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Deans, department chairpersons, program directors, faculty advisers, and individual investigators must be familiar with IRB policies and procedures as detailed throughout the IRB website. Interpretation of IRB policies and procedures is solely the right and responsibility of the IRB.
The University and the IRB recognize that honest errors may occur in the research process. To distinguish instances of knowing and willful research misconduct from “honest” errors, simple carelessness, and minor infractions, the IRB may conduct a for-cause audit.
For the purposes of IRB policy, research misconduct means knowing and willful non-compliance with requirements of the conduct of research involving human subjects. Examples of research misconduct might include:
Under 45 CFR 46.113 requirements, the IRB will perform this review when concerns regarding compliance, protocol adherence, or subject safety arise. This audit may take place on-site or on the Seattle University campus, at the discretion of the IRB, and may include review of:
The IRB will report all instances of human subject non-compliance to appropriate University officials, and depending on the severity of the event, also to OHRP, according to stated Federal reporting requirements and guidelines (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html).
University faculty, staff, and students who violate IRB policies and/or Research Misconduct may be subject to sanctions relating to their participation in research involving human subjects. Actions taken by the IRB and the University may also be subject to Federal reporting guidelines.
Seattle University is committed to supporting a research community of the highest integrity, especially with regard to the collegial, professional and ethical process of conducting research. To help promote research integrity, this policy issued by the Office of the Provost defines (a) “Research Misconduct,” (b) the steps for making an allegation of Research Misconduct, (c) the steps for examining and acting on such allegations and (d) the efforts the University will make to foster responsible conduct and provide training intended to prevent Research Misconduct. For more information, please review the policy and the procedure for reporting such allegations (both updated Feb. 2017):
For information about general policies and guidelines for SU faculty, please see the SU Faculty Handbook.
For information about research supported through the Office of Sponsored Projects, please see their website and accompanying policies.
The Office of Human Research Protections (OHRP) is the Federal authority that issue guidance on the welfare and protections of individuals involved in human subjects research.
The Federal Policy for the Protection of Human Subjects, known as the Common Rule, establishes regulations for all research involving human subject participants. OHRP within the Dept. of Health and Human Services retains general jurisdiction over these matters.
Institutions receiving Federal funds must have an Institutional Review Board (IRB) 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 ((FWA, on file with HHS) commits the University to abide by the Common Rule for all federally funded research.
Additionally, Seattle University's FWA has assured the Federal government that it will review all human subjects research according to the ethical principles of the Belmont Report, regardless of whether studies are funded.
Published in 1974 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report identifies three ethical principles for research involving human subjects and offers guidelines for meeting those principles: respect for persons, beneficence, and justice.
Individuals should be treated as autonomous agents and persons with diminished autonomy should be protected.
A researcher must employ safeguards to maintain a person’s maximum exercise of autonomy while protecting that person from detrimental effects of choices. Sometimes, this means excluding the person from participating in decisions that affect the person. (Application: The informed consent process must provide enough information to ensure the participants' full understanding of risks/benefits, as well as emphasizing the voluntary nature of participation.)
Do not harm.
Beneficence justifies conducting research that benefits society at large even if no likely benefit exists for individual participants -- for example, finding better ways to treat childhood diseases justifies involving children in research. (Application: Assess risk appropriately in terms of nature and scope, systematic assessment, minimizing risks and maximizing benefits.)
Equals should be treated equally.
In selecting subjects, do not offer beneficial research opportunities only to certain populations and possible negative participation experiences to others. (Application: Use fair and reasonable inclusion and exclusion criteria. Are certain people being included or excluded for a reason related to the research objectives, or merely due to convenience?)