The IRB is located in Hunthausen 125. Please use this address for all paper submissions via campus mail or personally delivered. To submit electronic applications, email irb@seattleu.edu (note: protocols submitted as Word docs or PDFs must be signed by PIs and faculty advisers). Questions? Don't hesitate to email or call (206) 296-2585. We're here to help make your research happen! We hope that your experience with the IRB will be a positive encounter whether engaging in new research or continuing previous studies
Remember: Always be sure to check this site and download the most recent forms! Do not save forms to your computer for future use, as they are frequently updated.
DID YOU KNOW? The IRB regularly offers pre-submission consultations to navigate the submission process. Whether you're a student or a seasoned researcher, we can help make your IRB experience go more smoothly. If you would like to meet to discuss questions or have a submission draft (at any stage!) reviewed, don't hesitate to contact the IRB to set up an appointment. Or if you have any concerns or confusion? We're here to help!
Mission
The primary goal of the Seattle University Institutional Review Board (IRB) is to create a favorable climate for the conduct of scientific inquiry and to guide that conduct involving human subjects while concurrently protecting the rights, well‑being, and personal privacy of individuals, as well as the interests of Seattle University. The IRB strives not only to ensure compliance with Federal regulations but also to foster the practice of research meeting the highest ethical standards and adhering to all principles, best practices, and policies related to research with human subjects.
The IRB works to ensure that all human subjects are treated with respect, beneficence, and justice during their participation in research conducted under the auspices of Seattle University. In accomplishing this mission, the IRB will:
- Promote awareness of and respect for the rights and welfare of all human subjects by educating students, faculty, and staff about the ethical principles and Federal regulations regarding research with human subjects.
- Inform researchers about the application of the Federal regulations and ethical principles in their particular area of research, as standards continue to evolve.
- Develop the most efficient methods for processing and reviewing applications, tracking and monitoring research activities, and conducting regular self-audits to ensure the continuing effectiveness of the IRB.
To assist the IRB in achieving these goals, all individuals conducting human subjects research must adhere to the guidelines outlined in this policy, which will be reviewed and approved every five years.
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, The Common Rule 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. It is the policy of Seattle University to apply the Federal regulations to all research and research related activities that involve living human subjects. The regulations require that all projects involving human subjects be approved by the IRB prior to the commencement of any data collection.
Definition of Research
Although many activities conducted by faculty, students, and staff may be labeled as research, the IRB reviews only those projects meeting all three criteria established by Federal regulations:
- The project involves obtaining data from a living human subject through intervention or interaction with the individual, or identifiable private information, AND
- The project is an intentional and systematic investigation using the prevailing methodologies in the discipline, including research development, testing, and evaluation, AND
- The ultimate aim of the project is to generate generalizable results expected to contribute to the development of knowledge in the discipline. (The concept of generalizability is usually applied to quantitative research, but applies to qualitative research as well because of the expectation to contribute to knowledge.)
Source: Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Part 46, Protection of Human Subjects (hereafter, 45 CFR 46).
Activities that meet these criteria constitute research for purposes of this policy, whether or not they are conducted or supported under a program considered research for other purposes (e.g., some demonstration and service programs may include research activities.)
Types of research reviewed by the IRB:
Click here for examples of Non-Research Activities that might appear to be research but do not meet the Federal definition, and would therefore be classified as "NHSR" (Not Human Subjects Research).
General Guidelines
The following guidelines apply to all research involving human beings, whether carried out solely with University resources or with the assistance of outside funds. The Seattle University IRB assumes responsibility for communicating and explaining these expectations to faculty, students, and staff, and for providing clear procedures through which to meet them. (See Definitions for key definitions used in human subjects research and review.)
- Seattle University faculty, staff, and students must accept responsibility for protecting the rights and welfare of human subjects.
- Appropriate professional attention and facilities must be provided to ensure the safety and well‑being of human subjects. No subject in a research activity may be exposed to unreasonable risk to health or well‑being.
- Before initiating research, the investigator will explain clearly any risk or potential stress or discomfort to the potential subject and ensure that the explanation has been understood. The investigator will obtain and retain for records the subject’s written consent on a form containing the substance of the explanation. (See “Sample Consent” documents on the Policies and Forms website.)
- Research involving children (i.e., persons under the age of majority—18 years in Washington State), legal incompetents, and persons unable to give informed consent will be IRB approved only with the permission of a parent or legal guardian or attorney‑in‑fact, or through a waiver issued by the IRB.
- The investigator must protect confidentiality of information received from subjects in experiments or from respondents to questionnaires both during and after the conduct of a research activity, within the limits of the law.
- A request by any subject for withdrawal from a research activity must be honored promptly without penalty or without loss of benefits to which the subject is otherwise entitled.
- The investigator must make every attempt to adhere to the research ethics outlined within the Belmont Report: respect, beneficence, and justice
IRB Staff
Dr. Andrea Rossing McDowell, IRB Administrator
Visiting Assistant Professor of Russian/Soviet Literature, Dept. of English
(206) 296-6125
mcdowela@seattleu.edu
IRB Members:
Dr. Bruce Koch, Albers School of Business and Economics, IRB Chair
(206) 296-5815
kochb@seattleu.edu
Dr. Deirdre Bowen, School of Law
Dr. Andrew Davis, School of Theology and Ministry
Dr. Michelle DuBois, College of Science and Engineering
Dr. Paul Holland, School of Law (Prisoner Advocate - ad hoc member)
Dr. Colette Hoption, Albers School of Business and Economics
Dr. William O'Connell, College of Education
Dr. Stefan Shipman, External Member
Dr. Mo-Kyung Sin, College of Nursing
Dr. Michael Spinetta, Psychology, College of Arts and Sciences
Dr. Jennifer Sumner, Criminal Justice, College of Arts and Sciences
Dr. Galen Trail, Center for the Study of Sport and Exercise, College of Arts and Sciences
Dr. Jeffrey Anderson, College of Education (ex-officio, Community Based Research Consultant)