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Human Research

FAQ DATABASE: Search ORD Policy and Guidance FAQs

DOCUSIGN: Requesting Use of DocuSign for VA-approved Research

See also

QUESTIONS: For policy and guidance questions contact VHA CO ORD Regulatory at

ORPPE Resources


Guidance Document

Release Date


 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


 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


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

Updated March 17, 2020


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


Memorandum:  Use of Video Communication Technology for VHA Research and Development Activities Under COVID-19

April 7, 2020


Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions

Updated March 31, 2021


The Mayo Clinic Expanded Access Program (EAP): Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 - Frequently Asked Questions

July 19, 2020


Frequently Asked Questions (FAQs) Regarding COVID-19 Impacts on Research

June 22, 2020


Frequently Asked Questions (FAQs) - COVID-19 and VA Animal Care and Use Programs

April 13, 2020


COVID-19 (SARS-CoV-2) Research Specimens - Frequently Asked Questions

Original Publication Date: April 4, 2020


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


 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

Employee Participation in COVID-19 studies

Veterans Health Administration (VHA) Office of Research and Development (ORD) Guidance on VA Employee Participation in VA-Conducted COVID-19 Research Studies

September 24, 2020

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

Updated March 31, 2021

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

Informed Consent Forms

Research Guidance for the Use of Electronic Methods to Securely Obtain Informed Consent (VA network access only)

October 15, 2020

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

Updated March 31, 2021

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)



Guidance on Conducting Research Involving Pregnant Women

October 20, 2014


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


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

Updated March 31, 2021

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)


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

VHA Directive 1200.01 Amendment #1 Guidance

Description of Amendment #1 to VHA Directive 1200.01


January 8, 2021

VHA Directive 1200.05 Amendment #2 Guidance

Description of Amendment #2 to VHA Directive 1200.05


January 8, 2021

VHA Directive 1200.08 Amendment #1 Guidance

Description of Amendment #1 to VHA Directive 1200.08


January 8, 2021

Requesting Use of DocuSign for VA-approved Research

ORD has purchased a supply of envelopes to be used in research studies requiring documentation of informed consent and or HIPAA Authorization. All requests are considered but studies requiring the creation of <100 envelopes (100 subjects) will need to provide justification due to the support required by the OI&T Identity and Access management Team. Inpatient studies are generally not appropriate for DocuSign and study teams should consider the use of iMedConsentTM for inpatient studies or studies where all study subjects will present to a facility with CPRS access. faq_imedconsent_asynchronous_signature_121714.pdf (

For studies funded by sponsors outside of VA, please make sure that your sponsor will not require the use of their electronic signature platform prior to requesting DocuSign use. Reimbursement to ORD may be required for studies funded by non-VA sponsors (process under consideration).

Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided.

The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: (VA network access only)

Post approval instructions, SOPs, and training materials can be found here: (VA network access only)


FDA Guidance Related to COVID-19

Federal Regulations

Good Clinical Practice

Guiding Principles


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