The Biomedical IRB reviews all University research designed to evaluate the safety, effectiveness, or usefulness of an intervention including research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans), and preventive measures.
The Social, Behavioral and Educational IRB reviews all University protocols involving human subjects that generate data by means of questionnaires, observation, studies of existing records, and other experimental designs involving exposure to some type of non-biomedical stimulus or intervention.
What kinds of research must be reviewed by the DHRP and IRBs?
In order to determine whether or not the research proposed meets the criteria for approval set by The University of Toledo and certain sponsoring agencies, all research involving human subjects must be submitted for prior review. Protocols are reviewed by the DHRP or the IRB office staff under the regulations set forth in 45 CFR 46 and placed into one of three categories: Convened Review, Expedited Review or Exempt. The DHRP may also determine that a certain application is not human subject research under the definitions set forth in 45 CFR 46.102.
It is the prerogative of the DHRP and IRB to determine whether proposed research is human subject research and which category of review is appropriate for the research.Only human subject research that is designated exempt by the IRB is exempt from review.
Investigators may not make an independent determination that their research proposal is exempt. For additional information regarding categories of review, please access the federal guidance information at http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
