Human Subjects Research Policies and Guidance

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</tr> <tr> <td width="100" valign="top"> 2020-06-18 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/Clinical-Trials-Webex.pdf" target="_blank">ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform </a> </td> <td width="200" valign="top"> Remote Monitoring </td> </tr> <tr> <td width="100" valign="top"> 2020-06-01 </td> <td width="300" valign="top"> <a href="https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1851" target="_blank">Please refer to VHA Handbook 1200.12; revised DUA Templates to be released </a> </td> <td width="200" valign="top"> Data Use Agreement </td> </tr> <tr> <td width="100" valign="top"> 2020-05-04 </td> <td width="300" valign="top"> <a href="/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf" target="_blank">FAQs: Spring Research Town Hall Q&A (Updated: 2021-03-31) </a> </td> <td width="200" valign="top"> Human Subjects Research </td> </tr> <tr> <td width="100" valign="top"> 2020-05-01 </td> <td width="300" valign="top"> <a href="/resources/policies/CRADO-memo-COVID19-biobank.pdf" target="_blank">Memorandum VA COVID-19 Research Biorepositories/Biobanks </a> </td> <td width="200" valign="top"> COVID-19 </td> </tr> <tr> <td width="100" valign="top"> 2020-04-13 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/animal-care-FAQ-COV-19.docx" target="_blank">Frequently Asked Questions (FAQs) - COVID-19 and VA Animal Care and Use Programs </a> </td> <td width="200" valign="top"> COVID-19- FAQs </td> </tr> <tr> <td width="100" valign="top"> 2020-04-07 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/video-comm-covid19.pdf" target="_blank">Memorandum: Use of Video Communication Technology for VHA Research and Development Activities Under COVID-19 </a> </td> <td width="200" valign="top"> COVID-19 </td> </tr> <tr> <td width="100" valign="top"> 2020-04-06 </td> <td width="300" valign="top"> <a href="/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf" target="_blank">Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions (Updated: 2021-03-31) </a> </td> <td width="200" valign="top"> COVID-19 FAQS </td> </tr> <tr> <td width="100" valign="top"> 2020-04-04 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf" target="_blank"> COVID-19 (SARS-CoV-2) Research Specimens - Frequently Asked Questions </a> </td> <td width="200" valign="top"> COVID-19- FAQs </td> </tr> <tr> <td width="100" valign="top"> 2020-03-17 </td> <td width="300" valign="top"> <a href="/resources/policies/ORD-COVID-19-Research-Admin-Hold.pdf" target="_blank">CRADO Memorandum for Administrative Hold on Non-Critical, In Person Interactions with Human Research Subjects in ORD-Funded Studies</a> </td> <td width="200" valign="top"> COVID-19 </td> </tr> <tr> <td width="100" valign="top"> 2020-03-06 </td> <td 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valign="top"> Azure Rights Management Services </td> </tr> <tr> <td width="100" valign="top"> 2019-10-02 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/E-Cigarette-ENDS-studies.docx" target="_blank">Notification Alert: Research Involving E-Cigarettes/ENDS </a> </td> <td width="200" valign="top"> E-Cigarettes/ENDS </td> </tr> <tr> <td width="100" valign="top"> 2019-09-01 </td> <td width="300" valign="top"> <a href="/programs/orppe/nci_irb.cfm" target="_blank">Information about Use of the NCI IRB by VA Facilities </a> </td> <td width="200" valign="top"> National Cancer Institute IRB </td> </tr> <tr> <td width="100" valign="top"> 2019-08-07 </td> <td width="300" valign="top"> <a href=" https://www.va.gov/ORO/Docs/RCO/ORO_Interpretation_VHA_Handbook_1058_01.pdf" target="_blank">Clarification of ORO's Requirements for the Review of Reportable Events in Exempt Human Subjects Research- VHA Handbook 1058.01 </a> </td> <td width="200" valign="top"> Exempt Research </td> </tr> <tr> <td width="100" valign="top"> 2019-08-02 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/transitioning-human-subj-research.pdf" target="_blank">ORD Guidance on Transitioning VA Human Research Studies to the Revised Federal Policy for the Protection of Human Subjects</a> </td> <td width="200" valign="top"> Transitioning to 2018 Requirements </td> </tr> <tr> <td width="100" valign="top"> 2019-01-09 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/CrosswalkComparison-1200-05Handbook-vs-Directive.pdf" target="_blank">Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05 </a> </td> <td width="200" valign="top"> VHA Directive 1200.05 General Guidance </td> </tr> <tr> <td width="100" valign="top"> 2018-08-02 </td> <td width="300" valign="top"> <a href="/resources/policies/ProgramGuide-Off-site-Research-1200-16.pdf" target="_blank">Program Guide 1200.16: Off-Site Research</a> </td> <td width="200" valign="top"> Off-site Research </td> </tr> <tr> <td width="100" valign="top"> 2018-07-28 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/draft-mta-guidance.pdf" target="_blank">DRAFT ORD Guidance on Material Transfer Agreements (Updated: 2021-03-31) </a> </td> <td width="200" valign="top"> Material Transfer Agreements </td> </tr> <tr> <td width="100" valign="top"> 2018-03-12 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf" target="_blank">Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet </a> </td> <td width="200" valign="top"> Email Communications </td> </tr> <tr> <td width="100" valign="top"> 2017-07-28 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/draft-electronic-mailtext.pdf" target="_blank">DRAFT Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research</a> </td> <td width="200" valign="top"> Electronic Mail and Texting </td> </tr> <tr> <td width="100" valign="top"> 2017-02-21 </td> <td width="300" valign="top"> <a href="/resources/policies/HIPAA-Revocation-FAQ.pdf" target="_blank">FAQ on Revocation of HIPAA Authorization for Research </a> </td> <td width="200" valign="top"> HIPAA Authorization </td> </tr> <tr> <td width="100" valign="top"> 2015-04-16 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/NonAffiliated-IRB.docx" target="_blank"> ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members </a> </td> <td width="200" valign="top"> Non-Affiliated IRB Members </td> </tr> <tr> <td width="100" valign="top"> 2015-03-09 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/recruitment-non-va.pdf" target="_blank">Guidance on Advertisement of Non-VA Funded Research in VA Facilities </a> </td> <td width="200" valign="top"> Advertising </td> </tr> <tr> <td width="100" valign="top"> 2015-03-09 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/pregnancy.pdf" target="_blank">Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring </a> </td> <td width="200" valign="top"> Pregnancy </td> </tr> <tr> <td width="100" valign="top"> 2014-10-20 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/research-involving-children.pdf" target="_blank">Guidance on Conducting Research Involving Children</a> </td> <td width="200" valign="top"> Children </td> </tr> <tr> <td width="100" valign="top"> 2014-10-20 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/intl-research.pdf" target="_blank">Guidance on Approval of International Research </a> </td> <td width="200" valign="top"> International Research </td> </tr> <tr> <td width="100" valign="top"> 2014-10-20 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf" target="_blank">Guidance on Conducting Research Involving Pregnant Women </a> </td> <td width="200" valign="top"> Pregnancy </td> </tr> <tr> <td width="100" valign="top"> 2014-09-05 </td> <td width="300" valign="top"> <a href="/resources/ssn.cfm" target="_blank">Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART) </a> </td> <td width="200" valign="top"> SSN Data Requests in DART </td> </tr> <tr> <td width="100" valign="top"> 2013-08-02 </td> <td width="300" valign="top"> <a href="//resources/policies/guidance/Financial-Conflict-of-Interest.pdf" target="_blank">FAQ on Financial Conflict of Interest</a> </td> <td width="200" valign="top"> Conflict of Interest </td> </tr> <tr> <td width="100" valign="top"> 2013-02-08 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/Changes-Team-Members.pdf" target="_blank">Guidance on IRB Approval of Changes in Study Team Members 2 </a> </td> <td width="200" valign="top"> Study Team Changes </td> </tr> <tr> <td width="100" valign="top"> 2012-03-12 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/IRB-Membership-admin.pdf" target="_blank">FAQ on Administrative Staff Membership on the IRB </a> </td> <td width="200" valign="top"> IRB Membership </td> </tr> <tr> <td width="100" valign="top"> 2012-03-12 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/Informed-Consent-Forms-revisions.pdf" target="_blank">FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms </a> </td> <td width="200" valign="top"> Informed Consent Forms </td> </tr> <tr> <td width="100" valign="top"> 2012-03-12 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/Informed-Consent-Forms-Expiration.pdf" target="_blank">Informed Consent Forms - Expiration Dates </a> </td> <td width="200" valign="top"> Informed Consent Forms </td> </tr> <tr> <td width="100" valign="top"> 2009-12-09 </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/Case-Report-Guidance.pdf" target="_blank">Case Report Guidance </a> </td> <td width="200" valign="top"> Case Reports </td> </tr> <tr> <td width="100" valign="top"> -- </td> <td width="300" valign="top"> ORD Guidance for Use of Facebook and Twitter when Recruiting Research Subjects in VA Research (Guidance Under Revision. Temporarily removed on 09/26/2017) </td> <td width="200" valign="top"> Social Media </td> </tr> <tr> <td width="100" valign="top"> -- </td> <td width="300" valign="top"> <a href="/services/shared_docs/Offsite-Waiver-Req.doc" target="_blank">Partial Off-site Waiver Request Template </a> </td> <td width="200" valign="top"> Off-site Research </td> </tr> <tr> <td width="100" valign="top"> -- </td> <td width="300" valign="top"> <a href="/resources/policies/guidance/MOU-Template-BiosafetyLevel3.docx" target="_blank">Biosafety Level 3 (BSL-3) MOU Template</a> </td> <td width="200" valign="top"> Off-site Research </td> </tr> </tbody> </table> <table width="700" > <tr><td> <p id="docusign"><strong> Requesting Use of DocuSign for VA-approved Research </strong><br> <p>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. </p> <p>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).</p> <p>Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided.</p> <p>The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: <a href="https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign" target="_blank">https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign</a> (VA network access only)</p> <p>Post approval instructions, SOPs, and training materials can be found here: <a href="https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign/SitePages/Post-Approval-Instructions.aspx" target="_blank">https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign/SitePages/Post-Approval-Instructions.aspx</a> (VA network access only)</p> </td></tr> </table> <p align="right"><a href="#top">top</a></p> <h3 id="fed-reg">Federal Regulations</h3> <ul> <li><a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf" target="_blank">Final Rule (2018 Requirements): Federal Policy for the Protection of Human Subjects</a></li> <li> <strong>Pre-2018 Requirements:</strong> <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-text/index.html" target="_blank">Federal Policy for the Protection of Human Subjects</a> </li> <li><a href="https://ecfr.io/Title-38/Part-17" target="_blank">38 CFR 17 VA</a>- Medical</li> <li><a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11" target="_blank">eCFR :: 21 CFR Part 11 -- Electronic Records; Electronic Signatures</a></li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50" target="_blank">21CFR50 (FDA - Protection of Human Subjects)</a></li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=56" target="_blank">21CFR56 (FDA - Institutional Review Boards)</a></li> <li><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312" target="_blank">21CFR312 (FDA - Investigational New Drug Application)</a></li> <li><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812" target="_blank">21CFR812 (FDA - Investigational Device Exemptions)</a></li> <li><a href="https://www.govregs.com/regulations/title32_chapterI_part219" target="_blank">32CFR219 (DOD - Protection of Human Subjects)</a></li> </ul> <h3 id="gcp">Good Clinical Practice</h3> <ul> <li><a href="https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm464506.pdf" target="_blank">Guidance for Industry E-6</a></li> <li><a href="http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm" >Comparison of FDA and DHHS Human Subject Protection Regulations</a></li> </ul> <h3 id="guiding">Guiding Principles</h3> <ul> <li><a href="https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html" target="_blank">The Belmont Report</a></li> <li><a href="https://history.nih.gov/research/downloads/nuremberg.pdf" target="_blank">The Nuremberg Code</a></li> <li><a href="https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/" target="_blank">Declaration of Helsinki - WMA - The World Medical Association</a></li> </ul> <p align="right"><a href="#top">top</a></p> <div class="clear"></div> </div>   <br style="clear: both" /> <br clear="all">  <div style="bottom:0; margin-left:30px; margin-top:30px; font-weight:bold; padding-top:10px; border-top:1px solid #cccccc;" id="footerBlock"> Questions about the R&D website? <a href="mailto:HSRDWeb.Boston@va.gov" style="color:#0B6CB2 !Important;">Email the Web Team</a> <span style="font-size:10px; font-weight:normal;"> <br> <br> Any health information on this website is strictly for informational purposes and is not intended as medical advice. 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