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Frequently Asked Questions

What is the IRB?

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.

What is research?

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.

How do I submit to the IRB?

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.

How do I know if I should submit a research protocol to the IRB?

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.

When should I submit my review request to 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.

What is informed consent?

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.

Who should I contact if I have questions about IRB review?

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.

Can a student serve as the Principal Investigator?

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.

Can the IRB stop me from conducting my research?

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.

My research with human subjects is not funded. Do I still have to submit an application to the IRB?

Yes, UMass Lowell institutional policy requires that all research with human subjects, regardless of funding, be reviewed and approved by the IRB.

Do student projects that are part of a class requirement have to be submitted to 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.

Who is responsible for reporting any problems that may occur during the conduct of approved human subject research activities?

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.

What should I do if I know of research that has violated ethics?

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.

Do I need IRB approval if my activities will be conducted someplace other than the UMass Lowell campus? Do I need IRB approval if my protocol is already approved by another IRB?

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.

If I make changes in my protocol, does the IRB have to review and approve it again?

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.

Do I need to register my research with Clinicaltrials.gov?

Yes, if, as described below, your clinical trial:

  • meets the definition of clinical trial and
  • you meet the requirements of the responsible person for registering the 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:

  • For any trials of drugs and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation.
  • For trials of biomedical devices: controlled trials with heath outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.

The ICMJE (International Committee of Medical Journal Editors) definition of a clinical trial includes:

  • Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

The NIH defines a clinical trial as:

  • A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions.
How do I register with clinicaltrials.gov?

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.

  1. Obtain an Individual User Account: Go to the ClinicalTrials.gov Protocol Registration System website to apply for an individual account. Question 6 asks if your organization is already registered with the PRS (Protocol Registration System). The answer to this question is “Yes”. The UMass Lowell PI is the responsible official for initial registration and for keeping the listing updated. You will receive an e-mail confirmation within two business days when the user account has been created.
  2. Login to PRS: Once your account has been created go to the ClinicalTrials.gov Registration webpage. Complete the three fields on the Login screen. See the example below:
    • Organization: UMass Lowell PI, Department/Division
    • Username: John Doe
    • Password: 1234
  3. Create a Protocol Record: A trial is registered in the system by creating a “protocol record.” Click on the Create link under Protocol Records on the Main Menu and fill in a series of data entry screens. Clicking on the various fields will allow you to access instructions for that field. If you still have questions, email: register@clinicaltrials.gov
    IMPORTANT NOTE: Using an electronic version of your protocol, you can copy and paste information into the requested data fields.
  4. Review the Protocol Record: After filing in the last data entry screen, the Edit Protocol screen will appear. Review the information for accuracy and completely and address any ERRORS, ALERTS, WARNINGS, or NOTES in the protocol record. If you fail to do so, you cannot complete the registration process.
  5. Mark the Protocol Record as Complete: If you fail to mark your record as complete, it will not be approved and released for publication and your trial will not be properly registered.
  6. Keep your Protocol Record Up-To-Date: An affirmative verification or update of the data in the protocol records that have not been closed or terminated is required every six months.
    Failing to login to the PRS and confirm or update your record(s) every six months, regardless of whether there has been a change to the trial or not, may result in a loss of funding and/or the inability to publish the results of a trial in an ICMJE associated journal.

IMPORTANT NOTE: You will receive a reminder e-mail notification from clinicaltrials.gov once every six months to update your study information.