The IRB is a committee of faculty from diverse backgrounds and community members who review research protocols involving human subject participants to ensure that the rights and welfare of the participants are protected, that they are not subject to unreasonable harm (physical and emotional), and that information about them is kept confidential.
According to 45 CFR 46.102(d) the definition of research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
You will need to complete an “Application for Initial Review” and the “Investigator Study Plan”. These forms can be found on the IRB forms webpage.
Once completed, please submit both forms and supporting documents by email to: IRB@uml.edu.
If your project meets the regulatory definition of research and involves interaction or intervention with a living individual or identifiable private information, it must be reviewed by the IRB.
It is advisable to submit your application for review to the IRB as soon as possible. Approval must be received before any research activities may begin (recruitment or data collection). For a full review, allow at least one month for approval.
Informed consent is a process by which an individual interested in participating in research learns about and understands the purpose, benefits and potential risks of participating in research. Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. Please review the consent form templates found on our Forms webpage.
You may contact either the IRB Compliance Manager at 978-934-4134 or internal extension: 4-4134 or the Director of Institutional Compliance at 978-934-3553 or internal extension 4-3553 for assistance.
Students cannot serve as PI. If a student, or other trainee is conducting research, the UML IRB requires that a Faculty Advisor be appointed as Principal Investigator to oversee the conduct of the research. As Faculty Advisor, this individual is expected to oversee and train the student investigator in matters of appropriate research compliance, protection of human subjects and proper conduct of research. The Faculty Advisor is also responsible to assure that the research is conducted in accordance with Institutional Policies and Procedures and the Investigator Manual (HRP-910). The IRB may, at its discretion, require a faculty member to function as PI, with a student, or other trainee functioning in a co-investigator role. This decision will be made on a case-by-case basis.
Yes. The IRB has the authority to disapprove, suspend, or terminate research that is not carried out according to its requirements or may be associated with unexpected serious harm to subjects. Any such action will include a statement of the IRB’s reasons for its action and may be reported promptly to the PI, the IO, and if applicable, the funding agency.
Yes, UMass Lowell institutional policy requires that all research with human subjects, regardless of funding, be reviewed and approved by the IRB.
If your project meets the regulatory definition of research and involves human subjects or obtaining private identifiable information about a human subject, yes, your project requires IRB review.
If there is any question, it is best to contact the Office of Institutional Compliance for guidance before the project is initiated.
PIs are responsible for reporting promptly to the IRB Compliance Manager and the Director of Institutional Compliance any serious or continuing noncompliance with federal regulations, university policies, injury to subjects, unanticipated problems, or changes in research activities. However, anyone who becomes aware of any serious or continuing noncompliance in the conduct of approved research should bring this to the attention of the IRB Compliance Manager and the Director of Institutional Compliance.
You should notify the Department Chair or the Director of Institutional Compliance. If you have any concerns or are uncertain about what constitutes a violation, contact the Director of Institutional Compliance at 978-934-3553 or internal extension 4-3553.
Yes. UMass Lowell is still responsible for the activities of its researchers and must comply with federal and university regulations and policies. It is important that the IRB be aware of where and by whom such activities are being conducted, even in another country.
The IRB/IEC form can be used to designate that an IRB from another institution will be responsible for oversight but the UMass Lowell IRB still needs to be notified of the activity and keep a copy of the form on file.
Yes. Any changes must be reviewed and approved by the IRB. In most cases, this can be done quickly through the expedited review process or by approval from an authorized IRB representative.
Yes, if, as described below, your clinical trial:
What Is the Definition of a Clinical Trial for Registration Purposes? Three similar definitions of a “clinical trial” are provided below. If your study meets any one of these definitions, the trial should be registered.
The FDA (Food and Drug Administration) requires registration for “applicable clinical trials” defined as follows:
The ICMJE (International Committee of Medical Journal Editors) definition of a clinical trial includes:
The NIH defines a clinical trial as:
Register a trial before any subjects are enrolled. The FDA requires you to register no later than 21 days after the first subject is enrolled; however, the International Conference of Medical Journal Editors (ICMJE) requires registration before the first subject is enrolled. To avoid publication restrictions imposed by the ICMJE, register your trial before enrolling the first subject. You may expect each registration to take approximately 1 to 2 hours.
Clinical trials are registered on ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS). As a PRS user you are responsible for ensuring that the information you provide on your trial is correct, complete, readily understood by the public, and updated in a timely manner.
IMPORTANT NOTE: You will receive a reminder e-mail notification from clinicaltrials.gov once every six months to update your study information.