• Research Integrity
• Conflict of Interest Policy
• Use of Animals in Research and Teaching
• Human Subjects
• Health and Safety Compliance

Research Integrity

The Fraud in Research Policy in the Tulane Faculty Handbook states: "It is the responsibility of all investigators to conduct their professional activities according to high standards of scholarship. Their responsibility to the community at large demands that they be honestly and sincerely devoted to the ideals of discovery and dissemination of truth and knowledge. Fraud in research undermines the academic enterprise. Institutions engaged in research have a responsibility, not only to provide an environment that promotes integrity, but also to establish and enforce policies and procedures that deal effectively and expeditiously with allegations or evidence of fraud."

It is within this framework that Tulane faculty are expected to conduct their research pursuits. The research environment is increasingly complex, and personal responsibility and integrity are essential to the research undertaking. There are general principles which can help guide research performance such as access to all data and research products by research chiefs, supervisors and collaborators, the proper recordation of data in permanent data books (for a further description of good record keeping practices, see Office of Technology Development web page, the open discussion of research activities, and the assurance of accuracy of data and scientific content through a comprehensive review by all authors or collaborators.

The Fraud in Research Policy sets forth the process used to resolve allegations of fraud. It is premised on an atmosphere of fairness and confidentiality and has been designed to maintain the integrity of the process, while resolving charges in an expeditious manner.

Conflict of Interest Policy

The purpose of the Tulane Conflict of Interest (COI) Policy is to safeguard the integrity and reputation of Tulane and its faculty, staff, and investigators. It seeks to foster the proper and unbiased conduct of sponsored research and other academic activities by providing guidelines and mechanisms for dealing with actual or perceived conflicts of interest. The policy can be found on the Office of Research web page.

The Conflict of Interest Policy states that faculty, staff, and administration of Tulane University have a common interest in the success of its academic pursuits, which requires an allegiance based on fairness and trust. Since academic enterprises may be vulnerable to conflicts of interest, teaching, research, promotion, the awarding of tenure, and the use of resources must be carried out in a manner consistent with the pursuit of academic achievement.

Tulane's policy requires annual disclosure of outside professional activities and other financial involvement that might be relevant to an individual's academic activities. In addition, the policy covers members of the individual's family whose financial interests might be relevant. Disclosures are updated as needed, such as when there is a significant change in the information or when an individual considers entering into an arrangement that might be viewed as a conflict. Disclosure statements are reviewed and maintained in confidence by the institution. When a potential conflict of interest exists, the review may involve a Conflict of Interest committee which will consider the circumstances described in the disclosure and work with the individual to resolve the issue. The policy sets forth the procedures that apply and the recourses available to an individual who does not agree with a determination.

In addition to the annual certification, the Proposal Routing Form includes a statement relative to Conflict of Interest. The PI must certify the presence or absence of certain conditions on each proposal submission. PIs provide certification that they will abide by Tulane University policy on conflict of interest and that no conflict of interest exists for any key personnel involved in the project.

Use of Animals in Research and Teaching

Tulane University is committed to the humane and proper treatment of animals used in research and teaching. It is the responsibility of the University to ensure that all research experimentation conducted under its auspices, whether funded or non-funded, classroom or laboratory, follow the regulations and guidelines mandated by the "Animal Welfare Act" (P.L. 89-544, as amended) and NIH Publication 86-23. In this regard, the Uptown Campus Institutional Animal Care and Use Committee (IACUC), a subcommittee of the Committee on Research, was established to oversee animal use in research and instruction, and to ensure compliance with regulations regarding the humane and ethical treatment of animals. Any projects involving use of live animals (vertebrates, warm- and cold-blooded) must be reviewed and approved by the IACUC.

Procedures for Using Animals

Investigators planning projects that involve the use of live animals must submit an Animal Use Protocol to the IACUC through the Office of Research, its administrative liaison. Protocol forms may be obtained from the Office of Research, from the IACUC Chairperson, or on the Office of Research web page. The investigator should submit a completed protocol form in advance of any animal experimentation to the Office of Research for dissemination to the IACUC. The IACUC meets once a month to review animal use protocols, so allow ample time for this process. In the event a protocol cannot be submitted to the IACUC in advance of proposal submission to a sponsoring organization, the PI should indicate in the appropriate space on the proposal cover page that IACUC approval is "pending" and submit the protocol as soon as possible thereafter. The Office of Research will not process an award involving animals until an animal use protocol has been reviewed and approved by the IACUC.

The IACUC considers each protocol and makes one of three recommendations: "approved," "disapproved" or "pending until receipt of additional information/changes." Faculty will be notified of any such action and given an opportunity to submit additional information if required. Once a protocol is approved by the IACUC, a protocol approval number is assigned and used when ordering animals for the approved research.

If a protocol is disapproved, the IACUC Chair will contact the investigator with the Committee's comments and recommendations. In some cases, a complete resubmission of the protocol may be required. A protocol deemed pending usually needs clarification. The IACUC Chair will notify the faculty member of the requested clarification and, upon receipt of the information, may approve the protocol without another full committee review.

An approved protocol can remain active for a maximum of three years, subject to the number of animals approved for use and an annual institutional review of the protocol status. An Annual Protocol Status Review form letter is sent to each investigator one to two months before the end of each approved protocol year. The PI should describe status of the protocol and return the form to the Office of Research, where the reports are reviewed and maintained. If a discrepancy arises between the status report and the protocol, the Office of Research will forward the information to the IACUC Chair for review. If the research is still in progress at the end of the third year of an approved protocol, the investigator must submit a new protocol in accordance with federal guidelines, regardless of whether the protocol has changed.

Federal guidelines also require that any changes to an approved protocol be documented and approved by the IACUC. Examples of changes include an addition or deletion in the number of animals used, a change in species, or a change in previously approved procedures. Most changes to an existing protocol can be reviewed and approved by the IACUC Chair without full IACUC review. Such changes must be requested on a Protocol Amendment Request form and include a detailed description and a justification. These forms are available in the Office of Research or on its web page.

Ordering Animals

Only designated individuals in the vivarium or the Office of Research are authorized to place orders for research animals. Investigators may not place orders directly with a vendor. To order animals, submit to the Office of Research a requisition which includes the number of animals to be ordered, the species, and any specific requirements such as age, sex, timed pregnancies, etc., the preferred vendor, the requested delivery date, the grant/contract account number to be charged, and the approved protocol number. The Office of Research will review the requisition to ensure that an approved protocol exists, the number of animals does not exceed the approved amount, and the funds are available in the grant/contract account. Once the request is reviewed and approved, the Office of Research will order the animals and notify the vivarium of the anticipated delivery. All ordering expenses are charged back to the investigator or department, along with the per diem charges incurred for the daily maintenance of animals.

All non-aquatic animals are housed in the Stern Hall vivarium. Special permission may be given by the IACUC to house aquatic animals such as fish or frogs in an investigator's laboratory. Animals in the vivarium are cared for by trained veterinary technicians and supervised by a veterinarian with credentials in laboratory animal medicine. The technicians are available to perform procedures approved in the protocol, implement special diets, or effect special housing conditions. Animal per diem rates are posted on the Office of Research web page.

Human Subjects

All research involving human subjects conducted by all Tulane personnel on the uptown campus must adhere to well established ethical standards in order to protect the rights of their subjects. The safety and privacy of participants must be protected. Subjects must give informed consent to the research and may not be exposed to unnecessary risk. To these ends, and in compliance with federal regulations, Tulane has adopted policies governing the conduct of all research using human subjects. Research design and execution must satisfy the following conditions:

• Research procedures should minimize the risk of psychological and physical harm to the subjects.
• Any remaining risk must be reasonable in relation to anticipated benefits.
• Research must respect the privacy of subjects.
• The investigator shall make available to the subjects information they request about any aspect of the research likely to be significant to them.
• The research shall not induce subjects to participate by means that might affect their ability to decide freely about their participation.
• Investigators who promise confidentiality are responsible for maintaining it and for informing subjects of limits on the capacity to meet this responsibility.
• Investigators shall explain to subjects, prior to their participation, the purposes of the research. Deception of human subjects is allowable only if necessary for the experiment, and then must be followed by a complete debriefing.

Federal regulations for the protection of human subjects in research establish six broad categories of research activity that are exempt from the federal policy. In general, these categories involve research that is routine and has minimal risk. Examples of exempt research include that which is conducted in established or commonly accepted educational settings involving normal educational practices (instructional strategies or curricula), that which involves the use of educational tests or survey procedures if information is recorded so the subject cannot be identified, that which involves the collection of existing data, records or specimens, and that which involves the evaluation of taste and food quality. This list is representative rather than fully inclusive. For a particular question, contact the Office of Research or the IRB Chair. To obtain an exempt status designation, a protocol must be submitted to the Office of Research for review by the IRB Chair or designee. Non-exempt research involving human subjects must be reviewed by the IRB committee.

Any research involving human subjects which is not exempt requires IRB approval prior to initiation. Protocol forms are available in the Office of Research or can be downloaded from the Office of Research web page. Returned the completed form to the Office of Research, which will distribute it to the IRB. If a protocol corresponding to the research has not been approved by the IRB at the time of grant proposal submission, the proposal will note that IRB review is pending. Once the protocol is approved, a signed certification will be sent to the agency by the Office of Research.

Some categories of research qualify for expedited or abbreviated review. Minor changes to a protocol approved within the past year may be granted through an expedited procedure. In addition, research activities involving no more than minimal risk and in which human subjects are involved only in prescribed categories may be reviewed through an expedited procedure. Categories which qualify for such an abbreviated review include collection of hair, nail clippings, or teeth, collection of excreta and external secretions, voice recordings made for research purposes, moderate exercise by healthy individuals, collection of blood samples, the study of existing data, documents, records, pathological specimens or diagnostic specimens, and research on individual or group behavior or characteristics such as studies of perception, cognition, game theory, or test development, and recording of data from subjects 18 years or older using non-invasive procedures routinely employed in a clinical practice. This partial list illustrates the type of research eligible for expedited review; for specific questions contact either the Office of Research or the IRB Chair.

Under an expedited review procedure, the review may be carried out by the IRB Chair and one or more experienced reviewers from the IRB. While the reviewers may exercise all of the authorities of the IRB, they may not disapprove the research. In such an instance, the protocol is sent to the full committee for review.

Several departments, including Psychology, Sociology and Social Work, have departmental human subjects committees which review protocols before IRB submission. These committees have no authority to approve protocols, but rather review them for compliance with federal regulations. They may require modifications or changes to methodology, research design, etc., and may also recommend that a protocol be categorized as exempt or eligible for expedited review. Final determination of exemption or expedited review, however, is made only by the IRB. Once the departmental committee review is complete, the protocol is forwarded to the Office of Research for distribution to the IRB for final review and approval.

If the IRB approves a protocol with no changes, the Office of Research notifies the researcher by letter. If revisions are necessary, the IRB Chair sends a revision request to the investigator. Once the protocol has been amended to the satisfaction of the IRB Chair (unless the IRB Committee has stipulated review of changes prior to approval), the IRB Chair notifies the Office of Research to issue an approval letter.

Approval is effective for one year, after which another protocol must be submitted and approved. Any changes to ongoing research also must be approved by the IRB in advance of implementation. Any unanticipated problems involving risks to subjects or others must be reported immediately in writing to the IRB Chair.

Health and Safety Compliance

Funded and non-funded research involving radiation, radioactive isotopes, biohazardous waste, or recombinant DNA are subject to special regulations. Investigators planning projects involving such materials should note the anticipated use on the Proposal Routing Form and contact the Office of Environmental Health and Safety (OEHS). In certain instances, OEHS approval may be required. OEHS is responsible for the pick up and disposal of biohazardous waste and will assist in developing proper disposal and inventory records. OEHS will work with PIs to develop and implement waste minimization procedures and inform them of pertinent material requirements. In addition, an OEHS staff member is designated to monitor radiation control activities and direct investigators in the proper handling of radioactive materials.

Research involving the use of recombinant DNA is reviewed by the Tulane Medical Center's Institutional Biosafety Committee. The Laboratory Wastes and Safety Committee for the uptown campus promotes laboratory safety, develops policies and practices to comply with state and federal waste disposal regulations, and ensures that the University monitors hazardous substance disposal in an environmentally sound manner.