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Topic

Guidance/Reference Doc/
source
HRPP Policy
Ch(s)
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
5, 8, 9, 12, 14
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
Compassionate Use
"Compassionate" and "Humanitarian" Use [FDA] GUI-36m 5
Expanded Access to Investigational Drugs and Devices GUI-19m
Confidentiality
Certificates of Confidentiality (COC) OHRP 6, 11
Confidentiality - Administrative Panel (IRB) Proceedings RPH 6
Privacy and Confidentiality (HRPP Ch 11) HRPP 11 11
Conflict of Interest
Faculty - Policy on Conflict of Commitment & Interest RPH 2, 3,12
IRB Members - Conflicting Interests
IRB Members - Conflict of Interest Declaration
GUI-15
RPT-I1
6
Consent
Consent Form Do's & Don'ts (a practical guide) AID-C1 12
GUI-C27
General Rqmnts for Informed Consent Medical
General Rqmnts for Informed Consent Nonmedical
GUI-C41
GUI-C41n
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 GUI-P20 3, 9, 11, 15
Data Security
Data Security - Secure Computing Guidelines
Retention of and Access to Research Data
ISO web
RPH
3, 9, 11, 15
Devices
FAQs About Medical Devices [FDA] FDA 5
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 5
Orphan Drugs FDA
Security and Controlled Access: Drugs and Biologics GUI-35m
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
5.8
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 5.8
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  
HIPAA
HIPAA and PHI
HIPAA at Stanford
GUI-3
IRB web
4, 11
Human Subject Research Determination of Human Subject Research: Application to IRB APP-H8 1, 3
Does My Project Need IRB Review? FLW-H4
What Qualifies as Human Subject Research GUI-H12
Quality Assessment & Quality Improvement (QA/QI) AID-H16
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
7
Exempt Review Categories GUI-4(p2)
Expedited Review Categories GUI-4(p1)
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 1, 6
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 1
MTA Material Transfer Agreements OTL  
Multi-Site Research Cooperative Research: Letter of Agreement GUI-31 13
Payment
Ethical Considerations GUI-39 10, 12, 14
Stanford University Job Aid: Paying Human Subjects AID-9
Prisoners
California Penal Code: Section 3501 - 3523 GUI-38 9, 12
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 Mtrl GUI-16 10, 20
General guidance on participant recruitment GUI-33
Use of Employees or Laboratory Personnel as Research Subjects RPH
Telephone Screening of Potential Subjects GUI-15
Reporting
Events and Information that Require Prompt Reporting to the IRB GUI-P13 3
Unanticipated Adverse Device Effect (UADE) GUI-P14 3
Risk Special Considerations about Risks in Behavioral and Social Sciences Research GUI-14n 9
Security
Data security - Secure Computing Guidelines Stanford ISO web 4, 11
Security and Controlled Access: Drugs and Biologics GUI-35m
Short Form
Consent
Short Form Consent Process - Guidance GUI-C39 12
Short Form Consent Process - Web Page IRB web
Sponsor-Investigator
Research (SIR)
Requirements for New, Continuing Review and Final Report AID-23m 5, 15
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 9, 15
Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects RPH
Study Design Evaluating Sound Study Design GUI-17 1
Terminology Clinical Trials Terms AID-20m  
Tissue & Samples Data and Tissue Repositories GUI

11, 12, 13

Transplantation of Human Fetal Tissue GUI-2m
Training Training in the Protection of Human Subjects in Research RPH 4
Waivers
Regulations for Waiver or Alteration of Consent Requirements GUI-C2 12
Women
Research Involving Pregnant Women, Fetuses, and Neonates GUI-8 9, 12
Women as Subjects in Research RPH

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