OFFICE OF RESOURCE DEVELOPMENT
Ann Smith, Director of Sponsored Programs Administration
Leigh A. Mogilles, Coordinator of Sponsored Programs
To be eligible for federal research funds, and to continue expending these funds after awarded, the University must comply with federal and state statutes and regulations related to research compliance. The Office of Sponsored Programs coordinates the workings of Xavier’s internal compliance committees whose purpose is to review, approve and regulate any research involving human subjects, animal testing, biohazardous materials and recombinant DNA, and radiation exposure. These committees are described below. Committee Chairs and members can be contacted through the Office of Sponsored Programs.
CITI Collaborative Institutional Training Initiative
Xavier University offers web-based research training through a subscription with Collaborative Institutional Training Initiative. CITI training provides research ethics education to all members of the research community. Xavier offers training in the following areas:
- Animal Care and Use
- Human Subjects Research
- Biohazard/Radiation Safety
The CITI course is a protected site. New researchers (students, faculty, and staff) at Xavier University are required to participate in research training through the CITI program. Below is the link for registering on CITI by creating a username and password:
When registered and logged in, click the “new users” section and complete the information requested by Xavier University.
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
- Xavier’s IACUC is governed by the Animal Welfare Act of 1966 and the regulations set forth by NIH’s Office of Laboratory Animal Welfare and the Animal Care Division of the USDA. Strict compliance with these guidelines and regulations promotes the humane treatment of animals used in research and education.
- Xavier’s OLAW Assurance number is A 3024-01
- The IACUC’s membership is in accord with 7 USC § 2131. The committee has a Chair with animal research expertise, a Veterinarian with laboratory animal experience, a non-affiliated member, and faculty with and without scientific research experience.
- Xavier’s Policy and Procedures Manual for the Animal Care facility is found in the Guide For the Care and Use of Laboratory Animals, an OLAW publication, available in Xavier’s Animal Care Facility.
- The IACUC Policy and Procedures Manual sets forth the guidelines for the IACUC’s approval or disapproval of new research projects, its continued review of ongoing projects, as well as the training, safety, and reporting requirements necessary to comply with all federal regulations.
- A Research Protocol Application is available for online application to the Committee Chair.
- Xavier has an Occupational Health Screening procedure for lab personnel.
- Xavier’s website has online confidential semiannual reporting for all IACUC members via the Blackboard system.
- The animal facility is inspected frequently, including
- Semiannual inspection of the Animal Care Facility by the IACUC
- USDA annual inspection by the Animal Plant Health Inspection Service
- Random and unannounced inspections by OLAW and USDA
- The IACUC’s reporting requirements are:
- Annual report to OLAW
- Annual report to USDA
- Four-year Assurance renewal to OLAW
- Semiannual reports to the Institutional Official
INSTITUTIONAL BIOHAZARD COMMITTEE (IBC)
- Xavier University is committed to the safe and ethical use of biologically hazardous materials. The Institutional Biohazard Committee assures that all activities involving biohazardous materials meet the ethical and legal requirements for the responsible use of these agents.
- The IBC is responsible for reviewing all research and teaching activities conducted by faculty, staff, students and/or visiting scientists on Xavier’s premises that involve the use of biohazardous materials: specifically regulated animal and plant pathogens, biological toxins, chemical toxins, and recombinant DNA molecules.
- The IBC is composed of a Chair and no less than five members who meet the educational and societal dictates of NIH regulations.
- The IBC Policies and Procedures Manual establishes the functions and duties of the Committee, as well as the guidelines for safe biohazard research.
- A Research Protocol Application is available for submission online to the Committee Chair.
INSTITUTIONAL REVIEW BOARD (IRB)
- Regulated by the policies and procedures as published in the Code of Federal Regulations by the Department of Health and Human Services, the IRB is charged with the protection of human subjects used in research and has adopted the policies and procedures of the World Medical Association Declaration of Helsinki and the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- Xavier’s Federalwide Assurance (FWA) number is 00004443.
- IRB Policybook, version 6 sets forth Xavier’s Policy and Procedures that are followed by the committee.
- Xavier’s IRB Committee is compliant with appropriate federal regulations that require a diverse and educated membership with specific qualifications and training.
- Forms required for research protocol submission (must be a hard copy to Committee Chair) include:
RADIATION SAFETY COMMITTEE (RSC)
- The use of radioactive isotopes at Xavier University is regulated by the State of Louisiana Department of Environmental Quality (DEQ), because Louisiana is an “agreement state.” The RSC establishes the policies, procedures, safety methods, and training for radiation safety controls within the campus facilities in compliance with the DEQ regulations and any regulations covered by the National Regulatory Commission.
- The RSC insures that radiation exposure will be at acceptable ALARA standards (“As Low as Reasonably Achievable”).
- The RSC Policy and Procedures Manual establishes the duties and requirements of the Committee.
- The Radiation Safety Manual is available for all personnel working in and around radioactive material.
- A Research protocol application is available for online submission to the Committee Chair.
- The RSC maintains control over all monitors and detection devices.
- The RSC is composed of a Chair, a Radiation Safety Officer, with scientific expertise and specific training, and a member of the Administration who is not a scientist.
- Public trust in the integrity and ethical behavior is essential to research and other scholarly pursuits at Xavier University. While federal funding agencies place the responsibility on Xavier to prevent and detect research misconduct, Xavier places the responsibility on each member of the academic community to foster an environment that promotes intellectual honesty and integrity.
- Research misconduct includes the fabrication or falsification of data, plagiarism, callous disregard of human subjects, animal subjects, or the public at large, failure to disclose financial conflicts and the failure to comply with applicable regulations.
- Xavier’s Policies and Procedures Manual establishes the method for reporting, investigation and final determination of a research misconduct allegation.
- Violations of Xavier’s Research Misconduct policy will be considered a serious breach of trust and may involve disciplinary sanctions.
- Every student and employee of Xavier University is charged with a duty to report evidence of research misconduct.