Approval Process
All research projects involving human subjects must secure approval from the IRB (Bellevue, NYU/ BRANY), prior to initiating enrollment at the site. Any research utilizing hospital provided services at NYUMC or Bellevue, require approval by respective hospital / Institutional Review Committees.
IRB review: The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. IRB exempt: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects, then the study is exempt from IRB review.
Feasibility Committee: The purpose of this committee is to review all cancer studies for feasibility- time & effort and reimbursement.
PRMC Committee: The Protocol Review and Monitoring Committee’s (PRMC) purpose is to scientifically review all human subject cancer or cancer-related protocols and establish their relative priority to the institutional mission. This review is intended to complement, but not duplicate, IRB review and focuses on:
- The scientific design and rationale of the proposed research
- Feasibility of completing the research study (relative to potential accrual and competing protocols)
- Risks and benefits
- Background data justifying the proposed research
- Biostatistics
Radiology: The radiology committee reviews studies involving radiology resources that will be billed to a sponsor and research that details specific imaging requirements for radiology.
Contact: Lois J. Mannon; Phone 212-263-4814
Institutional Biosafety Committees (IBCs): Established under the NIH guidelines of research involving recombinant DNA molecules to provide local review and oversight of nearly all forms of research that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens).
General Clinical Research Center (GCRC): Center funded by the NIH through the National Center for Research Resources (NCRR) that provides a facility and resources for clinical research to be conducted. GCRC Research Review Committee reviews all protocols proposing to use the GCRC. The GCRC also supports Biostatistics review.
Contact: Deborah Chavis-Keeling 212-263-6410
Bellevue Research Committee (BRC)
Applications will be concurrently reviewed both by the NYU IRB and the Bellevue Research Committee (Facility Research Review Committee, FRRC). All issues raised by the IRB and the BRC must be satisfactorily addressed/cleared before the application will be forwarded to the HHC Central Office for final approval.
Contact: Ernesto Marrero 212-562-6711
NYUMC Hospital Approval: Research studies that accrue patients at Tisch, Rusk, HJD, Hassenfeld, Rivergate and Cancer Center and utilize hospital services will be reviewed by Hospital administration for site, resource utilization and financial feasibility of proposed research.
Contact: Sumathy Sundarababu 212-263-4206
Contact: Kevin Kirchen 212-263-5500
Programmatic: Investigators must check with their respective departments to see if their Chairman has to sign off on participating in the trial.
BRANY: All trials that originate at BRANY must be reviewed by BRANY. If you have been offered trial information to participate in a clinical trial by BRANY, you must use their services as an IRB and for the contractual/budget process.
