IRB Overview

What does a Institutional Review Board do?

City University of Seattle values the participation of students, faculty, and community members in research efforts that attempt to add to the body of knowledge in business, education, leadership and the social sciences. In so doing, the University adheres to the highest standards of integrity, accountability and responsibility. When student and/or faculty research efforts under the auspices of the University include human participants, City University of Seattle ensures adherence to the requirements of the U. S. Department of Health and Human Services regulations applicable to all human subject research. 45 CFR 46.101 et seq. Canadian students and faculty must also meet requirements for ethical review as outlined by the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans in Canada (1998, amended 2005).

City University of Seattle Institutional Review Board review is required prior to commencement of student and/or faculty research when that research meets all three of the following definitions:

  1. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  2. Generalizable knowledge refers to any systematically gathered data which is intended for dissemination beyond the institutional source of the data (e.g., program evaluation research for internal use does not usually need review), and which might reasonably be applicable beyond the research sample.
  3. Human subjects are defined by HHS Regulations at 45 CFR 46.102(f) as “a living individual about whom an investigator conducting research; obtains (1) data through intervention or interaction with the individual; or 2) identifiable private information.” Intervention includes both the physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
    1. Interaction includes communication or interpersonal contact (e.g., questionnaires, interviews) between the investigator and the subject.
    2. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

To ensure adherence to the above Policy, all research involving human subjects must be approved by the City University of Seattle Institutional Review Board before the research is begun. For more information on how the Institutional Review Board process works please read the IRB Procedures or download a copy.