Human Subjects and IRB Review
General Guidelines and Data Handling
The approach to protecting human subjects is guided by the ethical principles and guidelines
outlined in the Belmont Report: respect for persons, beneficence, and justice. These ethical
principles are legally codified in the human subjects protection and regulations for the
Department of Health and Human Services (DHHS), under Title 45 CFR Part 46. Subpart A of
these regulations has been accepted as the “Common Rule” by many other federal agencies
that sponsor human subjects research.
Tulane University holds Federal-wide Assurances [Tulane University FWA No. 00002055) with
the DHHS Office for Human Research Protections (OHRP). These assurances are our formal
agreements with OHRP to ensure that all of our human subjects research is conducted in
accordance with 45 CFR 46 (and the FDA regulations, where applicable), including the
requirement for Institutional Review Board (IRB) review and approval. In addition to the federal
regulations, we take into consideration any state or local laws regarding human subjects that
may be more protective than the federal statutes.
Tulane University maintains an IRB that is responsible for reviewing and approving any human
subject research in which their staff are engaged, following the applicable regulations. All IRB
members are experienced and up-to-date in IRB issues. The Board contains Certified IRB
Professionals (CIP designations). The IRB meets regularly to provide timely review of all new
and ongoing projects.