Institutional Review Board (IRB) > Part One

The Institutional Review Board for Human Subjects Research (IRB) is the committee at OHIO charged with assuring the protection of human subjects. This is done through education as well as a review and monitoring process to ensure that the research complies with applicable regulations. All research studies conducted by faculty, staff, or students that involve human subjects must be approved by the IRB before the project can begin. To assist in the determination of whether a project requires review, it is important to know two definitions:

Research - a systematic investigation, including research development, testing and evaluations, designed to contribute to generalizable knowledge.
Human Subject - a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual OR 2) identifiable private information

In the definition of research, the clause, “designed to contribute to generalizable knowledge” is the part that most often is used to determine if a project meets the definition of research, and thus requires IRB review. For example, a survey done by a university department to assess how satisfied users of that department are with services provided would not be considered research if the use of the survey data was internal, i.e. to determine how the department might improve its services. If that same department wanted to publish a paper using that survey data, claiming that it had an innovative departmental structure as well as services that other University departments might benefit from, then this survey distribution is crossing over into being “designed to contribute to generalizable knowledge” and would require IRB review. Intent to publish is one possible indication of intent to contribute to generalizable knowledge.

Examples of circumstances where the definition of human subject is not met, is with archival data of individuals who are now deceased, or biological specimens that are completely stripped of any identifying information and not coded in any way. Any person who has questions as to whether or not activities would require IRB oversight is encouraged to contact ORC for assistance in making the determination.

The use of discarded human tissue may require IRB approval. The level of review required will vary depending on the type of identifying information that is used. Should you have the need to use discareded human tissue as a part of your research please consult the IRB staff, and they will assist you in determining the level of review that is required.

Why IRB is important to research
Review is required by federal legislation and serves to protect both the human subject and the researcher. Researchers applying for internal or external funding are required to receive IRB approvals prior to receiving, and in some cases prior to applying for, that funding. Many publications will no longer accept manuscripts that do not have IRB approval. The IRB does not issue approvals retroactively so understanding the requirements and seeking the appropriate approvals prior to engaging in research is critical.

DON'T FORGET: The IRB does not issue approvals retroactively so understanding the requirements and seeking the appropriate approvals prior to engaging in research is critical.

IRB Committee
The IRB is currently appointed through Faculty Senate. The committee membership includes faculty members with expertise in the area of human research, administrators, non-affiliated community representation and physicians. The IRB normally meets monthly and there is a submission deadline approximately two weeks ahead of each meeting for a protocol to be included on the agenda. Deadlines and meeting dates are posted on the compliance website, www.ohio.edu/research/compliance/, for each quarter.

DON'T FORGET: The IRB normally meets monthly and there is a submission deadline approximately two weeks ahead of each meeting for a protocol to be included on the agenda.

Part Two of this Section >

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