FAQs
A complete listing of HS-IRBs FAQs
Initial 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
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
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?
- What is a Certificate of Confidentiality and do I need one for my research?
- Which State Law(s) should be considered for research?
- Requirements for Registering with Clinicaltrials.gov
Other
- What are the Human Subjects Research training (and other training) requirements?
- 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 Procedures
- What are Material Transfer Agreements (MTAs) and when do I need one?