Frequently Asked Questions
How long does it take for approval?
Investigators are responsible for allowing a minimum of 30 business days for the review process. (This means that you should apply at least 5 weeks before your anticipated start date.) Please carefully edit and proofread all application materials before submission to HSRP as incomplete and missing information will cause delays in the protocol application review process.
The NU IRB meets monthly to review protocols. Depending upon the nature of the research, some studies may be reviewed and approved independently by the Chair of the NU IRB. Other studies may require review by the full committee.
What is human subject research?
Title 45 Code of Federal Regulations Part 46.102(f) defines a "human subject" as a living individual about whom an investigator obtains:
- data through intervention or interaction with the individual, (such as, interviews, surveys, clinical testing, or any other physical intervention or personal interaction), or,
- identifiable private information.
(Private information includes information such as medical records, blood, urine, or tissue samples, diagnostic specimens, and DNA samples, even if you did not collect these materials.)
Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. Protections are required for research that uses:
- Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials.
- Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research.
- Private information, such as medical information that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals fall into this category.
What research requires review by the Northeastern University Institutional Review Board (NU IRB)?
All research involving human subjects, as described above, that is conducted by faculty, staff or students of Northeastern University, whether conducted on-campus or off-campus, requires review. Research that uses any NU property or non-public information to identify or contact prospective subjects must be reviewed and approved prior to recruiting participants or collecting data. Approval by NU is required in addition to approval from any other institution.
My research is not federally funded. Do the federal regulations governing research still apply to it?
Yes. Northeastern University has elected to apply the protections of the federal regulations (45 CFR 46) to all of our human subject research regardless of its source of support, or lack thereof.
Are you planning to assign a research project to be conducted by students, graduate or undergraduate, as part of a classroom assignment?
Arrangements can also be made with HSRP to have someone speak to students who will be conducting research about protection of human subjects in research and the submission and review process.
How do I get approval for my research?
Read the Policies and Procedures Concerning the Protection of Human Subjects and the application forms to understand your responsibilities as an investigator. Once you have submitted your application, a review will be conducted to ensure that your study has documented procedures in place, in accordance with federal guidelines, that provide adequate protection for each study subject.
I need my protocol approved right away. Can it be "expedited"?
Expedited doesn't necessarily mean "quick". Expedited review refers to a process of review for certain research that falls within categories established by federal regulations. If a protocol meets the specific qualifications for Expedited review, it will not require review by the full Human Subjects Research Review Committee. Instead, the proposed research may be reviewed and approved by the Chair of IRB. Please note that Expedited research still undergoes complete review and a minimum of four weeks is required. Investigators are responsible for allowing sufficient time for review.
May I begin recruitment of subjects while approval of my protocol is pending?
NO. Final approval by Northeastern University's Office of Human Subject Research Protection is necessary before any recruitment or enrollment procedures may begin.
May I make changes to the protocol after it has been approved?
Yes, BUT, prior to making any changes to the approved protocol and informed consent, you must obtain formal written approval from the NU IRB.
Modifications that require approval include, but are not limited to, changes in Principal Investigator (PI), inclusion/exclusion criteria for subjects, sites of study, recruitment strategy, consent and authorization process, informed consent document, questions on survey/interview/focus groups, testing procedures, confidentiality measures, or safeguards for participants. Conducting a study with unapproved procedures invalidates the approval status.
Please submit all requests for modifications to an approved protocol in writing to the NU IRB.
How long is the approval valid?
Federal regulations stipulate that approved research requires continuing NU IRB review at least once a year. It is the responsibility of the investigator to request renewed approval, allowing sufficient time for review. If the renewal process is not completed by the expiration date, the project loses approval and the study cannot continue.