception.
  2. Beneficence: "Do no harm" while maximizing research benefits and minimizing participant risks.
  3. Justice: Ensure reasonable, non-exploitative, and well-considered procedures involve the fair and equal distribution of costs and benefits to potential research participants.

Researchers must also be aware of and adhere to any applicable state, local, and institutional regulations.

FDA regulations differ from OHRP. Please see Is Your Research FDA Regulated? for further guidance.


OHRP has specific definitions of "Research" and "Human Subject" provided below

If your project meets both definitions, you are conducting "Regulated Research" and IRB review is needed.

How Do the Federal Regulations Define Research?

“A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”

A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.


How do the Federal Regulations Define Human Subject?



With these definitions in mind, there are several possible next steps.  See below to learn more about your study.



If your study:

Does not meet the regulatory definition of research. IRB review is not required.
Meets the regulatory definition of research, but does not involve human subjects. IRB review is not required.
Meets regulatory definitions of both research and human subjects (a.k.a. "regulated research"). IRB review IS required. Research may not begin without approval.
Is a collaborative study with another institution (including HMS, HSPH, HSDM). A reliance agreement may be possible. See "Single IRB?" tab.
Requires a Not Human Research determination for funding or other purposes. An abbreviated submission is required. See "Before You Begin to Prepare" tab.
Lacks definite plans to involve humans, but an IRB determination is needed for funding or other purposes An abbreviated submission is required. See "Before You Begin to Prepare" tab.


What if you are not sure? The IRB office would be more than willing to help you determine whether your activity requires IRB review or not.

Find your IRB contact person!!

If You Are An UNDERGRADUATE Researcher

All undergraduate research starts with the Undergraduate Research Training Program