Last updated: January 22, 2021
This webpage has been created to share the answers to COVID-19-related questions. It will be updated frequently. See below for HS IRBs communications regarding COVID-19.
- UW-Madison is providing its COVID-19 updates here.
- Guidance on tools for exchanging and/or storing protected health information (PHI) can be found at the bottom of the HIPAA page. If you have question about this guidance, please contact your HIPAA security and privacy coordinator for assistance.
- COVID-19 related-guidance for clinical trials research can be found here.
- Research and Sponsored Programs (RSP) also has information on COVID-19’s impact on sponsored research, including links to federal agencies.
- The Pharmaceutical Research Center (PRC)'s FAQ can be found here.
COVID-19 Questions Answered
- Are the IRBs Offices operating as usual? (updated: 05.20.2020)
- Are the IRBs prioritizing reviews of submissions? (added 03.16.2020)
- Do all human subjects regulations apply as usual during this pandemic? (updated: 03.25.2020)
- What if researchers have an Initial Review application for a non-COVID-19 study currently under review? (updated: 04.14.2020)
Information for Researchers Planning Covid-19 Related Research or Treatment
- What is the IRB review process for COVID-19 research? (updated: 05.01.2020)
- What is the process for single patient emergency use and expanded access protocols? (updated: 04.07.2020)
- What if my new COVID-19 study involves collecting and/or analyzing biospecimens? (updated: 05.13.2020)
- Obtaining Informed Consent from COVID-19 Positive Patients (added: 04.02.2020)
- How do I obtain informed consent remotely? updated: 10.21.2020)
Mandatory Pause Considerations for On-going Research
- Can I still interact with my study subjects? (updated: 04.14.2020)
- What about study enrollment? (added 03.16.2020)
- What if I decide to temporarily halt study visits? (updated: 03.25.2020)
- How do I modify my study so study visits can occur remotely? (updated: 05.28.2020)
- Do I need to revise my consent documents to reflect the risks of COVID-19 if in-person study interaction will still occur? (added 03.16.2020)
- What about effects on enrollment goals? (updated: 03.25.2020)
- What about studies for which the UW is serving as the reviewing IRB? (added 03.17.2020)
- What about studies reviewed by a non-UW-Madison IRB? (added 03.17.2020)
New Information Reports and Changes of Protocol
- What information should be included in new information reports about halts to study visits/procedures? (updated: 11.16.2020)
- What information should I include in my COVID-19-related change of protocol? (added: 03.25.2020)
- Should I submit a New Information report or a Change of Protocol for my COVID-19-related protocol updates? (added: 03.25.2020)
FAQs for Restarting Face-to-Face Research
- Do the Safer Badgers building access requirements apply to research participants?
- What role can the IRB play for department chairs, center directors, and deans who are determining whether specific research studies can reopen face-to-face visits? (updated: 07.01.2020)
- What are the first steps for study teams to get approval to restart face-to-face visits for an IRB-approved study? (updated: 06.08.2020)
- What is required from an IRB standpoint before restarting face-to-face research activities? (updated: 07.01.2020)
- Are protocol and consent form changes required by the IRB for all studies prior to restarting face-to-face interactions? (added: 05.28.2020)
- What if I’m planning a new research study that requires face-to-face human subjects research activities? (added: 05.28.2020)
- Will remote study visits no longer be required after the campus begins allowing face-to-face visits to occur? (added: 05.28.2020)