Guidelines & Definitions

Safeguarding the rights and welfare of human subjects in research is a general institutional policy delegated by the President through the Academic Vice President to the Institutional Review Board (IRB). The IRB's policies are in compliance with the Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects (45CFR46). Any research project involving human subjects which is conducted by Xavier University faculty, staff, or students, or that takes place on the Xavier University campus, is subject to review and approval by the IRB. Key requirements for approval include:

  • Risks to subjects are minimized and are reasonable in relation to the anticipated benefits Selection of the subjects is equitable
  • If applicable, there are appropriate procedures for obtaining and documenting voluntary Informed consent
  • There are adequate provisions for the safety of subjects with special protections for vulnerable subjects
  • There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

Additional Guidance

List of selected activities as applied to the federal definition of human subject research.