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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
	Basic Research Consent Requirements	GUI-C27
	General Rqmnts for Informed Consent Medical General Rqmnts for Informed Consent Nonmedical	GUI-C41 GUI-C41n
	Glossary of Lay Terms for use in Consent Forms	IRB web
	Diagnostic Use of Ionizing Radiation - Consent Form Language	APRS web
	Observation of the Consenting Process - Checklist	CHK-C15
	Parental Permission	GUI-C34
	Waiver/Alteration of Consent Requirements	GUI-C2
	Research Surrogate Decision Makers	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
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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