How do I know if my study needs review and approval by a campus entity?

Human Subjects

If your research involves human subjects, or is regulated by the Food and Drug Administration (FDA), it requires review and approval from an institutional review board (IRB) or the Human Subjects Office. Visit the RCUsing human subjects in your research RC Using human subjects in your research webpage to review a list of guiding questions that will help you to determine if your proposal needs to be submitted to the IRB.

Animal Subjects

If your study involves animal research or testing, it must be thoroughly reviewed by a committee before your work can begin to ensure humane animal care and use. The principal investigator is responsible for submitting a protocol application for review and approval. The specific requirements and procedures will vary depending on your research activity. Review the IU Research RCProcedures for all studies involving live vertebrate animals RC Procedures for all studies involving live vertebrate animals webpage for more information about the submission and review process.

Biological Materials

All research activities at Indiana University involving recombinant DNA (rDNA) or synthetic nucleic acid molecules, and some non-recombinant biological materials, must go through a review process before work can begin.

IU’s Institutional Biosafety Committees (IBC) and the IU Environmental Health and Safety Office’s Biological Safety Program review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large.

Please visit the RCInstitutional Biosafety Committee RC Institutional Biosafety Committee webpage for additional information, including what needs to be reviewed by the IBC and the submission and renewal process.

How do I know what level of review is needed?

Human Subjects

If your proposal will require IRB approval, there are three levels of review - exempt, expedited, and full board. Additional information about each of the levels of review and the types of studies that fall into different categories can be found on the RCSubmitting a new study for review webpageInformation about submitting a new human subjects study for review by the IRB RC Submitting a new study for review webpage .

If your project involves no more than minimal risk, and meets the criteria specified in the IU RCHRPP Policy regarding Exempt ResearchPolicies and procedures for human subjects research exempt level reviews RC HRPP Policy regarding Exempt Research , it is eligible for review under the “Exempt” review process. “Minimal risk” means that the person participating in your study would experience no more risk than they would throughout the course of a normal day or during routine physical exams or psychological tests. “Exempt” review means review by one IRB or Human Subjects Office staff member, sometimes in consultation with others.

If your project is minimal risk, but not eligible for exempt review, it may be eligible for “Expedited” review. Research may qualify for expedited review if it involves only minimal risk and all study procedures fall within one or more of the expedited categories listed in federal regulations, as detailed under RCIU HRPP Policy on IRB Review Process, section 2.5HRPP Policy for exempt research policy statements regarding expedited reviews RC IU HRPP Policy on IRB Review Process, section 2.5 . “Expedited” review means review by one or more experienced IRB reviewers.

A full board review is required for research that is not eligible for an exempt or expedited review, either because it is greater than minimal risk or because the study procedures are outside the exempt and expedited categories. “Full board review” means review by the full Institutional Review Board, which is composed of at least five members with a range of expertise.

The RCProtocol Decision TreeIRB review level identification tool for investigators RC Protocol Decision Tree can help you determine what level of review will be needed. Please keep in mind that this tool is intended to be used as guidance. Ultimately, the Human Research Protection Program (HRPP) staff will determine the level of review needed based on the information available when the study is submitted.

Animal Subjects

For studies involving the use of animals, the review committee has the option to request a full committee review or allow the protocol to be reviewed by a designated committee member (or members). All protocols remain active for three years. At the end of that period, a new protocol application must be completed and submitted. For additional information on this process and related requirements, please visit the Animal Care & Use RCProtocol Reviews and RenewalsProtocol reviews and renewals for research involving animals RC Protocol Reviews and Renewals webpage.