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Office of Research & Development

Human Research

QUESTIONS: For policy and guidance questions contact VHA CO ORD Regulatory at VHACOORDRegulatory@va.gov.

Requesting Use of DocuSign for COVID-19 Studies- September 3, 2020

The Office of Research and Development has been given a limited supply of DocuSign "envelopes" for use though the ATO approved DocuSign Cloud. The use of DocuSign is currently limited to COVID studies intending to recruit >100 subjects until ORD can secure a contract for additional envelopes and more support staff can be trained.

The process to request the use of DocuSign for your COVID research involving more than 100 subjects is to complete the request form and email the form to VHACOORDREGULATORY@VA.GOV with the subject "DocuSign Request". Additional instructions will follow pending the review of your request. Review of request is currently within 1 business day. Failure to complete the form or improperly address the email will delay review.

What's New:
ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform (June 18, 2020)

Memorandum VA COVID-19 Research Biorepositories/Biobanks (May 1, 2020)

CRADO Memorandum for Administrative Hold on Non-Critical, In Person Interactions with Human Research Subjects in ORD-Funded Studies (March 17, 2020)

ORD Guidance on Human Subjects Protections Issues Related to COVID-19 Concerns (Updated March 10, 2020)

VA Innovation and Research Review System (VAIRRS) (February 2020)

ORPPE resources: Toolkits | Sample Templates | Webinars

Topic	Guidance Document	Release Date
Advertising	Guidance on Advertisement of Non-VA Funded Research in VA Facilities	March 9, 2015
Azure Rights Management Services	IRB and R&D Committee Considerations for Use of Azure Rights Management Services (RMS) in VA Research	October 25, 2019
Burden Reducing Provisions and the Final Rule	ORD Guidance on the Final Rule for the Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date While Allowing the Use of Two Burden-Reducing Provisions During the Delay Period	July 2, 2018
Case Reports	Case Report Guidance	December 9, 2009
Children	Guidance on Conducting Research Involving Children	October 20, 2014
Certificates of Confidentiality	FAQs: Certificates of Confidentiality	January 7, 2019
Conflict of Interest	FAQ on Financial Conflict of Interest	February 8, 2013
Continuing Review	Guidance on Continuing Review	October 22, 2014
COVID-19	Memorandum VA COVID-19 Research Biorepositories/Biobanks	May 1, 2020
COVID-19	CRADO Memorandum for Administrative Hold on Non-Critical, In Person Interactions with Human Research Subjects in ORD-Funded Studies	Updated March 17, 2020
COVID-19	ORD Guidance on Human Subjects Protections Issues Related to COVID-19 Concerns: Implementation of Clinical Screening Procedures for VA Research Protocols and Modifying Study Procedures	Updated March 10, 2020
COVID-19	Memorandum: Use of Video Communication Technology for VHA Research and Development Activities Under COVID-19	April 7, 2020
COVID-19 FAQS	Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions	April 6, 2020
COVID-19- FAQs	FAQs: COVID-19 Research Related FAQs (VA Network access only)	July 19, 2020
COVID-19 PREP Act	Implementation of the Public Readiness and Emergency Preparedness Act(PREP Act) for COVID-19 Research Activities	August 17, 2020
Data Use Agreement	Please refer to VHA Handbook 1200.12; revised DUA Templates to be released	Summer 2020
E-Cigarettes/ENDS	Notification Alert: Research Involving E-Cigarettes/ENDS	October 2, 2019
Electronic Mail and Texting	DRAFT Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research	July 28, 2017
Email Communications	Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet	March 12, 2018
Exempt Research	Guidance on Exempt Research Determination	October 20, 2014
Exempt Research	Clarification of ORO's Requirements for the Review of Reportable Events in Exempt Human Subjects Research- VHA Handbook 1058.01	August 7, 2019
Fetal Tissue	Restriction on Use of Fetal Tissue for All VHA Research Studies	August 28, 2019
HIPAA Authorization	FAQ on Revocation of HIPAA Authorization for Research	February 21, 2017
Human Subjects Research	FAQs: Spring Research Town Hall Q&A	June 30, 2020
Informed Consent Forms	FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms	March 12, 2012
Informed Consent Forms	Informed Consent Forms- Expiration Dates	March 12, 2012
International Research	Guidance on Approval of International Research	October 20, 2014
IRB Membership	FAQ on Administrative Staff Membership on the IRB	March 12, 2012
Material Transfer Agreements	DRAFT ORD Guidance on Material Transfer Agreements	July 28, 2017
National Cancer Institute IRB	Information about Use of the NCI IRB by VA Facilities	Check this
Non-affiliated IRB Members	ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members	April 16, 2015
Off-site Research	(see Off-site Research page)	n/a
Pregnancy	Guidance on Conducting Research Involving Pregnant Women	October 20, 2014
Pregnancy	Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring	March 9, 2015
PTSD	Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder be Considered a Vulnerable Population for the Purpose of Applying Guidelines for the Protection of Human Subjects in Research? Report of a Work Group Convened by the National Center for Ethics in Health Care of the Veterans Health Administration on Behalf of the Secretary of Veterans Affairs	October 2008
Remote Monitoring	ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform	June 18, 2020
R&D Committee	FAQs: R&D Committee	June 3, 2020
Single IRB Requests Single IRB Exceptions	Information about Requesting Use of IRBs and Exceptions to the Single IRB Requirement	January 22, 2020
Social Media	ORD Guidance for Use of Facebook and Twitter when Recruiting Research Subjects in VA Research (Guidance Under Revision. Temporarily removed on 09/26/2017)	n/a
SSN Data Requests in DART	Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART)	Sept. 5, 2014
Study Team Changes	Guidance on IRB Approval of Changes in Study Team Members	February 8, 2013
Transitioning to 2018 Requirements	ORD Guidance on Transitioning VA Human Research Studies to the Revised Federal Policy for the Protection of Human Subjects	February 8, 2019
VHA Directive 1200.01	Memorandum from the DEAN-DUSH: Delay in Implementation of VHA Directive 1200.01 Policies for Three Specific Areas until January 31, 2021	July 29, 2020
VHA Directive 1200.05 General Guidance	Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05	January 9, 2019
VHA Directive 1200.05 General Guidance	Summary of Significant Changes to VHA Directive 1200.05	January 9, 2019
VHA Directive 1200.05 General Guidance	Red-Line Version of VHA Directive 1200.05 (DRAFT)	January 8, 2019

FDA Guidance Related to COVID-19

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (March 2020)

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