HRPP Response to COVID-19 Public Health Emergency
Since the beginning of the COVID emergency, the Human Research Protections Program has made rapid adjustments to support the research community. Our goals are to accelerate COVID related research, assist researchers in complying with interim policies that ensure the safety of participants and research personnel, and provide timely review for all submissions.
The Full Board meeting schedule remains unchanged with no service interruptions. Many of our staff have been telecommuting for several years, allowing for a smooth transition for remote work. Hours of operation and the Analyst of the Day program have not changed. The HRPP is committed to maintaining research protections and providing support for investigators and their teams. To that end, the following new processes and resources have been implemented.
Changes at the IRB Relating to Review of COVID-19-Related Research
Priority Review for COVID-19-Related Studies
In early March, the HRPP implemented a process for investigators to request priority review of COVID-19-related research via email. The HRPP established a COVID-19 Rapid Review Team (RRT) to ensure COVID-19-related research receives fast-tracked approval.
The HRPP COVID-19 Rapid Review Team is led by two senior HRPP staff: Joanne Mickalian (IRB Manager) and Cheri Etter (Expedited/Exempt and GESCR Coordinator). Other HRPP Analysts, IRB Chairs, and IRB Members also conduct or participate in reviews, depending on the type of research, expertise needed, and level of review required.
COVID-19-Related Research – IRB Submission and Approval Volumes (March 11th – April 21st)
115 new studies received
- 77 new studies approved
- > 100 modifications mentioning COVID-19 or coronavirus have been approved
COVID-19-Related Changes to the Study Application and Modification Form
Several new COVID-19-related questions have been added to the Study Application and will be added to the Modification Form to help identify the types of studies and/or research activities that may be subject to additional review or reporting requirements, and particularly studies that involve ‘covered countermeasures’ under the 2020 COVID-19 Public Readiness and Emergency Preparedness (PREP) Act Declaration
. The PREP Act may apply to any study involving a drug, device, biologic or vaccine intended for testing, treatment or prevention of COVID-19 infection.
COVID-19 research that was approved in March and early April was submitted on the old application form. It is essential that studies involving biomedical COVID-19-related research be converted onto the new COVID-19 version of the Study Application. Selected staff from the HRPP will reach out to you individually to help with the conversion. There is one type of study that does not need to convert to the new application: Studies which were initially approved prior to 2015 and which have already been modified and approved to include COVID-19 research components.
All in-process submissions will be converted to the COVID-19 version of the form. The new forms will also enable iRIS to send automated emails to the RRT to flag the studies for priority review.
Instructions for Submitting New COVID-19 Studies and Requirements for Adding COVID-19-Related Research Activities to Ongoing Studies
The HRPP has updated the IRB’s site page
with instructions for new studies and modifications to add COVID-19 to existing studies.
The HRPP recommends that COVID-19 substudies be submitted as new studies in iRIS unless there is a clear relationship to the original study aims. If the substudy requires biomedical procedures relating to COVID-19 diagnosis, treatment or prevention, you will be required to convert to the new version of the Study Application. Instructions and information about exceptions to this requirement are posted on our website.
Updated IRB FAQs (for ALL studies, not just COVID-19 research)
The interim UCSF policy
on human subjects-related research visits has required many studies to implement immediate changes in order to limit exposure to COVID-19. One of the most common categories of questions is the “what/when/how” of IRB reporting. The IRB has created a summary chart with examples for investigators to use as a reference. Protocol changes are grouped according to the level of risk and the timeline for reporting.
As a reminder, the IRB continues to update the COVID-19 FAQs with information about what kind of study changes need to be submitted to the IRB for approval.