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Human Subjects: IRB

Welcome to UMass Lowell Institutional Review Board

SMART IRB Participating Institution Badge

As a member of SMART IRB, UMass Lowell can use, track and document reliance arrangements on a study-by-study basis.

If you plan to conduct research involving human subjects, the research study must be reviewed and approved by the UMass Lowell Institutional Review Board before the study begins. The UMass Lowell IRB serves as IRB of record for all human research conducted by UMass faculty, staff and students.

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 at 978-934-4134 or email: IRB@UML.edu. We look forward to assisting you!

Federalwide Assurance Information

Important Announcement

Starting January 21, 2019, the research community which involves human subjects will need to comply with the full set of Common Rule (45 CFR 46) changes. These changes are specific to research involving human subjects. The IRB has been working on new SOP’s, worksheets, checklists and other documents that will assist in keeping UMass Lowell compliant while also streamlining some processes. As a result, the IRB forms currently used are also undergoing changes.

The new forms will be available on January 21, 2019. The IRB will continue to accept the old forms for a period of 3 months during the transition period. Therefore, if you are already working on a submission, you may submit on the current forms. We will also update the FAQ section of the IRB website to address any questions you may have regarding which forms to use and how to submit. However, we encourage you to contact Michael Centola, email: Michael_Centola@uml.edu (Director of Institutional Compliance), or Emily Sousa, email: Emily_Sousa@uml.edu (IRB Manager) or stop by the IRB office if you need any assistance, or would like to provide any input.

We thank you in advance for your patience and understanding during this transition.

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Frequently Asked Questions:

How does this change affect me?

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (45 CFR 46 aka the Common Rule). These changes take effect on January 21, 2019 and are specific to research involving human subjects. The changes to the regulations allow more flexibility and are designed to lessen the administrative burden on researchers. We have made subsequent changes to our IRB forms and our internal processes to increase efficiencies while aligning with the changes to the revised regulations. The impact to investigators should be minimal and positive.

What is different in the new forms?

The new forms streamline the process. All new research projects will have one submission process. The investigators provide a detailed description of the project, and the IRB will provide a regulatory determination of the project. This means that the IRB and not investigators will determine whether the research is exempt, expedited or in need of a full review. As such, there will be one set of forms and one process for all new research regardless of which category the research falls under. Also, there are now four basic form fillable documents for the four basic submission types. These forms are designed to capture the required information while being more user friendly.

I have already submitted a protocol using the old form. What happens now?

Nothing. If you have already submitted a protocol using the old forms, we will review it as is. We will ask that going forward you use the new forms.

I have started writing a protocol with the old form. Should I start over?

No. One goal of the new forms and processes is to be more user friendly and accommodating. The IRB will continue to accept the current forms for three months after January 21, 2019.

How will the IRB decide level of risk? How will I know what documentation to provide?

The IRB has also developed multiple worksheets and checklists that are derived from the regulations and best practices. These documents will serve as a guide to the IRB to review all research that requires IRB approval. The forms indicate the necessary information to provide with each submission. If you are unsure, you can always call the IRB office at 978-934-4134, and we would be happy to guide you.

Federalwide Assurance

FWA#: 00000215
Expiration Date: November 7, 2023
IORG#: 0000499
IRB Registration #: 00000821