Health Sciences and Minimal Risk IRBs, IRB News/Volume 12, Number 3, May 2020
Coming Soon: IRB Efficiency Project
In conjunction with our partners at Huron Consulting, the UW-Madison human research protection program (HRPP) is launching a endeavor, called the IRB Efficiency Project. Some objectives of this project include revamping the current IRB committee structure to maximize flexibility and improve turnaround time, as well as, to streamline the ARROW application process. More details about this project – including a new project-specific website – will be announced soon.
Updated FAQ on Biospecimens and Covid-19 Research
We have posted a revised version of our FAQ on biospecimens and Covid-19 research to further clarify when IRB approval may be required. This revised FAQ also include a link to the recent SMPH memo regarding the application process for obtaining COVID-19 samples from the BioBank.
Reminder: Centralized Approval Process for Covid-19 Research
Study teams planning Covid-19 research projects that are interventional or involve the use of Covid-19 biospecimens must first seek approval via a centralized review process prior to submission to the IRB. Information about this process and additional guidance on conducting Covid-19 research can be found here.
Remote Consent and E-Consent Guidance
We have received many questions from study teams about both remote consent (i.e., obtaining informed consent using remote procedures such as email or phone) and electronic consent (i.e., obtaining informed consent via electronic platforms). We have guidance documents about both issues that study teams may find useful:
- How do I obtain informed consent remotely?
- Documenting Consent Electronically or for Remote Subjects Guidance
For FDA-regulated studies, please note that UW-Madison does not yet have a part 11 compliant platform for obtaining e-consent from subjects. Options for obtaining a part 11 compliant platform are currently being explored.