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, the Office of the Provost has provided a definition of “Research Misconduct,” the steps for making an allegation of Research Misconduct, the steps for examining and acting on such allegations, and the efforts the university will make to foster responsible conduct and provide training intended to prevent Research Misconduct.
For more information, please review the policies and the procedures available on the Academic Affairs website, paying particular attention to the latest version of the SU Faculty Handbook.
For information about research supported through the Office of Sponsored Projects, please see their website and accompanying policies.
The Seattle University IRB is registered with the U.S. Office for Human Research Protections (OHRP) and the U.S. Department of Health & Human Services (HHS). Its Federal Wide Assurance (FWA) has been approved by the OHRP.
This registration and approval means that the SU IRB its Office of Research Oversight is tasked -- by both the university and federal authorities -- with ensuring institutional compliance around research involving human subjects and their data.
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 and its Office of Research Oversight.
Seattle University and the SU 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 governing 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 at the research site or on the Seattle University campus, at the discretion of the IRB, and may include review of:
Review of research materials by the IRB may include the following:
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 the federal governing body. This latter would be the OHRP, and in accordance with stated Federal reporting requirements and guidelines (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html).
University faculty, staff, and students who violate institutional IRB policies and/or violate federal regulations and/or engage in Research Misconduct may be subject to sanctions relating to their participation in research involving human subjects. Actions taken by the IRB and Seattle University may also be subject to federal reporting guidelines.
The Office of Human Research Protections (OHRP), within the Department of Health & Human Services, is the federal authority that issues guidance on the welfare and protections of individuals involved in human subjects research. The OHRP is also the authority with whom U.S. institutions register their IRBs and obtain their FWAs.
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 IRB’s Federal Wide Assurance (FWA), which is on file with the HHS, commits Seattle University to abide by the Common Rule for all federally funded research.
Please refer here for Further OHRP Guidance.
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 HHS retains general jurisdiction over these matters.
Additionally, Seattle University IRB'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 1978 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 them.
The principles are Respect for Persons, Beneficence, and Justice.
"Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy." -The Belmont Report, 1978
What this means for a researcher at SU: 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 in a research project. Certain populations require more extensive safeguards to ensure no coercion to participate took place.
"Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being... The term 'beneficence' is often understood to cover acts of kindness... In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms." -The Belmont Report, 1978
What this means for a researcher at SU: Beneficence justifies conducting research that benefits society at large even if no direct benefit exists for individual participants -- but the researcher must assess risk appropriately in terms of its nature and scope, assessing how to minimize risks and maximize benefits to participants.
"Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of 'fairness in distribution'... Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits... These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit." -The Belmont Report, 1978
What this means for a researcher at SU: In selecting subjects, do not offer beneficial research opportunities only to certain populations and possible negative participation experiences to others. In other words, 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?