ETHICS and RULES

Our policies are based upon ethical principles put forth in the Belmont Report, international codes (Nuremberg Code and Declaration of Helsinki) and federal regulations (45CFR Part46 and 21CFR Parts 50 and 56).

MEMBERS and STAFF

The IRB is an administrative body established to protect the rights and welfare of human research subjects participating in biomedical, behavioral and social research activities conducted under the auspices of the Tulane University Health Sciences Center. The Tulane Biomedical IRB (roster) is composed of 20 regular members and 9 alternate members as well as consultants. We are fortunate to have representation from the Medical School, the School of Public Health, the New Orleans VA Hospital, the Medical Center of Louisiana, Tulane University Hospital and the New Orleans community. Among the members are legal counsel and a clergyman; physicians, nurses and other medical professionals with expertise in medicine, surgery, psychiatry, neurology, obstetrics and gynecology, pediatrics, radiology, pharmacology and biostatistics. We have two regular consultants, one in medical bioethics and the other in social sciences research. The office staff consists of dedicated, full time people experienced in IRB policy and procedures and always willing to help an investigator or study coordinator.

MEETINGS

The IRB Calendar includes twice monthly meetings, usually the second and fourth Thursday of each month. Every effort is made to review and vote on all material submitted by the meeting deadline (Wednesday afternoon, one week before meeting). Within one week of each meeting, letters describing IRB concerns and actions are sent to those principal investigators whose protocols and correspondence were reviewed.

FEDERAL WIDE ASSURANCE

The IRB's authority and obligation to approve, require modifications in or disapprove research involving human subjects is described in a document called the Federal Wide Assurance (FWA). This document is a formal agreement between the Department of Health and Human Services' (DHHS) Office for Human Research Protection (OHRP) and Tulane University to assure that human subjects involved in research will be protected.

We are required to provide a copy of this to each investigator whose research is reviewed by this IRB. If you have any questions about the FWA, please feel free to contact the IRB office at 988-2665.

WHAT REQUIRES IRB REVIEW?

All research which involves human subjects must be reviewed by the IRB.

Human Subject means a living individual about whom an investigator

Intervention includes manipulation of the subject or subject's environment as well as physical procedures.

Private information includes

WHAT IS RESEARCH?

Research means a systematic investigation, designed to develop or contribute to general knowledge. If you intend to publish your findings, you are most likely conducting research. At Tulane, all research involving human subjects requires IRB review and approval before research activities begin. This includes all studies, regardless of degree of risk or the source of funding. Simple, low risk studies such as surveys may qualify as exempt from IRB review under federal regulations. Exemptions can only be granted by the IRB. Investigators at Tulane may not declare their own studies exempt.

Further clarification regarding IRB-covered activities is available on the Tulane server at http://www2.som.tulane.edu/IRB/mpa/tsld001.htm. If you aren't sure whether your project requires IRB review call the IRB office at (504) 988-2665. One of us will be happy to help you.