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.
Title 45 Code of Federal Regulations Part 46.102(e)(1) defines a “human subject” 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.
(Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes)
(Interaction includes communication or interpersonal contact between investigator and subject.)
(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.
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.
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.
Professors who assign a research project to be conducted by students within the time frame of an academic course should consult the Policy for Classroom Research Involving Faculty and Students and contact HSRP to discuss the project and obtain guidelines for review and approval of such research. This process should be initiated prior to the start of the course.
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.
Read the Policies and Procedures Concerning the Protection of Human Subjects and the Assurance and 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.
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.
NO. Final approval by Northeastern University’s Office of Human Subject Research Protection is necessary before any recruitment or enrollment procedures may begin.
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.
Federal regulations (45 CFR 46.109(e)) mandate that Full Board research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.
Some Expedited Category research studies approved on or after January 21, 2019 may no longer be required to undergo continuing review and have their approval renewed on an annual basis (45 CFR 46.109(f)(1)(i)). At the time of initial Expedited approval, researchers will be informed about whether or not a determination for continuing review has been made. The NU IRB will make the final determination on the need for ongoing Continuing Review for all expedited category studies.
All Exempt Category research studies qualify for exemption from further institutional review.
Projects determined to require continuing review that do not receive written notice of renewed approval from the Office of Human Subject Research Protection may not continue past the expiration date.
Even when continuing review is not required, investigators remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.
Please note that research studies approved via expedited review and governed by the Pre-2018 Rule (prior to January 21, 2019) that are open to enrollment or closed to enrollment with either active or long-term follow-up ongoing still require continuing review.