Office of Research & Development |
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An official website of the United States government
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Topic |
Guidance Document |
Release Date |
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Advertising |
Guidance on Advertisement of Non-VA Funded Research in VA Facilities |
March 9, 2015 |
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Azure Rights Management Services |
October 25, 2019 |
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Burden Reducing Provisions and the Final Rule |
July 2, 2018 |
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Case Reports |
December 9, 2009 |
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Children |
October 20, 2014 |
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Certificates of Confidentiality |
January 7, 2019 |
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Conflict of Interest |
February 8, 2013 |
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Continuing Review |
October 22, 2014 |
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COVID-19 |
May 1, 2020 |
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COVID-19 |
Updated March 17, 2020 |
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COVID-19 |
Updated March 10, 2020 |
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COVID-19 |
April 7, 2020 |
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COVID-19 FAQS |
Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions |
Updated March 31, 2021 |
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COVID-19- FAQs |
July 19, 2020 |
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COVID-19- FAQs |
Frequently Asked Questions (FAQs) Regarding COVID-19 Impacts on Research |
June 22, 2020 |
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COVID-19- FAQs |
Frequently Asked Questions (FAQs) - COVID-19 and VA Animal Care and Use Programs |
April 13, 2020 |
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COVID-19- FAQs |
COVID-19 (SARS-CoV-2) Research Specimens - Frequently Asked Questions |
Original Publication Date: April 4, 2020 |
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COVID-19 PREP Act |
August 17, 2020 |
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Data Use Agreement |
Please refer to VHA Handbook 1200.12; revised DUA Templates to be released |
Summer 2020 |
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E-Cigarettes/ENDS |
October 2, 2019 |
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Electronic Mail and Texting |
July 28, 2017 |
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Email Communications |
Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet |
March 12, 2018 |
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Employee Participation in COVID-19 studies |
September 24, 2020 |
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Exempt Research |
October 20, 2014 |
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Exempt Research |
August 7, 2019 |
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Fetal Tissue |
Restriction on Use of Fetal Tissue for All VHA Research Studies |
August 28, 2019 |
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HIPAA Authorization |
February 21, 2017 |
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Human Subjects Research |
Updated March 31, 2021 |
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Informed Consent Forms |
FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms |
March 12, 2012 |
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Informed Consent Forms |
March 12, 2012 |
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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 |
October 20, 2014 |
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IRB Membership |
March 12, 2012 |
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Material Transfer Agreements |
Updated March 31, 2021 |
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National Cancer Institute IRB |
Check this |
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Non-affiliated IRB Members |
ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members |
April 16, 2015 |
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Off-site Research |
(see Off-site Research page) |
n/a |
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Pregnancy |
October 20, 2014 |
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Pregnancy |
March 9, 2015 |
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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 |
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Remote Monitoring |
ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform |
June 18, 2020 |
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R&D Committee |
Updated March 31, 2021 |
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Single IRB Requests Single IRB Exceptions |
Information about Requesting Use of IRBs and Exceptions to the Single IRB Requirement |
January 22, 2020 |
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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 |
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SSN Data Requests in DART |
Sept. 5, 2014 |
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Study Team Changes |
February 8, 2013 |
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Transitioning to 2018 Requirements |
February 8, 2019 |
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VHA Directive 1200.01 |
July 29, 2020 |
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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 |
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VHA Directive 1200.05 General Guidance |
January 9, 2019 |
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VHA Directive 1200.05 General Guidance |
January 8, 2019 |
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VHA Directive 1200.01 Amendment #1 Guidance |
Description of Amendment #1 to VHA Directive 1200.01
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January 8, 2021 |
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VHA Directive 1200.05 Amendment #2 Guidance |
Description of Amendment #2 to VHA Directive 1200.05
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January 8, 2021 |
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VHA Directive 1200.08 Amendment #1 Guidance |
Description of Amendment #1 to VHA Directive 1200.08
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January 8, 2021 |
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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) |