ORD would like to make the following announcements about new ORD and FDA guidance documents and ORD draft guidance documents.
1. Issue of two new ORD Draft Guidance Documents:
- ORD has issued a Draft Guidance document related to the use of email and texting in VA research titled, “Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research”. ORD created this draft guidance after receiving input from multiple program offices. ORD is aware that this complex guidance will require revision, and we need to obtain additional input from the VA research community.
- ORD has issued a second Draft Guidance document is related to the use of Material Transfer Agreements titled, “Draft ORD Guidance on Material Transfer Agreements”. This document has already undergone significant revision as a result of prior comments when initially posted as draft guidance, and additional comments are sought from the VA research community.
2. Addition to existing ORD Guidance Documents:
3. Removal of ORD Guidance Template:
- ORD has temporarily removed a previous Agreement template posted on ORD’s Policies and Guidance Documents webpage earlier this week called “Completion of Time-Effort MOU for DAPs” pending further revision.
4. New FDA Guidance on Waivers of Informed Consent:
- VA conducts multiple studies involving FDA-regulated research. ORD wants to ensure that the VA research community is aware that FDA has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirement for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections as described in the FDA guidance document. The guidance, which is in immediate effect, aligns FDA’s position on waiving or altering informed consent requirements with the Common Rule’s regulations for waiving or altering informed consent requirements as described in 38 CFR Part 16.116(d).