Institutional Review Board

Training in the Ethical Use of Humans in Research
The research community has a responsibility to ensure that the treatment of human subjects in research meets the highest ethical standard. Recognizing this responsibility, the National Institutes of Health implemented a requirement for NIH recipients to certify training in the ethical use of humans in research. Endorsing the goals of such training, the OSU Institutional Review Board (IRB) will require education in the protection of human research participants for all investigators conducting research involving human subjects, not just those receiving NIH funding. This new OSU policy goes into effect on April 1, 2002.

Effective April 1, 2002:

• All research staff (faculty, graduate students, and staff or other individuals who have direct and substantive involvement in proposing, performing, reviewing and reporting research) must provide a description of the education completed in the protection of human subjects with the submission of their Application for Research Involving Human Participants. It is left to the principal investigator's discretion whether or not to require the training of undergraduate students who serve as research staff.
• Education can be in the form of web-based tutorials, graduate seminars, professional or university-sponsored workshops, monographs, or other comparable means of study.
• The IRB has developed a certification form for documenting this education. The form lists recommended web resources while also leaving a space to document other methods of acquiring the education.
• Principal investigator(s) and research staff must have submitted documentation of their training prior to receiving IRB approval to conduct the proposed research.
• The OSU Research Office will maintain a database of those who document their education in the ethical use of humans in research. Principal investigator(s) and research staff can cite prior documentation when submitting subsequent proposals to the IRB.

Projects that Require IRB Review
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 human subjects? 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.

1) 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 widely disseminated, 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. Student thesis, dissertation, or honors thesis research that involves human subjects 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.

2) 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).

If the project involves the participation of human subjects in any manner described above, and it meets the above definition of research, then it must be reviewed by the OSU Institutional Review Board. Consult the OSU Human Subjects Handbook (which is available on the web at http://osu.orst.edu/research/RegulatoryCompliance/HumanSubjects.html) for the appropriate forms, a description of the review procedures, and for guidance in developing the proposal and informed consent documents.