As stated in the Federal Wide Assurances on file with the Office of Human Research Protection (OHRP; hhs.gov/ohrp/index.html), UMES is guided by the ethical principles stated in the Belmont Report and codified by the Department of Health and Human Services (DHHS) regulations at 45 CFR 46 (www.ecfr.gov/current/title-45), and the Food and Drug Administration (FDA) regulations at 21 CFR 50 (www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50) and 56 (www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56). UMES adheres to the guidance provided by the OHRP and by the FDA as part of that commitment. The UMES IRB also follows institutional policies that provide additional safeguards for human subjects, including those in place for the protection of vulnerable populations. This fundamental commitment to the protection of human subjects applies to all research overseen by the UMES IRB, regardless of the funding source or site of the research. The UMES IRB applies the same policies for the protection of human subjects in the United States to international research under their purview in addition to meeting international requirements.
UMES Statement of Commitment to the Principles Governing Human Subjects Research
