Levels of Review

Human subjects research, and when it needs review

Research activities at Indiana University and its affiliated institutions that use humans as research subjects must go through a review and approval process before any interaction with human subjects or data collection can begin.

The Institutional Review Board (IRB) reviews each study submission to ensure that research being conducted adheres to the highest ethical standards involving the use of humans as subjects in research, while complying with all university, state, federal, and agency requirements.

Does my study need IRB review?

  • If you gather data about an individual that is identifiable (i.e., the identity of the individual is or may be readily ascertained or associated with the information provided) and is considered private information, then IRB review and approval is required.
  • If you have an interaction (communication and/or interpersonal contact) with a human subject for the purposes of gathering data or information about that person for research purposes, then IRB review and approval is required.
  • If you perform an intervention that includes physical procedures by which data are gathered (e.g., taking blood or tissue samples, etc.) on an individual and/or that manipulate the individual’s environment for research purposes, then IRB review and approval is required.
  • Any activity that is subject to FDA regulations as a clinical investigation must be reviewed and approved by the IRB. FDA regulations apply if:
    • Your project involves the use of a drug, biologic, dietary supplement, or medical device that is not approved for use for any purpose in the United States;
    • Your project involves the study of a drug, biologic, dietary supplement, or medical device for which some aspect of the administration is dictated by your research protocol (e.g., randomization, protocol dictates route or dose, etc.); OR
    • Your study data will be reported to the FDA (e.g., comparison studies of marketed drugs, clinical trials of new or investigational drugs or devices, or studies of in vitro diagnostic devices).

What level of IRB review does my study need?

The Protocol Decision Tree can help you identify what level of IRB review you will most likely need for your study.

View information about submitting to the IRB

Research not subject to human subjects regulations

Any project that does not involve research as defined by the federal regulations, human subjects, or an FDA clinical investigation is considered a non-human subjects research project. IRB and HSO review of non-human subjects research is not required. Some examples of non-human subjects research are:

  • Quality improvement projects, including program evaluation
  • Single patient case studies
  • Projects where IU is not considered engaged. Refer to the Health and Human Services (HHS) Guidance on Engagement of Institution in Human Subjects Research for more information on what engagement means
  • Research with deceased individuals
  • Research accessing only a limited data set or deidentified data set
  • Research on coded tissues or samples for which the investigator does not hold the code linking samples to identifiable information

If your research falls into the categories listed above, you do not need to submit an application to the IRB. However, if documentation of a non-human subjects determination has been specifically requested by a sponsor or collaborator, a non-human subjects submission can be created in KC IRB for HSO review. If the project is not human subjects research, a letter will be generated indicating that determination.

Projects that involve accessing identifiable protected health information (PHI) where the IU personnel is not engaged in research, requires that a waiver of authorization be granted by the IU Privacy Board. To request this required waiver, you must submit a non-human subjects application in KC IRB.

Quick guide: KC IRB New Protocol — Non-Human Subjects Research

Contact

The Indiana University Human Subjects Office provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.

Indianapolis (Main):

Human Subjects Office
Office of Research Compliance
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
  • Phone: (317) 274-8289
  • Email: irb@iu.edu

Bloomington:

Human Subjects Office
Office of Research Compliance
Indiana University
2218 N. Dunn St.
Bloomington, Indiana 47408
  • Phone: (812) 856-4242
  • Email: irb@iu.edu