Search the ORD website Button to search ORD

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.

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 20, 2017) New!
  • Instructions for Submitting VHA Directive 1200.02 Required Agreements to ORD (July 20, 2017) New!
  • MOU Guidance:Completion of Time-Effort MOU for DAPs (June 5, 2017) See also: 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)
• 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

top