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

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