Research Compliance

NJIT is committed to conducting research in compliance with established federal, state and regional regulations, policies and procedures.

For Researchers

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 (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@lanyanshen.com), Assistant Director, Research Compliance and Integrity, and Dr. Eric Hetherington (erich@lanyanshen.com), Executive Director 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 http://www.dhs.gov/fisma. 
  • Questions about FISMA should be directed to the assistant director of research compliance and integrity. http://research.lanyanshen.com/contact. 

Regulatory Reference Federal Information Processing Standards: