Research studies must be reviewed and approved by the IRB before any study procedures begin, including recruitment or gathering of data if:
- you plan to conduct research, which is defined by DHHS 45 CFR 46 as being a “systematic investigation, including research development, testing and evaluation, that is designed to develop or contribute to generalizable knowledge”, and
- it involves human subjects who are defined 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; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
The IRB serves as a resource for faculty, staff and students for all research involving human subjects at the University of Massachusetts Lowell.
As a member of SMART IRB, UMass Lowell can use, track and document reliance arrangements on a study-by-study basis.
Detailed instructions on how to submit a research study to the IRB can be found in the Investigator’s Manual (pdf).
Additional help is always available at the IRB Office by phone at 978-934-4134 or email: IRB@uml.edu.
We look forward to assisting you!