Health Sciences IRBs KnowledgeBase

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 Non-Exempt Medical Records review?
• Does a pilot or feasibility study require IRB review and approval?
• Should my industry sponsored research study be submitted to WIRB?

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?
• Where do I go to create a new change, personnel change, continuing review, or reportable event in ARROW?
• How do you change the responsible principal investigator (PI)?
• How should investigators handle subject complaints?

ARROW

• Where do I go to create a new change, personnel change, continuing review, or reportable event in ARROW?
• How do I view reviewer notes in my legacy application?
• I can't find someone in the ARROW system to add them to a protocol, what do I do?
• I have a new MSN#, but can't find it in the ARROW-RSP database (Funding Section Question 10.1), what do I do?
• How do I find a submission in ARROW and check its status?

Exemption

• How can I tell if my study is exempt, and what categories of exemption can I choose from?
• Can changes of protocol be submitted for exemptions?
• Once my protocol has been determined to be exempt, what do I need to do in ARROW to update the status?

NEMR

• When does something qualify as a Non-Exempt Medical Records review?

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 is the difference between "de-identified", "anonymous", and "coded" data?

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?
• Do I need to register with Clinical Trials.gov?

Other

• What are the Human Subjects Research training (and other training) requirements?
• How can I request copies of documents from the study's IRB file?
• 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