II. Name, Purpose and Scope
2.1. Name
The name of the Institutional Review Board (IRB) shall be the Sinai Health System Institutional Review Board and referred to as the "IRB".
2.2. Purpose
The purpose of the IRB shall be to safeguard the rights and welfare of human subjects involved in research related to Mount Sinai Hospital, Schwab Rehabilitation Hospital, Sinai Medical Group, Sinai Community Institute and Access Community Health Center. An agreement exists between SHS' IRB and these entities. The IRB shall fulfill its mission by fulfilling the following: 1) review research to determine that the rights and welfare of human subjects are adequately protected; 2) assure that the benefits to an individual outweigh the potential risks to him or her or by the importance of knowledge to be gained; 3) require that legally effective informed consent or assent is obtained from research subjects; and 4) ensure that the conduct of research is reviewed at timely intervals.
2.3 Jurisdiction and Scope
The Assurance with OHRP authorizes Sinai Health System's IRB jurisdiction over all components of research at SHS, including but not limited to, inpatient care, outpatient care, Emergency Room, and medical records. In addition, the IRB has jurisdiction over research involving SHS patients in the context of their actively receiving treatment from an individual affiliated with SHS or entity. The IRB's responsibilities shall also extend to all studies and research projects in which an SHS employee, medical staff or associate is a researcher. The IRB procedures apply, regardless of the source of funding, to all research involving human subjects if one or more of the following circumstances apply:
- Human Subject: A living individual, about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46 Part 102 (f))
- Research: A systematic investigation including research development, testing or evaluation designed to develop or contribute to general knowledge (45 CFR 46.102 (d)) or as a "systemic investigation, including research development, testing and evaluation designed to develop or contribute to generalized knowledge. (38 CFR 16.102 (d)) FDA regulations state that clinical research is any experiment that involves a test article and one or more human subjects. The IRB has jurisdiction over clinical research that supports marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use.
- The research is sponsored by an SHS facility
- The research is conducted by or under the direction of any employee or agent of an SHS facility in connection with his or her institutional responsibilities.
- The research is conducted by or under the direction of any employee or agent of an SHS facility using any SHS facility.
- The research involves use of Sinai Health System's IRB non-public information to identify or contact human research subjects or prospective research subjects
2.4 Termination and Suspension of Research Projects
The IRB has the authority to take any action necessary to protect the rights and welfare of human subjects enrolled in projects that have been reviewed and approved by the IRB. The IRB has the authority to suspend or terminate the enrollment and/or ongoing involvement of human subjects research projects as it determines necessary for the protection of those subjects. The IRB also has the authority to monitor and/or observe human subject research to whatever extent it considers necessary to protect human subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the Principal Investigator, appropriate officials, and the Food and Drug Administration.
2.5 Cooperative Agreements
The IRB may enter into a joint review process, rely upon the review of another qualified IRB, or enter into a similar arrangement that avoids the duplication of efforts and promote the safety of research subjects. (21 CFR Part 56 (114))
2.6 General Research Policies
The IRB shall, prior to the onset of any research involving human subjects, determine the acceptability of all research protocols seeking to use human subjects affecting SHS in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, mission and goals, and community attitudes. The IRB may from time to time adopt policies and procedures on the general subject of research involving human subjects that it believes reflect standards to which the IRB should be committed. (45 CFR 46.102).
