IRB Submissions & Protocols

Research using Human Subjects requires oversight by the Institutional Review Board (IRB). Federal guidelines govern NJIT IRB protocols, membership and required training.  

As of July 2020, all submissions to the IRB are required via the IRB Streamlyne module.
Institutional Review Board

Human Subject Research

Process for Human Subject Research Approval

Please review this page to find important information to begin work with Human Subjects. Access to required training, guidance on the process, renewals and necessary forms can be found below.

Required Training

All NJIT researchers (faculty, students, post-docs, research associates, staff and external collaborators) are required to be in compliance with NJIT and federal requirements with respect to responsible conduct of research that emphasizes conflicts of interest, professional ethics, collegial and behavioral obligations to serve as a foundation of our professional academic research workplace. 

Required training for work on human subjects is accessible through our CITI Training Program.

A minimum of two courses are required to conduct research involving human subjects.

  • Responsible Conduct of Research (RCR) (all NJIT researchers are required to complete)
  • Human Subject Research (HSR): Biomedical Research OR Social & Behavioral (choose training relevant to research)

Certificates of completion and/or documentation that prior training is still current and valid are required prior to commencement of any work. The IRB will suspend any protocols for which study personnel's training is missing or expired.

Working with the NJIT IRB

IMPORTANT: The process for getting human subjects research approved by the NJIT IRB now requires all submission to IRB to be via the new Streamlyne IRB module.

IRB Applications & Approvals

  • IRB Meetings take place weekly on Tuesdays from 11:30-1:30pm in Fenster Room 398 or via Webex. All in person meetings subject to current NJIT regulations in effect at the time of the meeting.
  • All applications and requests for renewals are required to be submitted via the new IRB Streamlyne module at least 10 business days ahead of the posted IRB meeting date. 
  • Investigators (faculty, staff, or students with a faculty sponsor) must submit a formal application to the IRB in advance of carrying out ANY research involving human subjects.
  • A complete application includes verification of all required training. 
  • PI Designation: Applications involving students must list the faculty advisor as the PI. When the application refers specifically to the student’s Ph.D. dissertation research, Ph.D. candidates may be listed as Co-Investigators with the faculty advisor.
  • PIs are responsible for the protocol and the research carried out during the approval period as well as for a formal closeout of the project.
  • A protocol application must be submitted via Streamlyne. PDF applications will no longer be accepted for applications or renewals.
  • Model Consent Forms: An informed consent form (required) can be downloaded in the Forms section below.
  • Following IRB approval, research may begin. The approved research may proceed for one year and if necessary, may be renewed in the 11th month by submitting a Renewal via Streamlyne.  Written notification must be submitted to the IRB as soon as possible when approved research has been completed.

"Pending Status" for Research Proposals

  • Funding agencies often require research plans to be submitted for IRB approval prior to the proposal submission date and to state the “pending approval” in the proposal.
  • In these cases, researchers must secure a “pending status” before the proposal submission.
  • The IRB has no legal authority to, and will not, date a research plan submission prior to the actual submission date to the IRB.

Full IRB Committee or Expedited IRB Review

The determination of whether a project is to be reviewed by the expedited process or the full IRB Committee process is a decision of the IRB, not the investigator.  If you are uncertain whether a study requires IRB review, please contact the IRB Chairperson to discuss it.

  • Complex projects and those that may involve greater than minimal risk are reviewed by the full IRB Committee in their regular monthly meetings. Projects involving no more than minimal risk to subjects (as defined by the Federal Regulations) may be reviewed through expedited review.
  • Expedited review is conducted by one or more IRB members designated by the Chair, and is not necessarily faster than a review by the full IRB Committee. Expedited review can result in the approval, but not the rejection of an application.

Continuing Review or Renewals 

All applications and forms for IRB review are due in Streamlyne a minimum of 10 business days before the upcoming IRB meeting. 

As mandated by federal law, researchers must secure the IRB approval for all human subjects related scientific studies. Research plans must be subject to continuing review (“renewal”) no less than once per year (“expiration date”). Use Streamlyne to process the renewal application.

Renewal Process and Timing

  • Researchers are responsible for applying for renewal status at least 10 business days in advance of the last IRB meeting before the expiration date (published in the IRB website) so as to allow the IRB to review and approve the renewal before the expiration date.
  • If a research plan’s approval expires before the IRB completes its review, the researcher must stop all research procedures.
  • The IRB has no legal authority to, and will not, retroactively approve any research plan.
  • When stopping the research could place human subjects at risk, the researcher should contact the IRB immediately to obtain approval to continue treating subjects on that study.

Non-Research Activities Involving Human Subjects

  • Activities that involve human subjects, which are not research activities as defined by the Code of Federal Regulations are not subject to IRB scrutiny (the IRB has no jurisdiction over them). Therefore, they require no review by the IRB.
  • Note that this is different from an exemption, which, under certain circumstances, applies to research activities involving human subjects.
  • The definition of research given in the Code of Federal Regulations is 

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes."

Proposals involving an educational component often require the assessment of the proposed activities, and they do not meet the definition of research (in much the same way as the course evaluations are routinely carried out every semester are not considered research). If this is the case, the educational plan does not require IRB review. If at any point in time, the PI decides to change the project description in this regard in any way that transforms the proposed activities into research, then the PI should contact the IRB and apply for IRB approval.


Forms 

All applications and forms for IRB review are due a minimum of 10 business days before the upcoming IRB meeting. 

 

Contact the IRB

Questions or concerns can be addressed to the IRB at irb@njit.edu.

Completed forms should be submitted to:

Office of Research
Phone: 973-596-5275
Email: irb@njit.edu

Streamlyne for IRB

Streamlyne For IRBCallout Link