Committee Review

Research conducted at Hackensack Meridian Health may require oversight from certain research committees, depending on the nature of the research. 

The Human Research Protection Program (HRPP) is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under its auspices.

The mission is to:

  • Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
  • Provide guidance and support to the research community in the conduct of research with human subjects;
  • Assist the research community in ensuring compliance with relevant regulations;
  • To provide timely and high-quality education, review and monitoring of human research projects; and
  • To facilitate excellence in human subjects research.

The Institutional Review Board (IRB) reviews human subjects research studies and determines whether the studies are consistent with the principles of the Belmont Report and with relevant regulations and guidelines. The time and process of the review depends on the nature of the study submitted. Once the investigator submits his or her study, it is determined to be either exempt, expedited, or subject to a convened committee review. It is then forwarded to the appropriate reviewer(s) for consideration. The investigator is contacted once a determination is made regarding the study’s approval status.

The Human Research Protection Program policies and practices can be accessed via the HRPP (IRB) SOPS.

The IRB generally meets the first and third Wednesday of each month with submission one month prior to the meeting.

Our program is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

For more information, please contact 201-880-3669 or hmhirb@hmhn.org.

Actual, perceived or potential Conflicts of Interest (COI) can arise when an investigator or other research staff member involved in research activities sponsored by an industry or other organization has financial or associational interests directly or indirectly linked to the sponsor of the research in which s/he is engaged. While those who work on research studies are typically compensated for their time and effort, certain held financial interests warrant further review. There are three types of conflicts of interest:

1. Investigator COI-A situation in which the financial interests of the investigator or the investigator’s immediate family members could bias the research of the institution.
2. Institutional COI-A situation in which financial interests of HMH or those of an institutional official acting on behalf of Hackensack Meridian Health could bias the research of the institution.
3. Secondary Activity- This includes any activity undertaken in support of or in association with any person or entity other than Hackensack Meridian Health that would constitute an actual or perceived conflict as defined in Policy 541-2.

The COI Committee determines in what way potential conflicts of interest reported by Hackensack Meridian Health staff members should be addressed. The committee decides whether further management or elimination of the conflict is required. In some instances, the COI Committee will develop a plan in consultation with the faculty or staff member, and the faculty member or staff member must abide by the terms of the plan.

To submit a COI Disclosure Statement
All study staff must complete a Conflicts of Interest (COI) Disclosure Statement annually. No studies will be reviewed without receipt of the disclosure statement.

The committee typically meets on the fourth Monday of each month.
If the investigator or a member of his/her study team has a conflict, the investigator will be contacted and will be provided with instructions on any further information or steps required.

For more information, please contact Michelle Benson, PhD.

The Hackensack Meridian Health Data Safety and Monitoring Board (DSMB) provides multidisciplinary, independent oversight of research studies. Its focus is to ensure the integrity of research and the safety of human subjects. 

The DSMB will monitor studies referred to by the Institutional Review Board (IRB) and the Conflict of Interest in Research Committee. Data and safety monitoring is particularly appropriate for high risk research and for studies in which the investigator and/or the institution may have a potential conflict of interest.

The DSMB reports the outcomes of its deliberations to the referring body and makes recommendations to the IRB with respect to continuation, modification, or termination of the protocol. The DSMB has the authority to require protocol modifications related to participant safety and to recommend suspension or termination to the IRB and/or institution official of any research protocols that fall within its jurisdiction.

Meetings are the last Wednesday of the month.

For more information, please contact Linda Regensburg, CIC.

The Institutional Animal Care and Use Committee (IACUC) is charged with overseeing Hackensack Meridian Health’s animal program, facilities, and procedures. The committee is composed of at least 5 members, including a veterinarian, a scientist with experience in animal research, a non-scientist, and a lay person of the community not affiliated with the institution, except as a member of the IACUC.

The IACUC:

  • Ensures that all laboratory research animals are treated humanely and receive care that is consistent with the Animal Welfare Act Regulations (AWAR), Public Health Service (PHS) Policy, IACUC Guidelines, and/or other applicable regulations, guidelines, and policies for the species and the type of research that is conducted.
  • Reviews Hackensack Meridian Health’s program and facilities for humane care and use of animals, utilizing the Guide for the Care and Use of Laboratory Animals as a basis for evaluation at least once every six months.
  • Produces written reports with recommendations regarding any aspect of the Institution’s animal program, facilities, or personnel training.
  • Investigates and reviews any reported concerns involving the care and use of animals at the Institution.
  • Reviews all animal protocol applications and either approves, requires modifications in order to secure approval, or withholds approval of activities related to the care and use of animals.

Anyone interested in conducting research with animals should contact Leigh-Ann Tulleson.

The upcoming IACUC meeting dates are:

1/20/2022
2/17/2022
3/17/2022
4/21/2022
5/19/2022
6/16/2022
7/21/2022
8/18/2022
9/15/2022
10/20/2022
11/17/2022
12/15/2022

The Institutional Biosafety Committee (IBC) reviews all protocols utilizing recombinant DNA and/or Biosafety Level 3 biohazardous agents in both human and animal research. Approval from the IBC is required prior to submission to the Institutional Review Board (IRB) or the Institutional Animal Care & Use Committee (IACUC).

The objective of the IBC is to assure compliance with the National Institutes of Health-Office of Biotechnology Activities (NIH-OBA) regulations in the conduct of research involving recombinant DNA and other biological hazardous material.

Biosafety training for researchers and staff involved in clinical trial studies is located on the Hackensack Meridian Health CITI training system. For pre-clinical researchers, training is provided via in-classroom sessions and online supplementary materials provided by the Office of Biological Safety.

The committee meets on the fourth Wednesday of the month, as needed.

Before commencing work with any of the following agents, any components thereof, or any attenuated strains, researchers must contact Sean Fitzgerald, Network Biosafety Officer, at sean.fitzgerald@hmhn.org or at 201-880-3661. He will need information about the intended agent and project and will provide guidance on what conditions must be in place to begin this type of work and whether a submission to the Dual Use Research of Concern Committee is required.

  • Avian influenza virus (highly pathogenic)
  • Bacillus anthracis
  • Botulinum neurotoxin
  • Burkholderia mallei
  • Burkholderia pseudomallei
  • Ebola virus
  • Foot-and-mouth disease virus
  • Francisella tularensis
  • Marburg virus
  • Reconstructed 1918 Influenza virus
  • Rinderpest virus
  • Toxin-producing strains of Clostridium botulinum
  • Variola major virus
  • Variola minor virus
  • Yersinia pestis
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