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

Use "Ctrl+F" to search this page.

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
	Risk Level in Pediatric Research	GUI-01042
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
	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	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
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	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
	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	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 Material	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

return to top