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  HRPP Policy Manual

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Chapter/
Section
HRPP Policy Manual Chapters
AAHRPP
Std/Element
1 - All
Domains I, II
1.1
I.1.D.
1.2
I.1.D.
1.3
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

Domains I, II

2.1
I.2 (standard)
2.2 Matching IRBs to Volume and Types of Human Research I.2 (standard)
2.3
I.2 (standard)
II.3.A.
2.4
I.1.D.
3 - All
Domains I, II, III
3.1
I.1.D.
3.2
I.1.C.
3.3
I.1.A.
3.4
II.2.A.
3.5
II.2.B.
3.6 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 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 Short Form 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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