Safeguarding the rights and welfare of humans in research is a general institutional policy of Oregon State University, with oversight delegated by the Vice President for Research to the Institutional Review Board (IRB), as mandated by federal regulation (45 CFR 46.103(b)(2)). The OSU IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human subjects. The IRB is concerned with justifying the participation of humans in research and protecting their welfare, rights, and privacy.
The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member from the local community and one member who is not a scientist. The IRB has several Special Advisors who advise the Board and are periodically involved in protocol review.
Certain categories of research qualify for Exempt from Full Board review. These applications and protocols are reviewed and approved by the Human Protections Administrator, as authorized by the IRB. Work with human subjects (including recruitment of any fashion) may not begin until full approval has been issued.
Research involving the following cannot be reviewed at the Exempt from Full Board level:
Research activities in which the only involvement of human subjects will be in one or more of the following categories qualify for review under the exempt category (45 CFR 46.101(b)):
"Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods."
"Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."
"Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under category 2 of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter."
"Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects."
"Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs."
"Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient, or agricultural chemical or environmental contaminant at or below the level and for a use found to be safe, by the Food and Drug Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture."
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.
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.
promote the rights and welfare of human research participants
facilitate ethical research
provide guidance and support to the research community in the conduct of research with human subjects
assist the research community in ensuring compliance with the standards set forth in the Code of Federal Regulations by the U.S. Department of Health and Human Services
If the proposed research activity is a systematic investigation designed to develop or contribute to generalizable knowledge and it involves human participants, then the activity will require review and approval by the OSU IRB before any recruitment or research activities may begin.