Federal Wide Assurance #: FWA00002055
The primary goal of the Tulane University Human Research Protection Office is to balance the protection of human subjects while promoting and facilitating the research enterprise, and to maintain an open and cooperative relationship with the research community.
December 3, 2018
The Revised Common Rule (Federal Policy for the Protection of Human Subjects; “New Rule”) will become effective on January 21, 2019 and we are obligated under federal law to implement these changes. This transition will likely cause delays to our normal review processing timelines, in part due to the concurrent and necessary updates that are required to our electronic forms, determination letters, and reviewer checklists in IRBManager. We thank you in advance for your patience during this time and your partnership as we work together to assure that Tulane’s research and oversight are in compliance with the New Rule. The HRPO has implemented a plan to help make the transition from Old to New Common Rule as smooth as possible. Please see the "New Rule Information" Section for more information.
Tulane University is mandated to provide the US Department of Heath and Human Services (DHHS) with a formal assurance that it will follow procedures designed to assure the protection of all human subjects involved in research projects conducted at Tulane and elsewhere by faculty, staff, or other representatives of Tulane in connection with their institutional policies.
To this end, Tulane University has established two Institutional Review Boards (IRBs), one Biomedical and one Social Behavioral, to examine and approve research projects involving human subjects. The IRB members are chosen from within the research University and the outside community to represent a variety of scientific and non-scientific disciplines. While it is the role of the IRB to determine that the rights and welfare of human research subjects are protected, the investigator bears the primary responsibility for following the approved research protocol and meeting standards established by federal regulations and the IRB.
Before a research project involving human subjects is initiated, it must first be reviewed and approved by the IRB, then conducted according to the guidelines set forth by the FDA. This compliance is a crucial element of the IRB process, because it is the collective effort of individual investigators in this area that ensures the integrity of the University as a research institution.
If you would like to schedule a meeting with the Human Research Protection Office (HRPO) staff to answer questions about prospective or ongoing human subjects research projects, IRBManager electronic submissions, or questions on IRB review requirements, please send an e-mail request to email@example.com.
Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112