Human Research
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Off-site Research |
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Draft Guidance Documents
Guidance Documents
- Advertising: Guidance on Advertisement of Non-VA Funded Research in VA Facilities(March 9, 2015)
- Agreements:
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)
- 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)
- 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)
- 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)
- 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 (see Off-site Research page)
- 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)
- Recruitment: FAQ on "Recruitment Only" Studies (March 12, 2012)
- 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)
- 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
- VHA Directive 1200.05 General Guidance: Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05 (dated January 7, 2019) (guidance dated 1-9-2019)
- VHA Directive 1200.05 General Guidance: Summary of Significant Changes to VHA Directive 1200.05 (guidance dated 1-9-2019)
- VHA Directive 1200.05 General Guidance: Red-Line Version of VHA Directive 1200.05 (DRAFT) (1-8-2019)
Federal Regulations
Good Clinical Practice
Guiding Principles
VHA Handbooks
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