About Us

The New Brunswick/Piscataway Campus of UMDNJ reviews protocols for studies conducted at Robert Wood Johnson University Hospital, Robert Wood Johnson Medical School, The Cancer Institute of New Jersey, Environmental and Occupational Health Sciences Institute, School of Health Related Professions, School of Public Health, and other New Brunswick Campus affiliates.

The IRB is charged with the responsibility of reviewing and approving research that involves Human Subjects. The IRB Office provides support services (see below) to the committee and advises both the committee and investigators regarding regulatory issues and IRB submissions.

The IRB Committee is composed of physicians, professional staff, students, community members and lay members. You can see a listing of the IRB chair and staff by examining the Staff Profiles page.

The IRB holds 5 full board meetings a month. There are two Full Board teams that meet twice per month. Additionally, the Executive Board who primarily handles compliance and policy issues meets once a month.

The deadlines for submission to the full board are two weeks before the meeting by noon. Items received for the full board are reviewed and assigned to the appropriate Full board team.

Support Services Offered by the IRB:

Assistance with the IRB application: For help with your IRB application, have questions regarding sponsor requirements, questions regarding which category of review research falls under, or want to make sure that the application to undertake human subjects research is complete prior to submission for IRB review, contact the IRB Office located in the Professional Center Building, Suite 506 at 390 George Street in New Brunswick.

Assistance with protocol or proposal writing: Meeting with the IRB staff often helps investigators focus the content of their research into a protocol format so that nothing essential is left out, and to clarify important clinical and methodological information that will be needed for an IRB review. Assistance with data collection instruments and methods of maintaining privacy and confidentiality of research data is also available.

Pre-Review of Research: Upon request, a member of the IRB staff will review your research project and IRB submission materials prior to the IRB submission deadline to make sure that everything is in order.

Assistance with Informed Consent Documents: The informed consent document is a significant part of the research consent process. The document needs to convey all essential information about a research study, within the federal guidelines for informed consent-and in language written at the 6th-grade level! The IRB office provides assistance with consent documents before or after an IRB review or meeting if you need help. See consent templates.

Assistance to Student Researchers: Student researchers, residents or fellows who are approaching a clinical research project for the first time may need help with any or all of the above. A seminar for students is given in the spring semester about how to file an IRB application and how to prepare the accompanying documentation, and we are also available by appointment. Individual tutoring is also available by appointment.

Federal Regulatory Guidance: It's the job of the IRB Office to be knowledgeable about federal research regulations. We can walk investigators through complicated interactions as they relate to human subjects with research sponsors, and CROs, or the FDA or other regulatory agencies if need be. We can offer assistance with sponsor site visits, provide guidance regarding the responsibilities of the Principal Investigator, other investigators and staff under the regulations, assist with special requirements for INDs and IDEs, direct you to federal resources that can answer your questions, and generally serve as the "go-to" office about research regulations so that your research remains in good standing.

HIPAA Guidance: Since April 2003, the Health Insurance Portability and Accountability Act of 1996 has required additional documentation for researchers so that research projects remain compliant. The language and the specific requirements for confidentiality can be confusing. The IRB office can help you with your HIPAA documentation for research and other HIPAA research issues. See standard UMDNJ HIPAA language.

Resource Materials: Our resources include all applicable regulations for the protection of human subjects; federal guidance from OHRP and FDA, IRB related publications, as well as, a number of historical and recent journal articles on many clinical research topics.

Human Subject Protection Education: The IRB membership and the IRB Staff of the Office for Human Subject Protections Program provide institutional and department in-service education/orientation for research topics related to human subjects. IRB New Member Orientation is open to all Investigators and Research Staff and is offered throughout the calendar year. (Click here for scheduled time and place.)