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The University of Washington respects and values the volunteers who participate in University research. Strong adherence to ethical principles and to protection of participants’ rights and welfare is an institution-wide responsibility that is part of the University’s commitment to integrity and high quality in all of its activities. The University’s human research protection program is essential for maintaining the public trust in the value and oversight of the University’s research activities.
1. Principles
In order to protect the rights and welfare of human subjects, the University conducts research with human participants in accordance with the ethical principles of the U.S. Department of Health and Human Services’ Belmont Report: respect for persons, beneficence, and justice. The commitment to the Belmont principles is codified in a legally binding Federalwide Assurance between the University and the federal Office of Human Research Protections.
2. Policy Provisions
A. Responsibility
The University recognizes and accepts its responsibility for ensuring that research involving human participants abides by the Belmont ethical principles and with all federal regulations, state laws, and University policies governing such research. This responsibility is shared with University researchers, research staff, employees, and students.
B. Administration and Oversight
The University has established an administrative and oversight structure in the Office of Research, through the Vice Provost of Research, to facilitate and assure excellence in research with research participants as well as full compliance with applicable principles, regulations, laws, and policies. This includes the Institutional Official identified on the Federalwide Assurance, the Human Subjects Division, the Institutional Review Boards (IRBs), the Faculty Council on Research, the Human Subjects Advisory Board, and the Research Advisory Board. Most policies and procedures relating to research with human participants are developed, implemented, and enforced by delegated authority to the Human Subjects Division, in consultation with the IRBs and other appropriate University bodies.
C. Authority and Autonomy of the Institutional Review Boards (IRBs)
The University and its researchers recognize the authority and autonomy of the University IRBs, as outlined in the University’s Federalwide Assurance, applicable federal regulations, and by delegated authority. All University-conducted research with human participants that is not exempt from applicable regulations is required without exception to have prior approval from the IRB before the research is initiated. The IRB has sole authority to grant IRB approval for research with human participants. By specific federal regulation (45 CFR 46.112), if the IRB does not grant IRB approval (or suspends or terminates IRB approval), these decisions may not be overturned at any higher level. Implementation of IRB-approved research may be prevented or terminated by decision of other levels or offices of the University, although the IRB approval is not voided by such action.
D. Risks to Human Participants
Risks to human participants may be physical, psychological, social, legal, economic, or reputational. They vary in probability, magnitude, and duration. The University recognizes and accepts its dual responsibilities to protect participants by:
- Reducing risks as feasible, and
- Ensuring that the research consent process leads to an informed and voluntary decision about whether to participate that is free of undue influence or coercion and is made only after appropriate description of the research and its risks. This may require additional efforts with vulnerable populations.
E. Discretionary Assistance to Injured Research Participants
In recognition of the risks that may be assumed by individuals when they participate in research, the University, in its sole discretion, may offer medical and other treatment-related assistance, on a no-fault basis, to participants who, in the course of University-conducted research, experience adverse effects. The no-fault assistance program is administered by the Human Subjects Division, with significant participation by the Office of Risk Management, UW Medicine, and Health Sciences Risk Management.
F. Facilitation of Research
The University seeks to fulfill its ethical and compliance responsibilities in a manner that facilitates the entire breadth of its research mission, which ranges from qualitative observations to controlled trials in virtually every academic discipline. Risks to research participants vary from none to significant. In recognition of this wide variability, the University carefully considers and employs the flexibility built into the ethical principles, regulations, and its Federalwide Assurance so as to develop policies and ensure participants protections that are commensurate with the level of risk to participants.
3. Responsibility to Report
Anyone who becomes aware of an ethical concern, noncompliance or other problem concerning University research with human participants has a responsibility and right to notify the Human Subjects Division for investigation of the issue. Concerns and complaints may be brought to the attention of the Human Subjects Division.
June 7, 1972; November 20, 1975; June 15, 1976; October 1, 1982; September 12, 1990; June 8, 2005; October 11, 2013; RC, January 26, 2015.
For related information, see:
- Board of Regents Governance, Regent Policy No. 40, “Policy on Assistance for Human Subjects”
- Executive Order No. 8, “Classified, Proprietary, and Restricted Research”
- Executive Order No. 25, “Allocation of Institutional Allowances Associated with Graduate Fellowships”
- Executive Order No. 26, “Internal Support of Graduate Study and Research”
- Executive Order No. 34, “Grant and Contract Support of University Activities”
- Executive Order No. 53, “Animal Use”