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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)

See also: FDA Guidance Related to COVID-19 | Federal Regulations | Good Clinical Practice | Guiding Principles

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

Federal Regulations

Good Clinical Practice

Guiding Principles

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