Updated Electronic Consent Guidance & Memo for Sponsors

This is a follow-up to the HRPP Bulletin sent on May 28, 2020.

The HRPP has written a new Memo to Sponsors providing an update about available electronic platforms for obtaining electronic consent and HIPAA authorization signatures for research during the COVID-19 public health emergency. The Memo specifically addresses which platforms are compliant with the FDA’s privacy rules at 21 CFR Part 11 for electronic signatures and for comprehensive electronic study records.

This information is available on the IRB COVID-19 FAQs & Resources website, updated on 9/29/2020:

1. Detailed guidance about obtaining electronic consent signatures: See the update to FAQ #2 and reference the FDA Resources list.

2. Memo that researchers can share with sponsors about the use of DocuSign, REDCap, SecureConsent, FDA Covid MyStudies, and REDCap Cloud for obtaining electronic signatures: Attached to this email, and also available at Sponsor Memos