Institutional Review Board

Determining what activities are overseen by the IRB

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Research and Human Subject Definitions

FDA Regulated Activities

Department of Defense Support/Sponsorship

Submission Process for Determination


 

If the activity is RESEARCH and involves HUMAN SUBJECTS, an IRB application is required for review and approval.

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Systematic Investigation: an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Generalizable Knowledge: designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

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.

If the Activity is FDA Regulated, the following is overseen by the IRB:

Clinical investigation: means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

Human subject: means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

If any item below is true, it is research requiring IRB review:

  1. The activity involves the use of a drug other than the use of a marketed drug in the course of medical practice.
  2. The activity involves the use of a medical device to evaluate safety or effectiveness of the device.
  3. The results will be submitted to the FDA or held for inspection by the FDA.
  4. Tissue specimens are being used to test the effectiveness of a medical device where the data will be submitted to or held for inspection by FDA in support of a marketing application.
  5. The activity involves FDA regulated articles, food or dietary supplements that bear a nutrient content or a health claim, a food or color additive for human consumption, infant formula, biological or electronic product for human use, or other article subject to the FD&C Act.
  6. The activity involves a retrospective chart review of outcomes of patients on a certain drug or device in the course of medical practice where the data will be submitted to or held for inspection by the FDA in support of a marketing application.
  7. The activity involves a prospective study of the outcomes of patients who were prescribed a drug or device by their personal physicians, or compares the diagnostic results of scans or tests ordered by their personal physicians where the data will be submitted to or held for inspection by the FDA in support of a marketing application.
  8. Individuals will participate in an intervention either as subjects or as controls.
  9. Investigational devices are being used on subjects or their specimens.
Department of Defense:

If the research is supported or sponsored by the Department of Defense and involves non-exempt classified research, it must be conducted following the requirements of Instruction 3216.02.13. See the Department of Defense IRB policy for more information.

Submission Process for Determination:

Some activities are overseen by the IRB, but are not considered research. These include: