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Determine if your activity is research, involves human subjects, and exempt from full IRB review.
Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
Human subject means a living individual about whom an investigator, whether professional or student, conducting research obtains either
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.
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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Public Use Data Files are data files prepared by investigators or data suppliers with the intent of making them available for public use. The data available to the public are not individually identified or maintained in a readily identifiable form. Public use data files are data files that have been reviewed under the jurisdiction of an IRB with the intent of making them available for public use. In the case of Federal statistical data collections, the Federal government has responsibility for that review. Producers and suppliers of public use data files are responsible for having public use data files appropriately reviewed by IRBs before making them available to the public.
DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from Committee review must still be filed with the IRB and screened for exempt status.
Some minimal risk research is exempt from full IRB review. Exemption waives only the need for full IRB review and does not negate the need for the consent of subjects where applicable.
The authority to determine and confirm exempt status rests with the IRB and not with the investigator nor student advisor. Thus, an Exempt Screening Application Form is required for your exemption to be confirmed and granted by the IRB.
Survey interview research with adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity. Be sure to note the category specific advice in the right column.
Recomended Reading for Exempt Researchers
There are few common areas that researchers need to address for each type of exempt research. Here are a few common points of emphasis provided from an exempt study reviewer.
TIP: click on the title bars to open and close the topics.