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Topic

Guidance/Reference Doc/
source
Acronyms
Commonly Used Acronyms AID-22
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 Chidren in School Baesd Studes GUI-03045
Risk Level in Pediatric Research GUI-01042
Compassionate Use
"Compassionate" and "Humanitarian" Use [FDA] GUI-36m
Expanded Access to Investigational Drugs and Devices GUI-19m
Confidentiality
Certificates of Confidentiality (COC) OHRP
Confidentiality - Administrative Panel (IRB) Proceedings RPH
Privacy and Confidentiality (HRPP Ch 11) HRPP 11
Conflict of Interest
Faculty - Policy on Conflict of Commitment & Interest RPH
IRB Members - Conflicting Interests
IRB Members - Conflict of Interest Declaration
GUI-15
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 IRB web
Data & Safety Monitoring

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

GUI-P20

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
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
DOE - Protection of Personally Identifiable Information (PII) - eProtocol Required Attachment APP-14
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 GUI-H12
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
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-15
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
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 GUI-03H23
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
Security and Controlled Access: Drugs and Biologics GUI-35m
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-03C057
STANFORD SOPs FOR RELYING ON A SINGLE IRB (sIRB) GUI03H24
Sponsor-Investigator
Research (SIR)
Requirements for New, Continuing Review and Final Report AID-23m
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 Form - IND AID-40m
SIR Self-Assessment Form - IDE AID-41m
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
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

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