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
STANFORD HRPP Policies [Human Research Protection Program]
Research Policy Handbook
Veterans Health Administration
Supporting documents - To download current forms and to see current
guidances, 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

General Requirements for Informed Consent

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


Additional Protections for the Inclusion of Children in Research (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 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
Emergency Use of a Test Article	Emergency Use of a Test Article - guidance Emergency Use of a Test Article - web page	5.8
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 Significant Risk and Nonsignificant Risk Medical Device Studies [FDA]	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	5
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	Exempt Review Categories Expedited Review Categories Guidance on Obtaining Additional Expertise or an Expert Consultant Disapproval Memo 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
Tissue & Samples	Data and Tissue Repositories Transplantation of Human Fetal Tissue	10 11
Training	Training in the Protection of Human Subjects in Research	4
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	Requirements of the Sponsor and the Investigator as a Sponsor	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
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

topSTANFORD HRPP Policies

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:

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	The Organizations Covered by the HRPP
1.2	Goals and Objectives of the HRPP
1.3	Research Covered by the HRPP
1.4	Ethical and Legal Principles Governing Human Subject Research
1.5	Scientific/Scholarly Validity Review and Ethics Review
1.6	Delegation of Responsibility for HRPP Implementation to Stanford U.
1.7	Primary Officials and Organizational Components Carrying Out the HRPP
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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, and Other Reportable information
3.11	Reporting Internal and External: NonCompliance,Unanticipated Problems, Suspension, and Termination
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
4.1.1	Research Compliance Office (RCO) Educational Resources
4.1.2	Other STANFORD Educational Resources
4.1.3	Evaluation of Qualifications and Expertise of Individuals-Protecting Rights and Welfare of Participants
4.2	Required Training
4.2.1	Collaborative IRB Training Initiative (CITI)
4.2.2	Special Consideration for Training University Personnel Engaged in Human Stem Cell Research
4.2.3	Special Considerations Regarding VA Mandatory Training
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5	Investigational or Unlicensed Test Articles
5.1	Regulatory Requirements
5.2	Requirements of the Sponsor and the Investigator as a Sponsor
5.2.1	Sponsors
5.2.2	Investigator-Sponsors
5.3	IRB Review of Medical Devices
5.4	Radiology Devices and Radioactive Materials
5.5	"Off-label" (Unapproved) Use of FDA-Regulated Products
5.6	Other Unique Situations
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
general introduction	Purpose of IRBs Scope of the IRBs' Authority Decisions of the IRBs Appeal of IRB Determinations Interactions with other STANFORD Programs Reporting Obligations within STANFORD Responsibilities to Regulatory Agencies IRBs' Relationship to Industry Sponsors and Other IND/IDE Holders Administrative Review of Human Research Protection Activities
6.1	Scientific/Scholarly Expertise of IRB Members
6.2	Additional Expertise
6.3	IRB Member and Consultant Conflicting Interest
6.4	IRB Composition and Review of IRB membership
6.5	IRB Membership Appropriate for Each Protocol Review
6.6	Regular IRB Meeting with Timely Prior Review
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7	Systematic Review
7.1	Review Procedures for Regular and Expedited Protocols
7.2	Expiration of Approval Period
7.3	Initial Regular and Expedited Review
7.4	Continuing Review for Regular and Expedited Protocols
7.5	Amendments
7.6	Exempt Research
7.7	Exemption without Conflict of Interest
7.8	Protection for Participants in Exempt Research
7.9	Review of Protocols Using Biological Agents or Recombinant DNA Vectors
7.10	Emergency Use of an FDA Test Article
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8	Documentation of IRB Activities
8.1	IRB Protocol Files
8.2	Record Retention
8.3	IRB Minutes
8.4	Other Documentation
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9	Risks to Research Participants
9.1	Definitions
9.2	Measuring and Minimizing Risk
9.3	Analyzing Levels of Risk and Ensuring Risks Are Minimized (IRB Determination)
9.4	Data Monitoring Plan
9.5	Risks to Vulnerable Populations
9.6	Suspension or Termination of IRB approval
9.6.1	Protection of Participants Who May Be Affected by the IRB’s Action
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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	Determining if Private Information is Involved in the Protocol
11.2	General Considerations for Privacy of Private Information
11.3	Legally Required Release of Private Information
11.4	Confidentiality of Private Information during Research Activity
11.5	Protected Health Information Accessed and Utilized in Research and HIPAA Privacy Regulations
11.6	STANFORD Implementation of HIPAA Security Regulations
11.7	Confidentiality Breach -- Unauthorized Release of Private Information
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12	Informed Consent
12.1	The Process of Informed Consent
12.1.1	Specific Cautions about Elements of Informed Consent
12.1.2	California Experimental Subject's Bill of Rights
12.1.3	Additional VA-Specific Consent Requirements - VHA Handbook 1200.5
12.2	Consent Disclosures Required for Specific Types of Research
12.2.1	Protocols involving HIV Testing or Research on AIDS
12.2.2	Protocols including Genetic Testing
12.2.3	Protocols including Data and Tissue Repositories
12.2.4	Protocols Involving Xenotransplantation
12.2.5	Protocols Involving Stem Cell Research
12.3	Special California Consent Requirements
12.4	Documentation of Informed Consent
12.5	Waiver or Alteration of Informed Consent Requirements
12.6	Waiver of Documentation of Consent
12.7	Exceptions to Informed Consent in Emergencies
12.7.1	Exceptions from Informed Consent Requirements for Emergency Use of a Test Article
12.7.2	Exemption from IRB Review Requirements for Emergency Use of a Test Article
12.7.3	Planned Emergency Research
12.8	Consent Procedures for Research Involving Vulnerable Populations Including Consent from a LAR
12.8.1	Adults with Impaired Decision-Making Capacity
12.8.2	Adult Participants with Impaired Decision-Making Capacity at Non-VA Facilities
12.8.3	Adult Participants with Impaired Decision-Making Capacity at VA Facilities
12.8.4	Children and Minor Participants… Those under the Age of 18
12.8.5	Research Involving Prisoners
12.8.6	Research with Pregnant Women, Fetuses and Neonates
12.9	Special Considerations - Illiterate;Participants-Other Countries;NonEnglish Speaking U.S.
12.10	Observation of 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
13.3	Example of Multi-Site Research Arrangements
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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 Resource
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 Subject Interests
18.1	Publication of Research Results
18.2	Communication of Study Results to Participants
19	Addressing Concerns of Research Participants
20	Education and Outreach

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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 1200.5. 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