The Research Compliance Office (RCO) will be closed during Stanford’s Winter Closure from Thursday, December 21, 2023 through Wednesday, January 3, 2024.

Stanford
Research Compliance Office

Guidances

To see the most frequently used guidances, visit the Laminates page. 

NOTE:  If you are having trouble accessing these documents, please ask IRB Education (email or call 650-724-7141) to have them sent to you.

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TopicGuidance/ReferenceDoc/
source
AcronymsCommonly Used AcronymsAID-22
Biosafety (APB)Human Gene TransferStanford EH&S Web
Genome Editing and Gene Drives and StanfordStanford EH&S Web
Infectious Agents: Regulations and GuidelinesStanford EH&S Web
Children in ResearchAdditional Protections - Inclusion of Children (FDA)GUI-9
Additional Protections - Inclusion of Children (OHRP)GUI-1
Research Involving a Placebo Arm (implications of March 2013 FDA final rule, subpart D)IRB memo
Children Involved as Subjects in Research - "407" Review ProcessOHRP
Ethical Considerations for Clinical Investigations of Medical Products Involving Children – FDA GuidanceFDA
Consent for Children and Consenting MinorsGUI-C24
Parental PermissionGUI-C34
Parental Permission for Children in School Based StudiesGUI-45
Risk Level in Pediatric ResearchGUI01042
Compassionate UseHumanitarian Use Device HUDGUI-36m
Expanded Access to Investigational Drugs and DevicesGUI-19m
ConfidentialityCertificates of Confidentiality (COC) - Human Subjects NIH
Confidentiality - Administrative Panel (IRB) ProceedingsRPH
Privacy and Confidentiality (HRPP Ch 11)HRPP 11
Conflict of InterestFaculty - Policy on Conflict of Commitment & InterestRPH
IRB Members - Conflicting InterestsGUI-I5
IRB Members - Conflict of Interest DeclarationRPT-I1
ConsentAdobe Sign Information and InstructionsOffice of Research Web
Consent Form Do's & Don'ts (a practical guide)AID-C1
Basic Research Consent RequirementsGUI-C27
General Requirements for Informed Consent - OHRPGUI-C41
General Requirements for Informed Consent - FDAGUI-C42
Glossary of Lay Terms for use in Consent FormsIRB web
Diagnostic Use of Ionizing Radiation - Consent Form LanguageAPRS web
Observation of the Consenting Process - ChecklistCHK-C15
Parental PermissionGUI-C34
Waiver/Alteration of Consent RequirementsGUI-C2
Research Surrogate Decision MakersGUI-32
Short Form Consent ProcessGUI-C39
Pregnant Partner Consent ProcessGUI-C47
Data & Safety MonitoringData and Safety Monitoring - Guidance
DSM Plan - eProtocol Help & Hints		GUI-P20
DMSB in Phase I/II Cell and Gene Transfer Clinical TrialsAID-59
DSMP vs DSMBGUI-P46
Data SecurityData Security - Secure Computing GuidelinesISO web
Retention of and Access to Research DataRPH
DevicesClinical Decision Support (CDS) Software – FDA GuidanceFDA
Clinical Decision Support (CDS) Software Determination Graphic – FDA GraphicFDA
  
FAQs About Medical Devices [FDA]FDA
Frequently Asked Questions About Medical Devices  - FDA Information SheetFDA
Significant Risk and Non-Significant Risk Medical Devices Studies - Stanford GuidanceGUI-7m
Significant Risk and Nonsignificant Risk Medical Device Studies - FDA Information SheetFDA
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device StudiesGUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the IDEGUI-5m
STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device studyGUI-41m
DrugsGuidelines for Studies Involving Human Volunteers Receiving Potentially Addicting DrugsRPH
Orphan DrugsFDA
Security and Controlled Access Plan for Investigational Drugs and Biologics Maintained and Controlled by a PDSHC Policy
Supplement to Attachment B of the Security and Controlled Access Plan for
Investigational and Biologics Maintained and Controlled by a Protocol Director		SHC Policy
LCPH Policy on Investigational Drugs and BiologicsLPCH Policy
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device StudiesGUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the INDGUI-3m
Emergency UseEmergency Use of a Test Article - GuidanceGUI-6
Emergency Use of a Test Article - Web PageIRB web
Expanded Access to Investigational Drugs and DevicesExpanded Access to Investigational Drugs and Devices - GuidanceGUI-19m
Expanded Access to Investigational (Test) Articles - BrochureGUI-B1m
Federal Agency Requirements
[DoD, DON, DOE, etc.]		Other Federal Agencies - Additional Requirements:
    DoD, DON, ED, DOE, DOJ, EPA, NSF, PHS		GUI-42
DoD Reporting RequirementsGUI-46
DOE - Protection of Personally Identifiable Information (PII) - eProtocol Required AttachmentAPP-14
VA - Reviewing VA ResearchAID-27m
Genomic Data Sharing
(NIH grant info)		NIH Genomic Data Sharing for NIH Grant SubmissionGUI-G01
FAQs for Genomic Data SharingIRB web
HIPAAHIPAA and PHIGUI-3
HIPAA Privacy Policies at StanfordUniversity Privacy Offfice Web
Research Privacy OverviewPrivacy Office PPT presentation
Human Subject ResearchHuman Subject Research (HSR) Determination FormAPP-H8
Does My Project Need IRB Review?FLW-H4
What Qualifies as Human Subject ResearchGUI-H12
Research Involving Private Information or Biospecimens: NIH InfographicNIH
Guidance, Coded Private Information or Specimens Use in Research (2008)OHRP
Determining When an Organization is EngagedAID-H15
Engagement of Institutions in Human Subjects ResearchOHRP
Quality Assessment & Quality Improvement (QA/QI)AID-H16
CA Laws/RegulationsAID-H18
Humanitarian UseHumanitarian Use DeviceGUI-36m
International ResearchInternational Compilation of Human Research Protections (OHRP) - laws, regulations, guidelines on human subjects research in over 100 countries; standards (international, regional)OHRP
Guide to Conducting Research in India
General Data Protection Regulation (GDPR)IRB Web
IRB AuthorityCharge to Panel on Human Subjects Research-MedicalCHG-1
Charge to Panel on Human Subjects Research - NonmedicalCHG-2
Confidentiality of Panel (IRB) ProceedingsRPH
IRB RostersIRB web
IRB ReviewCriteria for IRB Approval of ResearchGUI-40
Institutional and Ancillary ReviewsAID-125
Exempt Review CategoriesGUI-4
Expedited Review CategoriesGUI-44
Obtaining Additional Expertise or an Expert ConsultantGUI-12
Guidelines for IRB Members on Conflicting InterestsGUI-I5
IRB Meeting SchedulesAID-18
IRB Member Conflict of Interest DeclarationRPT-I1
MTAMaterial Transfer AgreementsOTL
PaymentEthical ConsiderationsGUI-39
FDA info sheet: Payment and Reimbursement to Research SubjectsFDA
Stanford University Job Aid: Paying Human SubjectsAID-9
PrisonersCalifornia Penal Code: Section 3501 - 3523GUI-38
OHRP Guidance on Involvement of Prisoners in ResearchGUI-10
RadiationPreparing Research Proposals Involving Diagnostic Use of Ionizing RadiationAPRS web
Use of Radiology Devices and Radioactive MaterialsGUI
RecruitmentAdvertisements: Appropriate Language - Recruitment MaterialGUI-16
General guidance on participant recruitmentGUI-33
Use of Employees or Laboratory Personnel as Research SubjectsRPH
Telephone Screening of Potential SubjectsGUI-15
Non-English Speaking Research ParticipantsGUI03H23
ReportingEvents and Information that Require Prompt Reporting to the IRBGUI-P13
Unanticipated Adverse Device Effect (UADE)GUI-P14
RiskSpecial Considerations about Risks in Behavioral and Social Sciences ResearchGUI-14n
SecurityData security - Secure Computing GuidelinesStanford ISO web
Short Form
Consent		Short Form Consent Process - GuidanceGUI-C39
Short Form Consent Process - Web PageIRB web
Single IRB (sIRB)Stanford required consent language for sIRBAID-C57
STANFORD SOPs FOR RELYING ON A SINGLE IRB (sIRB)GUI-H24
Sponsor-Investigator
Research (SIR)		Requirements for New, Continuing Review and Final ReportAID-23m
Requirements for Sponsor-Investigators who hold their own IND/IDE (Memo from Ann Arvin, MD)MEM-1m
When the STANFORD Investigator holds the IDEGUI-5m
When the STANFORD Investigator holds the INDGUI-3m
When the STANFORD Investigator is the sponsor on a nonsignificant risk (NSR) device studyGUI-41m
SIR Self-Assessment Checklist - IND/IDEAID-58m
StudentsSpecial Considerations about Risks in Behavioral and Social Sciences ResearchGUI-14n
Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI ProjectsRPH
Study DesignEvaluating Sound Study DesignGUI-17
TerminologyClinical Trials TermsAID-20m
Tissue & SamplesData and Tissue RepositoriesGUI
Transplantation of Human Fetal TissueGUI-2m
TrainingTraining in the Protection of Human Subjects in ResearchRPH
Veterans Affairs (VA) Research38 CFR 16Department of Veterans Affairs
Research Involving VA StudiesCHK-07
Reviewing Veterans Affairs (VA) ResearchAID-27m
VHA Directive 1058 Research Compliance Reporting RequirementsVHA
VHA Directive 1200.05 Requirements for the Protection of Human Subjects in ResearchVHA
VHA Program Guide 1200.21 VHA Operations Activities That May Constitute ResearchVHA
WaiversRegulations for Waiver or Alteration of Consent RequirementsGUI-C2
WomenResearch Involving Pregnant Women, Fetuses, and NeonatesGUI-8
Women as Subjects in ResearchRPH