University Statement on Human Subjects Research
Texas A&M University is committed to the protection and safety of human subjects involved in research. As such, we take very seriously the need for compliance with applicable state and federal laws and regulations for human subjects research, and the need for compliance with the terms of the University’s Federal Wide Assurance for Protection of Human Subjects (as approved by the U.S. Department of Health and Human Services, Office of Human Research Protections), which provides our authority to carry out such research and receive federal funding for its support. The University is equally committed to the continued enhancement of our Human Subjects Protection Program (HSPP) in a manner that promotes compliance without compromising the conduct of outstanding research.
Investigators are responsible for reporting non-compliance to the Institutional Review Board (IRB) using the standard reporting form. Any change, divergence, or departure from the study design or procedures of a research protocol that affects the subject's rights, safety, or well being and/or the completeness, accuracy, and reliability of the study data constitutes non-compliance.
Changes or alterations in the conduct of the trial which do not have a major impact on the subject's rights, safety, or well-being, or on the completeness, accuracy, and reliability of the study data also represent non-compliance. For example, enrollment of more subjects than the number approved by the IRB is non-compliance and must be reported promptly.