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Tulane University Human Research Subject Protection Program

Tulane University is one of the premier research universities in the country. Of the 2267 four-year institutions of higher education, only 88 are classified as Carnegie Research I institutions, and only 60 are members of the Association of American Universities. Tulane University is a member of both these distinguished groups. Faculty and resources are integrated across organizational boundaries to capitalize on research and clinical strengths and focus on areas that have achieved or have the potential to achieve world-class excellence. The research focus in the School of Medicine includes the Center for Gene Therapy and Regenerative Medicine, the Vascular and Cardiac Institute, the Tulane Cancer Center/Louisiana Cancer Research Consortium, and the Center for Organ Transplantation. The School of Public Health and Tropical Medicine (SPHTM) continues to expand its public health activities in New Orleans in addition to its global research program. This effort includes research activities in New Orleans with special emphasis on community health, environmental health, vector-borne diseases, and health services research. SPHTM's global health research targets existing strengths in cardiovascular diseases, infectious diseases through the Center for Infectious Diseases and Biosafety, reproductive health, and will expand its programs in complex emergencies and disasters.

Research involving human participants is an important part of the overall research program at Tulane University. Human participant research encompasses biomedical studies, e.g. disease processes, new treatments and interventions, disease prevention and control, and investigations of social and behavioral human functioning.

Tulane University and its employees are required to comply with certain policies and procedures as published in the Code of Federal Regulations by the Department of Health and Human Services (26 January 1981) (45 CFR Part 46) and Food and Drug Administration (27 July 1981) (21 CFR Parts 50 & 56) regarding the rights and welfare of human subjects at risk, involved in activities supported by grants and contracts from the Department of Health and Human Services, the Food and Drug Administration, and certain other agencies providing funds to support investigations involving human subjects. The Tulane University Institutional Review Board (IRB) shall determine whether these subjects will be placed at risk and, if risk is involved, whether: the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks; the rights and welfare of any such subjects will be adequately protected; legally effective informed consent will be obtained by adequate and appropriate methods in accordance with provisions of applicable law, and the conduct of the activity will be reviewed at timely intervals.

This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this assurance. It is the policy of Tulane University that all research involving human subjects will be reviewed by an IRB which has been established under an assurance of compliance negotiated with the Department of Health and Human Services (DHHS). Except for those categories specifically exempted by this assurance, the involvement of human subjects in research will not be permitted until the IRB has reviewed and approved the research protocol (study design) and consent form, and informed consent has been obtained in accordance with and to the extent required by federal regulations. The IRB reviews ongoing research at appropriate intervals; but in no event, less than once per year. The interval for continuing review will be determined by the IRB.

This assurance is applicable to all activities which, in whole or in part, involve research with human subjects if: the research is sponsored by this institution; the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities; the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution; or the research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.