Human Subjects Research

I. Policy Summary

Research involving human subjects at NJIT requires oversight by the NJIT Institutional Review Board (IRB). Federal guideines govern NJIT IRB protocols, membership and required training.

II. Policy Purpose

This policy describes the ways NJIT guarantees that research involving human subjects is upheld to high ethical standards and that research projects preserve the autonomy of people who volunteer to be subjects.

III. Policy Scope and Applicability

This policy is in effect for all units of NJIT and applies to all research involving human subjects and to all protocols submitted to the NJIT IRB.

IV. Definitions

The Common Rule (45 CFR 46, as revised in 2018) of the United States Department of Health and Human Services defines research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." (§.102[l])

It also defines human subject as "a living individual about whom an investigator (whether professional or student) conducting research: 

i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 

ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." (§.102[e][1])

V. Policy Statement

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).

The NJIT IRB follows all regulations as outlined in 45 CFR 46.

VI. Procedures

All current administrative procedures relating to human subjects research can be found on the NJIT Research Compliance website.

All IRB protocols are submitted via the NJIT online grant management system, Streamlyne. Eligible individuals have login access to the system to input their protocol details. Problems with access or questions on system functionality should be addressed to the IRB administrator.

Once the Institutional Review Board (IRB) has reviewed a protocol and approved for the procedures and subjects described in the protocol:

All research must be conducted in accordance with the procedures outlined in the approved protocol.

The protocol is approved until the expiration date listed in the approval letter and must be reviewed for renewal on an annual basis for as long as the research remains active. The PI must submit a request for Continuing Review at least 30 days prior to the expiration date. If the study’s approval expires, investigators must stop all research activities immediately (including data analysis) and contact the IRB Office for guidance.

The principal investigator is responsible for the following:

• Conducting the research in a manner consistent with the requirements of the IRB and federal regulations 45 CFR 46.
• Obtaining informed consent and research privacy authorizations using the currently approved forms and retain all original, signed forms, if applicable.
• Requesting approval from the IRB prior to implementing any modifications.
• Promptly reporting to the IRB any unanticipated problems involving risks to subjects, as well as serious and unexpected adverse events.
• Maintaining accurate and complete study records.
• Reporting all non-compliance issues or complaints regarding the project promptly to the IRB.

All research records must be kept for a minimum of three (3) years after the project is finished. Once the project is complete, the PI must submit a Request to Close to the IRB.

VII. Roles & Responsibilities

The IRB is an autonomous university committee with the authority to approve or disapprove protocols involving human subject research as defined by HHS Revised Common Rule 45 CFR 46.

The IRB administrator is responsible for assisting PIs and co-investigators with the process of protocol submission and assists the committee chair(s) in organizing all IRB-related workflow and processes.

PIs and their co-investigators are responsible for submitting and completing protocols via Streamlyne for consideration by the IRB.

VIII. Authority and Responsibility

The Office of Research holds institutional authority for the issues covered in this policy. Any questions regarding this policy should be directed to the senior vice provost for research at irb@njit.edu.

Related Policies and Regulations

Office for Human Research Protections (OHRP) 45 CFR 46.