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Human Research

FAQ DATABASE: Search ORD Policy and Guidance FAQs


DOCUSIGN: Requesting Use of DocuSign for VA-approved Research


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QUESTIONS?
Contact VHA CO ORD Regulatory at VHACOORDRegulatory@va.gov


ORPPE Resources

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Topic 
Guidance Document 
Release Date 
Human Subjects Research Office of Research and Development (ORD) and Office of Nursing Services (ONS) Guidance: VA Facility Participation in the 2021 Press-Ganey Research Study: RN National Database of Nursing Quality Indicators RN Survey 2021-07-26
Proactive Calling for Recruitment Acting USH Memorandum on Recruitment of Veterans for Research Studies, June 29, 2021 (Proactive Calling for Recruitment) 2021-06-29
R&D Committee FAQs:  R&D Committee 2021-03-31
VHA Directive 1200.01 Amendment #1 Guidance Description of Amendment 1 to VHA Directive 1200.01 2021-01-08
VHA Directive 1200.05 Amendment #2 Guidance Description of Amendment 2 to VHA Directive 1200.05 2021-01-08
VHA Directive 1200.08 Amendment #1 Guidance Description of Amendment 1 to VHA Directive 1200.08 2021-01-08
Informed Consent Forms Research Guidance for the Use of Electronic Methods to Securely Obtain Informed Consent (VA network access only) 2020-10-15
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 2020-09-24
COVID-19 PREP Act Implementation of the Public Readiness and Emergency Preparedness Act(PREP Act) for COVID-19 Research Activities 2020-08-17
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 2020-07-29
COVID-19- FAQs The Mayo Clinic Expanded Access Program (EAP): Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 - Frequently Asked Questions 2020-07-19
COVID-19- FAQs Frequently Asked Questions (FAQs) Regarding COVID-19 Impacts on Research 2020-06-22
Remote Monitoring ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform 2020-06-18
Data Use Agreement Please refer to VHA Handbook 1200.12; revised DUA Templates to be released 2020-06-01
Human Subjects Research FAQs:  Spring Research Town Hall Q&A (Updated: 2021-03-31) 2020-05-04
COVID-19 Memorandum VA COVID-19 Research Biorepositories/Biobanks 2020-05-01
COVID-19- FAQs Frequently Asked Questions (FAQs) - COVID-19 and VA Animal Care and Use Programs 2020-04-13
COVID-19 Memorandum:  Use of Video Communication Technology for VHA Research and Development Activities Under COVID-19 2020-04-07
COVID-19 FAQS Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions (Updated: 2021-03-31) 2020-04-06
COVID-19- FAQs COVID-19 (SARS-CoV-2) Research Specimens - Frequently Asked Questions 2020-04-04
COVID-19 CRADO Memorandum for Administrative Hold on Non-Critical, In Person Interactions with Human Research Subjects in ORD-Funded Studies 2020-03-17
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: 2020-03-10) 2020-03-06
Single IRB Requests Single IRB Exceptions Information about Requesting Use of IRBs and Exceptions to the Single IRB Requirement 2020-01-22
Azure Rights Management Services  IRB and R&D Committee Considerations for Use of Azure Rights Management Services (RMS) in VA Research 2019-10-25
E-Cigarettes/ENDS  Notification Alert: Research Involving E-Cigarettes/ENDS 2019-10-02
National Cancer Institute IRB Information about Use of the NCI IRB by VA Facilities 2019-09-01
Fetal Tissue  Restriction on Use of Fetal Tissue for All VHA Research Studies 2019-08-28
Exempt Research Clarification of ORO's Requirements for the Review of Reportable Events in Exempt Human Subjects Research- VHA Handbook 1058.01 2019-08-07
Transitioning to 2018 Requirements ORD Guidance on Transitioning VA Human Research Studies to the Revised Federal Policy for the Protection of Human Subjects 2019-02-08
VHA Directive 1200.05 General Guidance Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05 2019-01-09
VHA Directive 1200.05 General Guidance  Summary of Significant Changes to VHA Directive 1200.05 2019-01-09
Certificates of Confidentiality FAQs:  Certificates of Confidentiality 2019-01-07
Material Transfer Agreements DRAFT ORD Guidance on Material Transfer Agreements (Updated: 2021-03-31) 2018-07-28
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 2018-07-02
Email Communications Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet 2018-03-12
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 2017-07-28
HIPAA Authorization  FAQ on Revocation of HIPAA Authorization for Research 2017-02-21
Non-affiliated IRB Members  ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members 2015-04-16
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 2015-03-09
Advertising  Guidance on Advertisement of Non-VA Funded Research in VA Facilities 2015-03-09
Continuing Review  Guidance on Continuing Review 2014-10-22
Exempt Research Guidance on Exempt Research Determination 2014-10-20
International Research Guidance on Approval of International Research 2014-10-20
Children  Guidance on Conducting Research Involving Children 2014-10-20
Pregnancy Guidance on Conducting Research Involving Pregnant Women 2014-10-20
SSN Data Requests in DART Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART)  2014-09-05
Study Team Changes  Guidance on IRB Approval of Changes in Study Team Members 2013-02-08
Conflict of Interest  FAQ on Financial Conflict of Interest 2013-02-08
IRB Membership  FAQ on Administrative Staff Membership on the IRB 2012-03-12
Informed Consent Forms FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms 2012-03-12
Informed Consent Forms Informed Consent Forms- Expiration Dates 2012-03-12
Case Reports Case Report Guidance 2009-12-09
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 E 2008-10-01
Off-site Research  (see Off-site Research page)
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)

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 (va.gov).

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: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign (VA network access only)

Post approval instructions, SOPs, and training materials can be found here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign/SitePages/Post-Approval-Instructions.aspx (VA network access only)

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