AAHRPP web site

 


Guidance and
HRPP Policies

 

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 (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
5
8
9
12
14
Compassionate
Use
5
Confidentiality 6
11
Conflict of Interest (COI)
2
3
6
12
Consent
12
Emergency Use of a Test Article
5.8
Data Monitoring & Security
3
9
11
15
Devices
5
Drugs
5
HIPAA
4
11
Human Subject Research
1
3
IRB Rosters & Authority 1
6
IRB Review
7
MTA  
Multi-site Research 13
Payment
10
12
14
Prisoners
9
12
Radiation
 
Reporting
3
Recruitment
10
20
Risk 9
Tissue & Samples 10
11
Training 4
Short Form
Consent
12
Security
4
11
Sponsor-
Investigator
5
15
Students
9
15
Study Design 1
Waivers
12
Women
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
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
1.1
1.2
1.3
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
2.1
2.2 Matching IRBs to Volume and Types of Human Research
2.3
2.4

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3
3.1
3.2
3.3
3.4
3.5
3.6
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.





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