When an activity meets the federal definition of “research” and involves “human subjects” or meets the Food and Drug Administration (FDA) definition of “clinical investigation,” then IRB review and approval is required.
According to the U.S. Department of Health & Human Services (DHHS), “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]
Human Subjects (DHHS definition) – “A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” [45 CFR 46.102(f)]
Human Subjects (FDA definition) – “An individual who is or becomes a participant in research either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient.” [21 CFR 56.102(e)] (Drug, Food, Biologic)
Human Subjects (FDA for medical devices definition) – “A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or who participates as a control. A subject may be in normal health or may have a medical condition or disease.”[21 CFR 812.3(p)] (Device)
For an activity involving drugs: “Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.” [21 CFR 312.3(b)]
For an activity involving devices: “Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.” [21 CFR 812.3(h)]
The IRB conducts the following reviews:
Initial IRB Review for new protocols.
Amendment Review for changes made to IRB approved studies.
Continuation Review for review conducted by the IRB for ongoing approved studies. The review will occur either annually or every 6 months.
Review of Unanticipated/Anticipated Problems/Serious Adverse Events associated with the study.
Reviews may be conducted via full board, expedited or exempt review.
Yes, if the study meets the definition of research with human subjects (see definitions above).
The time to get a study approved usually depends upon the type of review and the time it takes the investigator to respond to the IRB’s questions or requested revisions.
The IRB meets once per month. Full review is required for most new applications submitted for review and approval. Investigators will receive written notification from the IRB within 10 business days of the meeting. If the study requires minor revisions, the investigator can expect to wait another week after submitting the IRB’s requested revisions to determine the status of their study. If the study requires major revisions, the investigator’s response will be scheduled for full review at the next available convened meeting.
When a response is required from the investigator, the investigator will have three months to provide the additional information, as requested by the IRB. Otherwise, the application will be withdrawn from consideration.
Expedited and exempt reviews are conducted as they are received and investigators will receive written notification within three days of the review.
Generally, fees are not charged for IRB review, as the fees are included as part of FRI’s indirect fees. However, Principal Investigators who are not employed by FRI or do no submit grants through FRI and choose to use FRI IRB’s reviewing services will be charged. Please refer to “IRB Fees” to the left.
Yes, any change to your currently approved research must be submitted to the IRB as an amendment for review and approval before an implementation of changes can take place. Amendments may include changes in research interventions, research locations, advertisements for recruitment purposes, inclusion/exclusion criteria, etc. This is not an exhaustive list.
The submission deadlines for IRB meetings are posted to the left under “Meetings and Deadlines.” The IRB office generally tries to notify investigators via email when the next IRB meeting is scheduled and the submission deadline for that meeting.