Roles and Functions of the IRB

Fordham University ("Fordham") recognizes its ethical and federally mandated responsibility to safeguard the rights and welfare of human subjects in all research undertaken under its sponsorship. Fordham assigns to the Institutional Review Board for the Protection of Human Subjects ("IRB") the responsibility pf assuring that researchers protect the integrity and dignity of individuals who are the subjects of Fordham-sponsored research.

Fordham-sponsored research is defined as any of the following: a) funded or unfunded research conducted by or under the direction of a Fordham University employee in connection with his or her institutional responsibilities; b) research conducted by or under the direction of a Fordham University employee who makes substantial use of any Fordham property, personnel, equipment, or facility; or c) research involving the use of the institution s non-public information to identify or contact human research subjects or prospective subjects.

Members of the IRB are appointed by the Office of the Provost. They will serve for a term of three years with optional renewal. By the nature of their appointment, these terms will be staggered. The Chair will be elected by the Board and also serve a three year term. The IRB ensures that all members of the Fordham community, particularly research investigators, understand their responsibilities for the protection of human subjects at risk whenever research is determined by the IRB to occasion risk to human subjects.

With the assistance of the Associate Vice President for the Office of the Provost, the Director of Research, and the IRB, it is the responsibility of deans, department chairs, program directors, individual investigators, or anyone else engaged in the direction or supervision of research, including research performed by students, to familiarize themselves with the policies and procedures established by Fordham that protect human subjects who may be placed at risk in research.

Research subject to regulation by Fordham and its IRB includes all biological, behavioral, psychological and sociological investigations designed to elicit non-public information about individuals or groups. Such studies may involve adults, children, pre-natal life or dead persons, and other groups defined as vulnerable in Title 45 CFR Part 46. They may utilize organs, tissues or bodily fluids; they may employ graphic, written or recorded information about individuals even when this information has been collected by others. Certain research may be exempt from regulation by Fordham and its IRB. Activities eligible for exemption are listed below. Otherwise, all Fordham-sponsored research, funded or unfunded, involving human subjects at risk must adhere to the policies and procedures promulgated by Fordham through its IRB.

The determination of whether a project is Fordham-sponsored, "involves risk to human subjects," and/or is subject to review procedures, is reserved to Fordham acting through its IRB in accordance with all applicable laws and regulations. Exemptions to the review process will be made whenever appropriate but must not be taken for granted by any investigator, regardless of the source of, or the lack of, funding, the academic status of the investigator, or the nature of research protocols. The authority to approve protocols and exempt projects is reserved exclusively to Fordham acting through its IRB subject to the appropriate delegation of authority as noted below.

Fordham regards an infringement of its established policies and procedures as a serious breach of professional standards and cautions investigators and others who violate these standards that they will be subject to sanctions as outlined in the University Policy for Responding to Allegations of Scientific Misconduct, which also provides for due process. Procedures applicable to faculty discipline are contained in the University Statutes, Chapter Seven,Part II. Violations by investigators who do not hold faculty rank are handled through the established processes applicable to their employment or student status. Fordham also reserves the right not to defend investigators should litigation result from violations in connection with their research activities in circumstances where the investigator has failed to submit a research protocol for the required IRB approval, or, having submitted such a protocol, the investigator departs substantially from the approved research protocols or fails to implement the required emendations and/or alternative procedures. During the pendency of possible disciplinary action against an investigator, Fordham and its IRB reserve the right to suspend, take possession of, or destroy research that does not, in its judgment, conform to IRB requirements, guidelines or regulations.