What is Human Subjects 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.) "Contribute" may mean publication but can also mean dissemination in another venue, such as a conference, poster session, etc.
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 meeting these criteria constitute research for purposes of this policy, whether they are conducted or supported under a program considered research for other purposes (e.g., some demonstration and service programs may include research activities.
What is the Seattle University Institutional Review Board's purpose?
The SU IRB's primary goal is to create a favorable climate for the conduct of scientific inquiry involving human subjects while also protecting the rights, well‑being, and personal privacy of individuals, as well as the interests of Seattle University. The IRB works not only to comply with Federal regulation but also to follow and foster best practices and policies with human subjects research.
The IRB seeks to ensure all human subjects are treated with respect, beneficence, and justice while participating in research conducted by Seattle University affiliates. To accomplish 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 policies outlined throughout this site. These policies will be reviewed at least every five years and updated as necessary to keep up with best practices in the field.