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Institutional Review Board (IRB) FAQs

If the project will not be completed by the IRB expiration date, what is the procedure for requesting continuation?

Federal regulations require that all non-exempt protocols involving human subjects be reviewed by the IRB at least annually. If any project, including data analysis, will not be completed by the approved IRB expiration date, then the investigator must complete a Renewal Application and return it to the IRB not less than two months prior to the original expiration date so that there is no interruption in the approval period.

Enrollment of new subjects cannot occur on a project if it becomes inactive. In addition, research intervention or interaction with already enrolled subjects must stop if a project becomes inactive unless the IRB determines that it is in the best interest of individual subjects to continue. If a protocol becomes inactive, submission of a new Human Subjects Review Form(HRS-1) may be required.

Research designated as Exemptions do not have expiration dates; therefore, continuing review is not required. 

When it is necessary to change or add procedures on an approved protocol, what is the process for obtaining IRB approval of the change?

Note that any deviation from the approved research protocol must be reviewed by the IRB prior to implementation of those changes. For example, any changes in the consent form or the questionnaires/interview guides must be submitted to the IRB prior to use.

To request an amendment (change) or addendum (addition) to an approved protocol, send an electronic copy of the amendment request to the chair of the IRB Committee.

Include the following information: description of the change or addition, rationale for the modification, unmarked copy of new documents (e.g., consent form, study instrument, advertisement), and the revised documents (noting all changes by bolding additions and deletions via strikethrough; or via the track-changes feature in MSWord).

After IRB review, a Notice of Approval or revised Notice of Exemption will be emailed to the investigator. Changes to approved protocols may not be implemented until the change is approved by the IRB. Amendments to non-exempt protocols must be submitted by the 1st of the month for review at that month's IRB meeting. 

What kind of review is needed for class-related projects?

For research done within an undergraduate class as a class project, the instructor should submit a  Human Subjects Review Form (HRS-1) with Department Chair approval for a course in which research is students commonly do research (rather than students submitting independently for approval). The  instructor takes on full responsibility for monitoring the protection of human subjects, student training and keeping the project within the bounds of the IRB guidelines.

Undergraduate students doing independent senior theses, undergraduate research studies/projects, graduate students doing a master's research studies, and similar exercises must independently submit a Human Subjects Review Form (HRS-1) to the IRB as a student-researcher. A  supervising faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. During the design of a project, the supervising faculty member should instruct students on the ethical conduct of research, help the student prepare the application for IRB approval, and review the application prior to submission. In particular, students should:

  •     Understand the elements of informed consent,
  •     Develop a readable consent form following the sample,
  •     Plan appropriate recruitment strategies for identifying subjects,
  •     Establish and maintain strict guidelines for protecting anonymity and confidentiality, and
  •     Allow sufficient time for IRB review and completion of the project.

As assurance that the University's guidelines will be followed, the supervising faculty member is required to sign the student's application for IRB approval and obtain the Chair’s signature prior to submission.

After IRB approval, the supervising faculty member should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.

How is minimal risk defined?

A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Per 45 CFR 46.303, when prisoners are subjects in research, "minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. 

Why is it necessary for the federal government to require that institutions review research projects?

The vast majority of researchers plan and conduct their research in accordance with sound ethical principles. However, there is adequate documentation that some investigators do not take the necessary steps, either through conscious choice or as a result of ignorance, to protect the individuals who volunteer to participate in their research. When the researcher is affiliated with an academic institution, repercussions for failing to protect subjects affect not only the investigator, but the institution as well. For this reason, oversight by an institutional review board is necessary to ensure that projects include the appropriate safeguards to protect human subjects. The federal regulations found at 45 CFR 46 and 21 CFR describe those protections and form the basis for IRB policy.1) Why is it necessary for the federal government to require that institutions review proposed research projects? Don't all researchers take the appropriate steps to protect subjects on their own?