April 2021 Updated Electronic Consent Guidance & Memo for Sponsors

This is a follow up to the HRPP Bulletin sent on September 29, 2020. 

The HRPP is pleased to announce that UCSF now has two versions each of DocuSign and REDCap: a standard version and an FDA-compliant (also referred to as Part 11 compliant) version. Although studies not regulated by the FDA may use a standard version to collect research signatures, use of Part 11 compliant platforms represents a best practice for ensuring the identity of research participants who participate in studies remotely. All FDA-regulated studies should use an FDA-compliant version.

The FDA-compliant version of DocuSign is available to UCSF researchers now. The FDA-compliant version of REDCap for eConsent is being piloted with a limited number of studies and will be available to broader use once the pilot phase is complete.

The following guidance materials are now available:

  1. The HRPP has issued a new memo, dated April 14, 2021, with updated guidance regarding obtaining electronic consent and HIPAA authorization signatures for research during the COVID-19 public health emergency. This memo may be shared with study Sponsors. (Note: All Covid-related HRPP memos are available under “Sponsor Memos” on our IRB COVID-19 FAQs & Resources page.)
  1. FAQ #2 on the IRB COVID-19 FAQs & Resources website has been revised to include information about:
  • Determining whether your study is FDA-regulated
  • Availability of the new FDA-compliant DocuSign and REDCap platforms and how to request access to them
  • Instructions for researchers with FDA-regulated studies that have previously used a standard platform version (per the May 2020 and September 2020 memos) and are still enrolling new participants