Click on the column headings to sort the following list. To see the most used guidances, visit the Laminates page.

Topic	Guidance/Reference	Doc	HRPP Policy Ch(s)
Acronyms	Commonly Used Acronyms
Children in Research	Additional Protections for the Inclusion of Children in Research (FDA)	GUI-9	5, 8, 9, 12, 14
Children in Research	Additional Protections for the Inclusion of Children in Research (OHRP)	GUI-1	5, 8, 9, 12, 14
Children in Research	Children Involved as Subjects in Research - "407" Review Process	OHRP	5, 8, 9, 12, 14
Children in Research	Consent for Protocols Involving Children and Consenting Minors	GUI-C24	5, 8, 9, 12, 14
Children in Research	Parental Permission	GUI-C34	5, 8, 9, 12, 14
Compassionate Use	"Compassionate" and "Humanitarian" Use [FDA]	GUI-36m	5
Compassionate Use	Expanded Access to Investigational Drugs and Devices	GUI-19m	5
Confidentiality	Certificates of Confidentiality (COC)	OHRP	6, 11
Confidentiality	Confidentiality of Administrative Panel Proceedings	RPH	6
Confidentiality	Privacy and Confidentiality (HRPP Ch 11)	HRPP 11	11
Conflict of Interest (COI)	Faculty Policy on Conflict of Commitment and Interest	RPH	2, 3,12
Conflict of Interest (COI)	Guide To Ad Hoc Conflict of Interest Disclosures	DoR	2, 3,12
Conflict of Interest (COI)	Guidelines for IRB Members on Conflicting Interests	GUI-15	6
Conflict of Interest (COI)	IRB Member Conflict of Interest Declaration	RPT-I1	6
Consent	Basic Research Consent Requirements	GUI-C27	12
Consent	General Requirements for Informed Consent: Medical	GUI-C41	12
Consent	General Requirements for Informed Consent: Non-Medical	GUI-C41n	12
Consent	Glossary of Lay Terms for use in Preparing Consent Forms	IRB web	12
Consent	Observation of the Consenting Process	PRO-C2	12
Consent	Observation of the Consenting Process - Checklist	CHK-C15	12
Consent	Parental Permission	GUI-C34	12
Consent	Regulations for Waiver or Alteration of Consent Requirements	GUI-C2	12
Consent	Research Surrogate Decision Makers	GUI-32	12
Consent	Short Form Consent Process	IRB web	12
Data & Safety Monitoring	Data and Safety Monitoring	GUI-P20	3, 9, 11, 15
Data Security	Data Security - Secure Computing Guidelines	ISO web	3, 9, 11, 15
Data Security	Retention of and Access to Research Data	RPH	3, 9, 11, 15
Devices	FAQs About Medical Devices [FDA]	FDA	5
Devices	Frequently Asked Questions About Medical Devices  - FDA Information Sheet	FDA	5
Devices	Significant Risk and Non-Significant Risk Medical Devices Studies - Stanford Guidance	GUI-7m	5
Devices	Significant Risk and Nonsignificant Risk Medical Device Studies - FDA Information Sheet	FDA	5
Devices	Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies	GUI-26m	5
Devices	Sponsor-Investigator Research when the STANFORD Investigator holds the IDE	GUI-5m	5
Devices	When the STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device study	GUI-41m	5
Drugs	Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs	RPH	5
Drugs	Orphan Drugs	FDA	5
Drugs	Security and Controlled Access: Drugs and Biologics	GUI-35m	5
Drugs	Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies	GUI-26m	5
Drugs	Sponsor-Investigator Research when the STANFORD Investigator holds the IND	GUI-3m	5
Emergency Use of a Test Article	Emergency Use of a Test Article - Guidance	GUI-6	5.8
Emergency Use of a Test Article	Emergency Use of a Test Article - Web Page	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	5.8
Federal Agency Requirements [DoD, DON, DOE, etc.]	Other Federal Agencies - Additional Requirements: DoD, DON, ED, DOE, DOJ, EPA, NSF, PHS DOE - Protection of Personally Identifiable Information (PII) - eProtocol Required Attachment	GUI-42
HIPAA	HIPAA and PHI	GUI-3	4, 11
HIPAA	HIPAA at Stanford	IRB web	4, 11
Human Subject Research	Determination of Human Subject Research - Application to the IRB	APP-H8	1, 3
Human Subject Research	Does My Project Need IRB Review?	FLW-H4	1, 3
Human Subject Research	What Qualifies as Human Subject Research	GUI-H12	1, 3
Humanitarian Use	Humanitarian Use Device	GUI-36m
IRB Review	Criteria for IRB Approval of Research: Medical	GUI-40	7
IRB Review	Criteria for IRB Approval of Research: Non-Medical	GUI-40n	7
IRB Review	Exempt Review Categories	GUI-4(p2)	7
IRB Review	Expedited Review Categories	GUI-4(p1)	7
IRB Review	Guidance on Obtaining Additional Expertise or an Expert Consultant	GUI-12	7
IRB Review	Guidelines for IRB Members on Conflicting Interests	GUI-15	7
IRB Review	IRB Meeting Schedules	AID-18	7
IRB Review	IRB Member Conflict of Interest Declaration	RPT-I1	7
IRB Rosters & Authority	Charge to the Administrative Panel on Human Subjects in Medical Research	CHG-1	1, 6
IRB Rosters & Authority	Charge to the Administrative Panel on Human Subjects in Non-Medical Research	CHG-2	1, 6
IRB Rosters & Authority	Confidentiality of Administrative Panel Proceedings	RPH	1, 6
IRB Rosters & Authority	IRB Members - Rosters	IRB web	1, 6
International Research	International Compilation of Human Research Protections (OHRP) - listing laws, regulations, and guidelines on human subjects research in 96 countries, and standards from international and regional organizations	OHRP	1
MTA	Material Transfer Agreements	Stanford OTL
Multi-Site Research	Cooperative Research: Letter of Agreement	GUI-31	13
Payment	Ethical Considerations	GUI-39	10, 12, 14
Payment	Stanford University Job Aid: Paying Human Subjects	AID-9	10, 12, 14
Prisoners	California Penal Code: Section 3501 - 3523	GUI-38	9, 12
Prisoners	OHRP Guidance on the Involvement of Prisoners in Research	GUI-10	9, 12
Radiation	Preparing Research Proposals Involving Ionizing Radiation in Human Research	GUI-
Radiation	Use of Radiology Devices and Radioactive Materials in Research Protocols	GUI-
Recruitment	Advertisements: Appropriate Language for Recruitment Material	GUI-16	10, 20
Recruitment	General guidance on participant recruitment	GUI-33	10, 20
Recruitment	Use of Employees or Laboratory Personnel as Research Subjects	RPH	10, 20
Recruitment	Telephone Screening of Potential Subjects	GUI-15	10, 20
Reporting	Events and Information that Require Prompt Reporting to the IRB	GUI-P13	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	Security and Controlled Access: Drugs and Biologics	GUI-35m	4, 11
Short Form Consent	Short Form Consent Process - Guidance	GUI-C39	12
Short Form Consent	Short Form Consent Process - Web Page	IRB web	12
Sponsor- Investigator Research (SIR)	Requirements for New, Continuing Review and Final Report	AID-23m	5, 15
Sponsor- Investigator Research (SIR)	When the STANFORD Investigator holds the IDE	GUI-5m	5, 15
Sponsor- Investigator Research (SIR)	When the STANFORD Investigator holds the IND	GUI-3m	5, 15
Sponsor- Investigator Research (SIR)	When the STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device study	GUI-41m	5, 15
Students	Special Considerations about Risks in Behavioral and Social Sciences Research	GUI-14n	9, 15
Students	Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects	RPH	9, 15
Study Design	Evaluating Sound Study Design	GUI-17	1
Terminology - clinical trials	Clinical Trials Terms
Tissue & Samples	Data and Tissue Repositories		11, 12, 13
Tissue & Samples	Transplantation of Human Fetal Tissue	GUI-2m	11, 12, 13
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	Women as Subjects in Research	RPH	9, 12

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