Human Subjects Research Policy
Lewis & Clark College is committed to the conduct of quality research in an ethical and responsible manner to further science and to 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). Lewis & Clark College requires that all research conducted by faculty, staff, or students involving human subjects be reviewed and approved by the Institutional Review Board (“IRB”) prior to research initiation. An “exempt” determination must be made by the IRB after review by the IRB, not by the investigator. In addition, investigators must complete designated training in human subjects research as part of the protocol review process.
- 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.”
Regardless of the source of support, all activities related to human subjects’ research at Lewis & Clark will be guided by The Belmont Report. The Belmont Report, released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, provides the ethical framework for the federal regulations designed to protect human research subjects.
In addition, Lewis & Clark has a Federalwide Assurance (FWA), approved by the Office for Human Research Protections (OHRP), which applies whenever Lewis & Clark becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule). This FWA may not apply if the research is otherwise exempt from the requirements of the Common Rule or the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.
Institutional Review Board (IRB)
Lewis & Clark has established an Institutional Review Board (IRB) to ensure the protection of human research subjects. In accordance with 45 CFR part 46, the IRB must have 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 Lewis & Clark (or part of the immediate family of a person who is affiliated with the institution). The Vice President, Chief of Staff, General Counsel and Board Secretary 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 Academic Deans, the Institutional Official appoints all IRB members and the IRB chair to a designated term.
The IRB is the principal advisory source on human subjects research at Lewis & Clark and is the appropriate body for reviewing and investigating concerns or complaints involving human subjects. The IRB possesses appropriate knowledge of the local context in which Lewis & Clark’s 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 IRB, with the concurrence of the Institutional Official, is responsible for the development and implementation of standard operating procedures for the operation of the IRB and for the monitoring and oversight of human subject research activity at Lewis & Clark. The IRB has the authority to suspend or terminate approval of research activities involving human subjects that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. The IRB serves as a resource for investigators, staff, and administrators regarding the use of human subjects in research. The IRB complies with the Terms of the College’s Federalwide Assurance when reviewing research covered by this Assurance.
Regulatory Information Lewis & Clark College’s FWA Number: 00013631 Expiration Date: March 4, 2024
Adopted by Executive Council August 1, 2019