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Levels of Review
Human subjects research, and when it needs review
Human subjects research at Indiana University and its affiliated institutions must go through a review and approval process before any interaction with human subjects or data collection can begin.
Human subjects research is
- A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, AND
- Involves living individuals about whom an investigator (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.
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?
The following examples are considered human subjects research and require IRB review and approval,
- 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
- 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
- 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
- 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.
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 HRPP 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 Kuali Protocols for HRPP review. If the project is not human subjects research, you will receive a formal email notification from Kuali Protocols as documentation of the determination that IRB review is not required.
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 Kuali Protocols.
Student projects intended only for class assignments, or for presentation at internal IU events such as Student Research Days, are not designed to develop or contribute to generalizable knowledge and would not be considered human subjects research requiring a submission to the IRB.
Sometimes a project is not considered human subjects research at onset. However, on occasion, a project may later transform into human subjects research. For example, an IU faculty member implements an internal quality assurance project that is not considered human subjects research, but then it is later determined the data gathered can be considered generalizable and will be disseminated. In that case, once it’s discovered the project may be considered human subjects research, the project should be paused, and a research submission should be made to the IRB. Should this scenario occur, please contact the IU Human Research Protection Program at firstname.lastname@example.org for instructions related to your submission.
More information on submitting in Kuali Protocols can be found in the Kuali Protocols instructional guides.
The Indiana University Human Research Protection Program (HRPP) provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.
Indianapolis (Main):Human Research Protection Program (HRPP)
Office of Research Compliance
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
- Phone: (317) 274-8289
- Email: email@example.com
Bloomington:Human Research Protection Program (HRPP)
Office of Research Compliance
509 E. Third St.
Bloomington, Indiana 47401
- Phone: (812) 856-4242
- Email: firstname.lastname@example.org