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NJIT Implementation of Recent Executive Orders

Institutional Response on the Implementation of Recent Federal Executive Orders with Updates on Federally Funded Research Grants and Contracts

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  • Home
Research
In This Section
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  • Office of the Senior Vice Provost for Research
    • About - Senior Vice Provost for Research
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    • Commercialization service enhancements at NJIT
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  • Research FAQs
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    • Institutional Review Board (IRB) FAQs
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Start-ups or Working for a Licensee by Faculty or Staff
 

I want to start a company with my invention, what do I do?

We are to help you start your entrepreneurial journey! The Intellectual Property and Technology Licensing Office can connect you with a wealth of resources for inventors looking for help starting a company.

NJIT can provide NJIT inventors assistance with all facets of the startup process – from writing a business plan, to meeting like-minded entrepreneurs and investors, to attracting board members, to securing funding to demonstrate an invention's commercial viability. We even have our own business incubator where you can rent a desk, private office or dry or wet lab, see VentureLink for more information.

If I want to consult with a licensee, what do I do?

Please note that we do not negotiate or review consulting agreements on behalf of inventors. If a potential licensee is interested in having an inventor consult with the company, negotiations would be directly between the inventor(s) and the company.

If an inventor is planning to remain at NJIT while consulting with a company, the inventor should familiarize themselves with the policies of NJIT and their school relevant to consulting activities. The inventor is expected to ensure that the terms of the consulting arrangement are consistent with University policies, including those related to IP ownership and employment responsibilities.

Visit the University Policies site for the different policies for faculty, staff and students. Faculty should also refer to the requirements for faculty consulting activities and agreements at the Office of Ethics website ethics@njit.edu.

How does NJIT’s Supplemental Code of Ethics apply to me?

As State employees, NJIT faculty are bound by the State of New Jersey’s Conflicts of Interest Law which imposes standards for public employees’ conduct in order to preserve confidence in public institutions and their employees.

NJIT developed its Supplemental Code of Ethics to provide clear guidance to employees working in a scholarly capacity on consulting, development of commercial enterprises and other outside professional activities, in accordance with State ethics regulations. These activities provide an important means of continuing education for the faculty and grant experience in aspects of their professional fields outside the context of NJIT itself. These activities can also provide a mechanism for the transfer of knowledge from the University to the public good.

NJIT's Supplemental Code of Ethics guides employees on balancing their primary professional responsibility to NJIT against potentially conflicting outside activities and concerns. The parameters set forth in NJIT’s Supplemental Code of Ethics are intended to strike a fair balance between the University faculty’s professional responsibility to NJIT and outside activities, serve to safeguard the interests of both parties, and comply with State ethics regulations.

As such, employees are required to disclose outside activities for ethics review and approval on a regular basis in accordance with State ethics regulations. As part of the ethics review, the university’s Ethics Liaison Officer will assist faculty in determining and managing any potential conflicts of interest.

Any questions on NJIT’s policy and/or the State ethics regulations may be directed to ethics@njit.edu.

Submitted by damm on Fri, 05/03/2019 - 11:01
  • Read more about We're committed to continuously enhance research and innovation

 

 

The Office of Research provides institutional support and services, as well as fosters new opportunities to enhance NJIT research and scholarship enterprise engaging faculty, staff, students, external collaborators and partners for developing strong leadership and synergy. We are committed to providing interdisciplinary research and scholarship with the utmost professional integrity. 

Foundation Board of Directors Excellence in Research Prize and Medal

The Excellence in Research Prize and Medal is awarded in recognition of a sustained record of contributions that have enhanced the reputation of NJIT.

The NJIT Foundation Board of Directors is proud to award Bharat Biswal, distinguished professor of biomedical engineering.

 

Previous Prize and Medal Recipients

Highest

NJIT Earns Highest Research Rating (R1)

Source: Carnegie Classification

$167M

total research expenditures in FY2023

Through our many funding opportunities, we're enhancing NJIT's research enterprise.

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NJIT Research: Linking Laboratories to Lives

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NJIT Research Magazine

An overview of our growing materials science and engineering cluster, where engineers, physicists, mathematicians and chemists collaborate on projects that blur the borders of all of these disciplines.

Read the magazine   |   View our research publications   |   Research News

Research is an integral part of a strong academic experience and a critical priority in NJIT’s 2025 Strategic Plan. The university aims for national and international prominence in research through new discoveries in areas ranging from medical sensors and devices to robotics, to nanotechnology, to cybersecurity, to next-generation materials, among other topics of vital importance in basic, applied and translational research. 

Our research enterprise is comprised of core and transdisciplinary basic, applied and translational research interests through five research clusters:

Bioscience and Bioengineering

Bioscience and Bioengineering

Learn More

Data Science and Management

Data Science and Management

Learn More

Environment and Sustainability

Environment and Sustainability

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Innovation and Entrepreneurship

Innovation and Entrepreneurship

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Material Science and Engineering

Material Science and Engineering

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Robotics and Machine Intelligence

Robotics and Machine Intelligence

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National Academy of Inventors Chapter at NJIT

National Academy of Inventors Chapter at NJIT celebrates the outstanding innovation and invention contributions of faculty, staff, and students. To quote NAI President Dr. Paul Sanberg, “NAI is proud to have NJIT, a true innovation powerhouse, as part of our membership. [NJIT has] created an environment where research and innovation flourish in such diverse fields as bioengineering, chemistry, medicine, computer science, and much more.” As a Member Institution of the NAI, NJIT has the exclusive opportunity to recognize active researchers and faculty with success in patents, licensing and commercialization at the national level through the Fellows and Senior Members Program.

Research with NJIT

Research with NJIT is a collaborative effort by the New Jersey Economic Development Authority (NJEDA) and the Office of the Secretary of Higher Education (OSHE) to forge stronger connections between New Jersey’s research universities and industry.

What Our Students Say

We provide exceptional academic, research and innovation experience to students at all levels.

Learn More
Dylan  Renaud

Department of Physics provided me with skills and resources to perform and present research in four different countries.

Dylan Renaud
Class of 2018

Jason Ogbebor

Jason Ogbebor
Class of 2023

Mehnaz  Mursalat

I’m working on microfluidic biosensors for cancer detection. We hope this technology will replace invasive biopsies.

Mehnaz Mursalat
Class of 2020

All IRB submissions are required to be submitted via Streamlyne.

Purpose

Under a Federal wide Assurance with the United States Department of Health and Human Services, all research involving human subjects performed by NJIT faculty, staff, and students either on-campus or off-campus, including at other institutions, must be reviewed and approved prior to initiation by the NJIT Institutional Review Board (IRB). 

According to the United States Department of Health and Human Services:

  • Research is defined as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to new knowledge.
  • Human Subjects are living individuals about whom an investigator conducting research obtains (1) data from an intervention or interaction with the individual, or (2) identifiable information.

Required Training for Human Subject Research

To access required training, forms and IRB protocols for getting necessary approvals, click here.

Approval Timelines 

IRB submissions are required to be completed via the  IRB Streamlyne module**.  IRB Streamlyne submission training materials and other support are available here.

Submissions must be loaded into Streamlyne IRB module at least 10 business days before the posted meeting date to ensure enough time for accurate review.

**Due to the new submission process via Streamlyne, please be sure to leave enough time to work in Streamlyne and submit on time. If it is received after the deadline posted for the next meeting, it will be pushed out to be reviewed at the following month's meeting.

IRB Membership

The Institutional Review Board reports to the Senior Vice Provost for Research.  Members of the Institutional Review Board are:

  • Eric Hetherington, PhD, Office of Research, Co-Chair
  • Eugene Deess, PhD, Institutional Research
  • Britt Holbrook, PhD, Department of Humanities, Co-Chair
  • Xiaobo Li, PhD, Department of Biomedical Engineering
  • Lori York, Essex County College
  • Brian Tierney, University Counsel 
  • Raju Tamot, PhD, Office of Research
  • Donghee Yvette Wohn, PhD (Informatics)
  • Saikat Pal, PhD, Department of Biomedical Engineering
  • Atam Dhawan, PhD, Senior Vice Provost for Research (Resource)

IRB Meeting Schedule  - Meetings will be held on the second Tuesday of every month in 425 Fenster Hall 4th floor from 11:30 am -1:30 pm.

**All submissions are due in Streamlyne two weeks in advance of the next meeting to guarantee review.

Additional Resources

  • Revised Common Rule for Biomedical and Behavioral Research Involving Human Subjects
  • Class-based Assignment/Activities Involving Human Subjects 

Grants Opportunities Databases

Many grant opportunities can be found on the following sites. These are some of the major sites that we currently deal with. If you find or have others just give us the appropriate links in an e-mail and we will assist you as required.

  • Federal Business Opportunities
  • Grants.gov
  • National Science Foundation (NSF)
  • NSPIRES - NASA
  • National Institute of Health
  • National Center for Transportation and Industrial Productivity
  • Office of Science - US Department of Energy
  • US Air Force Office of Scientific Research
  • US Department of Education
  • US Department of the Army
  • US Environmental Protection Agency
  • EPA Brownfields Program

The IBC is a Federally-mandated review body established under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. The scope of biohazards overseen by the IBC is defined by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL).

All research activities and protocols dealing with live cells, tissues, genetically engineered organisms, gene therapy, and any laboratory- or greenhouse-contained experiments must be reported to the IBC for review and approval. 

The IBC meets on the third Monday of every other month. Materials are required to be submitted at least 10 business days before the meeting to allow enough time for accurate review.

The IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (such as human bodily fluids, cell lines, infectious agents) and other potentially hazardous agents (such as Select Agents and carcinogens).

Please submit an NJIT IBC Application Form with full disclosure if you are using any recombinant DNA, hazardous biological agents (infectious or potentially infectious), select agents/toxins, the use of hazardous chemicals used in research with invertebrate or vertebrate animals, and the use of nanomaterials with the above categories.

Which Form(s) to Submit

The IBC Registration Document for Biohazards must be submitted for all projects involving potential biohazards. Please include a biosketch (use the template provided but NIH format is also acceptable). Additionally, the IBC Laboratory Hazard Assessment Form must be submitted for all lab work.

Registration Document for Biohazards.

Instructions for completing the IBC Registration Document for Biohazards

All applicants are required to complete the following sections:

  • Principal Investigator Information
  • Location of Study
  • Section A: General Administrative Information
  • Section B: Material Use Checklist
  • Section H: Transport
  • Section I: Dual Use Research of Concern
  • Section J: Protocol Specific Laboratory Safety


In addition to the sections above, please complete the appropriate protocol-specific sections that pertain to the proposed research activities:

  • Section C: Exempt Recombinant DNA Experiments
  • Section D: Non-Exempt Recombinant DNA Experiments
  • Section E: Research with Potentially Infectious Biological Agents
  • Section F: Human and Non-human Primate Blood, Body Fluids, Cell Lines, and Tissue Explants
  • Section G: Toxins of Biological Origin

Registration document can be found here

For technical questions concerning the completion of the form, please contact: Michael Swan, Director, Environmental, Health & Safety  (973-596-5736, michael.swan@njit.edu).  Completed forms should be submitted to the IBC mailbox: IBC@NJIT.edu

For compliance questions, please contact: Raju Tamot, Director, Research Compliance and Services (973-596-5462, raju.k.tamot@njit.edu).

What Needs to be Reviewed by the IBC?

Federal regulations require all faculty members/principal investigators (PIs) to file a protocol when using recombinant DNA molecules or organisms. The use of any potentially hazardous material must also be reported to the NJIT Safety Officer. All research activities dealing with any recombinant DNA molecules, organisms and hazardous materials, regardless of the source of funding, must be reviewed by the IBC.


Recombinant DNA

All researchers using recombinant DNA molecules or organisms must file a protocol, although certain types of experiments will qualify as "Exempt from Full Committee Review". If you work with recombinant DNA, (see Section I-B of the NIH Guidelines: Definition of Recombinant DNA Molecules), a component of the protocol form will require you to identify the sections and appendices of the NIH Guidelines appropriate for your experiments. 

Biohazards  

Any live cell, tissue or biomaterial may impose a biohazard. A biohazard is a potentially dangerous infectious or toxic agent or material (such as tissue, blood or toxin) or a substance whose hazard status is unknown. Human or non-human primate-derived cell lines are considered biohazards (per OSHA definition). Infectious organisms include all agents (including prions) capable of causing disease in healthy humans or animals, whether these occur commonly in the environment or not.

The BMBL 5th Edition Manual should be used in completing the Biohazards Protocol section. Researchers or instructors working with human material, e.g. human blood, bodily fluids, unfixed human tissue, organs and established human cell lines must reported to the NJIT Safety Officer. All individuals dealing with such materials must complete Blood-Borne Pathogens (BBP) training annually (OSHA requirement) and be offered a Hepatitis B vaccination. If the Hepatitis B vaccination is declined, a waiver must be signed. Regardless of the source, any research involving human or non-human primate tissue or bodily fluids requires IBC approval.

Chemical Hazards and Select Agents

All projects using chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic or explosive on its SDS must be reported to the NJIT Safety Officer and require IBC approval. All students and research personnel dealing with such material must complete the NJIT Biosafety Training Protocol and be certified before working on the project.

Select Agents are biological substances or toxins regulated by the Department of Health and Human Services or the US Department of Agriculture. All Select Agent use must be reported to the Safety Officer and reviewed and approved by the IBC. A complete description of Select Agents can be found at http://www.selectagents.gov. At this time NJIT IBC only allows work with the following Select Agents in quantities that are not restricted (but still need to be reviewed), as described in the following table:


HHS Toxins [§73.3(d)(3)]


Non-Regulated Amount

Abrin

100 mg

Botulinum neurotoxins

0.5 mg

Short, paralytic alpha conotoxins

100 mg

Diacetoxyscirpenol (DAS)

1000 mg

Ricin

100 mg

Saxitoxin

100 mg

Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)

5 mg

T-2 toxin

1000 mg

Tetrodotoxin

100 mg

Regulated Medical Waste

Regulated medical waste (RMW; also known as biohazardous waste or infectious medical waste) is the waste that is contaminated by blood, bodily fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.  

There are several key categories of waste that are typically classified as regulated. Each category has special handling requirements that may be state-specific. See the Types of Regulated Medical Waste page for more information on the classification of RMW.

Any research that produces any RMW material requires IBC approval and must also be reported to the NJIT Safety Officer.

Radiological Hazards

If you are using any radioactive substance or a device or equipment that uses or emits any radiation, please inform the NJIT Safety Officer and submit an IBC application with full disclosure on radiation equipment, type of radiation and radioactive substance used in research for experimentation or with animal or human subjects.  All radioactive materials must be handled in designated Radiation Areas or Restricted Radiation Areas. Radioactive material should be treated as hazardous substances and handled with all cautionary procedures normally accorded such substances.

Nanomaterials 

Research and technology protocols involving structures with at least one dimension less than 100 nanometers (nm), frequently with atomic/molecular precision and creating or using structure, devices, and systems that have unique properties and functions because of their nanometer scale dimension must be submitted to NJIT IBC for approval.

NJIT Institutional Biosafety Committee (IBC)

Eun Jung (Alice) Lee (Chair)
Associate Professor, Department of Bio-medical Engineering 
Michael Swan (Co-Chair)
Executive Director, Environmental Health & Safety (Safety Officer)
Atam Dhawan
Senior Vice Provost for Research (Resource)
Eric Fortune
Associate Professor, Biological Sciences
Eric Hetherington
Associate Vice Provost, Sponsored Research Programs​
Edgardo Farinas
Professor, Chemistry and Environmental Science
Megan DeJoseph
Director, Office of Risk Management
Sanjiv M. Chokshi, Esq.
Assistant General Counsel for Patents and Intellectual Property
TBD
TBD (Community Representative)
Gary Sarkins
Director, Student 2 Science Program
Deneen Scuderi
Director, Campus Health Services
Sagnik Basuray
Associate Professor, Chemical & Materials Engineering
Raju Tamot
Director, Research Compliance and Services
Richard E. Arlaus
EHS Coordinator, Biosafety Officer

Federal Biosafety Guidelines and Protocols

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. Click here for NIH Guidelines for Biosafety. 

IBC Meeting Minutes
2025

Minutes from IBC Meeting on July 21, 2025

Minutes from IBC Meeting on September 15, 2025

Minutes from IBC Meeting November 25, 2025

For more information, see the Frequently Asked Questions.

The following policies related to professional conduct, academic affairs and ethics are observed and followed by NJIT. Additional policies are available at the NJIT Policies website.

  • Acceptable Use Policy for Cyber Resources
  • Policy on Integrity in Scholarship (pdf, 18 KB)
  • Uniform Ethics Code (pdf, 415 KB)
  • University Safety and Environmental Policy (pdf, 844 KB)
  • Drug Free Workplace Statement (pdf, 11KB)
  • Drug screening Policy and Procedure for Safety Sensitive Employees (pdf, 96KB)
  • Employment-Related Reasonable Accommodation Policy and Procedure​ (pdf, 1.3MB)
  • Smoke Free Workplace (pdf, 11KB)
  • Supplemental Ethics Codes (pdf, 7MB)

 

The Research Compliance unit in the central office helps to ensure that all research activities undertaken by faculty, staff, and students at NJIT are conducted ethically and in compliance with federal, state, local, and institute regulations and policies. It also serves as a resource for the NJIT research community for regulatory analysis and interpretation, policy development, and training and education. This unit has oversight and responsibility over the following areas::

  • Responsible Conduct of Research
  • Human Subjects Research via IRB
  • Biosafety: Recombinant DNA, BSL-3 Pathogens, Select Agents, Biohazards, Radioactive Materials, Radiation-Producing Devices, Lasers
  • Care and Use of Animals in Research (through Rutgers University-Newark Institutional Animal Care and Use Committee)
  • Export Control in Research
  • Conflict of Interest and Outside Activities in Research
  • Misconduct in Research
  • Federal Information Security Management Act


Responsible Conduct of Research (RCR)

All NJIT employees including students, staff, post-docs, research associates, faculty and collaborators are expected to be in compliance with NJIT and federal requirements with respect to responsible conduct of research. This training is available via the  CITI (Collaborative Institutional Training Initiative).

Human Subjects or associated data can only be used for research purposes after required review and institutional approval in compliance with federal requirements. Under a Federal wide Assurance with the United States Department of Health and Human Services, all research involving human subjects performed by NJIT faculty, staff, and students either on-campus or off-campus, including at other institutions, must be reviewed and approved prior to initiation by the NJIT Institutional Review Board (IRB).

A complete review and approval from the Institutional Biosafety Committee (IBC) is required for all research activities and protocols dealing with live cells, tissues, any environmental release of genetically engineered organisms, human gene therapy, and any laboratory- or greenhouse-contained experiments. The IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (e.g., human bodily fluids, cell lines, infectious agents) and other potentially hazardous agents (e.g., carcinogens). The IBC is a federally mandated review body established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA.

NJIT relies on the Rutgers-Newark IACUC for review and approval of vertebrate animal research conducted by NJIT researchers in order to ensure compliance with all regulations, policies and standards that protect animal welfare.  NJIT researchers contemplating the use of animals in their research or in the early stages of preparing to use animals in their research should contact Dr. Raju Tamot (raju.k.tamot@njit.edu), Director, Research Compliance and Services, and Dr. Eric Hetherington (erich@njit.edu), Associate Vice Provost for Sponsored Research Administration in the NJIT Office of Research. 

Export Control regulations are federal laws that govern the export, shipment, transmission, transfer, or sharing from the U.S. to foreign countries, persons, or entities of technology, technical data, technical assistance, and items or materials. The U.S. Department of State and the U.S. Department of Commerce each administers different export control regulations. Additionally, U.S. government sanctions restrict travel to, and financial transactions with, certain countries, individuals, and organizations, including certain foreign universities and research institutes. NJIT is committed to complying with applicable U.S. laws and regulations pertaining to exports of items, services and technology by or on behalf of the University and the Office of Research collaborates with other university offices, such as the Office of the General Counsel, to identify and manage export risks for national security and foreign policy reasons.

Conflict of Interest and Outside Activities in Research

NJIT follows several federal, state, and University guidelines that govern the disclosure of an outside activity, relationship, or interest, and the management of personal conflict of interest (COI) and conflict of commitments (COC) in research. The Committee on Conflict of Interest is charged with identifying and addressing any potential, actual, and apparent conflicts of interest in research that result from related external interests. The Office of Research supports the Committee while working collaboratively with the NJIT community to manage, reduce, or eliminate any identified potential, actual, or perceived conflicts of interest. Every NJIT researcher must disclose and certify through Streamlyne, all professional activities outside of NJIT and any financial interests in outside entities that the researcher, and his/her immediate family members may have that are related or have the appearance of affecting, the researcher's professional judgment in exercising any university duty or responsibility.

Misconduct in Research

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. All individuals affiliated with NJIT have an ethical responsibility to foster an environment that promotes intellectual honesty and integrity as well as act if they suspect research misconduct has occurred.

Many research compliance training courses including RCR training for required certification can be accessed online through the CITI (Collaborative Institutional Training Initiative) software programs.

NJIT faculty, student, post-docs, associates and staff can access the CITI software programs and courses through the website www.citiprogram.org.

Please register online through the website www.citiprogram.org and select  “New Jersey Institute of Technology” to set-up your account. Once your account is registered, you will be able to select and go through the specific courses in research compliance.

 

Streamlyne for Research Compliance

The Office of Research is developing the functionality of Streamlyne, an electronic research administration software, to serve as a dynamic content management system that will aid in the oversight of NJIT’s compliance related needs. As of July 2020, Streamlyne is used for both IRB and COI administration.

 

FISMA - Federal Information Security Management Act

What is FISMA:

The United States Federal Information Security Management Act (FISMA) defines a framework, standards, and guidelines to protect United States Government (USG) sensitive information. FISMA applies to the university research community, state agencies, entities and service providers including those who use data provided by the federal government.  Universities that have contracts with the US government need to comply with FISMA if the data is regulated.  Any noncompliance can reduce federal funding or incur other penalties.

FISMA Compliance:

FISMA defines roles and responsibilities for all agencies and related entities to protect sensitive information from compromise and ensure that compliance requirements of the federal government are met.  Specifically, FISMA requires entities and program officials to perform annual reviews of information security programs. FISMA compliance follows the guidelines and best practices laid out by the National Standards for Information Technology (NIST) standards.  

Resources:

  • NJIT’s Office of Research provides institutional support and services to the research community. This includes pre-award services, post-award management, and research compliance. The Office of Research has experience with FISMA compliance and can provide assistance accordingly. It is the researchers’ responsibility to be aware of FISMA requirements and seek assistance and guidance.
  • FISMA is administered by the Department of Homeland Security. Changes and updates can be found at https://www.dhs.gov/fisma. 
  • Questions about FISMA should be directed to the assistant director of research compliance and integrity. https://research.njit.edu/contact. 

Regulatory Reference Federal Information Processing Standards:

  • FISMA Implementation Project
  • NIAID Data Security Standard Operating Procedure
  • NIST Risk Management Framework
  • FIPS PUB 199   
  • FIPS PUB 200    
  • NIST SP 800-171 Rev. 2
  • NIST SP 800-60 Rev. 1
  • NIST SP 800-37 Rev. 2
  • NIST SP 800-39
  • NIST SP 800-53A Rev.  5

Responsible Conduct of Research (RCR) is the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research. Ethical and responsible conduct of research is critical for excellence in science and engineering, maintaining the public's trust, as well as for protecting institutions, investigators, research subjects, environment, federal funds, the public, and national interests. Consequently, education in the responsible and ethical conduct of research is considered essential in the preparation of future scientists and engineers.

RCR Required Training: NJIT requires that all personnel engaged in research be trained in the Responsible Conduct of Research (RCR) as part of their Research University experience as well as to meet institutional obligations as a federal grantee institution. NJIT has selected the electronic CITI (Collaborative Institutional Training Initiative) RCR course in the Responsible Conduct of Research to provide general and program-specific courses in RCR. All those with an NJIT UCID and NJIT email address are able to register for RCR training via the CITI portal.

Federal Requirements

Federal requirements require Responsible Conduct of Research (RCR) training for scholars funded by NSF, USDA and NIH.  Those requirements are detailed below and can be fulfilled via the CITI Training Portal.

National Science Foundation (NSF):  The recent America COMPETES Act requires responsible conduct of research (RCR) training for all undergraduates, graduates, and post-doctoral fellows who conduct research supported by NSF funds. All institutions submitting applications must certify at the time of application submission that plans are in place to provide appropriate training and oversight of the RCR training.

National Institutes of Health (NIH): NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, or dissertation research grant and who have direct and substantive involvement in proposing, performing, reviewing, or reporting research must receive a minimum of 8 hours of in-person training, developed and implemented by the awardee institution in responsible conduct of research. 

U.S. Department of Agriculture (USDA): Effective for awards subject to the February 2013 Research Terms and Conditions (and those issued subsequently), the USDA National Institute of Food and Agriculture (NIFA) has mandated that program directors, faculty, undergraduate students, graduate students, postdoctoral researchers and any staff participating in the research project receive appropriate training and oversight in the responsible and ethical conduct of research (RCR). Any award issued after February 1, 2013 must comply with this requirement.

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. 

  • Model Consent Form

 

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

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