FAQsA complete listing of HS-IRBs FAQsInitial Reviews How can I tell if my study is exempt, and what categories of exemption can I choose from? When does something qualify as a Health Care Records Review Only application? Does a pilot or feasibility study require IRB review and approval? Should my industry sponsored research study be submitted to a commercial IRB?My study involves working with students, parents, or staff at K-12 schools. Are there any special requirements that I need to be aware of related to my IRB submission? Reportable Events/Changes of Protocol/Continuing Reviews Can changes of protocol be submitted for exemptions? I received an Action Letter/CAEPR or a revised IDB from the Sponsor. Does this need to be reported to the IRB? I have a change of protocol and a continuing review coming up. Which should I submit first? How do you change the responsible principal investigator (PI)? How should investigators handle subject complaints? Implementing the Campus Revised Continuing Review Policy ARROW [Link for document 19974 is unavailable at this time.] Exemption How can I tell if my study is exempt, and what categories of exemption can I choose from?Do I need to get consent for my exempt study? Can changes of protocol be submitted for exemptions? How does the 5-year expiration date affect my exemption?What are exemption renewals? Health Care Records Reviews When does something qualify as a Health Care Records Review Only application? Samples/Images/Data I have samples/images/data that I want to use in a research study. When do I need IRB review? What type of application do I need to submit to use samples/images/data for research purposes? What if samples/images/data are coming from an outside source?What are Material Transfer Agreements (MTAs) and when do I need one? Do I need anything more than IRB approval for my NIH-funded study that involves large-scale genomic data analyses? HRPP Policies What are the criteria to be engaged in human subjects research at UW-Madison? Who may serve as a principal investigator on a protocol? I am a student researcher, what IRB approval do I need? What should I consider before conducting research with vulnerable populations? Does my research with coded information or specimens require IRB review? Does research with existing datasets require IRB review? What things should I consider to protect subjects' privacy and confidentiality of data? Who can I contact if I have concerns about human research protections at UW-Madison? What if my research involves the use of fetal tissue? Health Sciences IRBs Certificate of Confidentiality Guidance Which State Law(s) should be considered for research? Requirements for Registering with Clinicaltrials.gov Other Training & Education What documents related to IRB review should be maintained by the study team as part of the research record? What if my study team is not affiliated with a clinical department or unit but we need to recruit patients for our study? Does the IRB require submission and review of Manuals for ProceduresWhat are Material Transfer Agreements (MTAs) and when do I need one?