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.
January 24, 2019
Tulane HRPO has revised its policies and processes to be fully compliant with the Revised Federal Policy for the Protection of Human Subjects in Research (“revised Common Rule”) applicable to the agencies that have codified the Common Rule, effective January 21, 2019. The IRBManager Electronic Submission Platform has also been updated to support the new requirements.
Major changes in the regulatory landscape can be challenging, and Tulane is committed to working with its research community to make this transition as straightforward as possible. We have several new and updated resources are available on our website.
Our HRPP Standard Operating Procedures (SOPs) have been revised to address the Common Rule changes and include details on when compliance with the revised Common Rule is required and how to comply. The SOPs are available on our “Policies” page.
New Informed Consent templates are available on the “For Investigators” page.
Changes to the Common Rule are intended to modernize, simplify, and enhance oversight for human subjects research. The revised regulations seek to reduce administrative burdens and better protect research subjects, making informed consent more meaningful so that research subjects will have the necessary information to make decisions.
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.
With that said, the HRPO has implemented a plan to help make the transition from Old to New Common Rule as smooth as possible.
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 meet with HRPO staff to discuss your research project or if you are interested in scheduling a group training session, please click below:
If you would like to receive occasional news and updates from HRPO and the IRB, please click below:
Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112