Projects that Require IRB Review

 

For research involving humans, Oregon State University is guided by the ethical principles set forth in the Declaration of Helsinki and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. In addition, the IRB follows the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations.

Determining whether a project must be reviewed by the IRB is a two-step process: first, is the activity research, and, second, does it involve the participation of humans? To answer these questions, one must refer to the federal definitions of "research" and "human subjects," which are presented below. If the answer on both counts is "yes," then the project must be reviewed and approved by the IRB before subject recruitment is initiated, and the research staff must have completed training in the ethical use of humans in research.

• Defining Research

As defined by the Code of Federal Regulations (45 CFR 46), research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If there is a possibility that a project using human subjects might be published or disseminated outside of the OSU community, then the faculty member (and student, if a student project) must obtain IRB approval before starting the project or recruiting human subjects. In addition, pilot research work or methodological development that involves the participation of human subjects must also receive IRB review and approval because this work constitutes "research development" as described in the federal definition. Research that involves human subjects that is being done to fulfill thesis or dissertations requirements must receive IRB review and approval. An example of a project that would not be submitted for IRB review is a student's project that is conducted as a class assignment and that will not be communicated beyond the class.

• Defining Human Subject

The CFR defines human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information." Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject, such as interviews, surveys and questionnaires. 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 (e.g., medical records).

All research (including interviews, surveys, and questionnaires) involving human subjects must be reviewed by the IRB. Approval must be obtained when the experimental plans are complete and before human subjects are involved in the project.

Prior to commencing any aspect of human subjects research, including recruitment of any sort, IRB review and approval is required. The results from studies conducted without obtaining IRB approval may not be published, presented, or the results otherwise distributed, nor can such data be used to satisfy honors thesis, master’s thesis or doctoral dissertation requirements. It is, therefore, in the investigator's best interest to consider carefully the likelihood that the data will be published or used to fulfill thesis or dissertation requirements, and to err on the side of inclusion and seek IRB approval prior to commencing the work.

The IRB reviews projects by one of three methods: Exempt from Full Board review, Expedited review, and Full Board review. The investigator may recommend the review category, but final determination of the category will be made by the IRB. A project may be subject to more comprehensive review at the discretion of the IRB. The first page of the IRB application provides details on the review timelines for each level of review.