WMed fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted at, under the auspices of, or using the services or resources of the medical school. In the review and conduct of research, actions by the medical school are guided by the principles set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: respect for persons, beneficence, and justice. The actions of the medical school also conform to all applicable federal, state, and local laws and regulations. In order to fulfill this mission, the medical school has established a Human Research Protection Program (HRPP). The medical school HRPP, in collaboration with its research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted at, under the auspices of, or using the services or resources of the medical school. This includes research that is externally funded, funded from internal sources, or conducted without direct funding.
WMed holds Federalwide Assurance (FWA) #00009755 from the Office for Human Research Protections in the Department of Health and Human Services. This FWA is an agreement between DHHS and WMed to review and approve federally-sponsored research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.
Research is subject to the HRPP when it includes activities that are research involving human subjects as defined by either DHHS or FDA regulations. WMed becomes “engaged” in human subjects research, and therefore bears responsibility for protecting participants involved in the research, when its employees or agents intervene or interact with living individuals or obtain individually identifiable private information for research purposes. WMed is also engaged in human subjects research whenever it receives a direct DHHS award to support the research.