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ORD Policies and Guidance Documents

VHA HANDBOOKS AND DIRECTIVES
All VHA Handbooks and Directives can be found on the VHA Publications website at https://www.va.gov/vhapublications/. ORD Handbooks are in the 1200 series ( see 1200 Handbook series list).

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

Draft Guidance Documents

• Electronic Mail and Texting: Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research (July 28, 2017)
• Material Transfer Agreements: Draft ORD Guidance on Material Transfer Agreements (July 28, 2017)

Guidance Documents

• ACOS Responsibilities: FAQ on Delegation of ACOS/R&D Responsibilities (March 12, 2012)
• ACOS Responsibilities: FAQ on Role of ACOS/R&D and the R&D Committee (April 16, 2012)
• Advertising: Guidance on Advertisement of Non-VA Funded Research in VA Facilities (March 9, 2015)
• Agreements:
  • Guidance for Submitting MOUs, MOAs, and other Written Agreements to ORD (July 25, 2017) New!
  • Instructions for Submitting VHA Directive 1200.02 Required Agreements to ORD (July 25, 2017) New!
  • MOU Guidance: Checklist for use in Developing a Memorandum of Understanding (MOU) between a VA facility and an Affiliated IRB: Memo | MOU (Updated January 22, 2016)
• Annual Review of Publications: Enforcement of Annual Review of Publications (July 21, 2014)
• Authority of the ACOS/R&D: FAQ: Authority of the ACOS/R&D Relative to the R&D Committee (May 12, 2015)
• Case Reports: Case Report Guidance (December 9, 2009)
• Children: Guidance on Conducting Research Involving Children (October 20, 2014)
• Confidentiality: ORD Guidance on Certificates of Confidentiality (April 23, 2015)
• Conflict of Interest: FAQ on Financial Conflict of Interest (February 8, 2013)
• Continuing Review: Guidance on Continuing Review (October 22, 2014)
• CRADA Selections: Guidance on Selection of the Appropriate CRADA Model (April, 2014)
• Data Use Agreement with Non-Federal Entities: Data Use Agreement with Non-Federal Entities for Data Sharing Between DVA, VHA, and Non-Federal Entity/Recipient (March 2016)
• Exempt Research: Guidance on Exempt Research Determination (October 20, 2014)
• HIPAA Authorization: FAQ on Revocation of HIPAA Authorization for Research (February 21, 2017)
• Informed Consent Forms: FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms (March 12, 2012)
• Informed Consent Forms: FAQ on Expiration Dates on Informed Consent Forms (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)
• Non-Veterans in Research: FAQ on Recruitment of Non-Veterans for VA Research (March 12, 2012)
• Non-affiliated IRB Members: ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members (April 16, 2015)
• Off-site Research -- Guidance Documents
  (See also Off-site Research Handbook, VHA Handbook 1200.16)
  • Instructions for Preparation and Submission of Requests for Off-Site Waivers Updated 01/14/14
  • Partial Off-site Waiver Request Template Updated 01/14/14
  • Application for an Off-site Tissue Banking Waiver VA Form 10-0436
• 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)
• Publishing: Checklist for publishing VA research (August 3, 2015)
• Record Control Schedule: Guidance on ORD's New Record Control Schedule (August 20, 2015)
• R&D Committee: FAQ on Role of ACOS/R&D and the R&D Committee (April 16, 2012)
• RCO: Guidance on The RCOs Role on Research Review Committees (June 11, 2010)
• Record Retention: Guidance on VA Research Records and the Impact of the Federal Records Act (Revision Pending 09-14-2015)
• Recruitment: FAQ on "Recruitment Only" Studies (March 12, 2012)
• Request for Administrative Project Modification -- ORD Guidance Document and Form
  • Criteria and Instructions for Requesting a Project Modification
  • ORD Project Modification Form
• Social Media: ORD Guidance for Use of Facebook and Twitter when Recruiting Research Subjects in VA Research (March 9, 2015)
• SSN Data Requests in DART:
  Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART) (Sept. 5, 2014)
• Standard Operating Procedures - Using Schedule B and Title 38 Medical Support Authorities (June 4, 2013)
• Study Team Changes: Guidance on IRB Approval of Changes in Study Team Members (February 8, 2013)
• Training: FAQ on Training (March 12, 2012)
• VHA Handbook 1200.05: General Guidance Documents
• VHA Handbook 1200.05 Technical Amendment (February 22, 2017): Description of Technical Amendment
• VHA Handbook 1200.05 Technical Amendment (June 29, 2017): Description of Technical Amendment
• VHA Handbook 1200.05 Cyberseminars: Topics in Human Subjects Research Protection

Other

• VA Technology Transfer Program

Federal Regulations

• Final Rule: Federal Policy for the Protection of Human Subjects (January 19, 2017)
• 38 CFR 17 VA - Medical
• 21CFR11 (FDA - Electronic Records and Signatures)
• 21CFR50 (FDA - Protection of Human Subjects)
• 21CFR56 (FDA - Institutional Review Boards)
• 21CFR312 (FDA - Investigational New Drug Application)
• 21CFR812 (FDA - Investigational Device Exemptions)
• 32CFR219 (DOD - Protection of Human Subjects)

Good Clinical Practice

• Guidance for Industry E-6 (260 KB, PDF)
• Comparison of FDA and DHHS Human Subject Protection Regulations

Guiding Principles

• The Belmont Report
• The Nuremberg Code
• World Medical Association Declaration of Helsinki

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