Evergreen is committed to the conduct of quality research in an ethical and responsible manner to further science and improve the health of society. All research involving human subjects must be conducted in compliance with all applicable federal, state and local regulations, including the requirements outlined in the HHS Protection of Human Subjects regulations at 45 CFR part 46 (Protection of Human Subjects 2017). The college requires that all research conducted by faculty, staff or students involving human subjects be reviewed and approved by the Institutional Review Board prior to research initiation.
HHS regulations 45 CFR 46.102(l) defines research as a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
HHS at 45 CFR 46 defines a human subject as a “living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.”
All activities related to human subjects’ research at Evergreen will be guided by The Belmont Report and further guidance from the federal Office of Human Research Protections (OHRP).
Institutional Review Board
The Institutional Review Board was established to ensure the protection of human research subjects. In accordance with 45 CFR part 46, the board has at least five voting members. This includes at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in nonscientific areas, and at least one member who is not otherwise affiliated with Evergreen (or part of the immediate family of a person who is affiliated with the institution). The provost is the institutional official responsible for ensuring that the college’s human subjects research protection program functions effectively and is provided with the resources and support necessary to comply with applicable regulations. With input from the deans, the institutional official appoints all board members and the board chair to a designated term.
The board is the principal advisory source on human subject research at Evergreen and is the appropriate body for reviewing and investigating concerns or complaints involving human subjects. The board possesses appropriate knowledge of the local context in which research will be conducted and is responsible for ensuring that research involving human subjects is conducted in accordance with the highest scientific and ethical principles and is compliant with applicable regulations. The board, with the concurrence of the institutional official, is responsible for the development and implementation of standard operating procedures for the operation of the board and for the monitoring and oversight of human subject research activity. The board has the authority to suspend or terminate approval of research activities involving human subjects that are not being conducted in accordance with the board’s requirements or that have been associated with unexpected serious harm to subjects. The board serves as a resource for investigators, staff and administrators regarding the use of human subjects in research. The board complies with the terms of the college’s Federalwide Assurance when reviewing research covered by this Assurance.