OO - Organizational Overview

OO27: The institutions policies, procedures (including Institutional Review Board), and processes that protect the rights of participants in research. (NK2)

Jersey City medical center ensures the safety and rights of participants in research studies through established policies and procedures. To ensure the safety of subjects participating in research studies, all research activities involving patients, hospital employees, and hospital services, conducted at JCMC, must be approved by the Jersey CityMedicalCenter’s Institutional Review Board (IRB). Those who are voting members of the IRB and those who participate in research activities must complete the basic assurance training offered by the Office for Human Research Protections (OHRP) agency.

In addition to the IRB, nurses are also involved in the process of ensuring the safety of research participants. All nursing research studies must be approved through two levels of review. Approval for all nursing research studies or those involving nurses is submitted to the Nursing Research council for approval. Council members review the aims, methodology, and data collection procedures to ensure that the rights and safety of patients, staff nurses, and the nursing profession are maintained and protected. Once the approval is granted, the investigator may begin the IRB process.

Final approval by the IRB is required prior to beginning data collection procedures. The IRB process begins with submission of the “Investigator’s Packet” with all supporting documents, including a statement of approval from the respective department chair or Senior Vice President. The completed packet is forwarded to the Administrative Support Staff of the IRB and examined for completeness. Completed proposals can go through one of three IRB review procedures: Full/Convened Committee Review, Expedited Review, and Review of Exempt Status.

Nursing Members are actively involved in all IRB review procedures including voting on research proposals that require full review by the IRB panel. Jersey CityMedicalCenter maintains strict policies to protect the rights of research participants. Please refer to JCMC policies listed below for more information: