Stanford University: Research Compliance Office, Human Subjects



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Guidance and
HRPP Policies

Frequently referenced guidances - laminates provided to the IRB
Guidances and references
Policies: HRPP Policy Manual [Human Research Protection Program]
Research Policy Handbook
Veterans Health Administration
Supporting documents - To download current forms go to the Medical Forms and Nonmedical Forms pages.

Frequently referenced guidances
(laminates provided to all IRB Members and Staff)

Laminate
color

Criteria for IRB Approval of Research: Medical -or- Nonmedical

General Requirements for Informed Consent: Medical -or- Nonmedical

Additional Protections for the Inclusion of Children in Research (OHRP)


Additional Protections for the Inclusion of Children in Clinical Investigations (FDA)

Guidelines for IRB Members on Conflicting Interests

Regulations for Waiver or Alteration of Consent Requirements

Significant Risk and Non-significant Risk Medical Devices Studies

Research Involving Pregnant Women, Fetuses, and Neonates

OHRP Guidance on the Involvement of Prisoners in Research

HIPAA and PHI

Emergency Use of a Test Article

Exempt Review Categories

Expedited Review Categories

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Guidances and other references

Topic	Guidance or Reference	HRPP Policy [Chapter]
Children in Research	Additional Protections for the Inclusion of Children in Research (OHRP) Additional Protections for the Inclusion of Children in Research (FDA) Guidance For Investigators on Consent for Protocols Involving Children and Consenting Minors Children Involved as Subjects in Research - "407" Review Process Parental Permission	5 8 9 12 14
Compassionate Use	"Compassionate" and "Humanitarian" Use [FDA]	5
Confidentiality	Certificates of Confidentiality (COC) Confidentiality of Administrative Panel Proceedings Privacy and Confidentiality	6 11
Conflict of Interest (COI)	Conflict of Interest in Research Involving Human Subjects - flow chart Faculty Policy on Conflict of Commitment and Interest Guide To Ad Hoc Conflict of Interest Disclosures Guidelines for IRB Members on Conflicting Interests IRB Member Conflict of Interest Declaration	2 3 6 12
Consent	Basic Research Consent Requirements General Requirements for Informed Consent: Medical -or- Nonmedical Glossary of Lay Terms for use in Preparing Consent Forms Observation of the Consenting Process Observation of the Consenting Process - checklist Parental Permission Regulations for Waiver or Alteration of Consent Requirements Research Surrogate Decision Makers Short Form Consent Process	12
Data Monitoring & Security	Data Monitoring Plans Data Security - Secure Computing Guidelines Retention of and Access to Research Data	3 9 11 15
Devices	FAQs About Medical Devices [FDA] Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies Significant Risk and Non-significant Risk Medical Devices Studies - information sheet Significant Risk and Nonsignificant Risk Medical Device Studies [FDA] Sponsor-Investigator Research when the STANFORD Investigator holds the IDE	5
Drugs	Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs Orphan Drugs Security and Controlled Access: Drugs and Biologics Sponsor-Investigator Research when the STANFORD Investigator holds the IND	5
Emergency Use of a Test Article	Emergency Use of a Test Article - guidance Emergency Use of a Test Article - web page	5.8
HIPAA	HIPAA and PHI HIPAA at Stanford	4 11
Human Subject Research	Does My Project Need IRB Review? Determination of Human Subject Research - Application to the IRB	1 3
IRB Rosters & Authority	IRB Members - Rosters Charge to the Administrative Panel on Human Subjects in Medical Research Charge to the Administrative Panel on Human Subjects in Nonmedical Research Confidentiality of Administrative Panel Proceedings	1 6
IRB Review	Criteria for IRB Approval of Research: Medical -or- Nonmedical Exempt Review Categories Expedited Review Categories Guidance on Obtaining Additional Expertise or an Expert Consultant Guidelines for IRB Members on Conflicting Interests IRB Member Conflict of Interest Declaration IRB Meeting Schedules	7
MTA	Material Transfer Agreements
Multi-site Research	Cooperative Research: Letter of Agreement	13
Payment	Ethical Considerations Stanford University Job Aid: Paying Human Subjects	10 12 14
Prisoners	OHRP Guidance on the Involvement of Prisoners in Research California Penal Code: Section 3501 - 3523	9 12
Radiation	Use of Radiology Devices and Radioactive Materials in Research Protocols Preparing Research Proposals Involving Ionizing Radiation in Human Research
Reporting	Events and Information that Require Prompt Reporting to the IRB	3
Recruitment	General guidance on participant recruitment Advertisements: Appropriate Language for Recruitment Material Telephone Screening of Potential Subjects Laboratory Personnel: Use of Laboratory Personnel as Research Subjects	10 20
Risk	Special Considerations about Risks in Behavioral and Social Sciences Research	9
Short Form Consent	Short Form Consent Process	12
Security	Security and Controlled Access: Drugs and Biologics Data security - Secure Computing Guidelines	4 11
Sponsor- Investigator	Sponsor-Investigator Research when the STANFORD Investigator holds the IND Sponsor-Investigator Research when the STANFORD Investigator holds the IDE Sponsor-Investigator Research when the STANFORD investigator is the sponsor on a nonsignificant risk device study	5 15
Students	Student Projects, Pilot Studies and Oral Histories (NonMedical) Special Considerations about Risks in Behavioral and Social Sciences Research	9 15
Study Design	Evaluating Sound Study Design	1
Tissue & Samples	Data and Tissue Repositories Transplantation of Human Fetal Tissue	11 12 13
Training	Training in the Protection of Human Subjects in Research	4
Waivers	Regulations for Waiver or Alteration of Consent Requirements	12
Women	Women as Subjects in Research Research Involving Pregnant Women, Fetuses, and Neonates	9 12

topPolicies: The HRPP Policy Manual

The written plan for the STANFORD HRPP is comprised of a collection of policies, guidances, and supporting documents governing human subject research and the protection of participants. The policies are organized in the following 20 chapters of the HRPP Policy Manual:

Chapter Sections	Entire Chapter
1	The Human Research Protection Program
2	Resources Supporting the HRPP
3	Compliance Monitoring
4	Knowledge of Human Research Protection Requirements
5	Investigational or Unlicensed Test Articles
6	Structure and Composition of IRBs
7	Systematic Review
8	Documentation of IRB Activities
9	Risks to Research Participants
10	Participant Recruitment and Selection
11	Privacy and Confidentiality
12	Informed Consent
13	Multi-Site Research
14	Protocol Director Standards
15	Investigator Compliance
16	HRPP Coverage of Sponsored Research
17	Communication from Sponsors Affecting IRB Oversight
18	Knowledge Benefit and Subject Interests
19	Addressing Concerns of Research Participants
20	Education and Outreach
	Contents by Chapter
1	The Human Research Protection Program
1.1	Organizations Covered by the HRPP
1.2	Goals and Objectives of the HRPP
1.3	Delegation of the Responsibility for HRPP Implementation to Stanford University
1.4	Research Covered by the HRPP
1.5	Primary Officials, Administrative Units and Individuals of the HRPP
1.6	Ethical and Legal Principles Governing Human Subject Research
1.7	Scientific and Scholarly Validity Review and Ethics Review
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2	Resources Supporting the HRPP
2.1	Sufficient Human and Fiscal Resources
2.2	Matching IRBs to Volume and Types of Human Research
2.3	Human Research Protection, Care of Participants, and Safety
2.4	Communication and Interaction
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3	Compliance Monitoring
3.1	Policies and Procedures Available to Protocol Directors (PDs) and Research Staff
3.2	Independence of IRBs
3.3	Regulatory Definition of Human Research
3.4	Exempt Research Determinations
3.5	Policies and Procedures for Exempt Research
3.6	Federal versus State Requirements
3.7	Investigators' Conflicts of Interest
3.8	Institutional Conflict of Interest
3.9	Non-Compliance with HRPP Requirements
3.10	Unanticipated Problems Involving Risks to Participants or Others (UPs), and Other Reportable Information
3.11	Internal and External Reporting
3.12	Assurance of Compliance
3.13	HRPP Quality Improvement Activities
3.14	Investigators' Input to HRPP
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4	Knowledge of Human Research Protection Requirements
4.1	Education of Individuals Responsible for Human Research
4.2	Required Training in Human Research Protections
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5	Investigational or Unlicensed Test Articles - Research with Drugs, Devices or Biologics
5.1	Research with Test Articles
5.2	Research with Drugs
5.3	Research with Devices
5.4	Radiology Devices and Radioactive Materials
5.5	Research with Biologics
5.6	Sponsor-Investigator Research
5.7	Internal Handling of Test Articles
5.8	Emergency Use of a Test Article
5.9	"Compassionate Use" of a Test Article
5.10	"Humanitarian Use" of a Device
5.11	Planned Emergency Research
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6	Structure and Composition of IRBs
6.1	Scope of IRB Authority
6.2	Relationships Between the IRB and Others
6.3	IRB Composition and Membership
6.4	Scientific and Scholarly Expertise of IRB Members
6.5	Obtaining Additional Expertise
6.6	IRB Member and Consultant Conflicting Interest
6.7	Assessment and Evaluation of the IRB
6.8	IRB Roster and Quorum Requirements
6.9	Meeting Times and Materials
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7	Systematic Review
7.1	Protocol Review
7.2	IRB Protocol Applications (eProtocol System)
7.3	Submission, Preliminary Review and Assignment to IRBs
7.4	Assignment of protocols to IRB members
7.5	Protocol Review Material and Information
7.6	Protocol Review - Pre-Review Parallel Process
7.7	Protocols Presented at a Convened Meeting
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8	Documentation of IRB Activities
8.1	IRB Protocol Files
8.2	Record Retention
8.3	IRB Minutes
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9	Risks to Research Participants
9.1	Measuring and Minimizing Risk
9.2	Data Monitoring Plan
9.3	Risks to Vulnerable Populations
9.4	Suspension or Termination of IRB approval
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10	Participant Recruitment and Selection
10.1	Equitable Selection
10.2	Review of Recruitment Methods, Advertising Materials and Payment
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11	Privacy and Confidentiality
11.1	Protecting the Privacy of Participants
11.2	Protecting the Confidentiality of Participant Information
11.3	HIPAA - Health Insurance Portability and Accountability Act Regulations
11.4	Confidentiality Breach - Unauthorized Release of Information
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12	Informed Consent and Assent
12.1	Requirements for Informed Consent
12.1.1	Elements of Informed Consent
12.1.2	Additional Consent Requirements
12.1.3	Consent Templates and Glossary of Lay Terms
12.1.4	Consent Process
12.2	Consent Procedures for Vulnerable and Other Special Populations Including Consent by a Legally Authorized Representative
12.2.1	Adults with Impaired Decision-Making Capacity – “Decisionally impaired”
12.2.2	Pregnant Women, Fetuses and Neonates
12.2.3	Children and Consenting Minors
12.2.4	Illiterate Participants
12.2.5	Non-English Speaking Participants
12.2.6	Prisoners
12.3	IRB Review of the Consent Process, including Consent Documents
12.4	Documentation of Informed Consent - Signature Requirements
12.5	Waiver or Alteration of Informed Consent Requirements
12.5.1	Waiver or Alteration of the Consent Process
12.5.2	Waiver o f Documentation of Consent - ("Waiver of Signature")
12.6	Exceptions to Informed Consent in Emergency Situations
12.7	Observation of the Consent Process
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13	Multi-Site Research
13.1	Communication among IRBs in Multi-Site Research
13.2	Information Management in Multi-Site Research
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14	Protocol Director Standards
14.1	Identification and Management of Conflict of Interest
14.2	Sound Study Design
14.3	Detection of Harm, Minimization of Risks&Mitigation of Potential Injuries via Study Design,&During Research
14.4	Recruitment
14.5	Human Research Protection Resources
14.6	Consent Process
14.7	Response to Participants' Requests for Information and Complaints
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15	Investigator Compliance
15.1	Qualification of Protocol Directors and Research Staff
15.2	Reporting to the IRB - Unanticipated Problems Involving Risks to Participants or Others (UPs), and Other Reportable Information
15.3	Research Oversight
15.4	Data Monitoring Plan
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16	HRPP Coverage of Sponsored Research
16.1	Agreement Includes Protection for Research Participants
16.2	Provision Addressing Medical Care for Participants
17	Communication from Sponsors Affecting IRB Oversight
18	Knowledge Benefit and Participants' Interests
18.1	Publication of Research Results
18.2	Communicating Study Results to Participants
19	Addressing Concerns of Research Participants
20	Education and Outreach
20.1	On-line Resources and Educational Materials
20.2	Participant Research Inquiries
20.3	Outreach
20.4	Evaluation

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Research Policy Handbook

The Stanford University Research Policy Handbook is a collection of policies, guidelines and general information related to the research enterprise at Stanford University, including:

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Veterans Health Administration (VHA)

VHA requirements for the protection of human subjects in research are described in VHA Handbook 1200.05. This and other VHA Handbook sections pertaining to research (sections in the 1200 series) are found on the VA Handbooks website.

Stanford University | Dean of Research | Research Compliance

Guidance and HRPP Policies

Guidances and other references

Guidance and
HRPP Policies