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Guidances

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Guidances

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

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Topic

Guidance/Reference Doc/
source
Acronyms Commonly Used Acronyms AID-22
Biosafety (APB)

Human Gene Transfer

Stanford EH&S Web

Genome Editing and Gene Drives and Stanford Stanford EH&S Web
Infectious Agents: Regulations and Guidelines Stanford EH&S Web
Children in Research Additional Protections - Inclusion of Children (FDA)
Additional Protections - Inclusion of Children (OHRP)
GUI-9
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 Process OHRP
Consent for Children and Consenting Minors GUI-C24
Parental Permission GUI-C34
Parental Permission for Children in School Based Studies GUI-45
Risk Level in Pediatric Research GUI01042
Compassionate Use
Humanitarian Use Device HUD GUI-36m
Expanded Access to Investigational Drugs and Devices GUI-19m
Confidentiality
Certificates of Confidentiality (COC) - Human Subjects  NIH
Confidentiality - Administrative Panel (IRB) Proceedings RPH
Privacy and Confidentiality (HRPP Ch 11) HRPP 11
CoC Assurance letter template TEM-46
Conflict of Interest
Faculty - Policy on Conflict of Commitment & Interest RPH
IRB Members - Conflicting Interests
IRB Members - Conflict of Interest Declaration
GUI-I5
RPT-I1
Consent
Consent Form Do's & Don'ts (a practical guide) AID-C1
GUI-C27
General Rqmnts for Informed Consent GUI-C41
IRB web
APRS web
Observation of the Consenting Process - Checklist CHK-C15
Parental Permission GUI-C34
GUI-C2
GUI-32
Short Form Consent Process GUI-C39
Pregnant Partner Consent Process GUI-C47
Data & Safety Monitoring

Data and Safety Monitoring - Guidance
DSM Plan - eProtocol Help & Hints

GUI-P20

DMSB in Phase I/II Cell and Gene Transfer Clinical Trials

AID-59

DSMP vs DSMB

GUI-P46

Data Security
Data Security - Secure Computing Guidelines
Retention of and Access to Research Data
ISO web
RPH
Devices
FAQs About Medical Devices [FDA] FDA
Frequently Asked Questions About Medical Devices  - FDA Information Sheet FDA
Significant Risk and Non-Significant Risk Medical Devices Studies - Stanford Guidance GUI-7m
Significant Risk and Nonsignificant Risk Medical Device Studies - FDA Information Sheet FDA
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies GUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the IDE GUI-5m
STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device study GUI-41m
Drugs
Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs RPH
Orphan Drugs FDA

Security and Controlled Access Plan for Investigational Drugs and Biologics Maintained and Controlled by a PD

SHC 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 Biologics LPCH Policy
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies GUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the IND GUI-3m
Emergency Use
Emergency Use of a Test Article - Guidance
Emergency Use of a Test Article - Web Page
GUI-6
IRB web
Expanded Access to Investigational Drugs and Devices Expanded Access to Investigational Drugs and Devices - Guidance
Expanded Access to Investigational (Test) Articles - Brochure
GUI-19m GUI-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 Requirements

GUI-46

DoD Monitoring Requirements

GUI-47

DOE - Protection of Personally Identifiable Information (PII) - eProtocol Required Attachment

APP-14

VA - Reviewing VA Research AID-27m
Genomic Data Sharing
(NIH grant info)
NIH Genomic Data Sharing for NIH Grant Submission

GUI-G1

FAQs for Genomic Data Sharing

IRB web

HIPAA
HIPAA and PHI
HIPAA at Stanford
GUI-3
IRB web
Human Subject Research Human Subject Research (HSR) Determination Form APP-H8
Does My Project Need IRB Review? FLW-H4

What Qualifies as Human Subject Research

 

Research Involving Private Information or Biospecimens: NIH Infographic

 

Guidance, Coded Private Information or Specimens Use in Research (2008)

GUI-H12

 

NIH

 

OHRP

Determining When an Organization is Engaged

AID-H15

Engagement of Institutions in Human Subjects Research

OHRP
Quality Assessment & Quality Improvement (QA/QI) AID-H16
CA Laws/Regulations AID-H18

Humanitarian Use

Humanitarian Use Device GUI-36m
IRB Review
Criteria for IRB Approval of Research: Medical
Criteria for IRB Approval of Research: Nonmedical
GUI-40
GUI-40n
Institutional and Ancillary Reviews AID-125
Exempt Review Categories GUI-4
Expedited Review Categories GUI-44
Obtaining Additional Expertise or an Expert Consultant GUI-12
Guidelines for IRB Members on Conflicting Interests GUI-I5
IRB Meeting Schedules AID-18
IRB Member Conflict of Interest Declaration RPT-I1
IRB Authority Charge to Panel on Human Subjects Research-Medical CHG-1
Charge to Panel on Human Subjects Research - Nonmedical CHG-2
Confidentiality of Panel (IRB) Proceedings RPH
IRB Rosters IRB web
International Research
International 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
MTA Material Transfer Agreements OTL
Multi-Site Research Cooperative Research: Letter of Agreement GUI-31
Payment
Ethical Considerations GUI-39
FDA info sheet: Payment and Reimbursement to Research Subjects FDA
Stanford University Job Aid: Paying Human Subjects AID-9
Prisoners
California Penal Code: Section 3501 - 3523 GUI-38
OHRP Guidance on Involvement of Prisoners in Research GUI-10
Radiation Preparing Research Proposals Involving Diagnostic Use of Ionizing Radiation APRS web
Use of Radiology Devices and Radioactive Materials GUI
Recruitment Advertisements: Appropriate Language - Recruitment Material GUI-16
General guidance on participant recruitment GUI-33
Use of Employees or Laboratory Personnel as Research Subjects RPH
Telephone Screening of Potential Subjects GUI-15
Non-English Speaking Research Participants GUI03H23
Reporting
Events and Information that Require Prompt Reporting to the IRB GUI-P13
Unanticipated Adverse Device Effect (UADE) GUI-P14
Risk Special Considerations about Risks in Behavioral and Social Sciences Research GUI-14n
Security
Data security - Secure Computing Guidelines Stanford ISO web
Short Form
Consent
Short Form Consent Process - Guidance GUI-C39
Short Form Consent Process - Web Page IRB web
Single IRB (sIRB) Stanford required consent language for sIRB AID-C57
STANFORD SOPs FOR RELYING ON A SINGLE IRB (sIRB) GUI-H24
Sponsor-Investigator
Research (SIR)
Requirements for New, Continuing Review and Final Report

AID-23m

Requirements for Sponsor-Investigators who hold their own IND/IDE (Memo from Ann Arvin, MD) MEM-1m

When the STANFORD Investigator holds the IDE

GUI-5m

When the STANFORD Investigator holds the IND GUI-3m
When the STANFORD Investigator is the sponsor on a nonsignificant risk (NSR) device study GUI-41m
SIR Self-Assessment Checklist - IND/IDE AID-58m
Students Special Considerations about Risks in Behavioral and Social Sciences Research GUI-14n
Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects RPH
Study Design Evaluating Sound Study Design GUI-17
Terminology Clinical Trials Terms AID-20m
Tissue & Samples Data and Tissue Repositories GUI
Transplantation of Human Fetal Tissue GUI-2m
Training Training in the Protection of Human Subjects in Research RPH
Veterans Administration (VA) Research
38 CFR 16 Department of Veterans Affairs
  ORO Guidance Apparently Serious Research Info Security Problems ORO
  ORO Guidance Reporting Deficient HIPAA Authorizations ORO
  Required Questions-VA Research APP-1m
  Research Involving VA Studies CHK-07
  Reviewing Veterans Affairs (VA) Research AID-27m
  VHA Directive 1058 Research Compliance Reporting Requirements VHA
  VHA Directive 1200.05 Requirements for the Protection of Human Subjects in Research VHA
  VHA Program Guide 1200.21 VHA Operations Activities That May Constitute Research VHA
Waivers
Regulations for Waiver or Alteration of Consent Requirements GUI-C2
Women Research Involving Pregnant Women, Fetuses, and Neonates GUI-8
Women as Subjects in Research RPH