Introduction to Human Subject Research

The Institutional Review Board (IRB) is charged with review and approval of all research protocols being conducted at The Mount Sinai Medical Center, or by Mount Sinai School of Medicine faculty, with the aim of protecting the rights and welfare of human subjects enrolled in these research protocols. The regulations governing the IRB procedures developed as a result of reports produced by several Commissions which examined the use of human subjects in research; in particular the Belmont Report.

The Belmont Report, prepared by the National Commission for the Protection of Human Subjects of Biomedical and Biobehavioral Research in 1978, formulated three basic ethical principles that must be adhered to in the conduct of research involving human subjects. These are: (1) Respect for persons: recognition of the autonomy and personal dignity of each individual and provision of special precautions to protect vulnerable subjects; (2) Beneficence: potential benefits of participation in research must be maximized while potential harms must be minimized; (3) Justice: the benefits and risks of research participation must be distributed fairly within the general or subject population.

Following this, various legal codes were developed to specify, more precisely, actions that must be taken to ensure adherence to these principles. In particular, human research at Mount Sinai is governed by Federal Regulations (FDA, 21CFR50 and 21CFR56; DHHS, 45CFR46) in addition to applicable State and City Codes. The responsibility for protecting the rights and welfare of human subjects in research has been delegated to Institutional Review Boards (IRB) at each institution conducting federally-sponsored research. All proposals for conducting research on human subjects must be reviewed and approved by the IRB before they can be initiated, regardless of funding source. Certain types of research may be exempt from IRB review. Mount Sinai has assured the federal government, through a Federal Wide Assurance (FWA #00005656), that it will comply with all applicable regulations.

In order to carry out its mandated role of protecting human subjects, the Mount Sinai IRB has instituted a series of policies and procedures, and has developed guidelines to aid investigators in preparing research applications. This Web site contains the text of various codes, the MSSM MPA, the IRB Guidelines and Policies Manual, and the forms needed for submission of applications involving research on human subjects.

The IRB staff will be happy to discuss any questions that you have with regards to complying with these policies.

Other Resources

Office for Human Research Protections