The mission of the UMass Lowell (UML) Institutional Review Board (IRB) is to support high-quality Human Research by:

  • Safeguarding and promoting the health and welfare of human research participants by ensuring their rights, safety, and well-being are protected;
  • Educating our community about research and the rights and responsibilities of research participants;
  • Providing timely and high quality review and monitoring of human research studies.
Silhouette of man's head with words integrity, values, ethics, respect around it Image by Tryfonov

The UML IRB evaluates study protocols to confirm that risks are minimized, potential benefits are maximized, and participant consent is informed and voluntary. Its primary role is to ensure compliance with ethical principles outlined in the Health and Human Service (HHS) Belmont Report, as well as regulatory requirements like the HHS Common Rule and Food and Drug Administration (FDA) human subject guidelines. By providing oversight, the IRB fosters responsible research practices and builds public trust in the ethical conduct of human subjects research.

Research studies must be reviewed and approved by the IRB before any study procedures begin, including recruitment or gathering of data if the study meets both the definition of research and human subject:

Research is defined by:

  • HHS 45 CFR 46 as a “systematic investigation, including research development, testing and evaluation, that is designed to develop or contribute to generalizable knowledge”, OR
  • FDA 21 CFR 50 has defined "clinical investigation" to be synonymous with "research" which is defined as, "any experiment that involves a test article and one or more human subjects" (Example: Testing a device for safety or effectiveness, regardless of whether the findings will be used for a research or marketing permit would fall under FDA regulations.)

Human Subject is defined by:

  • HHS 45 CFR 46 as “a living individual about whom an investigator (whether professional or student) conducting research:
    • Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens;
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  • FDA 21 CFR 50 as "an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may either be a healthy individual or a patient."

Getting Started!

  1. Complete the Education Requirements for human subjects research found on the Collaborative Institutional Training Initiative (CITI) Program Information page.
  2. Use quick guides/videos to navigate the IRB Protocol Submission process and to find current IRB templates.
  3. If you are unsure if your study meets the regulatory definition of research, additional help is always available at the IRB Office by phone at 978-934-4134 or email: IRB@uml.edu.

IRB Meetings:

Submissions requiring review by the convened IRB are assigned after the pre-review process is complete and the submission is determined to be ready for full Committee Review.  Committee meetings are scheduled as needed.  Please be advised that the approval process for Committee reviewed studies are typically 2-3 months.


  • Federal Wide Assurance (FWA): 00000215
  • Expiration: 8/19/2029
  • IRB Registration: 00000821