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About the IRB

The IRB performs critical oversight functions for research conducted on human subjects. The committee is formally designated to review and monitor biomedical and behavioral research that takes place on campus.It is charged with the responsibility and authority of approving, requiring modification in, halting unapproved or non-compliant research, periodically monitoring the progress of long-term records, or disapproving all research activities involving human subjects that fall within its jurisdiction.

The Institutional Review Board (IRB) at the College of New Jersey is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities.

Mission

The Institutional Review Board of The College of New Jersey is charged with the responsibility and authority to approve, require modification in, halt unapproved or non-compliant research, periodically monitor the progress of long-term records, or disapprove all research activities involving humans that fall within its jurisdiction.

The IRB is responsible for protecting the rights and welfare of human subjects participating in research conducted by faculty, staff and students affiliated with TCNJ.

The IRB:

  1. Reviews and oversees research to ensure that it meets ethical principles and complies with federal regulations, state laws, and college policies.
  2. Assists researchers in the design and conduct of sound research in support of TCNJ’s mission to develop and disseminate new knowledge in the public interest.
  3. Conduct administrative review of new submissions.
  4. Manages application workflow.
  5. Manages communications between the research team and the IRB reviewer.
  6. Ensures the risks to human subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk.
  7. Ensures the risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
  8. Ensures the selection of human subjects for research projects is equitable.
  9. Ensures that human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.
  10. Ensures that informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulation and IRB policies.
  11. Ensures the research plan, when appropriate, makes adequate provision for monitoring the data collected to ensure the safety of the human research subject.
  12. Ensures there are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.

Designated IRB members also may conduct expedited review of applications on a rolling basis. Some qualified IRB staff members have the authority to issue exempt determinations and other decisions.

Researcher Roles & Responsibilities

Researchers at TCNJ are responsible for the ethical conduct of research with human subjects.  In compliance with federal regulations, state laws, and university policy, the investigator’s key responsibilities are to:

  • Determine if a study meets the federal definition of research: “A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
  • Apply for IRB approval or determination of exemption before conducting any research with human subjects or their personally identifiable data via TCNJ’s iMedris system
  • Designate a faculty advisor on the IRB application for research conducted by students.  The faculty advisor shares responsibility with the student for the ethical conduct of the research.
  • Complete the required ethical and regulatory training for the conduct of human subjects research
  • Conduct the research in accordance with the approved protocol
  • Submit amendments before initiating changes to the approved protocol
  • Submit scheduled continuing review reports to the IRB as required, and prior to the protocol expiration date
  • Report all unanticipated problems or serious adverse events involving risks to human subjects as soon as possible
  • Manage research data carefully to protect subject confidentiality

IRB Chair
Sandy Gibson, PhD, LCSW, LCADC
gibsonc@tcnj.edu
609-771-2136

IRB Vice-Chair
Tamra Bireta, PhD
biretta@tcnj.edu
609-771-3069

IRB Members
Diane Bates, PhD (non-scientist)
HeLen Chung, PhD
Maureen Connolly, PhD (non-scientist)
Avery Faigenbaum, PhD
Lauren Madden, PhD
Danielle Guarracino, PhD
Steffen Marcus, PhD (non-scientist)
Anneisha Walker, PhD, LCSW (Community Member)

Provost’s Designee
Carole Kenner, PhD, RN, FAAN, FNAP, ANEF

Laboratory Safety Specialist
Nina Morreale, M.A., PHO, CHO

TCNJ IRB Registration – IRB00002538
TCNJ IRB Registration Expires: 01/23/23

FWA Assurance: #FWA00023311
FWA Assurance Expires: 04/14/2025

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