Whether working with University resources or the assistance of outside funds, SU faculty, staff, and students must protect the rights and welfare of human subjects: in brief, no subject in a research activity may be exposed to unreasonable risk to health or well‑being, and the benefits of the proposed study must outweigh any potential risks of participation.
To assist researchers in meeting these goals, the SU IRB has developed policies and procedures in accordance with Federal human subjects regulations and best practices in the field of human subjects research, while remaining sensitive to the unique nature of Seattle University and its other guiding policies. The IRB takes responsibility for communicating these expectations to the SU community and for providing clear procedures through which to meet them. (See Definitions for key terms used in human subjects research and review.)
The Federal Policy for the Protection of Human Subjects, known as the Common Rule, establishes regulations for all research involving human subject participants. Sixteen Federal departments and agencies have adopted these regulations including: the Office of Science and Technology Policy, Dept. of Agriculture, Dept. of Energy, NASA, Dept. of Commerce, Consumer Product Safety Commission, International Development Cooperation Agency (AID), Dept. of Housing and Urban Development, Dept. of Justice, Dept. of Defense, Dept. of Education, Dept. of Veterans Affairs, EPA, Dept. of Health and Human Services (Office of the Secretary & FDA), NSF, and Dept. of Transportation. The Office for Human Research Protections (OHRP) within the Dept. of HHS retains general jurisdiction over these matters.
Institutions receiving funds from any of the above departments/agencies must establish institutional review boards to review and monitor all funded human subject research. Additionally, institutions must submit periodic letters of assurance to the Federal government indicating compliance with the regulations. Seattle University’s Federalwide Assurance (on file with HHS) commits the University to abide by the Common Rule regulations. Moreover, Seattle University has assured the Federal government that it will review all research proposals involving human subjects regardless of whether they are funded.
Researchers may not initiate any aspect of human subjects research (even recruitment) until IRB approval has been granted in writing. (IRB approval may not be granted retroactively.) Approval of proposed research is valid for one or two years upon written notification, as indicated in the approval letter.