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

Human Subjects

If your research involves interaction with individuals, or uses identifiable private information or identifiable biospecimens, it may be considered human subjects research and require review and approval by the Institutional Review Board (IRB). Research regulated by the Food and Drug Administration (FDA) also requires IRB review. Visit the RCUsing human subjects in your research Procedures for studies involving human subjects or regulated by the FDA catalog entrydirect link 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. You can also contact IU HRPP with questions.

Animal Subjects

All animal research, testing, or teaching activities conducted at Indiana University must receive prior review and approval from the Institutional Animal Care and Use Committee (IACUC). The principal investigator is responsible for submitting a protocol application well in advance of initiating any work involving animals. Requirements and procedures may vary depending on the campus or location where the work is conducted. For detailed guidance, including relevant policies, protocol submission resources, and campus-specific information, please visit the RCAnimal Care and Use Procedures for all studies involving live vertebrate animals catalog entrydirect link RC Animal Care and Use page on the IU Research website. Questions may also be directed to the RCAnimal Research Protections Office Procedures for all studies involving live vertebrate animals catalog entrydirect link RC Animal Research Protections Office .

Biological Materials

Principal investigators are responsible for submitting IBC protocol applications in advance of any research or teaching activity that includes, but is not limited to:

• All use of recombinant DNA (rDNA) or synthetic nucleic acid molecules, regardless of Biosafety Level (subject to the RCNIH Guidelines NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules catalog entrydirect link RC NIH Guidelines )
  • Viral vectors or plasmid vectors
  • Transgenic/Knock-in/Knock-Out animals (see RCOBA Transgenic Animal FAQs FAQs for Research on Genetically Modified (Transgenic) Animals catalog entrydirect link RC OBA Transgenic Animal FAQs )
  • Genetically modified plants
  • Transfer of rDNA or synthetic nucleic acid molecules into human participants
  • Transactive or infectious proteins
• Use of the following non-recombinant biological materials requires biosafety level 2 or higher containment:
  • Infectious agents
  • Prion proteins
  • Biohazards (e.g.: human or non-human primate tissues or fluids)
  • Select agents or toxins

If your research or teaching activities involve any of the above, you must submit an RCInstitutional Biosafety Committee Procedures for studies involving biological materials catalog entrydirect link RC Institutional Biosafety Committee protocol.

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 webpage Information about submitting a new human subjects study for review by the IRB catalog entrydirect link 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 Research Policies and procedures for human subjects research exempt level reviews catalog entrydirect link 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 2.5 HRPP Policy for exempt research policy statements regarding expedited reviews catalog entrydirect link 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 Tree IRB review level identification tool for investigators catalog entrydirect link 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 Renewals Protocol reviews and renewals for research involving animals catalog entrydirect link RC Protocol Reviews and Renewals webpage.